INDICATION
TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
•If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV-1 infection
Individuals at risk for sexually acquired HIV-1 may include those:
•With HIV-1 infected partner(s), or
•Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.
as reported by the CDC3
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
TRUVADA FOR PrEP is for individuals at risk for sexually acquired HIV-1. These may include:
•Individuals with HIV-1 infected partner(s), or
•Individuals who engage in sexual activity in a high prevalence area or social network and have an HIV risk factor, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or partners of unknown HIV status with any of these risk factors
Efficacy was strongly correlated with adherence2,10,11
Common adverse events (>2% and more frequently than placebo) with TRUVADA FOR PrEP were headache, abdominal pain, and weight loss1
Six important factors to consider when prescribing TRUVADA FOR PrEP to individuals at risk1,4
CDC=Centers for Disease Control and Prevention.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
The only medication approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk, in combination with safer sex practices1,2
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Health guidelines recommend TRUVADA FOR PrEP and emphasize the importance of counseling on adherence and HIV-1 risk reduction strategies.
National HIV/AIDS Strategy (NHAS) recommends TRUVADA FOR PrEP in combination with safer sex practices for HIV prevention9
The NHAS recommends TRUVADA FOR PrEP in combination with behavioral interventions that support engagement in care and adherence to treatment.9
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing 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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
Adverse reactions
•Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss
Drug interactions
•Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
•Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF 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
Pregnancy and lactation
•Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
•Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
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
| STATE | RISK* |
| DC | 1 in 13 |
| MD | 1 in 49 |
| GA | 1 in 51 |
| FL | 1 in 54 |
| LA | 1 in 56 |
| NY | 1 in 69 |
| TX | 1 in 81 |
| STATE | RISK* |
| NJ | 1 in 84 |
| MS | 1 in 85 |
| SC | 1 in 86 |
| NC | 1 in 93 |
| DE | 1 in 96 |
| AL | 1 in 97 |
| STATE | RISK* |
| NV | 1 in 98 |
| IL | 1 in 101 |
| CA | 1 in 102 |
| TN | 1 in 103 |
| PA | 1 in 115 |
| VA | 1 in 115 |
| MA | 1 in 121 |
| STATE | RISK* |
| AZ | 1 in 138 |
| CT | 1 in 139 |
| RI | 1 in 143 |
| OH | 1 in 150 |
| MO | 1 in 155 |
| AR | 1 in 159 |
| STATE | RISK* |
| MI | 1 in 167 |
| OK | 1 in 168 |
| KY | 1 in 173 |
| IN | 1 in 183 |
| WA | 1 in 185 |
| CO | 1 in 191 |
| NM | 1 in 196 |
| STATE | RISK* |
| HI | 1 in 202 |
| OR | 1 in 214 |
| MN | 1 in 216 |
| KS | 1 in 262 |
| NE | 1 in 264 |
| STATE | RISK* |
| WV | 1 in 302 |
| WI | 1 in 307 |
| IA | 1 in 342 |
| UT | 1 in 366 |
| ME | 1 in 373 |
| AK | 1 in 384 |
| SD | 1 in 402 |
| STATE | RISK* |
| NH | 1 in 411 |
| WY | 1 in 481 |
| VT | 1 in 527 |
| ID | 1 in 547 |
| MT | 1 in 578 |
| ND | 1 in 670 |
| STATE | RISK* |
| NV | 1 in 98 |
| CA | 1 in 102 |
| WA | 1 in 185 |
| CO | 1 in 191 |
| HI | 1 in 202 |
| OR | 1 in 214 |
| UT | 1 in 366 |
| STATE | RISK* |
| AK | 1 in 384 |
| WY | 1 in 481 |
| ID | 1 in 547 |
| MT | 1 in 578 |
| STATE | RISK* |
| DC | 1 in 13 |
| MD | 1 in 49 |
| NY | 1 in 69 |
| NJ | 1 in 84 |
| DE | 1 in 96 |
| PA | 1 in 115 |
| MA | 1 in 121 |
| STATE | RISK* |
| CT | 1 in 139 |
| RI | 1 in 143 |
| ME | 1 in 373 |
| NH | 1 in 411 |
| VT | 1 in 527 |
| STATE | RISK* |
| GA | 1 in 51 |
| FL | 1 in 54 |
| LA | 1 in 56 |
| MS | 1 in 85 |
| SC | 1 in 86 |
| NC | 1 in 93 |
| AL | 1 in 97 |
| STATE | RISK* |
| TN | 1 in 103 |
| VA | 1 in 115 |
| AR | 1 in 159 |
| KY | 1 in 173 |
| WV | 1 in 302 |
| STATE | RISK* |
| TX | 1 in 81 |
| AZ | 1 in 138 |
| OK | 1 in 168 |
| NM | 1 in 196 |
| STATE | RISK* |
| IL | 1 in 101 |
| OH | 1 in 150 |
| MO | 1 in 155 |
| MI | 1 in 167 |
| IN | 1 in 183 |
| MN | 1 in 216 |
| KS | 1 in 262 |
| STATE | RISK* |
| NE | 1 in 264 |
| WI | 1 in 307 |
| IA | 1 in 342 |
| SD | 1 in 402 |
| ND | 1 in 670 |
Overall, 1 in 99 Americans will be diagnosed with HIV in their lifetime.14
*Chances of an individual being diagnosed with HIV during their lifetime.
•HIV infections increased by 10% among those 20-29 years old between 2011 and 201615
