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AHF Files Brief Against CVS at the U.S. Supreme Court

October 29, 2021 (updated October 29, 2021) Published by BusinessWire

9^th Circuit Court of Appeals ruled earlier that HIV patients may make a discrimination claim under the Affordable Care Act against CVS for requiring HIV patients to use mail-order pharmacies or to go to a few of CVS’s selected specialty pharmacies, where patients say they are not getting full service

In 2018, AHF warned the U.S. Department of Justice that the then-proposed CVS merger with Aetna would create a monopoly-like behemoth that would harm patients, which appears to be the case here with pharmacy choice

WASHINGTON–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF), the largest global AIDS organization, filed a brief of amicus curiae with the Supreme Court of the United States earlier today in CVS Pharmacy, Inc. vs. Doe, a case set to be heard and decided by summer 2022.

In December 2020, the U.S. 9^th Circuit Court of Appeals ruled in Doe vs. CVS Pharmacy, Inc. that people living with HIV can state a discrimination claim under the Affordable Care Act against CVS Pharmacy, Inc., for requiring them to use mail-order pharmacies to obtain HIV/AIDS medications or to go to one of a few designated “specialty” pharmacies that are little more than pick-up stations, as part of in-network pharmacy services for private insurance plans. CVS appealed the ruling and the Supreme Court agreed to hear the case. In its brief, AHF asks the Supreme Court to affirm the earlier judgement of the Ninth Circuit.

“For people living with HIV/AIDS, real specialty pharmacies and pharmacists that focus on HIV/AIDS and in-person treatment provide demonstrably superior care than do mail-order pharmacies and retail pharmacies. We believe that CVS’s denial of choice in pharmacy services for HIV/AIDS patients is both wrong and discriminatory,” said Jonathan M. Eisenberg, Deputy General Counsel — Litigation for AHF.

AHF’s amicus curiae brief focuses on three primary arguments:

That U.S. Statutory Law Requires Courts to Protect People Living with HIV/AIDS from Disability Discrimination by Healthcare Providers,
That Coerced Use of Mail-Order Pharmacies Is Highly Detrimental to People Living with HIV/AIDS, and
That Coercing People Living with HIV/AIDS to Use Mail-Order Pharmacies Is a Disability-Rights Violation, by Both Intent and Impact.

“CVS said to people living with HIV that they can only go to a few of its selected pharmacies and/or be compelled to utilize its PBM’s mail order pharmacies. Patients asserted they weren’t getting full service there, which discriminated against them. They wanted to keep their current pharmacies which provide more comprehensive and specialty services,” said Tom Myers, Chief of Public Affairs and General Counsel for AHF. “We filed this amicus brief to support HIV/AIDS patients’ legal arguments in the case before the Supreme Court and to defend patients’ rights and choice in their pharmacy services.”

The December 2020 9^th Circuit Court ruling validated AHF’s earlier warning of the CVS threat to the HIV response back in 2018. See AHF press statement (Nov. 28, 2018) “CVS-Aetna Merger is Bad for HIV Patients.”

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.

Contacts

MEDIA CONTACTS:

Jonathan M. Eisenberg, Deputy General Counsel–Litigation for AHF +1.323.860.5361 w Jonathan.esienberg@ahf.org
Ged Kenslea, Senior Director, Communications, AHF +1.323.791.5526 [cell] +.323.308.1833 [work] gedk@aidshealth.org
John Hassell, National Director of Advocacy, AHF +1.202.774.4854 [cell] John.hassell@aidshealth.org

Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting

October 29, 2021 (updated October 29, 2021) Published by BusinessWire

– Clinical Data Across a Diverse Range of People Living With HIV on Biktarvy Treatment in the International BICSTaR Study Showed High Effectiveness and High Levels of Adherence –

– Long-Term Switch Data Presented at EACS 2021 Further Establish the Robust and Durable Efficacy Profile of Biktarvy –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 1,135 people living with HIV. The BICSTaR study also collected patient-reported outcomes in routine clinical practice to better understand the impact of treatment on health-related quality of life in people living with HIV. These data were presented at the 18th European AIDS Conference (EACS 2021).

Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at sites in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. The questionnaires assessed patient-reported outcomes covering a range of measures. The results underline the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV.

