FDA Approves Antiretroviral Viread for Use by All HIV Patients Regardless of Treatment History
The FDA on Friday announced its approval for Viread, or tenofovir, an antiretroviral drug that the agency said could be prescribed to all HIV patients regardless of their treatment history, the AP/San Diego Union-Tribune reports. The broader approval was welcomed by Foster City, Calif.-based manufacturer Gilead Sciences and AIDS activists, who "feared" that the FDA might limit use of the drug to only those who had become resistant to other antiretroviral drugs. "This is exactly what we had hoped for," Martin Delaney, founding director of the AIDS advocacy group Project Inform, said, adding, "This is going to be an important drug for AIDS treatment at every stage of the disease" (AP/San Diego Union-Tribune, 10/28). Tenofovir, the only HIV antiretroviral to be approved by FDA so far this year, works by blocking an enzyme needed in the HIV replication process. Gilead tested tenofovir, a once-a-day pill, on HIV-positive patients who had been taking other antiretrovirals for at least five years, most of whom had developed drug resistance and had experienced an increase in viral load. Trial results showed that when paired with other antiretroviral drugs, tenofovir reduced viral load by 75% (Kaiser Daily HIV/AIDS Report, 10/3). Dr. Stephen Becker, a San Francisco-based AIDS specialist who treated patients as part of those clinical trials, said he is not going to prescribe Viread for treatment-naive patients until Gilead releases the results of an ongoing 601-patient trial testing the safety and benefit of the drug in newly diagnosed HIV and AIDS patients. "I would expect the data to be good," he said. Gilead spokesperson Amy Flood said that the company will begin shipping Viread, which will cost $4,135 for a year's supply, to pharmacies this week (Abate, San Francisco Chronicle, 10/27).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.