The Food and Drug Administration (FDA) in the U.S. has granted approval for a three-ingredient fixed dose tablet for use as an antiretroviral treatment for human immunodeficiency virus (HIV-1) infection in adults.
The drug contains lamivudine, zidovudine and nevirapine, the active ingredients in the currently widely used antiretroviral drugs Epivir, Retrovir, and Viramune and the recommended dose is one pill twice a day.
The FDA hopes the new pill will make it easier for patients to stick with their treatments.
The drug, made by Indian company Aurobindo Pharma has received tentative Food and Drug Administration approval for use in a global relief plan and will provide HIV/AIDS drugs in 15 countries.
The FDA believes the drug will be of particular use in poor countries where patients find it difficult to afford and manage taking multiple drug cocktails every day to keep the HIV virus in check.
Dr. Murray Lumpkin, FDA deputy commissioner for international and special programs, says it has been a goal to have the ability to treat patients adequately with a very few number of tablets per day.
Interrupting HIV-drug treatment can give the virus a chance to evolve and resist the medicine.
The new drug will however carry a warning that it may cause liver failure, a severe rash and a build-up of acid in the blood.
The combination product cannot be sold in the United States because the ingredients are protected by drug makers’ patents; only the individual components are available in the United States.
In 2004, FDA issued a guidance encouraging manufacturers to develop fixed dose combination and co-packaged products consisting of previously approved antiretroviral therapies for the treatment of HIV infection.
Dr. Scott Gottlieb, FDA Deputy Commissioner for Medical and Scientific Affairs says ‘using a fixed dose combinations in developing countries may provide an added advantage by improving the patient’s ability to tolerate the treatment and better adhere to treatment regimens that will help minimize the development of viral resistance and result in long-term effective control of the disease’.
The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two week treatment with the individual components taken individually.
Revision date: July 7, 2011
Last revised: by Jorge P. Ribeiro, MD