“Despite advances in antiretroviral therapy, people living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centered care,” said Fernando Bognar, MD, Vice President, Medical Affairs, HIV at Gilead Sciences. “The patient-reported outcomes observed in the BICSTaR study provide a first-hand assessment of the impact of HIV treatment and care on the quality of life that people living with HIV experience. As physicians and people living with HIV look to understand what long-term treatment means to them individually, these data presented at EACS also reinforce that Biktarvy can meet the specific treatment needs of diverse groups of people, including men and women aging with HIV and those with existing comorbid conditions.”

In a second analysis of the BICSTaR study, 97% (n=149/154) of treatment-naïve adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA <50 copies/mL) after one year of treatment. Participants included adults 50 years of age or older, cisgender women, and late presenters (CD4 <200 cells/μl and/or ≥1 AIDS-defining event at baseline). Both treatment-naïve and treatment-experienced participants had high persistence with Biktarvy (91%, n=1032/1135) across both groups, Biktarvy was generally well-tolerated and no resistance to the components of Biktarvy emerged. 148 (13%) participants had any adverse event and 2 (<1%) had a serious adverse event. The most common drug-related adverse events observed to date in the BICSTaR study were weight increase (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhoea (1%) and sleep disorder (1%). These large cohort findings continue to reinforce the real-world effectiveness of Biktarvy across populations and are consistent with evidence from randomized clinical trials.

Additional Biktarvy data presented at EACS 2021 include a Phase 3 trial (Study 1878) that demonstrated the durable efficacy of Biktarvy. In the study, 99% of people living with HIV who switched to Biktarvy from a boosted protease inhibitor-based regimen maintained and achieved long-term viral suppression through a median of 101 weeks (n=525/532), including 98% of participants with pre-existing resistance (n=212/217; median of 108 weeks) and 98% of participants with viral blips (n=39/40; median of 109 weeks), with no treatment-emergent resistance to Biktarvy. A pooled analysis of five Phase 3 studies (1844, 1878, 4030, 4449, 4580) also found that regardless of pre-existing TAMS (thymidine analog-associated mutations M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E), a high proportion of those on Biktarvy were able to maintain virologic suppression and had an absence of treatment-emergent resistance. These data support the continued evaluation of Biktarvy as a potential option for virologically suppressed people living with HIV with known 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.

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.

There is currently no cure for HIV or AIDS.

About BICSTaR

The Bictegravir Single Tablet Regimen (BICSTaR) Study is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people living with HIV. Among the people living with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.

About Biktarvy

Biktarvy is a complete HIV-1 treatment that combines three powerful medicines to form the smallest integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy^® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete single-tablet regimen and should not be taken with other HIV-1 medicines.

In February 2018, the U.S. Food and Drug Administration (FDA) approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg. In October 2021, the FDA approved a new low-dose tablet formulation of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg. For all patient populations, Biktarvy is only indicated for the treatment of HIV-1 infection in people who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
Hepatic impairment: Not recommended in patients with severe hepatic impairment.
Prior to or when initiating: Test patients for HBV infection.
Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Biktarvy; the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy; Gilead’s ability to receive FDA and other regulatory approvals for additional indications for Biktarvy, and the risk that any such approvals, if granted, may have significant limitations on its use; the risk that physicians may not see the benefits of prescribing Biktarvy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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

Biktarvy, Descovy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).

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

Jacquie Ross, Investors

(408) 656-8793

Brian Plummer, Media

(202) 309-5207

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Illinois HIV Care Connect Launches HIV Innovation Campaign

October 5, 2021 (updated October 5, 2021) Published by BusinessWire

SPRINGFIELD, Ill.–(BUSINESS WIRE)–#GTZIL–Illinois HIV Care Connect today launched its HIV Innovation web and social media campaign, showcasing several Illinois HIV initiatives that are helping to prevent or treat HIV more effectively.

Articles about five initiatives so far are located on the HIV Innovation page of hivcareconnect.com. The page features the Getting to Zero Illinois HIV Dashboard, the Central Illinois Friends organization, the Transgender Women Involved in Strategies for Transformation (TWIST) intervention being implemented by the Community Wellness Project in E. St. Louis, RuralHarmony‘s outreach and research effort, and Cicero’s Corazón Community Services. More articles will be added in the coming months.

The #HIVInnovation campaign will be visible on Illinois HIV Care Connect’s Twitter, Facebook and Instagram social media platforms. A quiz relating to the five initiatives offers an easy way to understand how innovative programs are improving the lives of persons living with HIV in Illinois.

The HIV Innovation campaign is Illinois HIV Care Connect’s eighth annual quality improvement initiative, following programs on HIV stigma, HIV and youth, social determinants of health, HIV treatment as prevention, viral suppression, staying in HIV care, and HIV and mental health.

