hero hero
The only medication approved to significantly reduce the risk of sexually acquired HIV-1 in adults at high risk, in combination with safer sex practices.1,2
Help protect your patients from HIV with TRUVADA FOR PrEP, one tablet taken each day—as part of a comprehensive prevention plan.1

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter.

INDICATION

TRUVADA for PrEP (pre-exposure prophylaxis) is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Individuals at high risk for sexually acquired HIV-1 include:

Individuals with HIV-1 infected partner(s).

Individuals who engage in sexual activity in a high prevalence area or social network and have one or more of the following risk factors: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of these risk factors.

Prescribing considerations:

TRUVADA for PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection.

Uninfected individuals must strictly adhere to their dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiating TRUVADA for PrEP for at least 1 month until negative HIV-1 status is reconfirmed.

Alternatively, negative HIV-1 status can be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.

PRESCRIBING

CONSIDERATIONS

TRUVADA for PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection.

Uninfected individuals must strictly adhere to their dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiating TRUVADA for PrEP for at least 1 month until negative HIV-1 status is reconfirmed.

Alternatively, negative HIV-1 status can be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.

Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

~40,000 NEW HIV INFECTIONS

ARE DIAGNOSED ANNUALLY IN THE U.S.

as reported by the CDC3

Learn more

U.S. AND GLOBAL

HEALTH GUIDELINES

Health guidelines recommend TRUVADA FOR PrEP in combination with safer sex practices4-9
Health guidelines also emphasize the importance of counseling on adherence and HIV-1 risk reduction

Learn more

IDENTIFY APPROPRIATE CANDIDATES

FOR TRUVADA FOR PrEP

TRUVADA for PrEP is for adults at high risk of sexually acquired HIV-1. These include:

Individuals with HIV-1 infected partner(s)

Individuals who engage in sexual activity in a high prevalence area or social network and have one or more of the following risk factors: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of these risk factors

Learn more

PROVEN REDUCTION

IN HIV-1 ACQUISITION

Efficacy was strongly correlated with adherence2,10,11

Learn more

COMMON

ADVERSE EVENTS

Common adverse events (>2% and more frequently than placebo) with TRUVADA for PrEP were headache, abdominal pain, and weight decrease1

Learn more

PRESCRIBING

PRINCIPLES

Six important factors to consider when prescribing TRUVADA FOR PrEP to high-risk individuals1,4

Learn more


CDC=Centers for Disease Control and Prevention.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Proactive HIV
Prevention
hero hero

TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

HELP PROACTIVELY PROTECT YOUR PATIENTS FROM HIV WITH TRUVADA FOR PrEP—ONE TABLET, ONCE DAILY1

The only medication approved to significantly reduce the risk of sexually acquired HIV-1 in adults at high risk, in combination with safer sex practices1,2

IMPORTANT SAFETY INFORMATION (cont'd)

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

U.S. and global health guidelines recommend TRUVADA FOR PrEP in combination with safer sex practices to help reduce the risk of sexually acquired HIV-1 in adults at high risk4-8

CDC
Centers for Disease Control and Prevention
WHO
World Health
Organization
ACOG
The American College of Obstetricians and Gynecologists
IAS-USA
International Antiviral Society–USA

All of these organizations:

Provide criteria for determining a person's risk of HIV infection and for TRUVADA FOR PrEP use
Include TRUVADA FOR PrEP as a prevention option for HIV-1–negative adults at high risk for HIV infection
Emphasize the importance of counseling on adherence and comprehensive HIV risk reduction
Recommend confirming HIV-1–negative status prior to starting PrEP
Recommend that ongoing use of TRUVADA FOR PrEP be guided by regular risk assessment

Health guidelines recommend TRUVADA FOR PrEP and emphasize the importance of counseling on adherence and HIV-1 risk reduction strategies.1

National HIV/AIDS Strategy (NHAS) recommends TRUVADA FOR PrEP in combination with safer sex practices for HIV prevention9

A goal of the NHAS is to expand efforts to prevent HIV infection using a combination of effective, evidence-based approaches. These include:

HIV testing
PrEP (pre-exposure prophylaxis) and PEP (post-exposure prophylaxis) in combination with behavioral interventions that support engagement in care and adherence to treatment
TasP (treatment as prevention) in HIV-positive individuals. Adhering to HIV treatment and maintaining an undetectable viral load can help reduce the transmission of HIV to others
Correct and consistent condom use
Access to sterile needles and syringes

The NHAS recommends TRUVADA FOR PrEP in combination with behavioral interventions that support engagement in care and adherence to treatment.9

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

Drug interactions:

Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir increases tenofovir DF exposure; monitor for adverse reactions.

Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

Use in specific populations:

Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. An Antiretroviral Pregnancy Registry has been established; healthcare providers are encouraged to register patients by calling 1-800-258-4263.

Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA for PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired.

Pediatrics: TRUVADA for PrEP is based on studies in adults.

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

Risk & Patient
Identification
hero hero

TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

1.1 MILLION INDIVIDUALS ARE ESTIMATED TO BE AT ELEVATED RISK FOR SEXUALLY ACQUIRED HIV IN THE U.S., WITH ~40,000 DIAGNOSES ANNUALLY3,12

Learn more about lifetime risk of HIV infection in the U.S. by selecting a risk level OR interacting with the map below.

LIFETIME RISK OF HIV DIAGNOSIS BY STATE13

Highest
STATERISK*
DC1 in 13
MD1 in 49
GA1 in 51
FL1 in 54
LA1 in 56
NY1 in 69
TX1 in 81
STATERISK*
NJ1 in 84
MS1 in 85
SC1 in 86
NC1 in 93
DE1 in 96
AL1 in 97
  
High
STATERISK*
NV1 in 98
IL1 in 101
CA1 in 102
TN1 in 103
PA1 in 115
VA1 in 115
MA1 in 121
STATERISK*
AZ1 in 138
CT1 in 139
RI1 in 143
OH1 in 150
MO1 in 155
AR1 in 159
  
Low
STATERISK*
MI1 in 167
OK1 in 168
KY1 in 173
IN1 in 183
WA1 in 185
CO1 in 191
NM1 in 196
STATERISK*
HI1 in 202
OR1 in 214
MN1 in 216
KS1 in 262
NE1 in 264
  
  
Lowest
STATERISK*
WV1 in 302
WI1 in 307
IA1 in 342
UT1 in 366
ME1 in 373
AK1 in 384
SD1 in 402
STATERISK*
NH1 in 411
WY1 in 481
VT1 in 527
ID1 in 547
MT1 in 578
ND1 in 670
  
West
STATERISK*
NV1 in 98
CA1 in 102
WA1 in 185
CO1 in 191
HI1 in 202
OR1 in 214
UT1 in 366
STATERISK*
AK1 in 384
WY1 in 481
ID1 in 547
MT1 in 578
  
  
  
  
  
Northeast
STATERISK*
DC1 in 13
MD1 in 49
NY1 in 69
NJ1 in 84
DE1 in 96
PA1 in 115
MA1 in 121
STATERISK*
CT1 in 139
RI1 in 143
ME1 in 373
NH1 in 411
VT1 in 527
  
  
Southeast
STATERISK*
GA1 in 51
FL1 in 54
LA1 in 56
MS1 in 85
SC1 in 86
NC1 in 93
AL1 in 97
STATERISK*
TN1 in 103
VA1 in 115
AR1 in 159
KY1 in 173
WV1 in 302
  
  
Southwest
STATERISK*
TX1 in 81
AZ1 in 138
OK1 in 168
NM1 in 196
  
  
  
  
  
Midwest
STATERISK*
IL1 in 101
OH1 in 150
MO1 in 155
MI1 in 167
IN1 in 183
MN1 in 216
KS1 in 262
STATERISK*
NE1 in 264
WI1 in 307
IA1 in 342
SD1 in 402
ND1 in 670
  
  
 


Overall, 1 in 99 Americans will be diagnosed with HIV in their lifetime.14

IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions: (cont'd)

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

*Chances of an individual being diagnosed with HIV during their lifetime.

HIV risk and diagnosis varies by age, ethnicity, sexual orientation, and gender throughout the U.S.

Age
HIV diagnosis

HIV infections have increased 10% among those aged 20-29 between 2009-20153,15

Ethnicity
Lifetime risk of HIV diagnosis*
     Men13,16      Women13,16
Overall 1 in 68 1 in 253
African American 1 in 22 1 in 54
Hispanic 1 in 51 1 in 256
Native Hawaiian/
Pacific Islander
1 in 95 1 in 432
Caucasian 1 in 140 1 in 941
Asian 1 in 176 1 in 943
MSM
Lifetime risk of HIV diagnosis*
African American
1 in 2
Hispanic
1 in 4
Caucasian
1 in 11

Among MSM, African Americans and Hispanics are at the highest risk for HIV infection13

Receptive partners of anal sex are 13 times more likely to become infected with HIV than insertive partners17

MSM are 83 times more likely to become infected with HIV than heterosexual men13

Transgender
Prevalence

~1.4 million Americans identify as transgender18

~22% of transgender women in the U.S. are HIV-positive19

Among transgender women, HIV prevalence is ~34 times greater than cisgender adults19

72% of transgender women perceive themselves to be at low or no HIV risk20

An estimated 69% of transgender men report condomless sex with cisgender men21

~89% of transgender people believe that it is important for their HCP to know their gender identity22

IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions: (cont'd)

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.


