FDA Approves New Treatment for HIV

November 2015 - In the News - FDA Updates

The US Food and Drug Administration (FDA) today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric patients aged ≥12 years.

The Centers for Disease Control and Prevention estimates that 1.2 million persons aged ≥13 years 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, MD, 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 aged ≥12 years weighing ≥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 3171 participants enrolled in 4 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, CA.

US Food and Drug Administration. FDA approves new treatment for HIV. Updated November 5, 2015.

Related Items
Once-Daily Injection Approved for Patients with Type 2 Diabetes
July 2016 - In the News published on July 29, 2016 in FDA Updates
First Oral Regimen FDA Approved for Treatment of Chronic HCV
June 2016 - In the News published on June 29, 2016 in FDA Updates
Nuplazid Approved for Psychosis-Associated Hallucinations in Patients with Parkinson’s Disease
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Approves First Generic Version of Crestor for Multiple Indications in Adults
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Enhances Warnings for Serious Risks of Opioid Analgesics Abuse
April 2016 - In the News published on April 26, 2016 in FDA Updates
Obiltoxaximab FDA-Approved to Treat and Prevent Inhalation Anthrax
March 2016 - In the News published on March 24, 2016 in FDA Updates
FDA Approves First Coagulation Factor-Albumin Fusion Protein to Treat Patients with Hemophilia B
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Briviact to Treat Partial Onset Seizures
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers
January 2016 - In the News published on January 12, 2016 in FDA Updates
FDA Approves Basaglar, the First “Follow-On” Insulin Glargine Product to Treat Diabetes
January 2016 - In the News published on January 6, 2016 in FDA Updates
Last modified: November 9, 2015
  • American Health & Drug Benefits
  • The Journal of Hematology Oncology Pharmacy
  • Lynx CME
  • The Oncology Pharmacist

Search