“We chose HIV Innovation to celebrate the important role Illinois continues to play in the HIV arena,” said Jeffery Erdman, the associate executive director of the Illinois Public Health Association, which administers the Illinois HIV Care Connect program. “Illinois is a hub for leading HIV research, legislation, outreach and communication. Throughout the state, we continue to see remarkable innovations in virtually all aspects of HIV prevention and treatment.” Illinois HIV Care Connect is funded by the Illinois Department of Public Health.

About Illinois HIV Care Connect

Illinois HIV Care Connect is a statewide network providing medical case management, health care and support services to people living with HIV. Illinois HIV Care Connect’s eight lead agency offices serve people living with HIV in all of Illinois’ 102 counties. https://hivcareconnect.com

Contacts

Ray Valek, ray@valekco.com, 708-352-8695

City of Hope and Griffith University Researchers Use Novel Method to Block HIV in Mice

September 20, 2021 (updated September 20, 2021) Published by BusinessWire

Scientists developed an anti-HIV protein called ZPAMt that can be delivered to affected areas using exosomes, nanosized parts of cells able to reach difficult-to-access areas of the body, such as the brain.

DUARTE, Calif.–(BUSINESS WIRE)–Researchers at City of Hope, a world-renowned research and treatment organization for cancer and diabetes, and Menzies Health Institute Queensland at Griffith University have developed a novel anti-HIV protein that suppressed HIV levels in the bone marrow, spleen, and brain of mice and prevented the virus from replicating in those regions, according to a new study published in Nature Communications today.

Their research demonstrates that scientists could engineer nanosized parts of cells called exosomes to carry therapeutic cargo to hard-to-reach places, including the nearly impenetrable blood-brain barrier. This innovative delivery system paves the way for a future where it’s conceivable that engineered exosomes could carry cargo that either suppress infectious diseases or restructure genetic material so that pathogens are rendered harmless.

“This innovative technology could become a viable way to deliver therapies not only for HIV but also for other diseases, including ones that affect the brain, such as Alzheimer’s and Parkinson’s,” said Professor Kevin Morris, Ph.D. from City of Hope’s Center for Gene Therapy and Griffith University’s School of Pharmacy and Medical Sciences. Morris is senior author of the new study.

Human immunodeficiency virus attacks cells that help the body fight infection, making an individual more vulnerable to other infections and diseases. Many researchers believe one way to cure HIV is to “block and lock” the disease in a process that obstructs the ability of the virus to replicate and locks it in a dormant state.

“The ZPAMt HIV protein repressor we developed is packaged into exosome nanoparticles and can enter cells where it epigenetically silences HIV,” Morris said. “We show that these nanoparticles can systemically ‘block and lock’ HIV expression. This is the first time that block and lock has been successfully delivered to treat HIV in vivo in the brain.”

HIV can enter the human body in a dormant-like state; it is able to hide from the body’s immune system and evade treatments. Then, it can reactivate later. HIV hiding in the brain is especially difficult to treat because of the blood-brain barrier, which prevents both toxins and therapies from entering the brain.

Currently, there is no cure for HIV, so once someone contracts it, he or she will have it for life. An estimated 1.19 million people in the United States had HIV at the end of 2019, according to the Centers for Disease Control and Prevention.

The research was supported by the National Institutes of Health’s National Institute of Mental Health (R01 113407-01).

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope^TM, a subsidiary launched in 2019, serves employers and their health care partners by providing access to NCI-designated cancer center expertise. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Griffith University

Griffith University is a comprehensive research-intensive university ranked in the top 2% of universities globally with 50,000 students spanning six campuses in South East Queensland, Australia. Its research excellence, innovative teaching and learning practices, and strong industry ties makes it one of the leading providers of higher education in the Asia–Pacific.

Contacts

Zen Vuong

626-409-9367

zvuong@coh.org

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Magellan Rx Management’s AIDS Drug Assistance Program Center of Excellence Expands Program That Significantly Improves Medication Adherence and Quality of Care for Patients with HIV

September 18, 2021 (updated September 18, 2021) Published by BusinessWire

PHOENIX–(BUSINESS WIRE)–Magellan Rx Management, the full-service pharmacy benefits management division of Magellan Health, Inc. (NASDAQ: MGLN) has expanded Navigate Whole Health to include the AIDS Drug Assistance Program (ADAP) that applies an innovative and comprehensive approach to managing the quality of care for persons receiving treatment for HIV. Through the program, clinical pharmacists partner with providers to manage complex cases by promoting best-practices for HIV treatment and closing care gaps. The Navigate Whole Health ADAP program also supports participating ADAPs in meeting Health Resources & Services Administration (HRSA) performance measures.