*Chances of an individual being diagnosed with HIV during their lifetime.

MSM=men who have sex with men.

CONSIDER THREE STEPS TO PROACTIVELY IDENTIFY PATIENTS AT RISK FOR HIV AND PLAN AHEAD

ASSESS CUES TO TAKE A SEXUAL HISTORY
The following cues represent opportunities for you to take in-depth sexual histories with your patients. Certain cues may indicate increased likelihood of condomless sex.

Clinical23,24†

STI diagnosis or request for test

Request for HIV test

Recent PEP usage

Inquiry about PrEP

Sexual25-27

Sexual activity in high-prevalence areas or networks

Multiple partners or non-monogamous relationships

Change in sexual partner or use of dating/"hook‑up" apps

Circumstantial27-30

Recreational drug use or alcohol abuse

Exchange of sex for commodities
(eg, money, food, shelter, drugs)

Domestic violence or sexual assault

Incarceration of individual or partner

Hormonal birth control or pregnancy

TAKE A SEXUAL HISTORY
Create a more comfortable environment, and remind your patients that sexual health is a part of overall health. Let them know that this conversation is standard protocol and that anything they disclose is confidential. Avoid assumptions and judgments while maintaining a caring and matter-of-fact tone.30

Some questions to consider for all patients4,30,31:

Do you have sex with men, women, or both?

How many sexual partners have you had in the past 3 months?
Do you have multiple partners or are you in a non-monogamous relationship?

How do you protect yourself and your partners during sex?
How frequently do you have condomless sex?

How often do you use drugs or alcohol when having sex?
Which kinds of drugs are you using (eg, methamphetamine, crystal, or speed)?

Have you ever had an STI?
When was the last time you were screened for STIs?

Do you think any of your sexual behaviors may place you at risk?

For female patients30:

Are you using birth control?

Are you trying to become pregnant?

Are you pregnant or breastfeeding?

For MSM patients17,31:

When was the last time you had anal sex?

Were you the receptive or insertive partner, or both?

For transgender patients30,32:

Which name and pronouns would you like me to use?

Use a welcoming and inviting tone, as many transgender patients avoid examinations because of comfort issues

DEVELOP AN HIV PREVENTION PLAN
If you determine a patient is sexually active and at risk for HIV, consider30

Education and counseling on comprehensive HIV prevention options, including safer sex practices

Routine screening for HIV and other STIs

A proactive approach to prevention with TRUVADA FOR PrEP in combination with safer sex practices if a patient is HIV-negative, at high risk, and eligible to take TRUVADA FOR PrEP
If your patient needs assistance finding an HCP in their area who can prescribe TRUVADA FOR PrEP, direct them to preplocator.org

IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions: Risk reduction strategies:

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

May indicate exposure to HIV and other STIs.

HCP=healthcare provider, MSM=men who have sex with men, PEP=post-exposure prophylaxis, STI=sexually transmitted infection.

APPROPRIATE CANDIDATES FOR TRUVADA FOR PrEP MAY INCLUDE UNINFECTED INDIVIDUALS WITH THE FOLLOWING FACTORS1:

Have partner(s) who are HIV+
OR
Engage in sexual activity within a high-prevalence area or social network and one or more of the following:

Diagnosis of sexually transmitted infections

Use of illicit drugs or alcohol dependence

Inconsistent or no condom use

Partner(s) of
unknown HIV-1 status

Incarceration


Exchange of sex for commodities

INDICATION

TRUVADA for PrEP (pre-exposure prophylaxis) is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Individuals at high risk for sexually acquired HIV-1 include:

Individuals with HIV-1 infected partner(s).

Individuals who engage in sexual activity in a high prevalence area or social network and have one or more of the following risk factors: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of these risk factors.

Prescribing considerations:

TRUVADA for PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection.

Uninfected individuals must strictly adhere to their dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiating TRUVADA for PrEP for at least 1 month until negative HIV-1 status is reconfirmed.

Alternatively, negative HIV-1 status can be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.

When prescribing TRUVADA FOR PrEP, consider the following1:

TRUVADA FOR PrEP should only be prescribed to individuals who are confirmed to be HIV-1 negative immediately prior to initial use and who do not have signs or symptoms consistent with acute HIV infection.

While using TRUVADA FOR PrEP, HIV-1 screening tests should be repeated at least every 3 months.

Individuals must strictly adhere to the dosing schedule because the effectiveness of TRUVADA FOR PrEP is strongly correlated with adherence.

TRUVADA FOR PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing HIV-1 infection.

