A nurse tests a blood sample during a free HIV test at a blood tests party, part of a campaign to prevent HIV infection among male same-sex couples, in Bangkok September 20, 2014. Reuters/Athit Perawongmetha

Genvoya, a single-tablet regimen for long-term treatment of HIV has received approval from the US Food and Drug Administration (FDA). It is the first drug with tenofovir alafenamide (TAF) to be approved by the FDA.

The Wall Street Journal reports that the drugmaker, Gilead Sciences say that Genvoya is intended “as a complete regimen for the treatment of HIV-1 infection in adults and children 12 years and older who have no antiretroviral treatment history or to replace a current antiretroviral regimen. ”

Genvoya contains TAF, which has high antiviral efficacy just like Gilead’s Viread HIV treatment (TDF) . Since TAF enters the normal and HIV-infected cells more efficiently than TDF, only a small amount of TAF is required for the antiviral action.

Genvoya is a fixed-dose combination tablet containing cobicistat, emtricitabine, tenofovir alafenamide and elvitegravir. The drug is not recommended for patients with severe renal impairment. However, HIV infected patients with moderate renal impairment can safely take the drug.

“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Edward Cox of the FDA’s Center for Drug Evaluation and Research , in a press release.

A clinical trial involving 3,171 participants was conducted to assess the safety and efficiency of the drug. The subjects were randomly assigned to receive Genvoya or any other FDA approved HIV treatment option. The results showed that Genvoya was more effective in reducing the viral loads in the patients as compared to other approved treatment options.

According to Centers for Disease Control and Prevention, over 1.2 million people aged above 13 are living with HIV infection. In addition, another 150,000 people are unaware of their infection. Although the number of new HIV infections diagnosed each year in the last 10 years has remained relatively stable, the overall number of people with the infection have increased.

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