This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype.
Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.
The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.
The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.

Start Date01 Feb 2026

Sponsor / Collaborator

ViiV Healthcare Ltd.

NCT06468995

/ Active, not recruitingNot ApplicableIIT

Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study

This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.

Start Date02 Dec 2024

Sponsor / Collaborator

GSK Plc

NCT06694805

/ RecruitingPhase 3

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Start Date02 Dec 2024

Sponsor / Collaborator

ViiV Healthcare Ltd.

100 Clinical Results associated with Cabotegravir/Rilpivirine

100 Translational Medicine associated with Cabotegravir/Rilpivirine

100 Patents (Medical) associated with Cabotegravir/Rilpivirine

Literatures (Medical) associated with Cabotegravir/Rilpivirine

01 Mar 2026·Contemporary Clinical Trials

Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa

Article

Author: Nazzinda, Rashidah ; Mugerwa, Henry ; Walker, Simon ; Apoto, Naomi ; Kiilu, Cecilia ; Akabwai, George ; Namukwaya, Stella ; South, Annabelle ; Seeley, Janet ; Green, Alexandra ; Kityo Mutuluuza, Cissy ; Spittle, Ben ; Arumugam, Tiyara ; Thomason, Margaret J ; Burger, David ; Bevers, Lisanne ; Ford, Deborah ; Anena, Diana ; Archary, Moherndran ; Jafta, Lungile ; Pett, Sarah L ; Bamford, Alasdair ; Chappell, Elizabeth ; Bwakura-Dangarembizi, Mutsa ; Kekitiinwa, Adeodata R ; Bush, Molly ; Siika, Abraham ; Chitsamatanga, Moses

BACKGROUND:

Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.

METHODS:

LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.

CONCLUSION:

LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.

TRIAL REGISTRATION:

This trial has been registered with ClinicalTrials.gov (NCT05154747).

03 Aug 2022·Expert review of anti-infective therapy

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV

Review

Author: Namvar, Ali ; Heidary, Mohsen ; Ghahramanpour, Hossein ; Soleimani, Faezeh ; Taki, Elahe ; Asadi, Arezoo

INTRODUCTION:

The development of long-acting (LA) drugs has changed the management of common medical conditions for human replication immunodeficiency virus (HIV). Cabenuva (cabotegravir/Rilpivirine) is the first LA antiretroviral injectable drug composed of nano-formulation of cabotegravir (CAB) and rilpivirine (RPV).

AREAS COVERED:

In this review article, we aim to have a brief overview of results of major clinical trials that administrated Cabotegravir/Rilpivirine for patients considering the efficacy and safety profiles. Moreover, we discuss about CAB and RPV chemical structure, mechanism of action, ‎activity against drug-sensitive and -resistant HIV, and pharmacodynamics/pharmacokinetics properties.

EXPERT OPINION:

Based on the results of the ATLAS and FLAIR trials, Cabotegravir/Rilpivirine regimen once-monthly has shown equal effectivity to oral combination antiretroviral therapy (cART) in maintaining HIV-1 suppression in patients. Furthermore, ATLAS-2 M study revealed the non-inferiority of Cabotegravir/Rilpivirine regimen every 8 weeks compared to every 4 weeks. The injectable LA ART reduces the number of treatment intake as well as increases adherence, especially in patients with HIV-related stigma. Administration of extended-release agents probably minimize the risk of treatment-related toxicity and resistance related to sub-optimal adherence to oral ART, so Cabotegravir/Rilpivirine can be suggested as a suitable alternative for HIV infection control in current era.

01 Aug 2022·AIDS (London, England)

Cabotegravir–rilpivirine treatment initiation in a nonvirologically suppressed patient

Article

Author: Armas-Kolostroubis, Laura ; Barnett, Steven K. ; Riedel, David J. ; Sension, Michael

Currently, there is a single option for a complete parenteral HIV antiretroviral therapy (ART) regimen.Cabotegravir rilpivirine is a complete HIV ART regimen combining an extended-release injectable integrase strand inhibitor (INSTI) solution (cabotegravir) with an extended-release injectable nonnucleoside reverse transcriptase inhibitor (NNRTI) solution (rilpivirine), which allows for once-amonth dosing.We describe a patient who had failed four different traditional oral HIV ART regimens and had no ART resistance who was initiated on a once-monthly injection of cabotegravir-rilpivirine to circumvent poor pill adherence and gastrointestinal concerns.