IMPORTANT SAFETY INFORMATION (cont'd)
Warnings and precautions: Risk reduction strategies: (cont'd)

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

Drug interactions:

Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir increases tenofovir DF exposure; monitor for adverse reactions.

Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

Use in specific populations:

Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. An Antiretroviral Pregnancy Registry has been established; healthcare providers are encouraged to register patients by calling 1-800-258-4263.

Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA for PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired.

Pediatrics: TRUVADA for PrEP is based on studies in adults.

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

Efficacy &
Resistance
hero hero

TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

TRUVADA FOR PrEP™ TRIAL DESIGNS

Partners PrEP1,2

Randomized, double-blind, placebo-controlled efficacy and safety study (Kenya, Uganda)1,2

Clinical trial began in July 2008, with data collected through July 2011

*TDF alone is not approved to reduce the risk of sexually acquired HIV-1.

Study population2

Serodiscordant heterosexual couples (both men and women enrolled)

HIV-1–negative partner received either TRUVADA, TDF, or placebo

HIV-1–positive partner was not medically eligible for ART

≥18 years old

Baseline characteristics of uninfected partners1

Mean age of subjects: 33-34 years

Gender: 61%-64% male across study groups

All participants received1,2

Safer sex counseling (individually and as a couple)

Safety evaluations

Evaluation of adherence

Monthly HIV-1 testing

Free condoms

Testing and treatment for STIs

Monitoring and care for HIV-1

Primary endpoint2

HIV-1 infection in an HIV-1–negative partner

Cohort was followed for 7830 person-years for the assessment of HIV-1 incidence accrued (median, 23 months; interquartile range, 16 to 28; range, 1 to 36)

iPrEx1,10

Randomized, double-blind, placebo-controlled efficacy and safety study in Peru, Ecuador, South Africa, Brazil, Thailand, and the United States (Boston, San Francisco)1,10

Clinical trial began in July 2007, with primary analysis reported through May 2010

Study population1,10

HIV-1–seronegative men or transgender women who have sex with men

High risk for HIV-1 acquisition

≥18 years old

Baseline characteristics of uninfected partners1

Mean age of subjects: 27 years

Race/ethnicity:

72% Hispanic/Latino

18% White

9% Black

5% Asian

All participants received1

Monthly HIV-1 testing

Risk-reduction counseling

Condoms

Management of STIs

Primary endpoint1

HIV-1 seroconversion

Subjects were followed for 4237 person-years

IMPORTANT SAFETY INFORMATION (cont'd)

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

ART=antiretroviral therapy; STIs=sexually transmitted infections; TDF=tenofovir disoproxil fumarate.

Proven reduction in HIV-1 acquisition in uninfected individuals taking TRUVADA FOR PrEP1

Across all trial participants

HIV-1 seroconversion was observed in1,2:

13 out of 1576 subjects in the TRUVADA group

52 out of 1578 subjects in the placebo group

HIV-1 seroconversion was observed in1:

48 out of 1251 subjects in the TRUVADA group

83 out of 1248 subjects in the placebo group

In participants with detectable drug levels

Among TRUVADA users who became infected with HIV-1, 9 out of 12 did not have detectable drug levels.1,2

Among TRUVADA users who became infected with HIV-1, 31 out of 34 did not have detectable drug levels.1,10

These results were based on a post-hoc case control study of detectable plasma and intracellular drug levels in about 10% of subjects. Risk reduction appeared to be the greatest in subjects with detectable intracellular tenofovir levels.1,2,10

Efficacy was strongly correlated with adherence1

IMPORTANT SAFETY INFORMATION (cont'd)

Drug interactions:

Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir increases tenofovir DF exposure; monitor for adverse reactions.

Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

CI=confidence interval.

To minimize the risk of resistance, TRUVADA FOR PrEP™ should only be prescribed to individuals confirmed to be HIV-1–negative1

Of the individuals who had unrecognized/acute HIV-1 infection at the time of TRUVADA FOR PrEP initiation, resistance to the components of TRUVADA was observed in two pivotal trials1,10,11

TRUVADA FOR PrEP should only be prescribed to individuals who are confirmed to be HIV-1–negative immediately prior to initial use and who do not have signs or symptoms consistent with acute HIV infection1

      HIV+
(Subjects, n)
  HIV+ WITH
RESISTANCE
(Subjects, n)
Partners PrEP Trial   PLACEBO 6 0
  TRUVADA 3 1a
iPrEx Trial   PLACEBO 8 1a
  TRUVADA 2 2a
    aM184V/I.      