| 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 |
•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
~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
*Chances of an individual being diagnosed with HIV during their lifetime.
MSM=men who have sex with men.
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 nPEP usage
Inquiry about PrEP
Sexual25-27
Multiple partners or non-monogamous relationships
Sexual activity in high-prevalence areas or networks
Change in sexual partner or use of dating/"hook‑up" apps
Circumstantial27-30
Exchange of sex for commodities
(eg, money, food, shelter, drugs)
Recreational drug use or alcohol abuse
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 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
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
†May indicate exposure to HIV and other STIs.
HCP=healthcare provider; MSM=men who have sex with men; nPEP=nonoccupational post-exposure prophylaxis; STI=sexually transmitted infection.
Engaging in sexual activity within a high prevalence area or social network and having an HIV risk factor such as:
INDICATION
TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
•If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV-1 infection
Individuals at risk for sexually acquired HIV-1 may include those:
•With HIV-1 infected partner(s), or
•Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors
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, and upon diagnosis of any STIs.
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.
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
Adverse reactions
•Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss
Drug interactions
•Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
•Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF 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
Pregnancy and lactation
•Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
•Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
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)
•≥18 years old
•HIV-1–negative partner received either TRUVADA, TDF, or placebo
•HIV-1–positive partner was not medically eligible for ART
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)
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
•≥18 years old
•High risk for HIV-1 acquisition
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
Adverse reactions
•Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss
ART=antiretroviral therapy; STIs=sexually transmitted infections; TDF=tenofovir disoproxil fumarate.
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
Among TRUVADA users who became infected with HIV-1, 9 out of 12 did not have detectable drug levels.11
Among TRUVADA users who became infected with HIV-1, 31 out of 34 did not have detectable drug levels.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
Drug interactions
•Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
•Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF 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.
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 trials1,2,10
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.1
| 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 trials1,10,11
While using TRUVADA FOR PrEP, HIV-1 screening tests should be repeated at least every 3 months, and upon diagnosis of any STIs. Individuals should be counseled to adhere to the recommended TRUVADA dosing schedule. Some individuals, such as adolescents, may benefit from more frequent visits and counseling.
| 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 screening or symptoms consistent with acute HIV-1 infection indicate an individual may have become HIV positive while taking TRUVADA FOR PrEP, convert the regimen to an HIV treatment regimen until HIV-negative status is confirmed1
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Drug interactions
•Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
•Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF 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
iPrEx
Selected Adverse Events (All Grades) Reported in ≥2% in Any Treatment Group and Greater Than Placebo1
| TRUVADA | Placebo | |||
| (n=1251) | (n=1248) | |||
| Headache | 7% | 6% | ||
| Abdominal pain | 4% | 2% | ||
| Weight decreased | 3% | 2% | ||
Partners PrEP
•The frequency of adverse events in the TRUVADA treatment group was generally either less than or the same as in the placebo group
*Adherence in the TRUVADA arms of these two pivotal trials varied across participants.
