Benzinga | Jul 12, 2021 07:34AM EDT

Gilead To Present Abstracts At IAS 2021

Gilead Sciences, Inc. (NASDAQ:GILD) today announced the company's upcoming contributions to the 11th International AIDS Society (IAS) Conference on HIV Science, taking place virtually from July 18-21. Thirty-one abstracts reflect Gilead's ongoing commitment to scientific innovation, a key pillar to addressing unmet needs in HIV treatment and prevention. Beyond presenting new scientific data from the company's HIV research and development programs, Gilead will convene a symposium featuring a diverse, global panel of leading HIV researchers and people living with HIV, to discuss potential clinical pathways to achieve a functional cure and community perspectives on the process.

"Continued scientific innovation is essential to helping end the global HIV epidemic and we are committed to advancing the next generation of therapies to improve the care of people and communities impacted by this disease," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Our data at this year's meeting demonstrate the important scientific advancements we are making to help address critical unmet needs for people with HIV and those who could benefit from PrEP medicines."

Presentations from Gilead's HIV research program will include:

* A pooled analysis of 192-week data from open-label extension periods of two Phase 3 trials evaluating the once-daily, single tablet regimen, Biktarvy(r) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-na?ve adults living with HIV

* 72-week data from the BRAAVE trial evaluating the safety and efficacy of switching to Biktarvy in Black or African American adults who are virologically supressed

* Data from the Phase 2/3 CAPELLA trial evaluating the company's investigational, long-acting subcutaneously administered HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people living with multidrug resistant HIV

* Interim Phase 2 data from the open-label CALIBRATE trial evaluating the safety and efficacy of lenacapavir as an investigational, long-acting HIV capsid inhibitor in combination with other antiretroviral agents in treatment-na?ve people living with HIV

* Data from a Phase 1b trial examining the impact from the investigational TLR7 agonist, vesatolimod, between certain immune responses in people living with HIV on antiretroviral therapy

* Prevention research, including data exploring adherence to PrEP medicines among new PrEP users initiating Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP(r), real-world utilization of PrEP medicines during the COVID-19 pandemic and the safety and efficacy profile of Descovy for PrEP, as well as the use of novel study designs for HIV prevention trials

Select accepted abstracts are as follows:

HIV Treatment Research

Week 72 Outcomes and COVID-19 Impact From the BRAAVE 2020 Study: A RandomizedSwitch to B/F/TAF in African American Adults Living With HIV

Long-Term Efficacy Among Participants Switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) With Pre-Existing Resistance and Viral Blips

Long-Term Analysis of B/F/TAF in Treatment-Nai:ve Adults Living With HIVThrough Four Years of Follow-Up

Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Nai:ve ClinicalTrials

Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) inAdults Aged 65 Years or Older: Week 96 Results From an International, Phase 3b,Open-Label Trial

Investigational Long-Acting HIV Treatment Research (Lenacapavir)

Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as Part of aCombination Regimen in Treatment-Nai:ve People With HIV: Interim 16-WeekResults of a Randomized, Open-Label, Phase 2 Induction-Maintenance Study(CALIBRATE)

Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 inHeavily Treatment-Experienced People With HIV: Week 26 Results (CAPELLA)

HIV Cure Research

Proteomic Evidence of Vesatolimod-Induced Enhancement of "Cross-talk" BetweenInnate and Adaptive Immune Cells in HIV Controllers on ART

HIV Prevention Research

Outcomes of Participants Switching from F/TDF to F/TAF for PrEP: Week 48Results From the DISCOVER Open Label Phase

Comparing Adherence to HIV Pre-Exposure Prophylaxis (PrEP) Among New, Male PrEPUsers Initiating F/TAF vs. F/TDF

Real-World Utilization of F/TDF and F/TAF for HIV Pre-Exposure ProphylaxisDuring the COVID-19 Pandemic in the U.S., December 2019 ? June 2020

HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEPTrials

For more information, including a complete list of abstracts, please visit: https://www.ias2021.org/the-programme.

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

Lenacapavir and vesatolimod are investigational compounds and are not approved by the U.S. Food & Drug Administration or any regulatory authority for any use. Their safety and efficacy have not been established. 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 a history of treatment failure or 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 currently no cure for HIV or AIDS.