Viramune and Women in the News

Viramune (also known by the generic name of nevirapine) is one of the current antiretrovirals used in HIV therapy. Viramune use in women has been in the news lately, for different reasons. First, the FDA recently issued a public health advisory concerning the appropriate use of Viramune in women. The current recommendation is to not start taking Viramune if you are a woman who has more than 250 T-cells unless the benefits clearly outweigh the risks. This warning is because it can be damaging (or toxic) to your liver. Liver toxicity can be asymptomatic, which means that the only way you would know something was wrong is by doing blood tests. Symptomatic Viramune liver toxicity primarily involves a rash, but can also include flu-like illness or fever. This liver toxicity usually occurs fairly quickly, a few weeks after starting the drug. It may result in liver failure and death, despite monitoring of blood tests, which is not characteristic of other antiretrovirals. Here is the breakdown of who is at increased risk while taking Viramune:

• Women overall are three times more likely to develop liver toxicity than men.

• Women with T-cell counts above 250 are twelve times more likely to develop liver toxicity than women with T-cells below 250.
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• Men with T-cell counts above 400 are three times more likely to develop liver toxicity than men with T-cell counts under 400. However, men, as a group, experience less of a problem.

After reading this, you may wonder, "Why would anyone take Viramune?" There are many reasons why it remains an important part of HIV treatment. Remember, the FDA advisory states it should not be used in women with more than 250 T-cells "unless benefits clearly outweigh risks." If you are resistant to other drugs, Viramune may be the only one that will help keep your HIV under control. Yes, liver failure may be fatal. But so is HIV, especially if it is untreated. Other antiretrovirals can have serious side effects, including ones that can lead to death. The possibility of serious health risks while taking any medication can be greatly minimized by paying attention to side effects and seeing your healthcare provider regularly.

There is another important reason to use Viramune. Given in single doses, it can prevent mother-to-child (also called vertical or perinatal) HIV transmission. This is a huge problem in parts of the world where combination therapy is not possible. Of course, in an ideal world, all HIV-positive mothers would have access to combination therapies, for both their health and their children's, but reality is much different. In many places, the need for a simple and inexpensive means to prevent children from being infected is paramount. Such a therapy can easily mean the difference between HIV infection and noninfection for thousands of children. Viramune has been tested in multiple clinical trials and found to be an effective means to prevent children from being born HIV-positive. One such study called HIVNET 012 has been criticized for ethical and regulatory problems. While this is disturbing, these charges don't change the basic fact that Viramune works well in preventing mother-to-child transmission. Recently, the Associated Press published three articles dealing with Viramune. The first two concerned HIVNET 012 and the allegations of the ethical and regulatory problems. The third story was about a pregnant woman who died while she was taking Viramune in combination therapy, not a single dose. The studies conducted using single-dose Viramune, such as HIVNET 012, don't show the liver toxicity problems associated with long-term use. As a matter of fact, the women and babies who took Viramune in HIVNET 012 suffered fewer serious side effects than ones that took AZT. But the timing of the articles (published on three consecutive days) may have served to further confuse the issue in some people's minds.

The bottom line: If you are a woman considering using Viramune, make sure you talk with your healthcare provider. If you start, make sure to have your blood work done on time. Don't skip follow-up appointments and tell your healthcare provider if you have any symptoms.