Gilead Reports FDA-Approved HIV Therapy Demonstrates Long-Term Efficacy

On March 6th, Gilead presented long-term results from two Phase 3 clinical trials for Biktarvy at the Conference on Retroviruses and Opportunistic Infections (CROI). The results showed that Biktarvy successfully maintained viral suppression (HIV-1 RNA <50 copies/mL) for 144 weeks without the viruses resistant to the treatment emerging.

Patients living with the Human Immunodeficiency Virus (HIV) can experience a life-threatening loss of immune cells, which results in the body being unable to fight infections, better known as the Acquired Immunodeficiency Syndrome (AIDS).

As of 2019, there were over 38 million people living with HIV worldwide, over 1.2 million of them live in the US. Currently, there is no current medication that can eradicate HIV, treatment with antiretroviral therapies can suppress viral replication, and prevent the development of AIDS. Over time, the virus can mutate and become resistant to specific antiretrovirals. New antiretrovirals that are proven to provide long-lasting protection, and with low treatment-emergent virological resistance are necessary to provide a better standard of care for people living with HIV.

Biktarvy Studies

Biktarvy was approved by the FDA back in 2018. It is a once-daily single-tablet regimen composed of a dual nucleoside reverse transcriptase inhibitor and an integrase strand transfer inhibitor. It is approved for patients that have never received antiretroviral therapy before or those who are virologically suppressed.

The safety and long-term efficacy of Biktarvy were tested in two randomized, double-blind, active-controlled Phase 3 clinical trials. The results showed that over 98% of patients taking Biktarvy continued to be virologically suppressed, and there was no treatment-emergent resistance during the four-year follow-up period. Making Biktarvy a promising treatment for patients that have developed resistance to other antiretrovirals.

“Gilead is committed to developing innovative HIV treatments, like Biktarvy, that help to address the unmet needs of people living with HIV today, including achieving and maintaining an undetectable viral load over the long-term,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “These data reinforce that Biktarvy provides durable viral suppression, strong efficacy, and a high barrier to resistance in both adults that are new to HIV therapy and those replacing their existing treatment.”

Competition with ViiV’s Cabenuva

Gilead faces headwinds for its HIV treatment portfolio. First, the patent for their blockbuster Pre-Exposure Prophylaxis (PrEP) drug, Truvada, has expired and generic versions are now being sold. Second, ViiV Healthcare, a company primarily owned by GSK, has received approval for Cabenuva, which is the first antiretroviral treatment that does not require daily administration. Cabenuva consists of once-monthly injections of two drugs.

Gilead has been preparing for these challenges not only by testing the long-term efficacy of Biktarvy but by aiming to develop a cure for HIV. They began a collaboration with Gritstone to develop HIV-specific therapeutics vaccines and they have two therapies in Phase 2 clinical trials, two more in Phase 1 trials.

Related Article: Gilead Aspires to Prolong Leadership in HIV Market, Launches Therapeutic Vaccine Quest with Gritstone

Author

Daniel Ojeda