FDA approves new HIV treatment

The Food and Drug Administration announced that it had approved Gilead Sciences’ Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, or E/C/F/TAF) to treat HIV. It is a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Genvoya – developed from Stribild, an older version of the four drug cocktail – was also given positive recommendation from European health regulators in September. Genvoya is the first TAF-based regimen to receive FDA approval. While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya.

The tablet is meant to be a complete treatment regimen that can be taken once a day.

Genvoya, like other HIV medications, carries what’s called a “black box warning”, which details a few of the extreme adverse events that can happen while on the drug. The company offers financial assistance to patients unable to afford that. The bloodborne disease was once nearly universally fatal, but improving treatments over the past two decades have turned it into a chronic, manageable disease for patients who have access to the medicines. They showed Genvoya reduced blood levels of the HIV virus by about the same amount as the comparison treatments.

According to the Centers for Disease Control and Prevention, an estimated 1.3 million Americans are living with HIV, though a few haven’t been diagnosed yet.

Genvoya has a boxed warning regarding the risks for lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B. Health care providers are advised to monitor patients for kidney and bone side effects.