This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV < 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study.
Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs).
Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence.
Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs).
The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®. Both are approved in France for the treatment of HIV-1 infection.

Start Date15 Jan 2025

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

NCT06532656 / RecruitingPhase 2/3

A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN.
The primary objectives of this study are:
* To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1.
* To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.

Start Date20 Nov 2024

Sponsor / Collaborator

Gilead Sciences, Inc.

CTIS2023-507891-31-00 / Recruiting

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit from PrEP - GS-US-528-6727

Start Date25 Oct 2024

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Lenacapavir Sodium

100 Translational Medicine associated with Lenacapavir Sodium

100 Patents (Medical) associated with Lenacapavir Sodium

135

Literatures (Medical) associated with Lenacapavir Sodium

01 Jan 2025·Current Opinion in HIV and AIDS

Long-acting preexposure prophylaxis: early data on roll-out in the United States

Review

Author: Koss, Catherine A. ; Parikh, Urvi M.

Purpose of review:

Long-acting preexposure prophylaxis (LA-PrEP), including cabotegravir (CAB-LA) and lenacapavir, could expand biomedical prevention coverage and reduce HIV incidence. This review describes LA-PrEP rollout in the United States, early clinical innovations in delivery, as well as opportunities and challenges for future delivery.

Recent findings:

Although CAB-LA is approved in numerous countries, availability is limited outside of implementation studies. Data on CAB-LA rollout in routine care are mainly limited to the U.S at present. Early data indicate that oral PrEP far exceeds CAB-LA use and gaps exist between prescription and receipt of CAB-LA, with barriers including insurance coverage. Successful early clinic models include multidisciplinary staffing for benefits navigation, medication procurement, and injection provision, scheduling, and monitoring. Innovative models are being explored for community health worker delivery, low-barrier care for persons with psychosocial barriers, and telehealth and community-based models. Given persistent disparities in HIV diagnoses and oral PrEP use, there is a critical need for equitable implementation of CAB-LA and forthcoming products, including long-acting lenacapavir.

Summary:

Gaps exist between the promise of LA-PrEP and actual use in US settings. To achieve population-level impact with LA-PrEP, there is an urgent need for greatly expanded access, clinical systems prepared for delivery, and a focus on LA-PrEP equity.

01 Jan 2025·Current Opinion in HIV and AIDS

Use of long-acting injectable cabotegravir/rilpivirine in people with HIV and adherence challenges

Review

Author: Hickey, Matthew D. ; Christopoulos, Katerina A. ; Rana, Aadia

Purpose of review:

Recent changes in US Department of Health and Human Services and International AIDS Society USA guidelines now endorse use of long-acting injectable cabotegravir and rilpivirine (LA-CAB/RPV) in people with HIV (PWH) who have adherence challenges, including those with viremia. We sought to summarize clinical trial and real-world study data on outcomes and implementation strategies, highlight key unanswered questions, and provide recommendations for best practices.

Recent findings:

Studies of LA-CAB/RPV in PWH with adherence challenges demonstrate excellent virologic outcomes, although the rate of virologic failure is higher than that in registrational trials conducted in PWH with stable viral suppression. However, viral suppression is attainable on alternate antiretroviral regimen, including those that employ lenacapavir, another long-acting injectable antiretroviral drug, even after virologic failure on LA-CAB/RPV. Successful implementation strategies for long-acting programs include centralized multidisciplinary clinic teams (ideally with pharmacist/pharmacy technician involvement), small incentives to promote patient retention on injections, allowing for drop-in injections, outreach after late injections, and partnerships with home nursing, street medicine, and harm reduction sites.

Summary:

Creating programs that can support PWH with adherence challenges, their providers, and their clinics to use LA-CAB/RPV in service of sustained viral suppression is an urgent priority, particularly for PWH with CD4+ cell count <200 cells/mm3.

