Viramune – brand name

nevirapine – generic name

Viramune belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), also known as non-nucleoside analogs or “non-nukes.”

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

The Food and Drug Administration (FDA) has approved Viramune for use in combination with other HIV drugs for the treatment of HIV infection in adults and children over two months old.

The FDA has also granted tentative approval of generic formulations of Viramune. These versions are not yet available in the U.S.

Viramune comes in:

• 200 milligram (mg) tablets
• Liquid form

The dose of Viramune for adults is one 200 mg tablet twice daily:

• To reduce side effects, Viramune is given at a lower dose of one 200 mg tablet once daily for the first two weeks (the lead-in period) and then increased to its full dose

Check with your child’s doctor for children’s dosing. (Children’s dosing is based on body weight.)

Viramune must be used with other medications to treat HIV.

You can take Viramune 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 liver or kidney problems.

It can take two to three weeks for Viramune to be eliminated from your body after you stop taking it. Careful planning with your doctor is needed if you stop taking a drug regimen that contains Viramune, especially if you do not immediately switch to another drug regimen.

As with all HIV drugs, it is important to take Viramune 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.

Viramune should not be used as first-time treatment in women with CD4 cell counts over 250. In addition, women with over 250 CD4 cells should not switch to Viramune unless there are no other options.

• Recent research has shown that women with more than 250 CD4 cells are 12 times more likely to develop potentially-fatal liver problems when they use Viramune
• Although the overall rate of this severe toxicity from Viramune is low, there are other alternative drugs that are likely to be safer in women with higher CD4 cells

Men with CD4 cell counts over 400 should also consider other treatment options and should be monitored carefully if Viramune is used.

Viramune is one of the options to consider if you need a “protease-sparing” drug regimen (a regimen that does not include a protease inhibitor).

Viramune can be used if you’ve been on treatment before, however, it will not work well for people whose virus is already resistant to the other NNRTIs: Rescriptor (delavirdine) and Sustiva (efavirenz).

Your doctor can run a resistance test to help determine whether Viramune is likely to work for you.

Viramune crosses the blood-brain barrier (which protects the brain and spinal cord), so it may be able to fight HIV in the brain.

If your virus develops resistance to Viramune then it may stop working or not work as well for you. You are also not likely to benefit from the other NNRTIs.

Sometimes taking more than one medication can cause drug interactions. Taking certain drugs (such as protease inhibitors, TB drugs, antihistamines, sedatives, cholesterol-lowering drugs, and anti-fungal drugs) with Viramune 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:

• Methadone doses may need to be increased if you are taking Viramune
• Viramune decreases the effectiveness of birth control pills, so alternative birth control methods should be used

Do not take the herb St. John’s wort with Viramune.

Viramune plus Videx EC (ddI or didanosine) plus Viread (tenofovir) should not be used in patients new to HIV therapy.

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.

Some people experience Viramune side effects. It is important to be closely monitored by your doctor, especially during the first six weeks, when starting a regimen containing Viramune. Fortunately, many side effects are likely to be temporary and go away as your body adjusts to the medication. Side effects may include:

• Skin rash
• Fever
• Nausea
• Headaches
• Fatigue (unusual tiredness)

If you experience any side effects with Viramune you should call your doctor for close monitoring and advice. Don’t just stop taking your medication.

More serious side effects:

• Viramune can cause severe, life-threatening liver damage. If you experience any of the following symptoms, call your doctor immediately: excessive tiredness, lack of energy, upset stomach, loss of appetite, dark urine, pale stools, and yellowing of the skin or eyes.
• Viramune can cause a severe, life-threatening skin reaction called Stevens-Johnson syndrome. If you experience a severe rash or a rash together with any of the following symptoms, call your doctor immediately: fever, lack of energy, excessive tiredness, muscle or joint pain, blisters, blisters in the mouth, and pink eye.

Your doctor will order certain lab tests to check for liver damage and skin reactions, especially during the first 12 to 16 weeks of treatment. If you stop taking Viramune because of liver damage, skin reactions, or allergic reactions, you should not start taking it again.

Viramune has been studied in a large number of women. A study of Viramune pharmacokinetics (how the drug is processed by the body) that included 15 women and 15 men found that blood levels of the drug tend to reach levels higher in women, but didn’t stay in women’s bodies as long.

Trial BI-1090 compared Viramune plus Epivir (lamivudine or 3TC) plus background therapy (one or two NRTIs with or without a protease inhibitor) versus Epivir plus background therapy. This study included 21 percent women, or about 472 women out of 2,249 total participants. After 48 weeks, people taking Viramune had lower viral loads and larger CD4 cell increases.

Trial BI-1046 (also known as INCAS) included about 7 percent women, or 11 women out of 151 total participants. This study compared Retrovir (zidovudine or AZT) plus Videx plus Viramune to Retrovir plus Viramune to Retrovir plus Videx. After 48 weeks, more people taking all three drugs had decreased viral loads and increased CD4 cells, as well as half the rate of HIV disease progression or death.

Study ACTG 241 compared Retrovir plus Videx plus Viramune to Retrovir plus Videx. This trial included about 20 percent women, or about 80 women out of 398 total participants. After 48 weeks, people taking Viramune had lower viral loads and greater CD4 cell increases, but also more cases of severe rash.

The 2NN study compared Zerit (stavudine or d4T) plus Epivir plus Viramune to Zerit plus Epivir plus Sustiva to Zerit plus Epivir plus Viramune plus Sustiva in people who had not taken HIV drugs before. This trial included 37 percent women, or about 449 women out of 1,216 total participants.

