In the trial backed by Johnson & Johnson and GlaxoSmithKline, people living with the virus were given a shot containing two drugs every four or eight weeks. At both intervals, the shot worked just as well as people who were taking three pills per day to suppress their virus, Reuters reports.
Paul Stoffels, head of pharmaceuticals at Johnson & Johnson, told Reuters that the findings were “transformational” in the fight against HIV. Stoffels said he believed the long-acting injection could help improve the lives of those living with HIV by 2020.
The numbers: The study found that 94% of participants who received the monthly injection were viral suppressed 32 weeks into the trial, and 95% or those who got the shot every two months. By comparison, 91% of people on pill-based regimens achieved an undetectable viral load, according to Reuters.
The human immunodeficiency virus takes over a body’s white blood cells and turns them into factories that make more HIV. Those white blood cells, which fight off disease, are no longer able to do so. The number of viral copies in a person’s body is called someone’s viral load.
When HIV treatment is successful, a person is considered to be HIV undetectable, meaning the amount of virus in their blood is not able to be detected by many tests. Being HIV undetectable significantly reduces the chance of transmitting the virus.
New Single-Tablet HIV Treatment Wins FDA Approval.
In another related development, the U.S. Food and Drug Administration has approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable.
“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, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Genvoya is approved for use in HIV-infected adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed. While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya.
Genvoya’s safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.
Genvoya contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures. Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.
Genvoya carries a Boxed Warning alerting patients and health care providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. The Boxed Warning also states that Genvoya is not approved to treat chronic hepatitis B virus infection. The most common side effect associated with Genvoya is nausea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome). Health care providers are advised to monitor patients for kidney and bone side effects. Genvoya should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications.
Genvoya is marketed by Gilead Sciences Inc. based in Foster City, California.
