Viramune

Common Name: nevirapine

Brand Name: Viramune

Class: non-nucleoside analogs (also called non-nucleoside reverse transcriptase inhibitors, NNRTIs, or non-nukes)

Standard dose: One 200 mg tablet daily for two weeks, then full dose of one 200 mg tablet twice daily. Can be taken with or without food, with no food restrictions. Frequently prescribed as two 200 mg tablets once a day, although once-daily dosing is not FDA approved. Dose for children 15 days or older is 150 mg once daily for 14 days, then 150 mg twice daily thereafter. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose. For dialysis patients, an additional dose of 200 mg is required after each dialysis. A 50 mg/5 ml oral suspension is also available.

AWP: $547.20 / month

Manufacturer contact: Boehringer-Ingelheim,
www.viramune.com, 1 (800) 274-8651

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 health care provider immediately. Seek medical attention right away if you experience blistering, mouth sores, conjunctivitis (redness or inflammation of the eye, or pink eye, which if untreated may result in permanent vision loss), swelling, muscle or joint aches, fever or malaise (general ill feeling). Do not increase dose if rash develops during dose escalation or if you develop any rash accompanied by the above listed conditions. Once-daily lead-in dose should not exceed 28 days. An alternative drug should be considered at this time. An increase in liver enzyme levels has been observed and in rare instances, hepatitis has developed. In such cases, it may be necessary to stop taking Viramune until liver function returns to normal. Permanently discontinue it if abnormalities return. Rarely, severe and life-threatening hepatotoxicity (liver damage), including three 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, though liver damage can happen to anybody. The package insert says Viramune should not be started in these groups unless the benefit outweighs the risk. 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: Viramune should not be taken with Reyataz or St. John's wort. Rifampin should not be used with Viramune; rifabutin (Mycobutin) is the recommended alternative for the treatment of tuberculosis. Caution should be used with midazolam, triazolam, fluconazole, or ergot medications used for migraine headaches (Wigraine, Methergine, and Cafergot), 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. Use caution with anti-convulsants: Dilantin (phenytoin), phenobarbital, and Tegretol (carbamazepine). The effectiveness of birth control pills may be decreased; alternative contraception methods with barrier should be used. 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 more than seven days, you will need to start at the lower dose for two weeks and then increase back up to twice-daily dosing. Be careful when stopping Viramune, so that you avoid the rapid development of HIV resistance to it -- check with your doctor or pharmacist first. It is usually recommended that you continue your other HIV medications for several days after stopping Viramune. 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 in 2007, 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.

Doctor

Viramune (nevirapine) was approved for twice-daily dosing in 1996. It was the first drug approved in the NNRTI class. This drug is currently considered an alternative to Sustiva for a number of reasons. One is that its use is associated with a risk of a rash. To minimize this risk, the drug is taken as one pill per day for two weeks before going to the full dose of one pill twice daily. Furthermore, this drug must be given only to patients whose CD4 counts are below certain thresholds in order to minimize side effects -- these thresholds differ for men versus women and differ again if the person is viremic versus having a suppressed viral load when nevirapine is started. Finally, a small percentage of people have liver function test abnormalities when starting this agent -- more than what is observed with other choices -- thus, this drug requires careful monitoring when starting on it. It does have one attractive feature in those who do tolerate it in that it may have the most beneficial impact on lipid profiles with an increase in the HDL ("good") cholesterol fraction. It is not yet clear if this impact decreases the rate of heart attacks over time versus what is seen with the use of other agents. Finally, resistance to this drug is usually associated with the Y181C mutation which has a risk of conferring resistance to etravirine. Therefore, careful monitoring is necessary to ensure that this drug is carefully reconsidered if someone has developed viremia while taking a nevirapine-containing regimen. -- Cal Cohen, M.D.

Activist

A good twice-daily alternative for those who can't tolerate Sustiva's sleep and lipid problems, Viramune needs to be started carefully. In addition to women with over 250 T-cells and men with over 400 T-cells, everybody should be closely watched for liver toxicity for the first six months. After that, it should be smooth sailing, and Viramune may even be beneficial for cholesterol and triglyceride levels. Like Sustiva, Viramune has a very long half-life -- which means if you're stopping meds for any reason you should stop the Viramune several days before your other drugs to avoid developing resistance. -- Jeff Taylor