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Gilead Sciences Demonstrates Commitment to Scientific Innovation In HIV With New Prevention, Treatment and Cure Research Data Presented At AIDS 2020: Virtual

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.

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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:

Investigational Long-Acting HIV Therapy

E-posters – Track B

 

PEB0265: Lenacapavir/GS-6207 Sustained Delivery Formulation Supports 6-Month Dosing Interval

HIV Treatment Research

OAB04 – Antiretrovirals session 2

 

OAB0403: Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged >65 or Older Demonstrating Safety and Efficacy: Week 48 Results

E-posters – Track B

 

PEB0257: Baseline NRTI Resistance in Suppressed Participants Did Not Lead to Viral Blips on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) or Dolutegravir (DTG)+F/TAF Through Week 48 in Study 380-4030

E-posters – Track B

 

PEB0254: Prevalence and Risk Factors of Pre-Existing NNRTI Resistance Among Suppressed PLWH in B/F/TAF Switch Studies

E-posters – Track B

 

PEB0229: The BICSTaR Prospective Cohort: Real-World Effectiveness, Safety and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Routine Clinical Practice in People Living with HIV (PLWH)

Prime channel live sessions – Track D late-breaker abstracts

 

OABLB01: Safety, PK, and Efficacy of Low-dose E/C/F/TAF in Virologically Suppressed Children ≥2 Years Old Living with HIV

HIV Prevention Research

Prime channel live sessions – Track D late-breaker abstracts

 

OADLB01: Impact of COVID-19 Related Shelter-in-Place Orders on PrEP Access, Usage and HIV Risk Behaviors in the United States

E-posters – Track B

 

PEB0165: DISCOVER: Study for HIV Pre-Exposure Prophylaxis (PrEP): No Evidence of Risk Compensation in Participants Taking F/TDF or F/TAF for PrEP Through 96 Weeks

PDB04 – Resistance

 

PDB0404: Deep Sequencing with Unique Molecular Identifiers for Evaluation of HIV-1 Drug Resistance in the DISCOVER Pre-exposure Prophylaxis Trial

PDB03 – Opportunistic infections

 

PDB0303: Persistently High Rates of Sexually Transmitted Infections in the DISCOVER HIV PrEP Trial

HIV Cure Research

OAB02 – ARV, cure and testing strategies

 

OAB0205: Vesatolimod, a Toll-Like Receptor 7 (TLR7) Agonist, Induces Dose-Dependent Immune Responses in HIV Controllers

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

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy.

U.S. Important Safety Information and Indication for Descovy for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication:

Comprehensive management to reduce risks:

Warnings and precautions:

Adverse reactions:

Drug interactions:

Dosage and administration:

U.S. Indication for Descovy for PrEP

Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use:

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, Descovy for PrEP, the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod, and as a result, the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.

These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full Prescribing Information for Biktarvy, and Descovy for PrEP, including BOXED WARNINGS, is available at www.gilead.com

Biktarvy, Descovy, Descovy for PrEP, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Douglas Maffei, PhD, Investors

(650) 522-2739

Brian Plummer, Media

(202) 309-5207

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