The US Food and Drug Administration (FDA) has approved the sales of Genvoya, a 4-in-1 combination drug manufactured by Gilead Sciences, top maker of HIV drugs.
Genvoya is approved for the treatment of HIV so that it remains manageable and does not lead to full-blown AIDS.
To be taken only once a day, the drug combines Vitekta, Tybost, and Emtriva – three HIV drugs already produced by Gilead. There is also tenofovir, the main component of Viread, which Gilead has widely sold as HIV medication.
Added to these is tenofovir alafenamide, a chemical that delivers the drugs directly into the body cells where HIV virus tends to replicate itself. When drugs are delivered inside cells, it reduces the amount of drugs within the bloodstream, and this in turn reduces the chances of kidney damage and compromised bone density among other side effects.
Patients taking Genvoya must also be aware they could develop side effects such as liver problems and accumulation of lactic acid in the blood; and therefore must be watched by physicians for these side effects which could be severe in certain cases.
It needs to be pointed out that the drug can also cause redistribution of body fat as well as alterations to the immune system, while also capable of interacting with other medicines.
Due to these serious side effects, the FDA’s black box warning has been affixed to the drug packet as a form of serious warning.
It costs about $31,362 annually to use Genvoya, just about the same price for Stribild, an earlier 4-in-1 HIV drug sold by Gilead. But then, the drugmaker intends to provide financial help to patients who cannot afford the cost of the drug.
Gilead is getting to depend more on tenofovir alafenamide in its HIV treatments, and the company has two other drugs that has the chemical; both drugs are under review by the FDA.
Gilead CEO John C. Martin noted that although great achievements have been made in producing HIV drugs, more should still be done in treatment options that improve the health of aging patients who have the disease.
At the moment, the CDC estimates that about 1.3 million people in the US have HIV, but the number could actually be higher than this because thousands others remain undiagnosed yet.