“Navigate Whole Health ADAP offers a unique opportunity to support participating ADAP customers, providers and their members by concentrating on HIV/AIDS treatments, comorbid chronic diseases, behavioral health conditions, and social determinants that interfere with outcomes,” said Caroline Carney, MD, chief medical officer, Magellan Health. “We are using data science to tailor interventions to deliver the right supports to prevent interruptions in therapy and address behavioral healthcare, including depression and substance abuse.”

Adherence to antiretroviral therapy (ART) is critical to reducing viral load, transmission, and resistance. For most patients, nearly perfect (>95 percent) adherence is necessary to achieve optimal viral suppression and clinical success. However, the national average rate of adherence to ART is around 70 percent, and the total annual unadjusted costs per patient for non-adherence to HIV ART therapy ranged from $16,957 to $30,068.^1,2

The Navigate Whole Health ADAP pilot program was conducted for nine months. An analysis of the first three months of intervention shows a 26.7 percent increase in HIV/ART medication adherence in six months post intervention. This program also addresses behavioral concerns, like depression, and achieved a 60 percent increase in members being adherent to their antidepressant medication adherence. “It is particularly encouraging to note that 100% of the recommendations made by Magellan clinical team were accepted by prescribers,” says Astha Chopra, vice president, clinical effectiveness, Magellan Health.

ADAP Center of Excellence

Magellan Rx established a national ADAP Center of Excellence (COE) with a dedicated call center to provide timely service and continuity of care. The dedicated ADAP team provides a multi-faceted approach to State ADAP programs across the country with a best-in class operating paradigm to help improve patient outcomes and prevent HIV. Navigate ADAP is one of the ways the Magellan Rx ADAP COE helps improve clinical quality for ADAP members.

“With over three decades of experience in serving some of the largest state ADAP programs, our Magellan team is deeply invested in the national effort to combat AIDS and the HIV epidemic through education, awareness, research and access to medications for those living with the disease. We invested in the Center of Excellence to leverage significant expertise on behalf of all our ADAP customers and their members. This program is one of many examples of our commitment to this work.” Meredith Delk, general manager and senior vice president, government markets, Magellan Rx Management.

About Magellan Rx Management: Magellan Rx Management, a division of Magellan Health, Inc., is shaping the future of pharmacy. As a next-generation pharmacy organization, we deliver meaningful solutions to the people we serve. As pioneers in specialty drug management, industry leaders in Medicaid pharmacy programs and disruptors in pharmacy benefit management, we partner with our customers and members to deliver a best-in-class healthcare experience.

About Magellan Health: Magellan Health, Inc., is a leader in managing the fastest growing, most complex areas of health, including special populations, complete pharmacy benefits and other specialty areas of healthcare. Magellan supports innovative ways of accessing better health through technology, while remaining focused on the critical personal relationships that are necessary to achieve a healthy, vibrant life. Magellan’s customers include health plans and other managed care organizations, employers, labor unions, various military and governmental agencies and third-party administrators. For more information, visit MagellanHealth.com.

1.		Machtinger EL, Bangsberg DR. Adherence to HIV Antiretroviral Therapy. HIV in Site Knowledge Base Chapter; May. 2005. [Accessed on 2021 Mar 16]. Content Reviewed; January 2006. http://hivinsite.ucsf.edu/InSite?page=kb-03-02-09.
2.		Cutler RL, Fernandez-Llimos F, Frommer M, Benrimoj C, Garcia-Cardenas V. Economic impact of medication non-adherence by disease groups: a systematic review. BMJ Open. 2018;8(1):e016982. Published 2018 Jan 21. doi:10.1136/bmjopen-2017-016982

(MGLN-GEN)

Contacts

Media: Lilly Ackley, ackleyl@magellanhealth.com, (860) 507-1923

Investor: Darren Lehrich, lehrichd@magellanhealth.com, (860) 507-1814

Gilead to Present New Data at IAS 2021 Demonstrating the Company’s Commitment to Advancing Innovation in HIV Research

July 13, 2021 (updated July 13, 2021) Published by BusinessWire

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming contributions to the 11^th 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^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve 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-naïve 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^®, 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 Randomized Switch 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-Naïve Adults Living With HIV Through Four Years of Follow-Up

Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials

Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults 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 a Combination Regimen in Treatment-Naïve People With HIV: Interim 16-Week Results of a Randomized, Open-Label, Phase 2 Induction-Maintenance Study (CALIBRATE)

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

HIV Cure Research

Proteomic Evidence of Vesatolimod-Induced Enhancement of “Cross-talk” Between Innate 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 48 Results From the DISCOVER Open Label Phase

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

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

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

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^®and Descovy for PrEP^®.

