Gilead Sciences Inc. recently announced that the US Food and Drug Administration (FDA) has given final approval to its single tablet regimen Genvoya for the treatment of HIV-1 infection.

As per the makers of the drug, Genvoya is a full treatment of HIV-1 infection. It could be used in adults, in pediatric patients with 12 years of age and older that have no antiretroviral treatment history.

The drug could also replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen for at least six months. These patients should not have any history of treatment failure and there should be no known substitutions associated with resistance to the individual components of Genvoya.
Experts said that there is no need of dosage adjustment of Genvoya in patients that have creatinine clearance higher than or equal to 30 mL per minute.

The treatment comes with a warning mentioned in a box on the product label that details the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

Another warning on the product label states that the drug can increase lactic acid in the blood and can also cause severe liver problems, which can also be fatal. Boxed warning also alerts that Genvoya is not approved to treat chronic hepatitis B virus infection.

According to its makers, the most common side effect associated with Genvoya is nausea, other serious side effects includes worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system.