The US Food and Drug Administration (FDA) announced the approval of a new HIV treatment drug for adults and children to be released in the healthcare market.
The drug, Genvoya, manufactured by pharmaceutical company Gilead Sciences, is a fixed-dose tablet containing a combination of four different drugs. It is meant to be a complete Human Immunodeficiency Virus (HIV) treatment regimen for adults and for children 12 years and older.
"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 Dr. Edward Cox of the FDA's Center for Drug Evaluation and Research in the agency's press release.
Genvoya is approved for use in treating pediatric patients who weigh at least 77 pounds, patients who have never taken an HIV treatment and adults whose HIV-1 virus is currently suppressed.
Gilead conducted four clinical trials involving nearly 3,200 patients from 21 countries. Results showed that Genvoya was more effective in reducing viral loads compared to other available HIV treatment regimens.
The drug works by entering the patient's cells, including those already infected with HIV, preventing HIV replication. Genvoya, however, is not recommended for patients with severe renal impairment and should be used with caution on patients with moderate renal problems.
Genvoya also carries a boxed warning, informing prescribers and patients that taking the drug can cause severe liver damage and a buildup of lactic acid in the blood, both of which are considered to be fatal adverse effects. Nausea is to be expected while taking Genvoya; though more serious side effects like immune system changes, decreased bone mineral density and kidney problems may also occur.
Still, given the drug's effectiveness, Gilead believes that Genvoya can offer patients more viable options for treating and managing their HIV infections.
"Genvoya represents an important new treatment option for...patients who are either new to therapy or who choose to switch treatments," said Dr. David Wohl, lead author of the Genvoya efficacy analysis and a professor of Medicine at the University of North Carolina.
Wohl added that as HIV patient population grows older, there is an increased risk for them to develop co-morbidities brought about by age and treatment. Having other options for treating their condition may be able to help them manage HIV while gaining improved quality of life.