Partners PrEP Trial2,33
iPrEx Trial10
| Partners PrEP Trial1 | TDF-Containing Arms (Subjects, n) |
Placebo (Subjects, n) |
| Discontinuations due to an increase in serum creatinine | 6 | 0 |
| iPrEx Trial1 | TRUVADA (Subjects, n) |
Placebo (Subjects, n) |
| Discontinuations due to an increase in serum creatinine | 1 | 0 |
| Discontinuations due to low serum phosphorus | 1 | 0 |
Laboratory Abnormalities (Highest Toxicity Grade
Reported for Each Subject) in Pivotal Trials1
| Grade 2-4a | Partners PrEP Trial | iPrEx Trial | |||
| TRUVADA (n=1579) |
Placebo (n=1584) |
TRUVADA (n=1251) |
Placebo (n=1248) |
||
| Creatinine (>1.4 x ULN) | <1% | <1% | <1% | <1% | |
| Phosphorus (<2.0 mg/dL) | 9% | 9% | 10% | 8% | |
| AST (>2.6 x ULN) | <1% | <1% | 5% | 5% | |
| ALT (>2.6 x ULN) | <1% | <1% | 7% | 7% | |
| Hemoglobin (<9.4 mg/dL) | 2% | 2% | 1% | 2% | |
| Neutrophils (<750/mm3) | 5% | 3% | <1% | <1% | |
aGrading is per Division of AIDS (DAIDS) criteria.
•Not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min
•In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule
•In patients with chronic kidney disease, also assess serum phosphorus
| 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
ATN1131
In a 48-week, single-arm, open-label safety study examining TRUVADA FOR PrEP among 67 adolescent (15-18 years of age) MSM†:
•Median BMD increased from baseline to Week 48 by 2.58% for lumbar spine and 0.72% for total body
•1 subject had significant (≥4%) total body BMD loss at Week 24
•Median changes from baseline BMD Z-scores were 0.0 for lumbar spine and –0.2 for total body at Week 48
•3 subjects showed a worsening (change from > –2 to ≤ –2) from baseline in their lumbar spine or total body BMD Z-scores at Week 24 or 48
†Interpretation of these data may be limited due to low rate of adherence by Week 48.
•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 TDF. 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 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
Pregnancy and lactation
•Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
•Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
ALT=alanine aminotransferase; AST=aspartate aminotransferase; MSM=men who have sex with men; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing 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 loss
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
Learn more about these factors by selecting the icons below.
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
HBV=hepatitis B virus; STIs=sexually transmitted infections.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing 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 loss
TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
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.
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.
Gilead is committed to keeping healthcare providers and patients informed on HIV prevention.
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 for individuals at 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 risk for acquiring HIV-1
The goals of the REMS for TRUVADA FOR PrEP are to inform and educate prescribers and uninfected individuals at 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
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Pregnancy and lactation
•Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
•Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
INDICATION
TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.
•If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV-1 infection
Individuals at risk for sexually acquired HIV-1 may include those:
•With HIV-1 infected partner(s), or
•Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR 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 initiation and 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 if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
•Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Contraindications
•TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status
Warnings and precautions: Comprehensive risk reduction strategies
•Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, 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 immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. 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
•HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
•If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
•Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
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 (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
•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 TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
•Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
•Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions
Adverse reactions
•Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss
Drug interactions
•Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
•Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF 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
Pregnancy and lactation
•Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
•Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
Dosage and administration
•Dosage: One tablet once daily with or without food
•HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
•HBV screening: Test for HBV infection prior to or when initiating treatment
•Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.
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