13 Dec 2024·SCIENCE

The great work continues

Author: Thorp, H. Holden

In the highly acclaimed 1991 play Angels in America , which explores AIDS in the United States in the 1980s, one of the characters muses about the nature of knowledge and novelty: “Imagination can’t create anything new, can it? It only recycles bits and pieces from the world and reassembles them into visions.” Although the scene’s intent is to ponder the limits of human experience and how the constraints of day-to-day reality are inescapable, the description of imagination aptly describes the creative shuffling that can lead to breakthroughs, like the ones recognized by Science at this time every year. In naming the drug lenacapavir as the 2024 Breakthrough of the Year, Science acknowledges the next, but by no means final, step in the drive to fight HIV/AIDS, where the rigors of the laboratory and the needs of humanity are inseparable.

152

News (Medical) associated with Lenacapavir Sodium

12 Dec 2024

·www.echemi.com

Gilead's New Drug Set for 2025 Launch, 99.5% HIV Prevention

In recent years, Gilead Sciences' most profitable product, Biktarvy, has been the flagship of the company. However, as the patent for this HIV medication is set to expire in 2033, Gilead has unveiled a highly praised strategy at its HIV investor conference, aimed at consolidating its leadership in HIV treatment for the next decade and beyond. Gilead's star product, lenacapivir, an antiviral drug for multidrug-resistant HIV, is currently marketed under the name Sunlenca. Phase III studies have shown "unprecedented efficacy," demonstrating its significant potential as a long-acting pre-exposure prophylaxis (PrEP) option. Gilead plans to launch the drug in summer 2025 and expects to submit a marketing application this year. The report indicated that among more than 9,000 participants in the lenacapivir trial, over 99.5% remained HIV-negative. The HIV pharmaceutical company positions its biannual option as a disruptor in the PrEP market, committing to a "thoughtful and innovative approach" to reach underserved consumers and "transform HIV prevention" comprehensively. Citigroup analysts noted that while the drug is projected to generate $125 million and $500 million in revenue in 2025 and 2026, respectively, Gilead particularly needs a "targeted approach" to penetrate the currently underrepresented PrEP market, focusing on overseas markets. Leerink analysts foresee similar challenges, given that the PrEP market is predominantly limited to white men who have sex with men and are receiving HIV treatment. Analysts indicated that to expand the treatment population, Gilead may need to work on eliminating stigma around the disease and improving healthcare infrastructure in certain countries. Gilead has developed a game plan with unique strategies tailored to different global markets. The company is already working to overcome current market limitations by conducting studies involving transgender men, transgender women, non-binary individuals, and cisgender men. Nonetheless, in the U.S. alone, Gilead aims to target 44% of HIV-infected individuals who are not achieving viral suppression through PrEP, with a goal to expand the U.S. PrEP market to over one million people by the mid-2030s. Despite the ambitious targets, Leerink believes this is an achievable task, as lenacapivir is a "special" product. In addition to the monotherapy lenacapivir, Gilead has secured seven new HIV treatment regimens before the end of 2033, including 12 new molecules and 11 combination therapies, one of which relies on Merck's islatravir. Citigroup analysts acknowledged that these seven approvals would "greatly protect" the exclusivity that Biktarvy is about to lose. While Biktarvy is ambitious, Leerink analysts maintain that given Biktarvy's established antiviral expertise and capabilities, the company is "uniquely positioned to execute such a broad and diverse HIV development plan and R&D engine." The California-based pharmaceutical company reminded investors that this expertise dates back to the early 21st century, starting from Truvada, the first PrEP drug in 2012, and extending to Biktarvy, which has become the "most prescribed" HIV treatment ever. Now, with lenacapivir waiting for approval, Gilead could seize long-acting leadership from GlaxoSmithKline, which currently markets its Apretude, a PrEP option administered every two months. Mizuho analysts previously projected that lenacapivir could achieve peak sales of around $4 billion.

