– First Section 3 HIV Prevention Trial Ever to Present Zero Infections –
– Unbiased Information Monitoring Committee Really helpful That Gilead Cease the Blinded Section of the PURPOSE 1 Trial at Interim Evaluation and Supply Open-Label Lenacapavir to All Individuals –
Foster Metropolis, Calif. – June 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) as we speak introduced topline outcomes from an interim evaluation of its pivotal, Section 3 PURPOSE 1 trial indicating that the corporate’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender ladies.
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based mostly on these outcomes, the impartial Information Monitoring Committee (DMC) really useful that Gilead cease the blinded part of the trial and provide open-label lenacapavir to all members.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an essential new instrument to assist stop HIV infections,” mentioned Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We sit up for further outcomes from the continuing PURPOSE scientific program and persevering with towards our aim of serving to to finish the HIV epidemic for everybody, in every single place.”
These are the primary knowledge generated from Gilead’s landmark PURPOSE program, which is probably the most complete and various HIV prevention trial program ever performed. The PURPOSE program includes 5 HIV prevention trials around the globe which can be centered on innovation in science, trial design, group engagement and well being fairness.
Topline PURPOSE 1 knowledge
PURPOSE 1, a Section 3, double-blind, randomized examine, is evaluating the security and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in additional than 5,300 cisgender ladies and adolescent ladies aged 16-25 throughout 25 websites in South Africa and three websites in Uganda. The medicine are being examined in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Moreover, a 3rd group was assigned once-daily oral Truvada. Examine members had been randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. As a result of efficient PrEP choices exist already, there’s broad consensus within the PrEP subject {that a} placebo group can be unethical; thus, the trial used bHIV as the first comparator and Truvada as a secondary comparator.
There have been 0 incident instances of HIV an infection amongst 2,134 ladies within the lenacapavir group (incidence 0.00 per 100 person-years). There have been 16 incident instances amongst 1,068 ladies within the Truvada group (incidence 1.69 per 100 person-years). The outcomes demonstrated superiority of twice-yearly lenacapavir over bHIV (major endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p
HIV incidence within the Descovy group was numerically comparable (39 incident instances amongst 2,136 ladies, incidence 2.02 per 100 person-years) to that within the Truvada group and was not statistically superior to bHIV. Earlier scientific trials amongst cisgender ladies have generally discovered challenges with adherence to each day oral tablets for PrEP, and adherence analyses for Descovy and Truvada from PURPOSE 1 are ongoing. Within the trial, each Descovy and Truvada had been typically well-tolerated and no new security issues had been recognized.
Extra detailed knowledge from PURPOSE 1 might be introduced at a future convention.
“Twice-yearly lenacapavir for PrEP, if accredited, may present a vital new selection for HIV prevention that matches into the lives of many individuals who may gain advantage from PrEP around the globe—particularly cisgender ladies,” mentioned Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Middle on the College of Cape City, South Africa, and previous President of the Worldwide AIDS Society. “Whereas we all know conventional HIV prevention choices are extremely efficient when taken as prescribed, twice-yearly lenacapavir for PrEP may assist deal with the stigma and discrimination some folks might face when taking or storing oral PrEP tablets, in addition to probably assist improve PrEP adherence and persistence given its twice-yearly dosing schedule.”
Using lenacapavir and the usage of Descovy for the prevention of HIV in cisgender ladies are investigational and haven’t been decided to be protected or efficacious and will not be accredited wherever globally.
Further PURPOSE trials assessing twice-yearly lenacapavir for PrEP are ongoing
Gilead expects ends in late 2024/early 2025 from this system’s different pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP amongst cisgender males who’ve intercourse with males, transgender males, transgender ladies and gender non-binary people who’ve intercourse with companions assigned male at beginning in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and america. The regulatory submitting for lenacapavir for PrEP will embrace the outcomes of each PURPOSE 1 and PURPOSE 2, if optimistic, as a way to guarantee lenacapavir for PrEP could be accredited for a number of populations and communities most in want of further HIV prevention choices.
Gilead is dedicated to partnering with communities which can be disproportionately affected by HIV of their respective international locations and areas, and group enter on the PURPOSE trials has been instrumental in components starting from program design to participant recruitment methods. This sort of collaborative strategy will proceed to assist Gilead implement scientific trials with rigor, innovation and intentional inclusion of communities which have traditionally been underrepresented in HIV prevention analysis. It should additionally assist bolster the post-implementation science actions that Gilead will conduct for PURPOSE 1 and future profitable trials.