Of the individuals who became infected with HIV-1 after initiating TRUVADA FOR PrEP, no cases of resistance to the components of TRUVADA were identified at the time of HIV-1 seroconversion in two pivotal trials1,11

While using TRUVADA FOR PrEP, HIV-1 screening tests should be repeated at least every 3 months and individuals should be counseled to adhere to the recommended TRUVADA dosing schedule

      HIV+
(Subjects, n)
  HIV+ WITH
RESISTANCE
(Subjects, n)
Partners PrEP Trial   PLACEBO 51 0
  TRUVADA 12 0
iPrEx Trial   PLACEBO 83 0
  TRUVADA 48 0

For individuals who discontinue TRUVADA FOR PrEP but become infected with HIV-1 at a later date, prior use does not increase their risk of becoming resistant to a TRUVADA-based regimen.

For individuals who are HIV positive, TRUVADA alone does not constitute a complete regimen for HIV-1 treatment and therefore should not be given alone because resistance could occur1

If symptoms of acute HIV-1 infection develop following a potential exposure event, discontinue TRUVADA FOR PrEP until negative HIV-1 status is confirmed using a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection1

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

Safety &
Tolerability
hero hero

TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

CONTRAINDICATIONS AND DRUG INTERACTIONS

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

Drug interactions:

Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir increases tenofovir DF exposure; monitor for adverse reactions.

Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

Common adverse reactions (>2% and more frequently than placebo) were headache, abdominal pain, and weight decrease1

Overall, common AEs (all grades; ≥2% in any treatment arm) with TRUVADA FOR PrEP™ were comparable to placebo in two pivotal trials*

Partners PrEP Trial1
  TRUVADA
(n=1579)
Placebo
(n=1584)
 
 
Gastrointestinal Diarrhea 2% 3%
Abdominal Pain a
 
 
Reproductive Genital Ulceration 2% 2%
 
 
Infections Urinary Tract Infection 5% 7%
 

aNot reported or reported below 2%.

iPrEx Trial1
  TRUVADA
(n=1251)
Placebo
(n=1248)
 
 
Gastrointestinal Diarrhea 7% 8%
Abdominal Pain 4% 2%
 
 
Musculoskeletal Back Pain 5% 5%
 
 
Neurological Headache 7% 6%
 
 
Psychiatric Depression 6% 7%
Anxiety 3% 3%
 
 
Reproductive Genital Ulceration 2% 2%
 
 
Other Weight Decreased 3% 2%
 
 
Infections Pharyngitis 13% 16%
Urethritis 5% 7%
Urinary Tract Infection 2% 2%
Syphilis 6% 5%
Secondary Syphilis 6% 4%
Anogenital Warts 2% 3%
 

*Adherence in the TRUVADA arms of these two pivotal trials varied across participants.

Discontinuation rates due to adverse events with TRUVADA FOR PrEP were comparable to placebo2,10,33

Partners PrEP Trial2,33

PLACEBO
0.1%
(1/1584)
TDF-
CONTAINING
0.1%
(2/1579)

iPrEx Trial10

PLACEBO
6%
(72/1248)
TRUVADA
6%
(79/1251)

Renal and hepatic discontinuations due to adverse events

Partners PrEP Trial1 TDF-Containing Arms
(Subjects, n)
Placebo
(Subjects, n)
 
Discontinuations due to an increase in blood creatinine 6 0
iPrEx Trial1 TRUVADA
(Subjects, n)
Placebo
(Subjects, n)
 
Discontinuations due to an increase in blood creatinine 1 0
 
 
Discontinuations due to low phosphorus 1 0

Impact on renal and hepatic function with TRUVADA FOR PrEP

Laboratory Abnormalities (Highest Toxicity Grade)
Reported for Each Subject in Pivotal Trials1

Gradea Partners PrEP Trial iPrEx Trial
  TRUVADA
(n=1579)
Placebo
(n=1584)
TRUVADA
(n=1251)
Placebo
(n=1248)
Creatinine
 
 
1 (1.1-1.3 x ULN) 1% <1% 2% 2%
2-4 (>1.4 x ULN) <1% <1% <1% <1%
 
Phosphorus
 
 
1 (2.5-<LLN mg/dL) NRb NRb 7% 9%
2-4 (<2.0 mg/dL) 9% 9% 10% 8%
 
AST
 
 
1 (1.25-<2.5 x ULN) 1% 2% 14% 14%
2-4 (>2.6 x ULN) <1% <1% 5% 5%
 
ALT
 
 
1 (1.25-<2.5 x ULN) 1% <1% 14% 16%
2-4 (>2.6 x ULN) <1% <1% 7% 7%
 
Hemoglobin
 
 
1 (8.5-10 mg/dL) 4% 2% 4% 5%
2-4 (<9.4 mg/dL) 4% 2% 1% 2%
 
Neutrophils
 
 
1 (1000-1300/mm3) 13% 10% 2% 2%
2-4 (<750/mm3) 5% 3% <1% <1%
 

Renal monitoring information

Do not use TRUVADA FOR PrEP in individuals with estimated creatinine clearance (CrCl) <60 mL/min.

