Emtriva (emtricitabine)

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Emtriva, (also known as emtricitabine or FTC), is an anti-HIV treatment in a class of drugs called Nucleoside Reverse Transcriptase Inhibitors (NRTIs, or Nukes). This type of drug works by blocking HIV from completing an early step of the process HIV uses to make new copies of itself in already infected cells. Other drugs of this class include Retrovir (zidovudine), Epivir (lamivudine) and Ziagen (abacavir).

Treatment guidelines list Emtriva with Viread or Epivir with Viread or Retrovir in an initial HIV treatment regimen using the protease inhibitor Kaletra, or the non-nucleoside reverse transcriptase inhibitor Sustiva. There are also alternatives to these combinations listed in the guidelines.

The following considerations should be taken into account before starting any treatment combination. What anti-HIV drugs you have taken in the past, and your HIV resistance profile are important when planning your first, second or subsequent HAART regimen. The strength, or efficacy of the drug, the possible side effects, how it interacts with other drugs, how many pills and how often they must be taken, whether the drug needs to be taken with food or liquids, the overall toxicity of the drugs and how they may affect your current liver, heart or other organ functions should be considered.

Emtriva can be taken once a day, typically in combination with another NRTI Viread. The combination pill, taken once a day is called Truvada. Being co-infected with hepatitis C (HCV) or hepatitis B (HBV) or other conditions requires special consideration, especially when taking Emtriva, Viread or Truvada. Stopping these drugs when you are Hepatitis B co-infected may cause a serious hepatitis flare up. Symptoms of hepatitis B flare-ups are high liver enzyme levels, yellow skin (jaundice), nausea, vomiting, fatigue, and abdominal and joint pain.

Emtriva, Viread and Truvada have not been approved for the treatment of HBV. Although Epivir has been approved for the treatment of HIV/HBV co-infected individuals at the dose used to treat HIV, the lower dose used to treat HBV infection in people who are not HIV-infected should not be taken by someone with HIV. Please consult with an experienced HIV and/or liver disease specialist before starting or stopping any of these drugs.

Whether or not the drug or combination may cause blood fats to rise, a redistribution of fat in the body (especially the face, stomach or breasts), and whether the drugs may cause or promote insulin resistance, diabetes or other abnormalities are important considerations. See the Lipodystrophy Fact Sheet for more information.

Taking the drug:

Emtriva should not be taken with Epivir, since they are essentially identical and provide no benefit when used in combination. Epivir is also contained in the HIV drugs Combivir and Trizivir and Epzicom, so Emtriva should not be taken with these drugs either.

Emtriva is chemically very similar to an older drug, Epivir (lamivudine or 3TC), and works similarly. People already resistant to Epivir, usually because of the M184V mutation, will also be resistant to Emtriva and vice versa. There is evidence suggesting that this mutation may help the drug Retrovir work better. Drug resistance tests (genotypic or phenotypic) have been shown to be useful in choosing the optimal anti-HIV treatment regimen specific to an individual. See the Simple Fact Sheet Understanding Drug Resistance for more information.

If you are experiencing intolerable side effects that make you skip doses or not take the drugs as they are prescribed, contact your doctor or a health care provider immediately. Not being adherent to a regimen can do more harm than good. A case manager may also be able to help you resolve issues that prevent you from taking your medications as prescribed.Stopping a drug or drug combination for even a few days could pose an actual, serious health threat. Please consult with a qualified health care provider before you make any decisions.

Dosage:

Emtriva is taken as a single 200 mg capsule once daily, with or without food. Emtriva can be stored at room temperature. Emtriva is also approved for children at least 3 months old. The dose of Emtriva will depend on the child's weight. The typical dose of Emtriva for a child is 4 mg per kilogram, taken once a day in liquid form. The liquid form is usually easier to take for children, although the adult capsules can also be used. The dose for a child should not exceed 240 mg of liquid Emtriva or 200 mg of Emtriva tablets per day.

Serious kidney problems (renal impairment) can raise levels of Emtriva. Dose adjustments should be based on creatinine clearance, using a simple urine test.

Side effects:

Emtriva's side effects can include headache, diarrhea, nausea, weakness, fatigue, increased cough, rhinitis,and rash. Some people taking Emtriva experience skin discoloration.

Guidelines for Women:

Emtriva is not well studied in pregnant women. It is also not known if the drug passes to the baby in women who are breast feeding. Emtriva is a suggested alternative to other nucleoside drugs if needed.There is not enough data to recommend the use of Emtriva over the combination of Retrovir and Epivir. There are also other combinations of drugs that may be appropriate. Guidelines for the treatment of pregnant women, preventing transmission of HIV, and treating children and adolescents are available at http://AIDSinfo.nih.gov or by asking your Network case manager.

Warnings:

No drug interactions for Emtriva have been reported, although you should probably not drink alcohol while taking Emtriva. Tell your doctor about all of the drugs that you take, including non-prescription medicine and herbs.

A set of rare but serious side effects of nucleoside analog anti-HIV drugs is called lactic acidosis and severe hepatomegaly with steatosis (an enlarged fatty liver). Women, especially those who are overweight, are particularly at risk. This set of side effects is probably the result of mitochondrial toxicity. Mitochondria are cells' power organs that supply the energy needed for normal growth. Anti-HIV nucleoside analogs impair the function of mitochondria. This can lead to increased acid levels in the blood, and an enlarged fatty liver. The symptoms are severe nausea, shortness of breath and vomiting that does not get better. If you are taking anti-HIV drugs and experience one or more of these symptoms, tell your provider immediately.

Opiates, Methadone and Buproprion:

Methadone levels do not appear to be affected by Emtriva, but check to see if the combination of drugs you decide to take could affect the level of Methadone. Anyone who is taking Methadone, Buprenorphine or Opiate drugs should discuss how anti-HIV drugs could affect either the drug levels of the HAART regimen or of the opiate related drugs. Little is known about drug interactions with the newer drug Buproprion. Sudden feelings of opiate withdrawal, or toxicity due to increased concentrations of anti-HIV drugs may lead to non-adherence to prescribed HAART regimens. There are several successful models of anti-HIV treatment for active and recovering substance users, including those using prescribed opiates, although a specialty team of health care providers may be needed.

Gilead, the maker of Emtricitabine (Emtriva, FTC), has a patient assistance program for people having problems getting the drug. The number to call is (800) 226-2056.

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