Gilead acknowledges the significance of serving to to allow entry to ensure that twice-yearly lenacapavir for PrEP, if accredited by regulatory authorities, to attain the broadest impression. In mild of as we speak’s milestone and the corporate’s ongoing dedication to communities affected by HIV, Gilead intends to transient group companions and supply a public assertion relating to its deliberate entry strategy for high-incidence, resource-limited international locations, that are primarily low- and lower-middle-income international locations.
Extra details about the PURPOSE program, together with particular person trial descriptions, populations and places, could be discovered at www.purposestudies.com.
U.S. Indication for Descovy
for PrEP
®
DESCOVY for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to scale back the chance of sexually acquired HIV-1 an infection, excluding people in danger from receptive vaginal intercourse. HIV-1–destructive standing have to be confirmed instantly previous to initiation.
Limitation of Use: DESCOVY FOR PrEP shouldn’t be indicated in people susceptible to HIV-1 from receptive vaginal intercourse as a result of effectiveness on this inhabitants has not been evaluated by the U.S. FDA.
U.S. Essential Security Info 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 have to be prescribed solely to people confirmed to be HIV destructive instantly previous to initiation and no less than each 3 months throughout use. Drug-resistant HIV-1 variants have been recognized with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 an infection. Don’t provoke if indicators or signs of acute HIV-1 an infection are current except HIV-negative standing is confirmed
Extreme acute exacerbations of hepatitis B have been reported in people contaminated with hepatitis B virus (HBV) who discontinued merchandise containing FTC and/or TDF and should happen with discontinuation of DESCOVY. Intently monitor hepatic perform with each scientific and laboratory follow-up for no less than a number of months in people with HBV who discontinue DESCOVY. If applicable, anti-hepatitis B remedy could also be warranted
Contraindication
DESCOVY FOR PrEP is contraindicated in people with unknown or optimistic HIV standing
Warnings and precautions
Complete administration to scale back dangers:
Use DESCOVY FOR PrEP to scale back the chance of HIV-1 an infection as a part of a complete technique that features adherence to each day dosing and safer intercourse practices, together with condoms, to scale back the chance of sexually transmitted infections (STIs)
HIV-1 threat components: Behavioral, organic, or epidemiologic HIV-1 threat components might embrace, however will not be restricted to: condomless intercourse, previous or present STIs, self-identified HIV threat, having sexual companions of unknown HIV-1 viremic standing, or sexual exercise in a high-prevalence space or community
Scale back STI threat: Counsel on the usage of STI prevention measures (e.g., constant and proper condom use, information of companion’s HIV-1 viremic standing, common testing for STIs)
Scale back potential for drug resistance: Solely prescribe DESCOVY FOR PrEP to people confirmed to be HIV destructive instantly previous to initiation, no less than each 3 months whereas taking DESCOVY, and upon an STI analysis. HIV-1 resistance substitutions might emerge in people with undetected HIV-1 an infection who’re taking solely DESCOVY as a result of DESCOVY alone shouldn’t be an entire routine for treating HIV-1
Some HIV exams might not detect acute HIV an infection. Previous to initiating DESCOVY FOR PrEP, ask people about potential current publicity occasions. If current (
If HIV-1 an infection is suspected or if signs of acute an infection are current whereas taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP routine to an entire HIV therapy routine till HIV-negative standing is confirmed by a take a look at accredited by the FDA to be used within the analysis of acute HIV an infection
Counsel on adherence: Counsel people to strictly adhere to each day dosing, as efficacy is strongly correlated with adherence. Some people, equivalent to adolescents, might profit from extra frequent visits and counseling
New onset or worsening renal impairment: Postmarketing instances of renal impairment, together with acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing merchandise. Don’t provoke DESCOVY in people with estimated creatinine clearance (CrCl)
Lactic acidosis and extreme hepatomegaly with steatosis: Deadly instances have been reported with the usage of nucleoside analogs, together with FTC and TDF. Discontinue use if scientific or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, together with hepatomegaly and steatosis within the absence of marked transaminase elevations
Antagonistic reactions
Commonest hostile reactions (≥2%) within the DESCOVY FOR PrEP scientific trial had been diarrhea, nausea, headache, fatigue, and belly ache
Drug interactions
