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Drugs at a Glance: Truvada

by Liz Highleyman
July 2005 (Reviewed and Revised December 2005)

What is Truvada?

Truvada is a two-in-one combination pill containing Emtriva (emtricitabine or FTC) and Viread (tenofovir DF). Putting more than one drug in a single tablet means you can take fewer pills each day and may have lower insurance co-payments.


What type of drug is Truvada?

Truvada is made up of HIV drugs from a class called nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), also known as “nukes.” Emtriva is one of the many approved nucleoside reverse transcriptase inhibitors. It is very similar to another medication called Epivir (lamivudine or 3TC). Viread is the only approved nucleotide reverse transcriptase inhibitor.


How does Truvada work?

The NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself. This may slow down HIV disease.


Who is Truvada approved for?

The Food and Drug Administration (FDA) has approved Truvada for use in combination with other HIV drugs for the treatment of HIV infection in adults 18 years of age and older. Truvada has not been tested in children.


How do I take Truvada?

Truvada comes as a tablet that contains:

  • 200 milligrams (mg) of Emtriva
  • 300 mg of Viread

The dose is one tablet, once daily.


Truvada must be used with other medications to treat HIV from the protease inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI) drug classes. It should not be used only with other NRTIs.


You can take Truvada with food or on an empty stomach, but taking it with food may cut down on nausea or other side effects.


Speak to your doctor if you have kidney, bone, or liver problems. You may need a lower dose of Truvada.


Why is it so important to take Truvada exactly the way it is prescribed?

As with all HIV drugs, it is important to take Truvada as prescribed. Missing or skipping doses can cause your blood levels of the drug to fall too low and resistance can develop. When your virus becomes resistant to an HIV medication, that drug may stop working.


How is Truvada used?

Truvada can be used if you’re just starting HIV treatment.


Truvada can be used if you’ve been on treatment before, but it is not clear if Truvada will work for people who are already resistant to Emtriva, Viread, or Epivir.


Your doctor can run a resistance test to help determine whether the drugs in Truvada are likely to work for you.


What happens if my virus develops resistance to the drugs in Truvada?

If your virus develops resistance to the drugs in Truvada, then it may stop working or may not work as well for you. You also may not get as much benefit from other NRTIs.


Does Truvada interact with other drugs?

Sometimes taking more than one medication can cause drug interactions. Taking certain drugs (including Videx EC [didanosine or ddI], Kaletra [lopinavir/ritonavir], and Reyataz [atazanavir]) with Truvada can change the amount of each drug in your blood. Your doctor may need to adjust the doses of your drugs to avoid under- or overdosing.


Some drugs should not be taken with Truvada, including Emtriva, Viread, Epivir, Combivir, Trizivir, or Epzicom.


Several other medications may make the side effects of Truvada worse. Be sure your doctor knows about all the medications you are taking (including over-the-counter, prescription, street drugs, and herbs), even if you only use them occasionally.


For more information and additional resources to check interactions between the particular drugs you are taking, see our info sheet on drug interactions.


What are the side effects?

Truvada is associated with the same side effects as the drugs it contains. The side effects are likely to be temporary and go away as your body adjusts to the medication. If you are experiencing any of the side effects listed below, call your doctor for advice. Do not just stop taking your medication.

  • Nausea
  • Vomiting
  • Diarrhea
  • Intestinal gas (flatulence)
  • Headaches
  • Skin rash
  • Skin discoloration

More serious side effects:

  • Kidney problems: have your creatinine (kidney enzyme) levels monitored regularly; high levels can indicate kidney damage.
  • Bone problems such as osteopenia or osteoporosis.
  • An increase of lactic acid in the blood ( lactic acidosis), an enlarged liver, and liver failure have been reported in people using NRTIs. Lactic acidosis is a rare but potentially fatal side effect. Symptoms include nausea, vomiting, or stomach pain; feeling very weak and tired; and shortness of breath.
  • Lipodystrophy, which may include elevated blood sugar (glucose), elevated lipid levels ( cholesterol and triglycerides), and fat gain or loss in certain areas. The exact causes of lipodystrophy are not known, but may include HIV and/or HIV drugs. It is unclear if Truvada will cause or impact symptoms of lipodystrophy. For more information on lipodystrophy, see our info sheet.

