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Ziagen is a FDA approved anti-HIV drug in the class of drugs called nucleoside analogs (NRTIs). Abacavir is used more frequently in a combination two drug pill called Epzicom, or a three drug pill called Trizivir, although some people just take abacavir. Recent studies have shown that individuals with HLA B*5701 are those who are likely to develop an abacavir hypersensitivity reaction. Ask your doctor about getting the test done before starting Ziagen or Epzicom or Trizivir, to prevent undue anxiety and worrying - as well as a hypersensitivity reaction.

Taking the drug

The recommended dose of Ziagen is one 300 mg pill taken twice a day. Ziagen can be taken with or without food.For people that have already taken NRTI anti-HIV drugs, Ziagen may not always work so well due to drug resistance. The changes in HIV that cause drug resistance are called mutations, and different mutations cause resistance to different drugs. In clinical trials, if a person's HIV already had three or more mutations that made it resistant to other NRTI drugs, Ziagen did not have anti-HIV effect.

A set of rare but serious side effects of nucleoside analog anti-HIV drugs is called lactic acidosis. Severe hepatomegaly with steatosis (an enlarged fatty liver) can also occur. Women, especially those who are oveweight, are particularly at risk. This set of side effects is probably the result of mitochondrial toxicity. Mitochondria are cell's power organs that supply the energy needed for normal cell growth.

Anti-HIV nucleoside analogs impair the function of mitochondria. This can lead to increased acid levels in the blood, and an enlarged fatty liver. The symptoms are severe nausea, shortness of breath and vomiting that does not get better. If you are taking anti-HIV drugs and experience these symptoms, tell your provider immediately.

Side Effect Warning - Hypersensitivity (allergic) reactions to Ziagen have been reported in approximately 3-5% of people in the clinical trials. Symptoms began an average of 11 days after starting the drug. Symptoms were a general sick feeling, low grade fever and nausea, with or without vomiting. There can also be symptoms that affect breathing, such as shortness of breath, cough and sore throat. In some people, a rash appeared 1-3 days after onset of these symptoms. All symptoms resolved within 1-2 days after stopping treatment. If treatment was started again at reduced doses, potentially fatal symptoms developed within hours.

Several study participants who tried to restart Ziagen after having a hypersensitivity reaction had to be hospitalized, and two people died. Study participants are now being told to report any flu-like symptoms with or without rash beginning several days to 4 weeks after starting treatment, and to stop treatment immediately if symptoms occur. Treatment with Ziagen should not be restarted.

Some people have experienced potentially fatal symptoms after restarting Ziagen even though they did not stop the drug due to a hypersensitivity reaction. In these reports, people interrupted treatment with Ziagen for other reasons and were not having problems with Ziagen when they stopped. When they restarted the drug, they developed the same severe life-threatening symptoms as those seen in people who stopped due to an allergic reaction. Several people are thought to have died as a result. Restarting Ziagen after an interruption should be done with extreme caution and only when emergency medical care is easily accessible.

The other side effects that have been seen so far with Ziagen include increased fatigue, changes in liver function tests, headache, abdominal pain, constipation, diarrhea, nausea, vomiting, sleeplessness, skin rash, and dizziness. Taking Ziagen may also lead to a greater risk of heart related conditions. Review the latest FDA information with your doctor.