News (Medical) associated with Cabotegravir/Rilpivirine

22 Apr 2026

·allsci.com

FDA approves Merck’s Idvynso for HIV-1 treatment in virologically suppressed adults

The US FDA approved Idvynso (doravirine/islatravir) for Merck, marking the first non-integrase strand transfer inhibitor (INSTI), tenofovir-free, once-daily complete two-drug regimen to reach approval for HIV-1 treatment in adults. The fixed-dose combination of 100 mg doravirine and 0.25 mg islatravir is indicated as a switch regimen for virologically suppressed adults with no history of virologic treatment failure and no known resistance substitutions associated with doravirine. The approval covers use in adults with HIV-1 RNA below 50 copies per mL on a stable antiretroviral regimen for at least three months. Idvynso is a complete regimen; co-administration with other antiretrovirals is not recommended. The drug is contraindicated with strong CYP3A enzyme inducers and with lamivudine or emtricitabine, as co-administration may reduce islatravir-triphosphate concentrations and compromise efficacy. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with doravirine-containing regimens, and one case of Drug Rash with Eosinophilia and Systemic Symptoms was observed during clinical trials. The approval is supported by Week 48 data from two randomized, active-controlled, non-inferiority Phase III trials. Trial 052 (NCT05630755) was a double-blind study in 513 virologically suppressed adults previously receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), randomized 2:1 to switch to Idvynso or continue BIC/FTC/TAF. At Week 48, 1% of participants in each arm had HIV-1 RNA ≥50 copies/mL (treatment difference 0.9%, 95% CI: -1.9%, 2.9%), with 92% of Idvynso recipients maintaining viral suppression versus 94% on BIC/FTC/TAF. Trial 051 (NCT05631093) enrolled 551 participants switching from a range of antiretroviral regimens, including 64% on INSTI-based therapy. In this open-label study, 1% of Idvynso recipients versus 5% of those continuing baseline therapy had HIV-1 RNA ≥50 copies/mL at Week 48 (treatment difference -3.6%, 95% CI: -7.8%, -0.8%), with 96% versus 92% maintaining suppression. Safety profiles across both trials were comparable to comparator arms, with adverse events leading to discontinuation in 3% and 0.5% of Idvynso recipients in Trials 052 and 051, respectively. The approval adds a mechanistically distinct oral option to a treatment landscape that has been shaped predominantly by INSTI-based regimens. Gilead’s Biktarvy (BIC/FTC/TAF) and ViiV Healthcare’s Dovato (dolutegravir/lamivudine) have become the reference standards for virologically suppressed adults, while ViiV’s long-acting injectable Cabenuva (cabotegravir/rilpivirine) addresses the growing demand for less frequent dosing. Idvynso enters this field as the only approved oral two-drug regimen that avoids both INSTIs and tenofovir, a profile relevant to patients managing renal impairment, bone density concerns, or INSTI-associated metabolic effects including weight gain. Islatravir’s dual mechanism — translocation inhibition and delayed chain termination — distinguishes it from conventional NRTIs, and its activity at low doses underpins the two-drug strategy. The published Phase III data supporting the approval appeared in The Lancet HIV in 2024, including a head-to-head comparison against BIC/FTC/TAF by Mills et al. and a broader switch study by Molina et al. Islatravir’s broader role in Merck’s HIV pipeline extends beyond the approved daily formulation. The company is evaluating islatravir in combination with Gilead’s lenacapavir as a potential once-weekly oral regimen in the Phase III ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299) trials, and in combination with the investigational NNRTI ulonivirine (MK-8507) in Phase IIb development. A separate once-monthly oral PrEP candidate, MK-8527, has entered Phase III evaluation in collaboration with the Gates Foundation, targeting HIV acquisition in women and adolescent girls in sub-Saharan Africa. These programs reflect a broader industry shift toward reducing dosing frequency while preserving or improving the tolerability profile that has defined the modern ART era. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultDrug ApprovalPhase 2Accelerated Approval

31 Mar 2026

·endpoints.news

Exclusive: ViiV R&D head Kimberly Smith heads to retirement after three decades in HIV care