If you are experiencing persistent, unusual, or serious side effects, call your doctor right away.


What specific research has been done on Truvada and women?

The drugs in Truvada (Emtriva and Viread) have been studied in both men and women (see the fact sheets on these separate drugs for more information). Their effectiveness and side effects seem very similar in both sexes. But some research suggests that women are more likely than men to develop liver problems and the rare but very serious side effect, lactic acidosis, while taking NRTI drugs. In addition, Viread may reduce bone mineral density. Since HIV+ women are already at higher risk for bone problems, it is important to get enough calcium and vitamin D and to ask your doctor about a bone mineral density test.


Study 303 compared Emtriva and a similar drug, Epivir, in people who were already taking HIV medications. This study included 14 percent women, or about 61 women out of 440 total participants. In this trial, Emtriva and Epivir worked about equally well in people who were also taking Zerit (stavudine or d4T) or Retrovir (zidovudine or AZT) plus a protease inhibitor.


Study 903 looked at 602 people who had not taken HIV drugs before, of whom 26 percent (or about 156) were women. In this study, after 144 weeks, Viread plus Epivir plus Sustiva (efavirenz) controlled HIV as well as Zerit plus Epivir plus Sustiva. But elevated blood lipid levels and fat loss in the arms and legs (lipoatrophy) were less common in the people taking Viread.


Study 934 compared Emtriva plus Viread plus Sustiva against Combivir (Retrovir plus Epivir) plus Sustiva. After 48 weeks, the drugs in Truvada appeared to work better than Combivir. In addition, adverse side effects were about half as common in the Emtriva plus Viread group. This analysis included 509 participants, of whom 14 percent (or about 71) were women.


In the COMET study, people who switched from Combivir to the Truvada combination pill (while continuing to take Sustiva) were more likely to have undetectable HIV viral loads after 24 weeks. This ongoing study includes 411 participants, of whom 14 percent (or about 58) are women.


What about pregnancy?

Studies have shown that pregnant women who use HIV drugs can greatly reduce the risk of passing HIV on to their babies. There have been no formal studies on the use of the Truvada combination pill or of Emtriva or Viread during pregnancy.


Check with your doctor about the best treatment options for you and your baby if you are thinking of getting pregnant.


Click this link for more information about pregnancy.


Are there any special considerations?

Hepatitis B

Emtriva and Viread both work against the hepatitis B virus (HBV); however they are not yet FDA approved for hepatitis B treatment. If you are co-infected with HIV and HBV and taking Truvada for HIV treatment, discontinuing the drug may result in a worsening of hepatitis. If you are co-infected, speak to your doctor about treatment options.


Immune Reconstitution Syndrome

People who are starting HIV treatment for the first time may develop Immune Reconstitution Syndrome or IRS (also called Immune Reconstitution Inflammatory Syndrome or IRIS). IRS can happen as a result of the immune system getting stronger and responding to an HIV-related infection such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), or tuberculosis (TB). People may have been treated for these infections in the past or not even know they have them. If you notice any unusual symptoms soon after starting HIV drugs for the first time, let your doctor know right away so you can be evaluated and, if necessary, treated.


1

Gallant, J., et al. (2004). Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. Journal of the American Medical Association,292. 191-201. 

2

Pozniak, A., et al. (2005). Superior outcome for tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV in antiretroviral naive patients. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment. Abstract WeOa0202.

3

Ruane, P., et al. (2005). Improved virologic suppression after HIV-infected patients are switched from fixed dose zidovudine/lamivudine to fixed dose tenofovir DF/emtricitabine. 10th European AIDS Conference (EACS). Abstract PE7.3/5.

4

Van der Horst, C., et. al. (2001). Two randomized controlled equivalence trials of emtricitabine (FTC) to lamivudine (3TC). 8th Conference on Retroviruses and Opportunistic Infections. Abstract 18.

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Information provided on this website is for educational purposes only. It is designed to support, not replace, personal medical care and should never be used as a substitute for personal medical attention, diagnosis, or hands-on treatment. We recommend all medical decisions be made in consultation with your personal health care provider.