Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Information Bulletin #17 - February 2003
The initial studies of Viramune turned out to be poorly planned, and the drug gained a reputation for causing nasty rashes and causing serious liver damage. In most cases, the drug's reputation is worse than its' side effects. There are now new guidelines on recognizing and managing the "one in a thousand" chance of developing a serious liver problem.
Viramune belongs to the class of drugs called "non-nukes", or NNRTIs. The most commonly prescribed NNRTI is Sustiva (efavirenz). With studies showing the ability of Sustiva to decrease viral load, and increase CD4 counts, why take Viramune? Some scientists believe that blood fat and lipodystrophy problems (such as facial wasting, high triglyceride and cholesterol levels, and bulging stomachs, breasts and back humps) are caused by "nukes" or NRTIs, which include drugs like Zerit and Retrovir. Protease inhibitors and Sustiva can also cause blood fat problems, as well as psychological and neurological side effects. There are some compelling studies to suggest that Viramune is a better choice than Sustiva, especially if cholesterol and triglyceride levels (blood fat) are a problem.
The makers of Viramune, Boehringer Ingelheim (BI), will announce the results of an international study comparing Viramune to Sustiva at the upcoming Retrovirus Conference in Boston in February 2003. One part of the study looks at combining Viramune and Sustiva. The study will also look at taking Viramune once daily - a practice that is already common. The NRTI backbone of the Viramune versus Sustiva will be Zerit and Epivir, both taken twice a day.
Considering the beating that the drug Zerit has been taking in study after study, and the fact that once daily dosing of Epivir is a common practice, it would have made more sense to study once a day Viramune versus the new one pill daily Sustiva formulation, and have the backbone be Epivir and Viread.
Is Viramune more liver toxic than other drugs? Liver-related disease is the number one cause of death among people who are HIV-positive. There are three main causes: The effects of antiviral medications on the liver, co-infection with acute or chronic hepatitis or other liver damaging germs, and alcohol or drug use. Viramune, like every other anti-HIV drug used today, has the potential to cause liver damage, including chemical hepatitis.
A very large study of people taking all different types of anti-HIV medications over varying periods of time, showed that the liver damage isn't significantly higher among people who use one anti-HIV drug over the other. It did show, however, that certain drugs, such as Norvir in high doses, and Viramune, are special cases. Norvir is now used mainly as a protease-boosting agent, meaning one or two hundred milligrams are taken a day along with a protease inhibitor such as Crixivan, making it a twice a day drug with no eating restrictions.
Viramune Guidelines In rare cases, Viramune can cause a serious liver problem. The company has developed guidelines to possibly avoid and manage this potential problem. Some people have been taking Viramune for many years, without major complications reported from using the drug. Viramune is no more likely to cause liver problems than any other medication - unless side effects accompany the typical elevation in liver enzymes seen with most HIV drug combinations. When taking Viramune, any symptoms of liver disease, such as right upper quadrant pain or anorexia, could be a serious sign. People with chronic hepatitis B (HBV) probably shouldn't take Viramune. You may develop a rash while taking Viramune. It may just go away, or you may need to treat it. Most Viramune rashes go away. But get your liver enzymes measured right away. Most Viramune rashes are not liver related, but if you have a rash and your liver enzymes go up , or you have liver symptoms, see a doctor immediately. Treatment for a Viramune rash is usually Benadryl, some other type of cream or lotion, or an antianxiety drug. The drug prednisone, which is hard on the liver, actually makes things worse.
An adverse reaction (or bad side effects) from Viramune will usually occur within the first 6 to 12 weeks of starting the drug if it is going to occur. If you're not having symptoms, but your liver enzymes do go up, you and your doctor may decide to just keep taking the drug and monitor your liver more closely. If your liver enzymes go up and you have liver symptoms, such as upper right quadrant pain or anorexia, consult your doctor right away. If you have a severe liver, skin or hypersensitivity (allergic) reaction, stop taking the drug.
Because of the potential side effects that can be caused by the drug abacavir (Ziagen), most notably a potentially life threatening rash, it's not recommended that someone start Viramune and Ziagen at the same time, or even take them together. You wouldn't know if the Viramune or the Ziagen were causing any rashyou may have, and restarting Ziagen (including Trizivir) can be very dangerous.
The Benefits of Viramune Viramune is a drug, like Sustiva, that crosses the blood-brain barrier, an important way to keep any HIV in your brain under control. For some people the side effects of Sustiva are too hard to take. One recent study from France showed that people were still experiencing psychological and cognitive side effects like depression, confusion, memory problems and inability to focus or concentrate three months or more after starting Sustiva. The psychological and neurological side effects - as well as increases in cholesterol - experienced by some people taking Sustiva occur rarely in people taking Viramune. The possible side effects of Viramune are rash and liver events, which about 9% of people taking the drug experience. Fever, nausea and headache have been reported as well. People who take Viramune usually have an increase in CD4 cells, and a decrease in viral load. Although being co-infected with hepatitis B (HBV) or hepatitis C (HCV), or having elevated liver enzymes before starting HIV treatment of any kind is a risk factor for liver problems, some co-infected individuals have taken the drug successfully for many years.
A recent study demonstrated that people who switched from a protease inhibitor containing regimen to a Viramune containing regimen had a significant drop in their blood fats, especially triglycerides. Elevated triglycerides can cause pancreatitis, as well as lead to fatty liver. Fatty liver may lead to insulin resistance and diabetes, and may even lessen the anti-HIV effects of any drug combination you take.
At the same time at least 90% of the people who switched kept their HIV viral load under control (under 50). Several other studies have shown similar results when switching to Viramune from a protease inhibitor, including an increase in the good cholesterol (HDL) ration. In the study, far fewer people stopped taking their new Viramune combination than those taking their protease containing regimens.
The Bottom Line You need to be monitored closely for the first 6 to 12 weeks that you take Viramune. At least 90% of people who take the drug will not have a serious adverse reaction to the drug. The possible side effects of Viramune are rash and liver events, which about nine percent (9%) of people taking the drug experience. You may also experience fever, nausea and headache. People who take the drug usually have an increase in CD4 cells, and a decrease in viral load, but typically not as great as with Sustiva. People who develop a rash on Viramune usually have no liver involvement, but get your liver enzymes checked right away if you do develop a rash.
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