FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that new data from the company’s HIV research and development program will be presented at the 23rd International AIDS Conference (AIDS 2020: Virtual) from July 6-10. The breadth of data presented at the meeting, along with Gilead-led symposia and workshops, reflect the company’s commitment to advancing the scientific understanding of HIV prevention, treatment and cure strategies.

“Continued scientific innovation is essential to better understanding and addressing the evolving needs of people living with or at risk for HIV,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “Gilead is actively pursuing innovative cure and long-term viral suppression strategies, while seeking to optimize antiretroviral and prevention therapies for all individuals impacted by HIV. Through the data presented at AIDS 2020: Virtual, we aim to advance care in a transformative way and contribute to the shared goal of ending the HIV/AIDS epidemic.”

Phase 1 trial results supporting further evaluation of a six-month dosing interval for a sustained delivery formulation of Gilead’s novel, investigational HIV-1 capsid inhibitor, lenacapavir (GS-6207), will be presented. Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

HIV treatment data to be presented includes a pooled analysis of four international trials evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; B/F/TAF) in adults aged 65 or older. Additionally, data evaluating the safety and efficacy of an investigational low-dose formulation of E/C/F/TAF (elvitegravir 90 mg/cobicistat 90 mg/emtricitabine 120 mg/tenofovir alafenamide 6 mg) in virologically suppressed children two years or older and weighing 14 to less than 25 kg who are living with HIV will be shared in a late-breaking presentation.

Prevention data around the impact of COVID-19 shelter-in-place orders on pre-exposure prophylaxis (PrEP) access and usage and HIV risk behavior in the United States will be shared in a late-breaking presentation. Data from the ongoing DISCOVER multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg; F/TAF) for PrEP® will also be presented.

Insights from Gilead’s cure research program include an oral presentation on vesatolimod, a toll-like receptor 7 (TLR7) agonist, and dose-dependent immune responses induced in HIV controllers.

Select accepted abstracts are as follows:

Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy® and Descovy for PrEP®.

Lenacapavir (GS-6207), vesatolimod, and the low-dose formulation of E/C/F/TAF are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority. Their safety and efficacy have not been established. In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir (GS-6207) for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.

Biktarvy and Descovy do not prevent other sexually transmitted infections or cure HIV or AIDS.

U.S. Important Safety Information and Indication for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
• New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl)