HIV Digest	HIV Digest Archive

Ziagen (abacavir sulfate) which is conveniently dosed with one pill twice daily and easily incorporated into multi-drug regimens, is now being marketed for use in combination with other drugs to treat HIV and AIDS. Ziagen becomes the 15th drug approved by the FDA to treat HIV and AIDS and is the first new drug in its class (nucleoside analog reverse transcriptase inhibitors) to be approved in more than three years.

Ziagen has been studied in clinical trials that have included previously untreated patients as well as heavily pre-treated patients. Studies show that combinations containing Ziagen have proven antiviral activity in patients who have not previously received treatment with antiretroviral drugs. Patients who have had prolonged prior exposure to Retrovir (zidovudine; AZT) and Epivir (lamivudine; 3TC) may have a minimal response to combinations containing Ziagen. However, studies have shown some of these patients to have experienced significant antiviral activity as a result of switching to new combinations containing Ziagen. The three drug combination of Ziagen+Epivir+Retrovir was shown to be superior to the combination of Epivir+Retrovir in reducing HIV-1 RNA viral load.

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Ziagen is dosed as one 300-mg tablet twice daily with no food or water restrictions or requirements. In clinical trials to date, the most commonly reported adverse events were headache, nausea, vomiting, malaise and diarrhea when Ziagen was taken, primarily with Epivir and Retrovir but also with all marketed and most investigational compounds. The most serious adverse event associated with Ziagen is a hypersensitivity reaction that can be life threatening and has been fatal in some cases. The hypersensitivity reaction has been observed in approximately 3 to 5 percent of patients receiving Ziagen in clinical trials and is characterized by fever, skin rash, fatigue, and gastrointestinal symptoms, such as nausea, vomiting, diarrhea, or abdominal pain. The symptoms of this reaction get progressively worse if treatment continues. Patients experiencing these symptoms should stop taking Ziagen and contact a physician immediately.

Editor's Note: from various wire service reports and press releases