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.

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 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: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate Biktarvy in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Biktarvy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1.
Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
Renal impairment: Not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history.
Hepatic impairment: Not recommended in patients with severe hepatic impairment.
Prior to or when initiating: Test patients for HBV infection.
Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

Pregnancy: There is insufficient human data on the use of Biktarvy during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using Biktarvy during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

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:

Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

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

Descovy for PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate
(FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
Severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of Descovy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue Descovy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindication:

Descovy for PrEP is contraindicated in patients with unknown or positive HIV status.

Comprehensive management to reduce risks:

Use Descovy for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs).
Reduce potential for drug resistance: Only prescribe Descovy for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Descovy, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Descovy because Descovy alone is not a complete regimen for treating HIV-1.
- Some HIV tests may not detect acute HIV infection. Prior to initiating Descovy for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
- If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Descovy for PrEP, convert the Descovy for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.

Warnings and precautions:

New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section).

Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions:

Most common adverse reactions (≥2%) in the Descovy for PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain.

Drug interactions:

Prescribing information: Consult the full Prescribing Information for Descovy for more information, warnings, and potentially significant drug interactions, including clinical comments.
Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of Descovy. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy.
Drugs affecting renal function: Coadministration of Descovy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration:

Dosage: One tablet taken once daily with or without food.
HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section).
HBV screening: Test for HBV infection prior to or when initiating Descovy.
Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

About Gilead Sciences

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; the possibility of unfavorable results from such ongoing and additional clinical trials; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and vesatolimod and as a result, these compounds may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including marketing approvals of lenacapavir and vesatolimod, and the risk that any such approvals, if granted, may have significant limitations on its use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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

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

Contacts

Jacquie Ross, Investors

+1 (650) 358-1054

Brian Plummer, Media

+1 (202) 309-5207

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

June 28, 2021 (updated June 28, 2021) Published by BusinessWire

– If Approved, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Every 6 Months –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. Key data on lenacapavir will be presented during the 11th International AIDS Society (IAS) Conference on HIV Science in July 2021.

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. Lenacapavir, which is being studied as an every-six-month subcutaneous injection, is a potential first-in-class capsid inhibitor for the treatment of HIV-1 infection without overlapping resistance with any currently approved antiretroviral therapy (ART).

“Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV.”

Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with MDR HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is designed to inhibit HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation.

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3 double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir administered every 6 months as a subcutaneous injection in HTE people with MDR HIV-1 infection. CAPELLA includes men and women living with HIV-1 and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. The primary endpoint was the proportion of participants randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥ 0.5 log₁₀ copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

The study achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log₁₀ copies/mL from baseline compared with those receiving placebo during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). Those who received lenacapavir (n=24) achieved statistically significantly greater mean decrease in viral load than those who received placebo (n=12) during the functional monotherapy period (-1.93 log₁₀ copies/mL vs. -0.29 log₁₀ copies/mL, p<0.0001). Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events. The most common adverse events observed were injection site reactions.

Following the 14-day functional monotherapy period, participants who were randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The trial data for the first six-month period (Week 26) have been submitted to the FDA as part of the NDA filing, and will be presented at an upcoming conference.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068.

About Lenacapavir

Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir’s multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes.

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from a completed Phase 1 study support further evaluation of lenacapavir administered subcutaneously every six-month for both HIV-1 treatment and prevention. During IDWeek 2020, the company announced plans to evaluate the use of lenacapavir as an injectable PrEP option administered every six months among cisgender women, men who have sex with men and persons of trans experience. The prevention trials have projected initiation dates in 2021.

About Gilead Sciences

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving lenacapavir; the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving lenacapavir; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA, European Medicines Agency or other regulatory approval of lenacapavir, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and that, as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

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

Jacquie Ross, Investors

(650) 358-1054

Brian Plummer, Media

(202) 309-5207

Tag: HIV Treatment

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