Truvada

What is Truvada?

Truvada is a combination antiviral tablet that may be used to reduce the risk of adults and teenagers getting HIV-1 infection (this is called HIV-1 PrEP [pre-exposure prophylaxis]) OR to treat HIV-1 infection in combination with other HIV-1 medications.

• Truvada is only approved for PrEP in adults and teenagers who weigh at least 77 pounds (at least 35 kg). It is used alongside practicing safer sex (for example, condom use).
• Truvada can be used for HIV treatment in adults and teenagers who weigh at least 37 pounds (17 kg).
• Truvada is not a cure for HIV or AIDS (acquired immunodeficiency syndrome).

Truvada is a prescription medicine that contains 2 antivirals, emtricitabine and tenofovir disoproxil fumarate that both work by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. They both belong to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs).

When used for PrEP, Truvada acts as a preventive measure against HIV-1. As long as consistent levels of Truvada are maintained in the blood. Truvada will stop the virus from multiplying and spreading from the site of infection if a person is exposed to the virus.

When used to treat HIV-1 infection, Truvada, when taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level. This reduces viral load and improves the CD4+ T cell count. Truvada will not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

Truvada gained FDA approval on August 2, 2004. Generic Truvada has been available since June 8, 2017.

Truvada side effects

The most common side effects of Truvada in people who take it daily for HIV-1 PrEP include:

• headache
• stomach-area (abdomen) pain
• decreased weight.

The most common side effects of Truvada in people who take it in combination with other antivirals for HIV-1 treatment include:

• diarrhea
• nausea
• tiredness
• headache
• dizziness
• depression
• problems sleeping
• abnormal dreams
• rash.

Serious side effects and warnings

Do not take Truvada if you also take other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir.

Truvada can cause the following serious side effects;

Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before start or when you start treatment with Truvada. If you have an HBV infection and take Truvada, your HBV may get worse (flare-up) if you stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

• Do not run out of Truvada. Refill your prescription or talk to your healthcare provider before it is all gone.
• Do not stop taking Truvada without first talking to your healthcare provider.
• If you stop taking Truvada, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Truvada.

New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with Truvada. Your healthcare provider may tell you to take Truvada less often or to stop taking Truvada if you get new or worse kidney problems. Tell your healthcare provider if you have any kidney problems such as swelling, urinating less, or feeling tired or short of breath.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when taking medicines to treat HIV-1 infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Truvada can affect your immune system (even weeks or months after you’ve used this medicine). Tell your doctor if you have signs of a new infection such as fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, or weight loss.

Bone problems can happen in some people who take Truvada. Bone problems include bone pain, or softening or thinning of bones, which may lead to fractures. Your healthcare provider may need to do tests to check your bones. Tell your healthcare provider right away if you have sudden or unusual bone pain.

Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feeling dizzy or lightheaded, or a fast or abnormal heartbeat. Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal.

Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: 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, or stomach-area pain.

Truvada does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.

These are not all the possible side effects of Truvada. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Get emergency medical help if you have signs of an allergic reaction to Truvada: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.