Smallest Single-Tablet HIV Rx Approved

Sometimes treatments for big diseases come in small packages.

At least that's the case with Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide), Gilead's newly approved treatment for human immunodeficiency virus (HIV). This drug, which the US Food and Drug Administration (FDA) approved last week, is the smallest single-tablet HIV regimen approved to date.

Despite its small size, Odefsey was approved as a complete treatment for HIV for patients older than 12. This medication does not cure or prevent HIV.

HIV is a virus that suppresses the immune system over time. When the immune system becomes too suppressed, and HIV progresses, HIV can lead to acquired immune deficiency syndrome (AIDS). There is no known cure for HIV or AIDS, although medication can help fight the virus.

In studies of Odefsey, the drug appeared similar to other medications already being used to treat HIV.

Odefsey carries a boxed warning. This medication may raise the risk for lactic acidosis, a condition in which too much lactic acid builds up in the bloodstream, which can cause nausea and weakness. The boxed warning also notes that there may be a raised risk of swelling of the liver with steatosis, which is a buildup of fat in the liver. Odefsey may also worsen symptoms of hepatitis B, which is an inflammation of the liver caused by the hepatitis B virus.

As part of a corporate partnership, Gilead and Janssen will co-distribute Odefsey.