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“Novel Investigational Combination Regimen is Advancing to Phase 3 and has the Potential to Become the First Weekly Oral HIV Treatment”
FOSTER CITY, Calif., & RAHWAY, N.J.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced significant findings from a Phase 2 clinical trial assessing the combination of islatravir, an experimental nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a novel HIV-1 capsid inhibitor. These results were unveiled during an oral presentation at IDWeek 2024, held in Los Angeles and online from October 16-19.
After 48 weeks of treatment, the investigational combination demonstrated a strong rate (n=49; 94.2%) of viral suppression, maintaining low levels of HIV-1 RNA.
Dr. Jared Baeten, Senior Vice President and Head of the Virology Therapeutic Area at Gilead Sciences, emphasized the importance of a person-centered approach to HIV treatment, highlighting the need for flexible long-acting options designed to cater to the unique requirements and preferences of individuals facing HIV. He remarked, “There is no ‘one size fits all’ approach. The complexities of HIV care require fostering innovations prioritizing people as we strive to expand options for all living with HIV.” The findings shared at IDWeek underscore his commitment to ongoing scientific advancements that could reshape the HIV treatment landscape.
This open-label, active-controlled study (NCT05052996) enrolled virologically suppressed adults (n=104) currently on Biktarvy® (a combination treatment of bictegravir, emtricitabine, and tenofovir alafenamide). Participants were randomized 1:1 to receive either the weekly regimen of oral islatravir 2 mg and lenacapavir 300 mg (n=52) or continue with their daily Biktarvy regimen (n=52). The median age of participants was 40 years (ranging from 20 to 76), with 18% assigned female at birth, 50% identifying as non-white, and 29% as Latine.
In terms of treatment-related adverse events (TRAEs), 19.2% of participants in the ISL + LEN group experienced such events, with the most common being dry mouth and nausea, each affecting 3.8% of participants. In contrast, only 5.8% of the Biktarvy group reported TRAEs. Notably, no severe (grade 3 or 4) TRAEs related to study drugs were reported in either group, although two participants discontinued ISL + LEN due to unrelated adverse events. Throughout the trial, there were no significant differences observed between the two treatment groups concerning changes in CD4+ T-cell counts or absolute lymphocyte counts, and no participants ceased treatment due to reductions in these counts.
Dr. Elizabeth Rhee, Vice President of Global Clinical Development at Merck Research Laboratories, noted, “While daily single-tablet regimens have revolutionized HIV care, maintaining adherence can be difficult for some. Innovative treatment options that reduce the frequency of dosing could enhance adherence and alleviate stigma associated with daily therapy.” She expressed satisfaction with the promising results after 48 weeks for the once-weekly oral combination regimen, paving the way for phase 3 clinical trials to follow in collaboration with Gilead.
The robust antiviral activities and pharmacokinetic profiles of islatravir and lenacapavir lend further credibility to their development as a potential once-weekly oral combination regimen for those living with HIV. The combination of ISL 2 mg and LEN 300 mg is currently undergoing evaluation in two Phase 3 studies (NCT06630286 and NCT06630299) specifically targeting virologically suppressed populations.
It is important to note that islatravir combined with lenacapavir remains investigational and has not received approval anywhere globally. As a result, the efficacy and safety profile of this combination therapy has not been definitively established.
Lenacapavir is also under investigation in various early and late-stage clinical trials, aiming to present a range of personalized treatment possibilities that adapt to the lifestyles of individuals managing HIV. Again, its use in treating virologically suppressed patients remains investigational and has not yet achieved global approval.
For more information about Biktarvy’s U.S. indication and important safety information, including boxed warnings, please review the relevant documentation.
Currently, there is no cure for HIV or AIDS.
About Islatravir (MK-8591) and Merck’s HIV Research
Islatravir (MK-8591) is Merck’s candidate nucleoside reverse transcriptase translocation inhibitor (NRTTI) being evaluated in multiple clinical studies in conjunction with other antiretrovirals for the treatment of HIV-1. The trials exploring islatravir focus on offering varied dosing options, including potential daily and once-weekly regimens.
About Lenacapavir
Lenacapavir distinguishes itself with a multi-faceted mechanism of action, tackling HIV at various stages of its lifecycle while existing antiviral agents tend to target only one replication phase. As part of Gilead’s HIV treatment and prevention research, lenacapavir is being evaluated for long-acting applications through both oral and injectable formats, aiming to fulfill the diverse needs and preferences of people impacted by HIV, including those who may benefit from pre-exposure prophylaxis (PrEP). Its role in prevention remains investigational, and its safety and efficacy in that context have not been conclusively verified.
About Merck
For over 130 years, Merck, or MSD outside the U.S. and Canada, has dedicated efforts to harnessing cutting-edge science to enhance lives globally. Merck aspires to lead in research-driven biopharmaceuticals, focusing on developing medicines and vaccines that address urgent health needs, including viral diseases like HIV. The company commits to responsible operations ensuring a sustainable future, promoting an inclusive workforce, and participating in educational initiatives to help eliminate health disparities.
Merck’s Commitment to HIV
Merck has been invested in HIV research for over 35 years, achieving significant milestones that have shaped contemporary HIV treatment. Their initiatives work to expand treatment options across various drug classes to aid those affected by the virus. The ongoing development of multiple antiviral strategies aims to mitigate HIV’s global impact while promoting transformational innovations and collaborations within the global HIV landscape.
About Gilead Sciences
Gilead Sciences, Inc. has dedicated over three decades to achieving breakthroughs in medicine aimed at fostering global health. Committed to advancing treatment options for severe diseases including HIV, the company operates in over 35 countries, with headquarters in Foster City, California.
About Gilead Sciences in HIV
Recognized as a front-runner in HIV innovation for 35 years, Gilead has developed 12 distinct HIV medications, pioneering significant advancements like the first single-tablet regimen and long-acting injectable treatment. Their research agenda is aimed at meeting the evolving treatment needs of individuals affected by HIV worldwide while fostering educational initiatives and access programs to combat the epidemic.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE OF BIKTARVY
Biktarvy is approved as a complete regimen for managing human immunodeficiency virus type 1 (HIV-1) in adults and pediatric patients (weighing at least 14 kg) who are either treatment-naïve or virologically suppressed on a stable regimen, provided they do not have any resistance to its components.
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B have emerged in patients co-infected with HIV-1 and HBV following the cessation of therapies containing emtricitabine and/or tenofovir disoproxil fumarate, necessitating careful monitoring of hepatic function during treatment discontinuation.
Contraindications
Coadministration: BIKTARVY should not be used alongside dofetilide or rifampin.
Warnings and precautions
Monitor for potential drug interactions that might affect Biktarvy therapy, immune reconstitution syndrome, and renal impairment, as well as the potential for lactic acidosis and severe hepatomegaly with steatosis.
Adverse reactions
The most common adverse reactions in clinical studies through week 144 included diarrhea, nausea, and headache.
Dosage and administration
Biktarvy is prescribed as a single tablet daily, with adjustments based on renal function or in the context of pregnancy.
Gilead Forward-Looking Statements
This press release contains forward-looking statements per the Private Securities Litigation Reform Act of 1995, indicating the potential for risks and uncertainties that could impact clinical trial outcomes, regulatory approvals, and market viability.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
Merck’s news release includes forward-looking statements that are subject to inherent risks, including regulatory uncertainties and industry conditions that may disrupt the expected trajectories for their pipeline candidates.
U.S. full Prescribing Information for Biktarvy, including BOXED WARNING, is available at www.gilead.com.
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