Hello, Genvoya: Gilead does it again with approval of single-dose, once-daily HIV pill
- On Thursday, the FDA approved Gilead's Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for the treatment of HIV-1 infection in adults and pediatric patients aged 12 and older.
- One differentiating feature of this all-in-one combo treatment from other tenofovir-containing regimens is that this drug uses a new form of tenofovir.
- Genvoya carries a boxed warning about possible buildup of lactic acid in the blood, as well as severe liver problems, both of which are potentially fatal.
In the arena of HIV treatment, where the target virus is constantly mutating and developing resistance, the advent of an approved, well-tested treatment is always good news.
Genvoya can be used for treatment-naive patients, as well as treatment-experienced adults whose virus is currently suppressed. Pivotal trials included a total of 3,171 participants, and in those trials, Genvoya was shown to be as effective as other approved treatment regimens in reducing viral loads.
When tenofovir was approved by the FDA as Viread in 2001, it became the backbone for numerous combination regimens and continues to be a cornerstone of treatment. However, it was associated with certain toxicities. This newer version is less toxic than the previous version, making it easier for patients to gain the therapeutic benefits without as much downside, such as loss of bone density. Gilead has proven once again that it has lasting prowess in the antiviral marketplace.