– 19 Abstracts Will Feature the Latest Advances in the Company’s HIV, COVID-19 and Viral Hepatitis Research Programs –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new data from the company’s HIV, hepatitis C virus (HCV), and COVID-19 research and development programs at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021) taking place from March 6-10. The breadth of data at the meeting reflects Gilead’s longstanding commitment to applying its scientific innovation toward addressing some of the world’s most challenging viruses and advancing global health.

“The impact of COVID-19 on its own has been devastating for public health, and the disruption to the healthcare system and worsening health inequity driven by the pandemic are threatening to set back efforts to end the HIV epidemic and the hard-won progress toward HCV elimination,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “Now more than ever, there is an urgent need to accelerate and advance innovative antiviral research to help prevent transmission and provide a portfolio of therapeutic options for those affected. The data we will present at CROI 2021 demonstrate the important scientific advancements we have made to help address the needs of people living with HIV and HCV, and those affected by COVID-19.”

HIV Research

At CROI 2021, Gilead will share new findings on daily and long-acting HIV prevention and treatment strategies, as well as updates from the company’s continued pursuit of a cure for HIV.

Data will include Phase 2/3 CAPELLA trial results evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug resistant HIV-1 infection. The company will also present data from a pre-clinical study evaluating lenacapavir for HIV pre-exposure prophylaxis (PrEP).

Insights from Gilead’s cure research program include new data on vesatolimod, an investigational toll-like receptor 7 (TLR7) agonist, as well as analyses of analytical treatment interruption studies using mathematical modelling techniques and approaches for assessing broadly neutralizing antibodies (bNAbs) sensitivity.

HIV treatment research includes long-term data from two Phase 3 studies (Study 1489 and Study 1490) that demonstrated the safety and efficacy profile of the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) compared with dolutegravir (DTG)-containing regimens for the treatment of HIV-1 infection in treatment-naïve adults. The data include a sub-analysis in participants with certain transmitted drug resistance and cumulative outcomes from an open-label extension (OLE) phase of two Phase 3 studies evaluating treatment outcomes in participants who initiated therapy with Biktarvy and those who switched to Biktarvy from a DTG-containing regimen.

HCV Research

Results from the ACTG A5360 Study will be presented on the minimal monitoring (MINMON) approach to HCV treatment with Epclusa® (400 mg sofosbuvir/100 mg velpatasvir) across a range of settings and in key populations most impacted by the virus.

Please refer to the full Prescribing Information for complete monitoring information for Epclusa.

COVID-19 Research

Gilead will also present preliminary data from the ongoing Phase 2/3 CARAVAN study evaluating the safety and efficacy of Veklury® (remdesivir) for the treatment of hospitalized pediatric patients two months to 17 years of age. Additional data from an open-label, Phase 3 trial evaluating Veklury's impact on kidney function in patients with moderate COVID-19 will also be presented. Veklury is the only approved antiviral for the treatment of COVID-19.

Select accepted abstracts are as follows:

For more information, including a complete list of abstracts, click here.

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

Lenacapavir and vesatolimod are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. In May 2019, 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.

The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

There is no cure for HIV or AIDS.

U.S. Important Safety Information 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)