New York Times Examines FDA’s Tentative Approval of Aurobindo’s Three-Drug Combination Antiretroviral Treatment for PEPFAR

The New York Times on Thursday examined FDA's tentative approval of Indian drug manufacturer Aurobindo Pharma's generic medication that combines the antiretroviral drugs lamivudine, zidovudine and nevirapine (McNeil, New York Times, 7/6). FDA on Friday granted tentative approval to Aurobindo, which means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief. The new treatment includes a warning that it might cause liver failure, severe rash or acid build-up in the blood (Kaiser Daily HIV/AIDS Report, 7/3). Acting U.S. Global AIDS Coordinator Mark Dybul said the new combination drug will improve treatment for people living with HIV/AIDS in developing countries. Dybul said the twice-daily pill "should facilitate better therapies and better adherence." It is not yet clear how much money the generic combination pill will save, according to the Times. Dybul said he is pleased that the pill does not contain the antiretroviral drug stavudine because that drug is more toxic than other antiretrovirals, and toxicity can be difficult to control in countries where blood and liver tests are infrequent. PEPFAR is the largest provider of antiretrovirals for HIV-positive people in Africa, Asia and the Caribbean, providing treatment for 561,000 people, according to the Times. The Global Fund To Fight AIDS, Tuberculosis and Malaria is the second largest provider of antiretrovirals, providing treatment for 541,000 HIV-positive people, according to Dybul (New York Times, 7/6).