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Common Name:
nevirapine (NVP)
Brand Name:
Viramune |
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Class: non-nucleoside analog (also called non-nucleoside reverse transcriptase inhibitor, NNRTI, or non-nuke)
Standard dose: One 200 mg tablet daily for two weeks, then full dose of one 200 mg tablet twice daily, no food restrictions, may be taken with or without food; frequently prescribed as two 200 mg tablets once a day, although once-daily dosing is not FDA-approved. Take missed dose as soon as possible but do not double up on your next dose. For dialysis patients, an additional dose of 200 mg is required after each dialysis.
AWP: $463.85 / month
Manufacturer contact: Boehringer-Ingelheim,
www.viramune.com, 1 (800) 274–8651
AIDSInfo:
1 (800) HIV–0440 (448–0440), www.aidsinfo.nih.gov
Potential side effects and toxicity: Most common side effects include headache, nausea, vomiting, fever and rash. 14-day lead-in dosing reduces the frequency of rash. Severe rash, including Stevens-Johnson syndrome, while rare, can be life-threatening; notify your healthcare provider immediately. If you experience blistering, mouth sores, conjunctivitis (redness or inflammation of eye, or pink eye, which if untreated may result in permanent vision loss), swelling, muscle or joint aches, fever or general malaise (general ill feeling), you may need to stop all medications, so seek medical attention immediately. Do not increase dose if rash develops during dose escalation or if you develop any rash accompanied by the above listed conditions. An increase in liver enzyme levels has been observed and in rare instances the development of hepatitis. May need to stop taking nevirapine until liver function returns to normal. Permanently discontinue if abnormalities return. Although rare, severe and life-threatening hepatotoxicity (liver damage), including fatal cases have occurred. Women with CD4 counts greater than 250 T-cells, including pregnant women, and men with more than 400 T-cells have a higher risk of serious hepatotoxicity (liver damage), with women being at greater risk. The package insert says Viramune should not be started in these groups unless the benefit outweighs the risk. But the liver damage can happen to anybody. The highest risk period is within the first six weeks of treatment, but patients should be monitored closely for the first 18 weeks.
Potential drug interactions: Caution should be used with midazolam, triazolam, fluconazole, or ergot medications, used for migraine headaches (Wigraine, Methergine, and Cafergot), St. John’s wort, Cordarone, lidocaine or disopyramide, carbamazepine, ethosuxomide, or clonazepam, calcium channel blockers (Procardia, diltiazem, verapamil), immunosuppressants, or the blood thinner Coumadin (warfarin). Do not use with Biaxin (clarithromycin) or Nizoral (ketoconazole). Viramune decreases methadone levels; dosing adjustment may be necessary to avoid withdrawal symptoms. Viramune can reduce levels of protease inhibitors; dose adjustment may be needed if they are taken at the same time. Kaletra should be increased to three tablets twice-a-day in people who previously took HIV drugs. Viramune interacts with rifampin, requiring dose adjustment, and caution is advised with Mycobutin. The effectiveness of birth control pills may be decreased; women and their male partners should consider the use of alternative contraception methods with barrier. During the first six weeks of therapy, prednisone should be avoided. It can cause increased severity and incidence of rash.
Tips: Monitor liver function tests and signs of rash during first six months. The increased period of risk for liver injury is primarily in the first 18 weeks of taking Viramune. Do not ignore yellowing of your eyes or skin, as this may be a sign of a severe liver effect. Studies show that Viramune crosses the blood-brain barrier to a useful degree, which may be beneficial for patients at risk for neurological damage (such as dementia) from HIV. Lead-in dosing has been shown to lessen the risk of rash. If at any time of treatment you stop Viramune for seven days, you will need to start at the lower dose for two weeks and then increase back up to twice-daily dosing. Viramune has also been shown to have a positive impact on triglycerides and cholesterol levels. When given around the time of labor Viramune has demonstrated effectiveness in preventing the transmission of HIV from mother to child, but there was an increase in HIV drug resistance when given alone. The use of at least one other HIV drug helped to cut down the incidence of resistance, and women have been shown to experience effectiveness with the drug six months after giving birth. Viramune was updated from Pregnancy Class C to Class B last year, meaning that it was found to be even safer. Single or two dose Viramune may be used for babies born to HIV-positive mothers. Mothers should not breastfeed their infants while taking Viramune. Please see package insert for more complete potential side effects and interactions.
Viramune, the first NNRTI, is now considered to be an “alternative” to Sustiva. Even though it’s been around longer, it hasn’t been studied as extensively, so we can’t say whether it’s just as effective. It can also be more toxic: Rashes from Viramune can be more severe (even life threatening) than with Sustiva, and there is also a risk of serious liver damage. These toxicities tend to occur early—within the first few weeks of therapy—and are more common in women and people with high CD4 counts. Women starting therapy with CD4 counts above 250 and men starting with counts above 400 should not start Viramune. Take just one pill once a day for the first two weeks, and then, if your liver tests are okay and you have no rash, increase to the full dose (one pill twice a day). Once you’ve made it through the first few weeks, Viramune is a very safe and well tolerated drug.—Joel Gallant, M.D.
Viramune was the first drug approved in the non-nucleoside class. It has none of the mental/emotional side effects of Sustiva but shares its long half life and generally high potency. Its most common side effect is a mild to moderate rash, which is usually easily treatable. The bigger risk with Viramune is liver toxicity, particularly for women with high CD4+ counts. Why this is the case no one knows. It just is. Viramune is also widely used in the developing world for prevention of mother-to-child transmission. A single dose can block most such transmission, although this use has also shown that some women can develop resistance to the drug after that one dose. All things considered, Viramune is probably one of the more underrated HIV treatments. There is no convincing data showing it to be inferior to Sustiva, and overall it appears to be somewhat less toxic. Yet somehow it doesn’t have quite the same “buzz” about it as Sustiva and is nowhere near as widely used. A number of people think this is a mistake and that wide use of Viramune would likely be a good thing.—Martin Delaney
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