In all patients, assess CrCl prior to initiating and during therapy; reassess potential risks and benefits of use if a decrease in CrCl is observed.

In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein.

Decreases in bone mineral density (BMD) were observed with TRUVADA FOR PrEP and returned toward baseline after discontinuation in the iPrEx trial1

  iPrEx Trial1 Partners PrEP Trial1
 
  TRUVADA Placebo TRUVADA Placebo
 
 
Subjects who lost at least 5% of BMD at the spine during treatment 13% 6%
 
 
Bone fractures 1.7% 1.4% 0.8% 0.6%
 

iPrEx Trial1

No correlation between BMD and fractures was noted
 

Partners PrEP Trial1

No BMD evaluations were performed

Similar fracture rates between treatment and placebo groups
 

Warnings and precautions: Bone mineral density

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

aGrading is per Division of AIDS (DAIDS) criteria.

bGrade 1 phosphorus was not reported for the Partners PrEP trial.

AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; LLN=lower limit of normal; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal.

WARNINGS AND PRECAUTIONS

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

Use in specific populations:

Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. An Antiretroviral Pregnancy Registry has been established; healthcare providers are encouraged to register patients by calling 1-800-258-4263.

Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA for PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired.

Pediatrics: TRUVADA for PrEP is based on studies in adults.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Prescribing
Principles
hero hero

TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

SIX IMPORTANT FACTORS TO CONSIDER WHEN PRESCRIBING TO HIGH-RISK INDIVIDUALS1,4

Learn more about these factors by selecting the icons below.

Confirm individual is HIV negative, and screen for HBV

  • TRUVADA FOR PrEP must only be prescribed to HIV-1–negative individuals
  • Drug-resistant HIV-1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV-1 infection
  • If signs or symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation of TRUVADA FOR PrEP for at least 1 month or discontinue usage and reconfirm HIV-1–negative status
  • Test and monitor for chronic HBV, and if negative, consider vaccination

Advise pregnant women on the risks and benefits

  • Conduct pregnancy testing for women of childbearing potential
  • Counsel on the risks and benefits of using TRUVADA FOR PrEP during pregnancy, taking into account the increased risk of HIV-1 infection during pregnancy
  • An Antiretroviral Pregnancy Registry is available. Enroll women taking TRUVADA FOR PrEP by calling 1-800-258-4263

Monitor renal function

  • Assess estimated creatinine clearance (CrCl) in all patients prior to initiating and during therapy. Only use TRUVADA FOR PrEP in individuals with estimated CrCl above 60 mL/min
    • Reassess potential risks and benefits of using TRUVADA FOR PrEP if a decrease in CrCl is observed during use
  • In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein

Use as part of a comprehensive HIV prevention strategy

  • TRUVADA FOR PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
  • Counsel individuals on how to consistently and correctly use condoms and lubricants, safer sex practices, and the importance of knowing their HIV status and that of their partner(s)

Counsel individuals on the importance of daily dosing

  • Advise on strict adherence to dosing since efficacy is strongly correlated with adherence

Test individuals routinely for HIV and other STIs

  • Repeat HIV-1 screening tests at least every 3 months and regularly test individuals for STIs that can facilitate HIV transmission
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IMPORTANT SAFETY INFORMATION (cont'd)

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

HBV=hepatitis B virus; STIs=sexually transmitted infections.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

Access &
 Resources
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TRUVADA for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

PrEP Provider Directory

If your patients need assistance finding an HCP in their area who can prescribe TRUVADA FOR PrEP, direct them to preplocator.org

This tool is not owned or maintained by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for the content of the PrEP Provider Locator or how it is used. The PrEP Provider Locator was developed by researchers from Emory University's Rollins School of Public Health with funding from MAC AIDS Fund.


HELPING ELIGIBLE PATIENTS AFFORD TRUVADA FOR PrEP™ with Advancing Access®

Advancing Access

Advancing Access is committed to helping eligible patients afford their Gilead medication whether they are insured, uninsured, or underinsured by:

Connecting patients to appropriate financial assistance: co-pay cards, independent foundations, and the Medication Assistance Program

Addressing insurance issues: coverage and benefits investigation, prior authorization support, and navigating alternative coverage options


Terms and conditions apply, and can be found at www.gileadadvancingaccess.com/copay-coupon-card

Not all patients will be eligible.

Enroll patients at:
GileadAdvancingAccess.com
   OR   
1-800-226-2056

ORDER HIV PREVENTION MATERIALS

Gilead is committed to keeping healthcare providers and patients informed on HIV prevention.

