Pronunciation(s): true-VAH-duh; ten-OH-foh-veer; em-trih-SIGH-ta-been
|What is Truvada?
- Truvada is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Truvada prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- Truvada is marketed by Gilead Sciences. It was first approved by the U.S. Food and Drug Administration (FDA) as a component of therapy for people living with HIV in August 2004. It was subsequently approved as pre-exposure prophylaxis (PrEP)--used to prevent HIV among those at high risk for the infection, in conjuntion with condoms and other safer-sex measures--in July 2012.
- Truvada is a combination of two drugs: 300mg of Viread (tenofovir DF) and 200mg of Emtriva (FTC). Truvada should be prescribed by a healthcare provider for patients who need both of these drugs. Both of these drugs can still be purchased individually for use in combination with other HIV drugs.
- As treatment, Truvada must be combined with at least one other HIV drug, usually a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). As PrEP, Truvada should be used in combination with risk-reduction counseling, correct and consistent condom use, regular HIV testing and screening for and treatment of other sexually transmitted infections.
- Atripla, a combination tablet containing the NNRTI Sustiva (efavirenz) and the tenofovir and emtricitabine in Truvada, was approved for use in the United States in July 2006. Truvada can still be purchased for use in combination with HIV drugs other than Sustiva.
- Both the Viread and the Emtriva in Truvada are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. Although Emtriva and Viread have not been approved by the FDA for the treatment of hepatitis B, some doctors may prescribe Truvada to treat both hepatitis B and HIV. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.
- Gilead has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Truvada. To learn more about the PAP for Truvada, call Gilead (800-226-2056). For those with private health insurance, Gilead has established a program to help cover up to $200 toward each monthly Truvada co-payment. To learn more about this co-pay program, call 866-784-3431.
What is known about Truvada?
- Truvada is a tablet taken once a day. It can be taken with or without food. If you have kidney problems, you may need to take Truvada less often.
- Truvada should not be any more or less effective than Viread and Emtriva taken as separate pills together. However, it is considered to be a much more convenient way of taking these two HIV drugs.
- For HIV-positive adults beginning HIV drug therapy for the first time, the medications in Truvada are listed as a "preferred" NRTI options by the United States Department of Health and Human Services in its treatment guidelines. To learn more about these recommendations and options, click here.
- See the "What is known about..." sections of Viread and Emtriva for information about possible drug resistance.
What about drug interactions?
- Truvada should not be taken at the same time as Atripla, Emtriva, Viread, Hepsera, Epivir or other combination tablets that contain Epivir (for example, Epzicom, Combivir, or Trizivir). This is because these medications contain the same or similar ingredients as Truvada.
- The Viread in Truvada may increase the amount of Videx EC (didanosine) in the blood. You may need to be followed more carefully if you are taking Truvada and Videx EC together. Also, the dose of Videx EC may need to be reduced.
- The protease inhibitors Reyataz (atazanavir), Prezista (darunavir) and Kaletra (lopinavir/ritonavir) can increase the amount of Viread in Truvada in the blood, which could result in more side effects. You may need to be followed more carefully if you are taking Truvada and Reyataz, Prezista or Kaletra together. Truvada may decrease the amount of Reyataz in your blood. If you are taking Truvada and Reyataz together you should also be taking Norvir.
What about side effects?
- Lactic acidosis, which can be fatal, and severe liver problems have been reported in people taking nucleoside reverse transcriptase inhibitors (NRTIs). Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area.
- The Viread in Truvada may cause bone problems. In one clinical trial conducted by the manufacturer involving HIV-positive patients who were new to HIV therapy, Viread [combined with Sustiva and Epivir] caused decreases in bone mineral density (osteopenia) at the hip and spine. Researchers are currently looking into the seriousness of this possible side effect. If you have a history of bone fracture or are at risk for osteopenia, your doctor may want to consider ordering bone scans on a regular basis while you are taking Truvada. While it's not clear if calcium and vitamin D supplementation can help this side effect, it might be beneficial if you are taking Viread.
- Some patients treated with Viread have had kidney problems. The Viread in Truvada can be problematic for HIV-positive people who have a history of kidney problems (renal impairment). If you have a history of kidney problems, including kidney problems after using the hepatitis drug Hepsera (adefovir), your doctor will need to order a simple laboratory test to calculate your "creatinine clearance," which is a measure of your kidney function. Depending on the results of this test, you may not be able to take Truvada. It is always important to be careful if using Truvada in combination with drugs that cause kidney problems or other drugs that are removed from the body by the kidneys.
- HIV drug regimens containing nucleoside reverse transcriptase inhibitors (NRTIs), including Truvada, can cause increased fat levels (cholesterol and triglycerides) in the blood, and abnormal body-shape changes (lipodystrophy; including increased fat around the abdomen, breasts, and back of the neck, as well as decreased fat in the face, arms, and legs). These side effects of HIV drug therapy are reviewed in our lessons on Lipodystrophy, Facial Lipoatrophy, and Risks To Your Heart (Hyperlipidemia).
- If you have hepatitis B and HIV and plan to stop taking Truvada, you need close medical follow-up and for several months your doctor might want to frequently check your liver enzymes after stopping treatment. This is because the Viread and Emtriva in Truvada are also active against the hepatitis B virus (HBV). If Truvada is stopped abruptly, it can cause liver disease to "flare" and damage the liver.
- The most common side effects of Truvada are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash.
- See the "What about side effects?" sections of Viread and Emtriva for additional possible side effects.
Can pregnant women take Truvada?
- Truvada is classified by the FDA as a pregnancy category B drug. Pregnancy category B means that animal studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. HIV-positive women who become pregnant should discuss the benefits and possible side effects of HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
- It is not known whether the two drugs in Truvada pass into breast milk and what effect they may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
What should I tell my doctor before taking Truvada?
- Before taking this medication, tell your doctor if you have: kidney disease; liver disease (including hepatitis B); or bone problems.
- Tell your doctors and pharmacists about all medicines you take. This includes prescription medications, over-the-counter products, or herbal/natural remedies.
Where can I learn more about clinical trials involving Truvada?
- If you would like to find out if you are eligible for any clinical trials that include Truvada, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email email@example.com.