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We Want A New Drug!

Fall 1996

There's a new class of anti-HIV drugs on the market and most likely available in a pharmacy near you. The Food and Drug Administration granted accelerated approval to Viramune (Viramune), a non-nucleoside reverse transcriptase inhibitor. ( Don't let this scare you ... it just means that it works on a different point in the life-cycle of the HIV virus. ) Viramune is the first of this class of drugs to enter the ever expanding arena of therapies for HIV infection.

In several studies, Viramune with AZT and ddI pushed viral load below the level of detection and increased T-cells in 70% of participants on this combination, some for as long as 18 months. Viral load rose in patients who failed to follow the therapy as prescribed.

Triple Combo

The level of HIV suppression shown in the triple combination with Viramune creates a powerful alternative to more expensive and sometimes intolerable combinations with protease inhibitors. Viramune adds a new option to combination therapy and provides physicians and patients with a new drug to treat HIV infection.

The combination of Viramune, and two other agents in the nucleoside analogue class (such as; AZT, 3Tc, D4t, etc.- not protease inhibitors) had significantly successful results in both previously untreated patients and patients who had received extensive prior anti-retroviral therapy. In general, "treatment-naive" patients' response to therapy is much stronger than that of treatment-experienced patients.

The standard widely used antiviral nucleoside analogues AZT, ddI, ddC, d4T (Zerit) and 3TC - (Epivir) inhibit HIV's reverse transcriptase ( an enzyme necessary for the virus's replication). Non-nucleoside reverse transcriptase inhibitors like Viramune (nevirapine) and others also inhibit reverse transcriptase, but by a different mechanism.

Viramune must be taken in combination with a nucleoside analogues. Taken by itself, HIV can develop resistance to Viramune in as little as two weeks.

One thing that makes this drug so attractive is that you only have to take one 200 miligram tablet 2 times a day. The biggest side effect is a rash seen in 17% of patients. To avoid rash, use a lead-in dose of one 200mg tablet once a day for two weeks before taking the standard dose of two tablets daily.

Another important feature of this therapy is that it crosses the blood-brain barrier. This allows the drug to attack virus that may be in the central nervous system as well as the blood. Many standard therapies do not have this ability, and are only effective against virus in the blood stream.

Good News For Women

Coincidentally, about 12% of participants in Viramune studies were women. This is statistically significant and means that enough women took this drug and there is enough data about its' effects in women's bodies to allow researchers to draw conclusions about how it may or may not work differently for us. The pharmaceutical company promises to do a gender analysis. We look forward to publishing data when it becomes available. Hopefully, this will establish a trend and other studies will make an effort to enroll enough women to gather useful data for and about women with AIDS.

If you are having trouble tolerating the protease inhibitors or simply cannot adjust your life style to accommodate the medicine, you may want to consider a combination therapy with Viramune. Ask your doctor. Remember, do not take Viramune by itself, it could cause more harm than good.

Good News For Kids

"Being Alive" reports that one promising aspect of Viramune is its potential for preventing the passing of HIV infection from woman to newborn. Preliminary data from a study of the administration of a single dose of Viramune to HIV infected pregnant women when they begin labor, followed by a single dose given to the newborn suggests that the drug could be highly useful in this area. Since the drug crosses the placenta easily and is found in the umbilical cord, and remains in the blood stream for a relatively long period of time, Viramune may provide protection against woman-to-infant transmission. This will give HIV infected pregnant women a choice in therapy, and provide a possible alternative to the AZT mono-therapy regimen currently being used.

Women Organized to Respond to Life-threatening Diseases reported in May 1996 - on the high profile pregnancy of HIV positive Rebecca Dennison: "Toward the end of my pregnancy I joined a study. It involved getting one dose of navirapine as I went into labor and giving one dose to the babies 2 days after they were born. ...the good part is that it brings viral load down quickly. Researchers want to find out if giving it to women can reduce perinatal transmission. As a mother, I was interested in the study because it might offer extra protection at the riskiest time - the delivery. As an activist, I was interested in the study because if it works, it's the first treatment to prevent perinatal transmission that I've seen, that would be accessible to women in poor countries. (Two doses of Nevirapine has to be cheaper than the AZT regimen.) ... On the fourth day, we got results from the first PCR tests - Negative for both babies!"

Rebecca and her twin daughters were in Vancouver at the conference. We are happy to report, both Sara & Sophia remain HIV negative. WORLD is published every month. It is a newsletter by, for and about women with HIV/AIDS. Write to them at WORLD, PO Box 11535, Oakland, CA. 94611 or call: 510.658.6930.

Navirapine is currently being studied in children with HIV/AIDS.

For more information on Viramune, and other drugs, call 800.554.4876. For access call 800.595.5494. Viramune should not be combined with protease inhibitors at this time. Studies are underway to see if this is effective and safe.

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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.