In this study, Viramune and Sustiva worked about equally well overall, but Sustiva appeared to work better in people with high viral loads. People who took both Viramune and Sustiva did worse than those who took only one NNRTI, since more stopped treatment due to side effects.

The COMBINE study compared Combivir (the Retrovir/Epivir combination pill) plus either Viramune or Viracept (nelfinavir). Viramune appeared to work slightly better in people with low viral loads, but the drugs worked similarly in people with high viral loads. This study included about 25 percent women, or 36 women out of 142 total participants.

The ATLANTIC study, which included 20 percent women, or about 59 women out of 298 total participants, compared Zerit plus Videx plus either Epivir or Viramune or Crixivan (indinavir). In this study, Crixivan appeared to work slightly better than the other two drugs.

Several studies have looked at people switching from protease inhibitors to Viramune. Most of these studies have found that people who switch to Viramune had decreased total cholesterol and increased HDL (“good”) cholesterol levels, which may lower their risk for heart disease. The FRAMS study, a sub-study of the ATLANTIC trial, found that people who took Viramune had lower blood fat levels than people taking Crixivan. In general, most studies suggest that high blood fat levels occur less often in women taking HIV drugs than in men.

In terms of side effects, research has shown that women taking Viramune are more likely than men to develop a rash. In an analysis of four trials (including BI-1090 and BI-1046), 24 percent of people taking Viramune developed any degree of rash after 52 weeks, and about 2 percent developed severe rash (compared with about 15 percent and 0 percent, respectively, of people taking comparison regimens).

Another study found that 12 percent of women and 8 percent of men developed some degree of rash while taking Viramune. About 9 percent of women and about 1 percent of men developed a severe rash. This study included 27 percent women, or about 96 women out of 358 total participants.

Similarly, a British study found that 15 percent of women and 3 percent of men taking Viramune developed a rash. Another study found that a rash accompanied by liver damage was more common in women with fewer than 250 CD4 cells.

Some studies also suggest women taking Viramune are more likely than men to develop liver damage, but this is not as clear. In trial BI-1090, 3.5 percent of participants experienced severe liver toxicity, but in this study there was no difference between women and men.

Study FTC-302, done in South Africa, compared regimens of Zerit, plus either Viramune or Sustiva, plus either Epivir or Emtriva (emtricitabine or FTC). This trial included 59 percent women, or about 227 women out of 468 total participants (of whom 385 received Viramune). About 12 percent of participants in this study developed severe liver toxicity overall, but this was twice as likely to happen in women as in men. Two women with high liver enzyme levels died in this study.

A Dutch study found that women were nearly three times more likely than men to develop severe liver toxicity while taking Viramune. In this study, about 22 percent of the total 560 participants were women, but 37 percent of the 35 people who developed severe liver problems were women. Research indicates that pregnant women and people with chronic hepatitis B or C may be more likely to develop liver problems while taking Viramune.

Studies have shown that pregnant women who use HIV drugs can greatly reduce the risk of passing HIV on to their babies. Research shows that Viramune in particular is very effective in preventing mother-to-child HIV transmission.

In the HIVNET 012 study, 626 pregnant women in Uganda received either Viramune or Retrovir when they gave birth. The 313 women who took Viramune received a single dose of Viramune when they started labor, and their babies were also given a single dose after birth. Viramune reduced HIV transmission by nearly 50 percent—even more than Retrovir—in women who breast-fed their babies. But even one dose caused HIV to become resistant to Viramune and other NNRTI drugs.

If a single dose of Viramune is given to the mother, consideration should be given to adding Retrovir and Epivir starting as soon as possible (during labor or immediately after labor) and continuing for three to seven days. This may reduce the development of Viramune resistance in the mother.

In the U.S. and other countries where HIV treatment is readily available, most HIV+ pregnant women would take a combination of drugs on an ongoing basis, not just one. This is probably best for mother and baby.

Women who do not take combination therapy at any time during pregnancy can still reduce the risk of transmitting the virus by taking HIV medications, including Retrovir, Epivir, and Viramune, during labor and delivery and by administering HIV drugs to the newborn for a short time after birth.

Viramune is one of the drugs recommended for use in pregnancy except as first-time treatment in women with CD4 cell counts over 250 (because of increased risk of liver problems). Viramune has been used during pregnancy without any significant negative effect to the baby; however, long-term effects on the child are not known. 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.

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		Guay, L.A., et. al. (1999). Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomized trial. The Lancet, 354(9181). 795-802.
2		Martinez, E., et. al. (1999). Reversion of metabolic abnormalities after switching from HIV-1 protease inhibitors to nevirapine. AIDS, 13(7). 805-810.
3		Squires, K., et. al. (2000). The Atlantic study: a randomized, open-labeled trial comparing protease inhibitor (PI)-sparing anti-retroviral strategies versus a standard PI-containing regimen, final 48 week data. XIII International AIDS Conference. Durban, South Africa. Abstract LB B7046.
4		Van Leth, F., et. al. (2003). Results of the 2NN study: A randomized comparative trial of first-line antiretroviral therapy with regimens containing either nevirapine alone, efavirenz alone or both drugs combined, together with stavudine and lamivudine. 10th Conference on Retroviruses and Opportunistic Infections. Boston, MA.  Abstract 176.
5		United States Department of Health and Human Services. (2005). Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. Retrieved December 2005 from http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf.