Treating Your HIV

Clinical trial results help healthcare providers evaluate how medicines can help people. In one study—in patients new to HIV treatment—the medicines in TRUVADA were compared with the medicines in a different HIV treatment called Combivir (lamivudine/zidovudine). In both groups, the medicines were taken once a day. As part of this study, all patients took another HIV medicine called Sustiva (efavirenz) once a day, so that every patient was taking 3 medicines per day. Here are the results.

This chart shows the percentage of patients with viral loads less than 400 copies/ML in a clinical trial.

The difference in the results was largely due to the higher number of patients in the Combivir group who dropped out of the study because of side effects and other reasons.

TRUVADA
plus efavirenz
Combivir
plus efavirenz
After 48 weeks 84%
of 244 patients
73%
of 243 patients
After 3 years 71%
of 227 patients
58%
of 229 patients
This table shows that the results between the TRUVADA and Combivir groups were similar.

During the study, the most common side effects that occurred in 5% or more of patients in the TRUVADA group were:

  • Diarrhea
  • Nausea
  • Fatigue
  • Sinusitis
  • Upper respiratory tract infections
  • Inflammation of the nose and throat
  • Headache
  • Dizziness
  • Depression
  • Trouble sleeping
  • Abnormal dreams
  • Rash
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What is TRUVADA?

TRUVADA (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) is a prescription medicine used with other HIV-1 medicines to treat HIV-1 infection in people who weigh at least 35 kg (77 lbs).

TRUVADA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-1 related illnesses, you must keep taking TRUVADA. Ask your healthcare provider if you have questions about how to prevent passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TRUVADA?

TRUVADA can cause serious side effects:

  • Too much lactic acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, nausea, vomiting, stomach-area pain, cold or blue hands and feet, feeling dizzy or lightheaded, and/or fast or abnormal heartbeats.
  • Serious liver problems. Your liver may become large and tender, and you may develop fat in your liver. Symptoms of liver problems include your skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, and/or stomach-area pain.
  • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking TRUVADA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
  • Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking TRUVADA, your hepatitis may suddenly get worse. Do not stop taking TRUVADA without first talking to your healthcare provider, as they will need to monitor your health. TRUVADA is not approved for the treatment of HBV.

Who should not take TRUVADA?

Do not take TRUVADA if you also take a medicine that contains: emtricitabine, tenofovir alafenamide, or tenofovir disoproxil fumarate (ATRIPLA, COMPLERA, EMTRIVA, DESCOVY, GENVOYA, ODEFSEY, STRIBILD, VIREAD); lamivudine (Combivir, Dutrebis, Epivir, Epivir-HBV, Epzicom, Triumeq, Trizivir); or adefovir (HEPSERA).

What are the other possible side effects of TRUVADA?

Serious side effects of TRUVADA may also include:

  • Kidney problems, including kidney failure. Your healthcare provider may do blood tests to check your kidneys before and during treatment with TRUVADA. If you develop kidney problems, your healthcare provider may tell you to take TRUVADA less often, or to stop taking TRUVADA.
  • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
  • Changes in body fat, which can happen in people taking HIV-1 medicines.
  • Changes in your immune system. Your immune system may get stronger and begin to fight infections. This may cause minor symptoms such as fever, but can also lead to serious problems. Tell your healthcare provider if you have any new symptoms after you start taking TRUVADA.

The most common side effects of TRUVADA in people taking TRUVADA to treat HIV-1 infection include diarrhea, nausea, tiredness, headache, dizziness, depression, problems sleeping, abnormal dreams, and rash. Tell your healthcare provider if you have any side effects that bother you or do not go away.

What should I tell my healthcare provider before taking TRUVADA?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, or liver problems, including hepatitis virus infection.
  • If you are pregnant or plan to become pregnant. It is not known if TRUVADA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking TRUVADA.
    Pregnancy Registry: A pregnancy registry collects information about your health and the health of your baby. There is a pregnancy registry for women who take medicines to treat HIV-1 during pregnancy. For more information about the registry and how it works, talk to your healthcare provider.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRUVADA may interact with other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • If you take certain other medicines with TRUVADA, your healthcare provider may need to check you more often or change your dose. These medicines include: didanosine (Videx EC), atazanavir (Reyataz), atazanavir with cobicistat (Evotaz), darunavir (Prezista), darunavir with cobicistat (Prezcobix), lopinavir with ritonavir (Kaletra), or ledipasvir with sofosbuvir (HARVONI).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.

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