Biopharmaceutical firm Gilead Sciences Inc. said it has received approval from the US Food and Drug Administration (FDA) to market its antiretroviral agent Viread (tenofovir disoproxil fumarate) for the treatment of HIV in combination with other antiretroviral agents.
Like Viread, such drugs work by blocking the process needed for HIV replication in the body. But Viread is the first nucleotide analogue reverse transcriptase inhibitor to be approved for treatment of HIV in the US. As a result, it may offer a treatment option for patients whose infections have become resistant to currently available medications.
Foster City, California-based Gilead said that the 300 milligram tablet should be available within a few days. The company added that the once-a-day drug would be indicated for use in combination with other antiretroviral agents for the treatment of previously diagnosed patients.
In clinical trials, Viread reduced the level of circulating HIV by about 75%. The most common side effects included nausea, diarrhea, vomiting and flatulence. The drug has demonstrated a significant antiviral response, even in patients who may no longer respond well to available therapies due to the development of viral resistance.