What Is Epivir?

EPIVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The use of EPIVIR is based on the results of clinical studies in HIV-infected patients in combination regimens with other antiretroviral agents. EPIVIR does not cure HIV infection/AIDS or prevent passing HIV to others.


Important Safety Information

• EPIVIR, like other HIV medicines, can cause a condition called lactic acidosis and severe liver problems. Lactic acidosis occurs when acid builds up in the blood, which can affect how the body functions. In some cases, lactic acidosis can cause death. Nausea and tiredness that don't get better may be symptoms of lactic acidosis

• If your child is taking EPIVIR, your doctor will tell you to watch carefully for signs and symptoms of an inflamed pancreas, such as, severe stomach pain, nausea and vomiting, mild fever, and clammy skin

• Patients with hepatitis B virus (HBV) infection who take lamivudine, the active ingredient in EPIVIR, and then stop taking it, may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping lamivudine. You may need to take anti-HBV medicines

• Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPIVIR as well as interferon with or without ribavirin, and you experience side effects, be sure to tell your doctor

• When you start taking HIV medicines, your immune system may get stronger and may begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor

• Changes in body fat may occur in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also occur. The cause and long-term health effects of these conditions are not known at this time

• The most common side effects with EPIVIR were headache, nausea, weakness or tiredness, and nasal signs and symptoms. In children, the most common side effects are fever, cough, skin rash, and an enlarged liver

• These are not all the side effects you could have when taking this medicine. Your healthcare professional can talk to you about these and other side effects with EPIVIR

• Tell your doctor promptly about any side effects or other unusual symptoms you may experience

How Does Epivir Work?

As with all the NRTI * drugs, Epivir works by terminating the growing DNA (gene) chain of HIV as it is trying to reproduce itself. This results in defective HIV particles that are unable to infect new cells.

When taking regularly as prescribed, Epivir combination therapy usually leads to a decrease in HIV viral load (RNA) in the blood and an increase in the CD4 cell count. Epivir combination therapy has been associated with decreased rates of AIDS opportunistic infections, improved quality of life and increased survival.

* NRTI: nucleoside reverse transcriptase inhibitor

What About Drug Interactions?

TMP/SMX (Bactrim; Septra), a treatment used to prevent Pneumocystis pneumonia (PCP), can increase the amount of Epivir in the body. However, it is not necessary to change the doses of either TMP/SMX or Epivir.

Epivir should not be taken at the same time as Emtriva or Truvada (containing Viread and Emtriva). This is because Epivir and Emtriva are very similar and it is not believed that combining these two anti-HIV drugs will make a regimen any more effective against the virus.

Other drug interactions might be possible. However, it is believed that Epivir can be safely taken at the same time as most drugs used to treat HIV and AIDS-related complications.

What About Side Effects?

• Lactic acidosis, which can be fatal, and severe liver problems (fatty liver) have been reported in people taking nucleoside reverse transcriptase inhibitors (NRTIs). These problems are more likely to occur in HIV-positive people taking drug regimens that contain Zerit (d4T) or Zerit and Videx (ddI). It is possible that Ziagen (abacavir) can also cause these side effects. 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. These may be early symptoms of lactic acidosis or liver problems.

• Rarely, Epivir can cause inflammation of the pancreas (pancreatitis). Pancreatitis is a rare but serious side effect that can be life-threatening in some cases. Notify your doctor immediately if you develop symptoms of pancreatitis, including nausea, vomiting, diarrhea, and abdominal pain.

• Another rare side effect of Epivir is peripheral neuropathy, which can result in pain, tingling, numbness, or burning in the hands and/or feet. Stopping Epivir and starting another NRTI that does not usually cause peripheral neuropathy—for example, Retrovir (AZT) or Ziagen (abacavir)—is often the best way to stop peripheral neuropathy.

• Other, less serious side effects may occur. Continue taking Epivir and talk to your doctor if you experience a cough, dizziness, fatigue, stomach discomfort, headache, and trouble sleeping. Epivir has also been known to cause anemia (decreased red blood cell function), hair loss, rash, and neutropenia (decreased neutrophils, a type of white blood cell)

• Anti-HIV drug regimens containing NRTIs, including Epivir, can cause increased fat levels (cholesterol and triglycerides) in the blood, 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), and diabetes. These side effects of anti-HIV drug therapy are reviewed in our lessons on Lipodystrophy, Facial Lipoatrophy, and Risks To Your Heart (Hyperlipidemia).