Gilead Announces FDA Approves HIV-1 Treatment Odefsey

Gilead Sciences, Inc., and partner Janssen Sciences Ireland UC, recently announced the US Food and Drug Administration (FDA) has approved its new HIV-1 medication, Odefsey. Odefsey is a combination of four active ingredients, including tenofovir alafenamide (TAF). TAF is a cutting edge version of Viread (another HIV-1 medication) and is extremely effective at less than one-tenth of the typical Viread dose. Odefsey is also the smallest sized pill of all existing one-tablet treatments.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” Gilead chairman and CEO John Martin said. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

The drug comes with a boxed warning about the risk for lactic acidosis/severe hepatomegaly with steatosis, as well as post-treatment acute exacerbation of hepatitis B.

Human Immunodeficiency Virus (HIV) attacks the body’s immune system and eventually destroys the body’s ability to fight off infections or disease. The immune system goes into a progressive decline until it reaches a final stage known as Acquired Immunodeficiency Syndrome (AIDS). There is no cure for HIV or AIDS, but new advances in medications like Odefsey have increased the survival rate and prolonged the lifespan of affected patients.

Because patients are living longer with HIV, there has been a recent push by manufacturers to develop more effective and tolerated drugs. The original HIV medications had to be given in very high doses and had many serious side effects that affected patients’ quality of life. Now that the technology has advanced, patients not only experience higher efficacy rates with fewer adverse effects, they also are able to decrease the number of pills they take each day and how frequently they take them.

Odefsey is indicated in patients 12 years or older who haven’t been on HIV medications before and whose tests show the amount of virus in their system is below a certain threshold. Patients who have had a very low level of virus for at least six months and who meet certain requirements may be switched to Odefsey as their maintenance treatment.

Severe risks for the drug include lactic acidosis (a serious metabolic imbalance from high levels of lactic acid), fatty liver, and flare ups of hepatitis B after treatment.

About the Author

Julie Kaplan, Pharm. D.
Julie Kaplan is a licensed pharmacist in Virginia and the District of Columbia. She received a Bachelor’s of Arts in English from The College of William and Mary and a Doctor of Pharmacy from Virginia Commonwealth University. She has experience in patient communication from working as a retail pharmacist.