Prescribing data: Seek the advice of the total Prescribing Info for DESCOVY for extra data, warnings, and probably vital drug interactions, together with scientific feedback
Metabolism: Medicine that inhibit P-gp can improve the concentrations of tenofovir alafenamide (TAF), a element of DESCOVY. Medicine that induce P-gp can lower the concentrations of TAF, which can result in lack of efficacy
Medicine affecting renal perform: Coadministration of DESCOVY with medicine that scale back renal perform or compete for energetic tubular secretion might improve concentrations of FTC and tenofovir and the chance of hostile reactions
Dosage and administration
Dosage: One pill taken as soon as each day with or with out meals
HIV screening: Check for HIV-1 an infection instantly previous to initiating, no less than each 3 months throughout use, and upon analysis of an STI (see Warnings and Precautions part)
HBV screening: Check for HBV an infection previous to or when initiating DESCOVY
Renal impairment and monitoring: Not really useful in people with creatinine clearance (CrCl)
About Gilead HIV
Gilead Sciences, Inc. is a biopharmaceutical firm that has pursued and achieved breakthroughs in medication for greater than three a long time, with the aim of making a more healthy world for all folks. The corporate is dedicated to advancing modern medicines to forestall and deal with life-threatening ailments, together with HIV, viral hepatitis, COVID-19, and most cancers. Gilead operates in additional than 35 international locations worldwide, with headquarters in Foster Metropolis, California.
For greater than 35 years, Gilead has been a number one innovator within the subject of HIV, driving advances in therapy, prevention and treatment analysis. Gilead researchers have developed 12 HIV drugs, together with the primary single-tablet routine to deal with HIV, the primary antiretroviral for pre-exposure prophylaxis (PrEP) to assist scale back new HIV infections, and the primary long-acting injectable HIV therapy treatment administered twice-yearly. Our advances in medical analysis have helped to rework HIV right into a treatable, preventable, continual situation for hundreds of thousands of individuals.
Gilead is dedicated to continued scientific innovation to offer options for the evolving wants of individuals affected by HIV around the globe. By way of partnerships, collaborations and charitable giving, the corporate additionally goals to enhance schooling, broaden entry and deal with obstacles to care, with the aim of ending the HIV epidemic for everybody, in every single place. Gilead was acknowledged because the primary philanthropic funder of HIV-related packages in a report launched by Funders Involved About AIDS.
Study extra about Gilead’s distinctive collaborations worldwide and the work to assist finish the worldwide HIV epidemic.
Ahead-Trying Statements
This press launch contains forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995 which can be topic to dangers, uncertainties and different components, together with Gilead’s capability to provoke, progress and full scientific trials within the anticipated timelines or in any respect, and the potential for unfavorable outcomes from ongoing and extra scientific trials, together with these involving Descovy, Truvada and lenacapavir (equivalent to PURPOSE 1 and PURPOSE 2); uncertainties regarding regulatory functions and associated submitting and approval timelines, and the chance that any such approvals, if granted, could also be topic to vital limitations on use; the likelihood that Gilead might make a strategic resolution to discontinue improvement of Descovy and lenacapavir for indications at the moment beneath analysis and, in consequence, Descovy and lenacapavir might by no means be efficiently commercialized for such indications; and any assumptions underlying any of the foregoing. These and different dangers, uncertainties and components are described intimately in Gilead’s Quarterly Report on Type 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Alternate Fee. These dangers, uncertainties and different components may trigger precise outcomes to vary materially from these referred to within the forward-looking statements. All statements apart from statements of historic truth are statements that may very well be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements will not be ensures of future efficiency and contain dangers and uncertainties, and is cautioned to not place undue reliance on these forward-looking statements. All forward-looking statements are primarily based on data at the moment accessible to Gilead, and Gilead assumes no obligation and disclaims any intent to replace any such forward-looking statements.
U.S. full Prescribing Info for Descovy and Truvada, together with Boxed Warnings, is out there at
www.gilead.com
Descovy, Descovy for PrEP, Gilead, the Gilead brand, Truvada, and Truvada for PrEP are registered logos of Gilead Sciences, Inc., or its associated corporations.
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