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Viread OK’d for Treating HIV With Other Antiretrovirals

Viread OK’d for Treating HIV With Other Antiretrovirals

ROCKVILLE, Maryland—The Food and Drug Administration has approved
Viread (tenofovir disoproxil fumarate, Gilead Sciences, Inc.) for the treatment
of HIV-1 infection in combination with other antiretroviral agents. Viread, a
nucleotide analog, remains in cells longer than other antiretrovirals, which
enables a dosage of 300 mg taken once a day in tablet form.

Viread’s approval marks the first entry of a nucleotide analog reverse
transcriptase inhibitor into the HIV-medication market. Nucleotide analogs are
similar to nucleoside analogs and inhibit HIV replication in the same way, by
blocking the enzyme reverse transcriptase. The FDA action occurred 6 months
after Gilead submitted its new drug application to the FDA.

The drug won marketing approval based on data the FDA reviewed from two
clinical studies submitted by the sponsor that involved more than 700 patients.
One was a 24-week, phase III, placebo-controlled trial; the other was a 48-week
controlled dose-ranging trial.

"Patients who received Viread showed significant decreases in the
quantities of HIV RNA in their blood, compared to patients who received a
placebo with the standard antiretroviral regimen," the FDA said in
announcing the approval.

Both clinical trials enrolled patients previously treated with
antiretroviral drugs. As a result, the risk-benefit ratio for patients who have
not had antiretroviral therapy remains unknown.

Gilead said that an ongoing clinical trial is evaluating Viread in 601
treatment-naïve HIV patients who will receive the drug for 96 weeks in
combination with lamivudine (Epivir) and efavirenz (Sustiva). Controls will
receive stavudine (Zerit), lamivudine, and efavirenz. Safety and efficacy data
for the first 48 weeks of the trial will become available in the first half of
2002.

The FDA noted that there are no Viread study results to show a long-term
inhibition of HIV progression.

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