Phase 3Drug ApprovalClinical Study

03 Dec 2024

·www.drugs.com

Incidence of HIV Lower With Twice-Yearly Subcutaneous Lenacapavir

TUESDAY, Dec. 3, 2024 -- In a population of cisgender men, transgender women, transgender men, and gender-nonbinary persons, the incidence of HIV is lower with receipt of twice-yearly subcutaneous lenacapavir compared with daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), according to a study published online Nov. 27 in the New England Journal Medicine . Colleen F. Kelley, M.D., M.P.H., from the Hope Clinic of the Emory University School of Medicine in Decatur, Georgia, and colleagues randomly assigned cisgender men, transgender women, transgender men, and gender-nonbinary persons to receive subcutaneous lenacapavir every 26 weeks or daily oral F/TDF in a 2:1 ratio in a phase 3 trial. The modified intention-to-treat analysis included 3,265 participants: 2,183 were assigned to lenacapavir and 1,088 to F/TDF. The researchers found that HIV infections occurred in two and nine participants in the lenacapavir and F/TDF groups, respectively (0.10 and 0.93, respectively, per 100 person-years). In the screened population (4,634 participants), the background incidence was 2.37 per 100 person-years. In the lenacapavir group, the incidence of HIV infection was significantly lower than the background incidence and the incidence in the F/TDF group (incidence rate ratios, 0.04 and 0.11, respectively). There were no safety concerns reported. Overall, 1.2 and 0.3 percent of the lenacapavir and F/TDF groups, respectively, discontinued the trial regimen due to injection site reactions. "Twice-yearly lenacapavir offers an efficacious choice for prevention of HIV infection, which may increase preexposure prophylaxis uptake," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures lenacapavir and funded the study.

Phase 3Clinical Result

28 Nov 2024

·www.drugs.com

Twice-Yearly Injection 96% Effective in Preventing HIV Infection

THURSDAY, Nov. 28, 2024 -- People whose partners have HIV must remember to take antiretroviral pills every single day or risk infection themselves. But researchers have come up with a way to avoid that daily hassle – an injectable drug that patients would only have to receive twice a year. What’s more, the new drug works even better than the currently available pills, clinical trial results show. A twice-yearly injection of Sunlenca (lenacapavir) reduces the risk of HIV infection by 96%, which is significantly more effective than oral pre-exposure prophylaxis (PrEP) using pills like Truvada , researchers report in the New England Journal of Medicine . “Seeing these high levels of efficacy – at almost 100% -- in an injectable that people only have to take every six months is incredible,” lead researcher Dr. Colleen Kelley , a professor of medicine at Emory University, said in a news release. “This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV,” she added. In the new clinical trial, 99% of the patients receiving Sunlenca did not become infected with HIV, results show. There were only two infections among 2,179 people taking Sunlenca, compared with nine infections among the 1,086 people randomly assigned to take Truvada. Results also showed it was easier for people to stick with the twice-yearly injections than to take a daily pill. Truvada’s effectiveness becomes greatly compromised if it’s taken inconsistently, researchers noted. “What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors,” Kelley said. “Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.” People at risk of HIV also tend to be people who have limited access to the pills, or may have trouble taking their meds consistently, researchers said. “We are not reaching everyone we need to reach with our current HIV prevention interventions, such as those who are disproportionately impacted by HIV and health care disparities,” Kelley said. “For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative.” The U.S. Food and Drug Administration approved the drug, marketed as Sunlenca, in December 2022 as a treatment for people with HIV, to help control their infection. These results show that it also could be used by people without HIV to prevent infection, researchers said. The trial data have been submitted to the FDA, and Kelley is hopeful the drug will be approved for this use by 2025. “Long acting antiretrovirals offer new hope for those who are not able to take oral medications,” Dr. Carlos del Rio , chair of medicine at Emory University, said in a news release. “The challenge is now to roll out and make these tools available and accessible in an equitable way — only then we will see new HIV infections dramatically decreased locally and globally.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical ResultClinical Study

