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MORE INFORMATION ON: VIRAMUNE

NOTICE:  For your convenience we copied key information from each product's site and have provided it here, with some content edited to make it more readable.

Nevirapine (trade name Viramune) is one of a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is a part of HIV required to infect cells in the body and make more virus. NNRTIs stop the reverse transcriptase from working properly. The recommended dosage of nevirapine is 200 mg once a day for the first two weeks, and then 200 mg twice a day thereafter. Nevirapine is also available as a liquid suspension for children.

Nevirapine has been approved for use in combination with other anti-HIV drugs, including protease inhibitors. New Public Health Service HIV treatment guidelines recommend combinations of three or four anti-HIV drugs as first treatment for HIV:

Two nucleoside analogs (AZT+3TC, d4T+3TC, d4T+ddI, AZT+ddI, or AZT+ddC) with one of the following: Crixivan, Fortovase, Norvir, Sustiva, Viracept or Norvir and Fortovase combined.

If one of the above combinations cannot be used, an alternative is two nucleoside analogs (same combinations as listed above) with Viramune or Rescriptor.

The guidelines also say that nevirapine may be useful as part of a second-line combination if a standard combination stops working.

Trial results: In a trial known as the INCAS study, nevirapine was combined with ddI (Videx) and AZT (Retrovir). This three-drug combination reduced viral load (the amount of HIV in the blood) very effectively. After a year, just over half the people taking the triple combination had a viral load of less than 20 copies. T4 cell counts increased by an average of 140 cells. No one in the study had taken anti-HIV drugs before. Smaller studies have been done of nevirapine combined with other anti-HIV drugs, including d4T (Zerit) and 3TC (Epivir), AZT and 3TC, d4T and ddI. All of these combinations seem promising as potential first-line HIV treatments.

Nevirapine has also been studied with protease inhibitors. A recent trial of nevirapine, d4T and nelfinavir (Viracept) reported that the combination appears safe and effective over the short term. This study is ongoing. Nevirapine combined with indinavir (Crixivan) has been shown to have a strong anti-HIV effect, but the dose of Crixivan may need to be increased to 1,000mg every 8 hours due to a drug interaction (see below).

Nevirapine has also been studied in people whose first-line combination has failed them. The best results reported so far have been with a combination of nevirapine and two protease inhibitors: ritonavir (Norvir) and saquinavir (Fortovase). Another second-line combination that has shown promise is nevirapine, 3TC and Crixivan.

Resistance: HIV seems to get resistant to the effects of nevirapine very quickly unless the drug is uased as part of an effective anti-HIV drug combination. If a person becomes resistant to nevirapine, they may also be resistant to other NNRTI drugs such as delavirdine (Rescriptor) and efavirenz (Sustiva). This is called cross-resistance.

Drug interactions: Nevirapine is processed in the body by the liver, as are many other drugs. Nevirapine can affect the liver and cause other drugs to be processed too quickly. Due to this effect, nevirapine often lowers the levels of other drugs in the body. With the protease inhibitor Crixivan, it may be necessary to increase the dose to offset the effect of nevirapine. Other protease inhibitors can be given at standard doses with nevirapine. Nevirapine greatly reduces the levels of methadone in the body, which can lead to symptoms of withdrawal. In one recent nevirapine study, the methadone dose had to be increased to 150mg a day or more in order to avoid withdrawal symptoms.

The antibiotic drugs rifabutin and rifampin can lower nevirapine levels. People taking these drugs with nevirapine should be closely monitored for interactions. In studies, taking nevirapine with the antifungal drug fluconazole (Diflucan) increased the chance of getting a rash. For updated information on drug interactions, there is a medical information contact at the manufacturer that can be reached by calling (800) 542-6257.

Side effects: The major side effect of nevirapine is a rash, which happened to 22% of people in studies. 6% of people in studies had a severe rash. 6.7% of people had to stop taking nevirapine because of this problem. If nevirapine causes a severe rash and you have to stop treatment, the company that makes the drug recommends that you DO NOT try the drug again. Other side effects can be elevated liver function tests, fever and muscle soreness.

Warning: Nevirapine has been associated with severe liver toxicity in some cases, and a new warning has been issued by the FDA. Liver function should be closely monitored when a person is taking nevirapine, particularly during the first 12 weeks of treatment. Call the Network for a copy of the warning letter or download it from the internet at: http://www.fda.gov/medwatch/safety/2000/virahp.pdf

Avoiding the rash: There may be ways to reduce the chance of getting a rash from nevirapine. One recent study gave antihistamines (e.g. Benadryl) during the first two weeks of nevirapine treatment, and no-one in this study got a rash. The drug prednisone should not to be used to prevent nevirapine-associated rash, as a clinical trial found that this made the problem worse.

Boerhinger Ingelheim/Roxane, the manufacturers of nevirapine, have set up a patient assistance program for people needing assistance accessing the drug. Call (800) 274-8651 for more information.

1 Based on information obtained from manufacturer's/retailer's website.
2 Reflects approximately average retail price as provided by popular online drugstores and other supplement outlets.
3 Reflects approximately average shipping costs as provided by popular online drugstores and other supplement outlets.
4 Our opinion only, not based on statistical analysis of study results supplied by manufacturer or other source.
5 Based on our opinion only, calculated by considering its price, shipping costs, efficacy, ingredients/content, value or any combination of the categories.