Washington, DC – Genvoya, a four-component combination pill for HIV-1 treatment, was approved today by the U.S. Food and Drug Administration (FDA). It can be used by adults and pediatric patients having 12 years of age and older.
The fixed-dose combination tablet, marketed by Gilead Sciences Inc., based in Foster City, California, contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, and it is expected to work as a daily complete regimen for people suffering the HIV-1 infection.
“While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease,” Gilead CEO John C. Martin said according to 6ABC.
The form of tenofovir that the treatment contains wasn’t approved until now. It works by lowering the levels of the drugs running through the bloodstream, focusing more on the cells that the HIV-1 virus uses to replicate itself. Also, it reduces some of the side effects, lowering the amount of toxins sent to the kidneys and stabilizes the cholesterol in a way that other treatments fail to do.
According to statistics from the Centers for Disease Control and Prevention (CDC), over 1.2 million people from 13 years old and older have the HIV infection, as well as another 150,000 people that are not aware of having it. Although this numbers raised on the past decade, the annual number of new people infected remains stable.
The use of Genvoya is recommended for adults and children — at least 12 years old, and weighing 35 kilograms— who have never taken HIV therapy before, and for those HIV-infected adults that have the HIV-1 virus suppressed. The FDA warns about the dangers of using Genvoya on patients with severe renal impairment.
The safety and efficacy of the treatment were evaluated in more than 3,100 adults that participated in 4 clinical trials. There were two groups: one that received Genvoya and the other that received another FDA-approved treatment, showing that Genvoya was more effective compared to the other regimens.
The treatment will come with a Boxed Warning, alerting patients and doctors of the dangers of applying the regimen. A buildup of lactic acid in the blood, as well as severe liver problems —both potentially fatal— are among the side effects. It also clarifies that can’t be used for treating chronic hepatitis B virus infection.
Other common side effects that Genvoya can produce are kidney problems, decreased bone density, fat redistribution, and changes in the immune system, as well as nausea —being this the most common effect. The FDA encourages doctors and health providers to follow the progress of their patients to contrast this possible side effects.
Source: FDA