FDA Approves Once-Daily Dose of Bristol-Myers Squibb’s Sustiva

The FDA announced yesterday that it has approved a once-daily 600 mg tablet of Bristol-Myers Squibb's antiretroviral drug Sustiva, Reuters/New York Times reports. Bristol-Myers said that the new single pill will be easier for HIV/AIDS patients to take than the current regimen of three 200 mg pills taken together once daily (Reuters/New York Times, 2/5). "It is clear that one of the major issues associated with HIV therapy is the frequency and amount of pills patients take. Our aim at BMS is to enable the creation of a range of simple once-daily regimen options," Jeffrey Hatfield, senior vice president of BMS Virology, said, noting that the one-pill dosing will help patients "better adhere" to their treatment regimens. Dr. Brian Boyle, an assistant professor at Cornell University's Weill Medical College, added that the new pill will be a "cornerstone" of once-daily treatment. The new form of Sustiva -- a non-nucleoside reverse transcriptase inhibitor sold in Europe as Stocrin -- will be available by the end of the month in 30-tablet bottles. However, the company will also continue to manufacture and sell Sustiva, known under the generic name efavirenz, in 200 mg tablets for patients who prefer to take three pills. Last year, HHS in its HIV treatment guidelines for adults and adolescents listed Sustiva as the only NNRTI "strongly recommended" as part of a "first-line" combination therapy (BMS release, 2/4).