TRUVADA FOR PrEPRisk Evaluation and Mitigation Strategy (REMS)

Information about the REMS program for TRUVADA FOR PrEP:

TRUVADA FOR PrEP—in combination with safer sex practices—can help reduce the risk of sexually acquired HIV-1 infection as part of a comprehensive HIV-1 prevention strategy in adults at high risk. TRUVADA FOR PrEP does not replace existing prophylaxis strategies

REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks

To help ensure TRUVADA FOR PrEP is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the REMS program to educate and inform healthcare providers and uninfected individuals at high risk for acquiring HIV-1

The goals of the REMS for TRUVADA FOR PrEP are to inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:

The importance of strict adherence to the recommended dosing regimen

The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take TRUVADA FOR PrEP, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants

The fact that TRUVADA FOR PrEP must be considered as only a part of a comprehensive strategy in order to reduce the risk of HIV-1 infection and that other preventative measures should also be used

For further information and to download REMS materials, visit:
truvadapreprems.com

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Use in specific populations:

Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. An Antiretroviral Pregnancy Registry has been established; healthcare providers are encouraged to register patients by calling 1-800-258-4263.

Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA for PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired.

Pediatrics: TRUVADA for PrEP is based on studies in adults.

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

Important Safety Information

INDICATION

TRUVADA for PrEP (pre-exposure prophylaxis) is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Individuals at high risk for sexually acquired HIV-1 include:

Individuals with HIV-1 infected partner(s).

Individuals who engage in sexual activity in a high prevalence area or social network and have one or more of the following risk factors: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of these risk factors.

Prescribing considerations:

TRUVADA for PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection.

Uninfected individuals must strictly adhere to their dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.

If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiating TRUVADA for PrEP for at least 1 month until negative HIV-1 status is reconfirmed.

Alternatively, negative HIV-1 status can be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.


IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications:

Do not use TRUVADA for PrEP in individuals with unknown or positive HIV status.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (DF). In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure have been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients.

Do not use TRUVADA for PrEP in individuals with CrCl <60 mL/min. Reassess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue TRUVADA for PrEP if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir alafenamide, tenofovir DF, lamivudine, or adefovir dipivoxil.

Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

Warnings and precautions: Risk reduction strategies:

Reduce exposure to HIV-1 infection: TRUVADA for PrEP is not always effective in preventing the acquisition of HIV-1. Therefore, use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other sexually transmitted infections, and counseling on reducing sexual risk behaviors.

Reduce potential for drug resistance: TRUVADA for PrEP should only be used in individuals confirmed to be HIV negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1.

Confirm HIV-negative status immediately prior to initiation.

Many HIV tests are antibody tests and may not detect acute HIV infection. Delay initiating (≥1 month) or discontinue TRUVADA for PrEP if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash) and recent exposures are suspected. Prior to initiating or continuing TRUVADA for PrEP, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection.

Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.

Adverse reactions:

Common adverse reactions (>2% and more frequently than placebo) of TRUVADA for PrEP in clinical trials were headache, abdominal pain, and weight decreased.

Drug interactions:

Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir increases tenofovir DF exposure; monitor for adverse reactions.

Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

Use in specific populations:

Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. An Antiretroviral Pregnancy Registry has been established; healthcare providers are encouraged to register patients by calling 1-800-258-4263.

Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA for PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired.

Pediatrics: TRUVADA for PrEP is based on studies in adults.

Dosage and Administration:

Adult dosage: One tablet once daily with or without food.

Renal impairment: Do not use in individuals with CrCl <60 mL/min.

Testing prior to initiation: Test for HIV-1 and HBV infection.

Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.

