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.

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. The total length of the lead-in period should not be longer than 28 days.
  

If you stop taking Viramune for more than seven days, ask your health care provider how much to take before you start again. You may need to start with once-a-day dosing again.

Check with your child’s health care provider 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. Do not take Viramune if you have serious liver problems.

It can take two to three weeks for Viramune to be eliminated from your body after you stop taking it. Most of the other HIV drugs are eliminated much faster. This means that if you stop taking a regimen that contains Viramune and other HIV drugs, the Viramune will stay in your body longer than the other drugs. This can lead to the development of resistance. Careful planning with your health care provider 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. This may cause Viramune and any other HIV drugs you may be taking to stop working.

If you miss your dose of Viramune, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time.

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.

• Research has shown that women with more than 250 CD4 cells are 12 times more likely to develop life-threatening liver problems when they use Viramune
• Although the overall rate is low for this severe reaction to Viramune, there are other HIV drugs that are probably safer for 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 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 including Rescriptor (delavirdine) and Sustiva (efavirenz).

You and your health care provider should use resistance testing and your treatment history to help guide the use of Viramune and to determine which drugs will work best 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 some of the other NNRTIs.

Sometimes taking more than one medication can cause drug interactions. This can lead to the drugs not working as well or an increased risk of side effects.

Taking certain drugs with Viramune can change the amount of each drug in your blood. Your health care provider may need to adjust the doses of your drugs to avoid under- or overdosing.

Viramune should not be combined with:

• Rifadin (rifampin)
• Priftin (rifapentine)
• Nizoral (ketoconazole)
• Reyataz (atazanavir)
• Crixivan (indinavir)
• St. John's wort (herbal product)
• Viramune plus Videx EC (didanosine or ddI) plus Viread (tenofovir) should not be used in people new to HIV therapy

If you are taking any of the following medications, speak to your health care provider as your doses may need to be adjusted:

• Invirase (saquinavir)
• Kaletra (lopinavir/ritonavir)
• Viracept (nelfinavir)
• Prezista (darunavir)
• Norvir (ritonavir)
• Some medications used to treat TB, MAC, and other bacterial infections
• Some medications used to treat thrush (candidiasis) and other fungal infections
• Some medications used to treat heart problems
• Some medications used to treat seizures
• Some medications used to suppress the immune system (e.g. after transplantation or to treat auto-immune disease such as psoriasis)
• 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
  

This is not a complete list of medications. Because there are many possible drug interactions with Viramune, it is very important to go over all your medications with your health care provider. Be sure your health care provider 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 or go to:

http://www.hiv-druginteractions.org/
OR
http://hivinsite.ucsf.edu/insite?page=ar-00-02

Some people experience Viramune side effects. It is important to be closely monitored by your health care provider, especially during the first six weeks, when starting 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
• Stomach pain
• Diarrhea
• Nausea
• Headaches
• Fatigue (unusual tiredness)
• Vomiting
• Muscle pain
  

If you experience any side effects with Viramune you should call your health care provider 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 health care provider 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 health care provider immediately: fever, lack of energy, excessive tiredness, muscle or joint pain, blisters, blisters in the mouth, and pink eye.
• 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 Viramune will cause or impact symptoms of lipodystrophy. For more information on lipodystrophy, see our info sheet.
  

Your health care provider will order certain lab tests to check for liver damage and skin reactions, especially during the first 18 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 small study of Viramune pharmacokinetics (how the drug is processed by the body) found that blood levels of the drug tend to reach levels higher in women, but didn’t stay in women’s bodies as long.

• 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. 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. Some studies also suggest women taking Viramune are more likely than men to develop liver damage. 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 study PACTG 250, single doses of Viramune were given to HIV+ pregnant women before delivery and to their babies within three days of being born. Viramune did not cause any significant short-term or long-term side effects in the mother or the baby.

In the HIVNET 012 study, HIV+ pregnant women in Uganda received either Viramune or Retrovir (zidovudine or AZT) when they gave birth. The women who took Viramune received a single dose when they started labor, and their babies were also given a single dose after birth. Viramune reduced HIV transmission by nearly 50 percent. 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 US 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 health care provider about the best treatment options for you and your baby if you are thinking of getting pregnant.

An Antiretroviral Pregnancy Registry has been established to collect information on pregnant women who take HIV drugs, including Viramune. If you are pregnant and taking Viramune or other HIV drugs, your health care provider can register you by calling 1-800-258-4263 or going to www.apregistry.com.

It is not known whether Viramune passes into breast milk. HIV+ women should not breast-feed because their babies could be infected with HIV through the breast milk.

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 health care provider know right away so you can be evaluated and, if necessary, treated.