Re: Use of Navirapine

[Guest guest]

Dear Forum members,

Here's something (below) on neviripine. go to: www.thebody.com for more detailed

information. Also to the s Hopkins site: www.hopkins-aids.edu

Good luck, J.

________________

For more information about clinical trials for anti-HIV treatments currently

enrolling, see the clinical trials page Drugs for treating HIV.

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.

The Simple Facts Project is a program of the AIDS Treatment Data Network (The

Network). This information does not intend to promote or endorse any specific

treatment for any health related condition.

Simple Facts Sheets Network home pageLast updated 12/13/2000

The Network copyright © 2000 The Network The Network

_____________________________

Janice Price, M.Ed., RN

HIV Research Coordinator

Swedish Medical Center

747 Broadway, Rm. 833

Seattle, WA 98122

Phone: 206.386.2523

Fax: 206.386.6121

Beeper: 206.405.6634

Email: janice.price@...