References: 1. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. 3. Centers for Disease Control and Prevention. HIV Surveillance Report, 2015; vol. 27. CDC website. http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf. Published November 2016. Accessed June 8, 2017. 4. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014: a clinical practice guideline. http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf. Published 2014. Accessed June 13, 2017. 5. World Health Organization. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd ed. http://www.who.int/hiv/pub/arv/arv-2016/en/. Published June 2016. Accessed June 13, 2017. 6. Günthard HF, Saag MS, Benson CA, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2016 recommendations of the International Antiviral Society–USA Panel. JAMA. 2016;316(2):191-210. 7. Marrazzo JM, del Rio C, Holtgrave DR, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society–USA Panel. JAMA. 2014;312(4):390-409. 8. The American College of Obstetricians and Gynecologists. Committee on Gynecologic Practice. Preexposure prophylaxis for the prevention of human immunodeficiency virus. Committee Opinion No. 595. Obstet Gynecol. 2014;123(5):1133-1136. 9. White House Office of National AIDS Policy. National HIV/AIDS strategy for the United States: updated to 2020. https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update. Published July 2015. Accessed June 14, 2017. 10. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2‍587-2599. 11. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women [supplementary appendix]. N Engl J Med. 2012;367(5):399-410. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1108524/suppl_file/nejmoa1108524_appendix.pdf. 12. Smith DK, Van Handel M, Wolitski RJ, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition–United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-1295. 13. Centers for Disease Control and Prevention. 2016 Conference on Retroviruses and Opportunistic Infections. http://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html. Published 2016. Accessed June 8, 2017. 14. Centers for Disease Control and Prevention. Lifetime risk of HIV diagnosis. https://www.cdc.gov/nchhstp/newsroom/2016/croi-press-release-risk.html. Accessed June 8, 2017. 15. Centers for Disease Control and Prevention. HIV Surveillance Report, 2010; vol 22. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2010-vol-22.pdf. Published March 2012. Accessed June 8, 2017. 16. Hess KL, Hu X, Lansky A, Mermin J, Hall HI. Lifetime risk of a diagnosis of HIV infection in the United States. Ann Epidemiol. 2017;27(4):238-243. 17. Centers for Disease Control and Prevention. Anal sex and HIV risk. https://www.cdc.gov/hiv/risk/analsex.html. Accessed June 8, 2017. 18. Flores AR, Herman JL, Gates GJ, Brown TNT. How many adults identify as transgender in the United States? Los Angeles, CA: The Williams Institute. June 2016. https://williamsinstitute.law.ucla.edu/wp-content/uploads/How-Many-Adults-Identify-As-Transgender-in-the-United-States.pdf. Accessed June 8, 2017. 19. Clark H, Babu AS, Wiewal EW, Opoku J, Crepaz N. Diagnosed HIV infection in transgender adults and adolescents: Results from the National HIV Surveillance System, 2009–2014. AIDS Behav. 2016;11(7-8):866-887. 20. Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008;12(1):1-17. 21. Reisner SL, Murchison GR. A global research synthesis of HIV and STI biobehavioural risks in female-to-male transgender adults. Glob Public Health. 2016;11(7-8):866-887. 22. Maragh-Bass AC, Torain M, Adler R, et al. Is it okay to ask: transgender patient perspectives on sexual orientation and gender identity collection in healthcare. Acad Emerg Med. 2017;24(6):655-667. 23. Feinstein BA, Johnson BA, Parsons JT, Mustanski B. Reactions to testing HIV negative: measurement and associations with sexual risk behaviour among young MSM who recently tested HIV negative. AIDS Behav. 2017;21(5):1467-1477. 24. Golub SA, Rosenthal L, Cohen DE, Mayer KH. Determinants of high-risk sexual behavior during post-exposure prophylaxis to prevent HIV infection. AIDS Behav. 2008;12(6):852-859. 25. Adimora AA, Schoenbach VJ, Doherty IA. Concurrent sexual partnerships among men in the United States. Am J Public Health. 2007;97(12):2‍230-2237. 26. Landovitz RJ, Tseng CH, Weissman M, et al. Epidemiology, sexual risk behavior, and HIV prevention practices of men who have sex with men using GRINDR in Los Angeles, California. J Urban Health. 2013;90(4):729-739. 27. Henry-Reid LM, Martinez J. Care of the adolescent with HIV. Clin Obstet Gynecol. 2008;51(2):319-328. 28. Nehl EJ, Klein H, Sterk CE, Elifson KW. Prediction of HIV sexual risk behaviors among disadvantaged African American adults using a syndemic conceptual framework. AIDS Behav. 2016;20(2):449-460. 29. New York State Office for the Prevention of Domestic Violence. Domestic violence and HIV/AIDS. http://www.opdv.ny.gov/professionals/health/hivaids.html. Accessed June 8, 2017. 30. Makadon HJ, Goldhammer H. Taking a sexual history and creating affirming environments for lesbian, gay, bisexual, and transgender people. J Miss State Med Assoc. 2015;56(12):358-362. 31. CDC Sexual Health (PPP) Centers for Disease Control and Prevention. A guide to taking a sexual history. https://www.cdc.gov/std/treatment/sexualhistory.pdf. Accessed June 8, 2017. 32. NTSD Transgender Facts National Center for Transgender Equality. National Transgender Discrimination Survey: Full Report. http://www.transequality.org/issues/resources/national-transgender-discrimination-survey-full-report. Published September 2012. Accessed June 8, 2017. 33. Data on file. Gilead Sciences, Inc. 2016.

Tap for Important Safety Information, including BOXED WARNING on the risk of drug resistance with TRUVADA FOR PrEP in undiagnosed early HIV‑1 infection and post-treatment acute exacerbation of hepatitis B.