100 Deals associated with Lenacapavir Sodium

External Link

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R&D Status

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Indication	Country/Location	Organization	Date
HIV Infections	EU	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	IS	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	LI	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	NO	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) Manual	Phase 3	HIV Infections	3,265	Lenacapavir	hdsfuxrosa(vufkmrtxwb) = esawhyijba xolnnfykzq (notwcgdjba, 0.01 - 0.37) View more	Positive	27 Nov 2024
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	hdsfuxrosa(vufkmrtxwb) = kfjifgyobe xolnnfykzq (notwcgdjba, 0.43 - 1.77) View more
NCT05502341 (ARTISTRY-1, Pubmed) Manual	Phase 2/3	HIV Infections	128	Bictegravir 75 mg + Lenacapavir 25 mg	mzdenzcqvw(lekaijeolj) = cgovqlmpjg osfznwtwvd (fahbbljizu ) View more	Positive	26 Nov 2024
				Bictegravir 75 mg + Lenacapavir 50 mg	mzdenzcqvw(lekaijeolj) = anoqldtzoc osfznwtwvd (fahbbljizu ) View more
NCT04811040 (BusinessWire) Manual	Phase 1	HIV Infections	-	Lenacapavir + Teropavimab (TAB) + 10 mg/kg Zinlirvimab (ZAB)	tweazrdrgu(mejfumeiyr) = kfdsvqwczg pakkdffzsr (qruesjwnae )	Positive	12 Nov 2024
				Lenacapavir + Teropavimab (TAB) + 30 mg/kg Zinlirvimab (ZAB)	tweazrdrgu(mejfumeiyr) = xfsbbvgxxc pakkdffzsr (qruesjwnae )
NCT05502341 (ARTISTRY-1, BusinessWire) Manual	Phase 2/3	HIV Infections	128	Bictegravir 75 mg + Lenacapavir 25 mg	vxbphrxtou(bkoyjctiva) = gmwerkpzld gtbpvpeorg (zmgyritsen ) View more	Positive	12 Nov 2024
				Bictegravir 75 mg + Lenacapavir 50 mg	vxbphrxtou(bkoyjctiva) = mfmwmbzvtj gtbpvpeorg (zmgyritsen ) View more
NCT05052996 (Company_Website) Manual	Phase 2	HIV Infections	104	Islatravir 2 mg + Lenacapavir 300 mg once a week	vbmmkqkgly(ugdevaxbrz) = None xnarxkktsf (vbvxrkwtwx ) View more	Positive	19 Oct 2024
				Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets)
NCT04925752 (PURPOSE 2, Biospace) Manual	Phase 3	HIV Infections	3,267	Lenacapavir	eatyfdvhyu(egwoolaapx) = qchiimsgos hacmzhmxlf (fvqxcwygix ) View more	Positive	12 Sep 2024
				Truvada	eatyfdvhyu(egwoolaapx) = uxvrefzjko hacmzhmxlf (fvqxcwygix )
NCT04994509 (PURPOSE 1, Pubmed)	Phase 3	HIV Infections	5,338	Lenacapavir	zysstwudws(chvydcsgna) = Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions lwaphkvklx (dmhgzizdoy )	Positive	24 Jul 2024
				Emtricitabine-tenofovir alafenamide (F/TAF)
NCT04994509 (PURPOSE 1, Biospace \| Company_Website) Manual	Phase 3	HIV Infections	5,300	lenacapavir	hlyaemsjsm(exxzgkzlkv) = cxwzfirqpb mlnxkbfmgd (dsdcyyhdme ) Met	Positive	20 Jun 2024
				Truvada	hlyaemsjsm(exxzgkzlkv) = hkrguuuvuu mlnxkbfmgd (dsdcyyhdme ) Met
NCT05052996 (BusinessWire) Manual	Phase 2	HIV Infections	104	Islatravir+lenacapavir	ohpjtbjyqq(iqnuaqoxkb) = lbhhtwwmdg mfasrkjizq (hdrhdbmytt ) View more	Positive	06 Mar 2024
				Biktarvy	rdwwsvnlcm(nexleehuoi) = opsbxsikgq rhuhxlspts (ohzdyhbobb )
NCT04811040 (Pubmed \| Lancet HIV)	Phase 1	HIV Infections	21	Lenacapavir + Teropavimab + Zinlirvimab 10 mg/kg	fyjtxtfimh(igyswipmbr) = No serious adverse events occurred nijpimfblz (uqkvzpiyzm ) View more	Positive	01 Mar 2024
				Lenacapavir + Teropavimab + Zinlirvimab 30 mg/kg

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