After more than 30 years fighting the HIV epidemic as a clinician and researcher — 13 of those years spent at ViiV Healthcare’s R&D unit — Kimberly Smith is retiring. “Many of the things that I really wanted to see happen with the evolution of HIV treatment and PrEP have happened,” Smith told Endpoints News . “And so I feel extremely proud and extremely fortunate to be able to be a part of the teams that have brought that to fruition.” Smith stepped into the chief scientific officer role at ViiV in 2019. Today’s her last day at the GSK subsidiary. In an interview, she reflected on what made her realize she was “100% determined” to work on HIV. “Most of what you saw on television in those [early] days was the impact on gay men, but it was also impacting communities of color disproportionately,” Smith said. “All of those things — the science, the social aspects, and really the clinical aspects — drew me in as a medical student.” In 2013, Smith made the pivot from patient care to drug development because she wanted “to have a bigger impact” on those marginalized communities. Smith said one of her milestones at ViiV was helping build the first two-drug oral regimens (now sold as Juluca and Dovato) that significantly reduced pill burden and improved tolerability for certain patients. She later worked on advancing a long-acting injectable (LAI) pre-exposure prophylaxis (PrEP) product called Apretude that dramatically cut the risk of acquiring HIV compared with oral PrEP. Both Apretude and an LAI treatment called Cabenuva were greenlit by the FDA in 2021 under Smith’s scientific leadership. “The combination of getting everybody who’s living with HIV on treatment, and getting everybody who might be vulnerable to acquiring HIV on PrEP, could mean we get to the end of the epidemic… meaning we don’t have new cases,” Smith said. “We have the tools in hand if we can get everybody access.” The next frontier in HIV will be finding a cure, or at least getting patients into remission, Smith said, adding that ViiV is at the forefront of this mission. The company is advancing a broadly neutralizing antibody candidate, called lotivibart, that’s designed to help the immune system clear infected cells, instead of just suppressing viral replication. That program is in mid-stage development in combination with long-acting cabotegravir. Smith will be succeeded by Charlotte Allerton, who was most recently head of preclinical and translational sciences at Pfizer, which is divesting its stake in ViiV. Lotivibart will be one of Allerton’s key projects going forward, alongside a pipeline of ultra-long acting treatments and prophylactics. “There are not very many examples of women being heads of R&D or chief scientific officers at pharmaceutical companies,” Smith said. “To pass the baton on to another woman is even better.” While Smith said she is looking forward to focusing on her family during retirement, she said she will always be an HIV advocate, whether she is in a clinical setting or not.

Executive Change

26 Feb 2026

·www.fiercepharma.com

GSK's ViiV confirms staying power of long-acting HIV treatment Cabenuva in adolescents

The IMPAACT 2017 study showed adolescents using Cabenuva largely preferred the injections to daily oral therapies. As GSK’s HIV unit ViiV Healthcare grapples with a new rival in the injectable HIV prevention and treatment field, the company is reinforcing the staying power of its long-acting treatment Cabenuva in adolescents.ViiV originally tested its long-acting injectable Cabenuva, made from ViiV’s cabotegravir and Johnson & Johnson’s Edurant (rilpivirine), as an every-two-month HIV treatment in children 12 years and older in its Mocha (More Options for Children and Adolescents) study, born from a collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). A Week 16 interim analysis of the study helped the company secure an expanded FDA approval covering the younger population of HIV patients in 2022, marking another milestone for what was then the only marketed long-acting HIV treatment regimen. Since then, Gilead Sciences’ twice-yearly lenacapavir has entered the scene as both a long-acting pre-exposure prophylaxis med and as a treatment for multidrug-resistant HIV.With Gilead looking to edge in further on the long-acting treatment market by testing lenacapavir in the broader HIV population, ViiV is sharpening the case for Cabenuva with 96-week data from its Mocha study, also referred to as IMPAACT 2017. As ViiV announced at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Colorado this week, 94.4% of virologically suppressed adolescents with HIV who switched from a daily oral treatment to every-two-month Cabenuva maintained viral suppression at Week 96. The study enrolled adolescents between the ages of 12 and 18.More than 97% of the trial participants indicated they preferred long-acting injections over daily oral antiretrovirals at “all weeks evaluated,” ViiV said in a Feb. 24 press release, with 100% of the group expressing the preference for injections at Week 96 specifically. For many in the 144-person study, the treatment period was “the first time in their lives they did not have to take an oral HIV medicine every day,” co-lead investigator Aditya Gaur, M.D., said in a statement. Meanwhile, ViiV is looking to grow the reach of its long-acting treatment with its IMPAACT 2036 study in younger children between the ages of 2 and 12. The study is in very early stages, but the company recently secured the first pharmacokinetic and safety evidence that can help inform the remainder of the trial, ViiV said at CROI. Elsewhere, ViiV hopes to reach new ultralong-acting heights with its investigational lotivibart, a broadly neutralizing antibody that it has paired with Cabenuva in studies. Newly presented 12-month data on the treatment regimen showed efficacy when dosed every four months, but the company hopes to eventually progress the trial to a twice-yearly dosing interval. Long-acting Cabenuva made up 55% of total HIV growth for GSK in 2025, raking in yearly sales of 1.4 billion pounds sterling ($1.9 billion).

Clinical StudyClinical ResultDrug Approval

100 Deals associated with Cabotegravir/Rilpivirine

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KEGG	Wiki	ATC	Drug Bank
-	-	J05AR	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	Canada	ViiV Healthcare Srl	18 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Seropositivity	Phase 3	Kenya	Janssen-Cilag Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	Kenya	ViiV Healthcare Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	South Africa	ViiV Healthcare Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	South Africa	Janssen-Cilag Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	Uganda	Janssen-Cilag Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	Uganda	ViiV Healthcare Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	Zimbabwe	ViiV Healthcare Ltd.	22 Jun 2023
HIV Seropositivity	Phase 3	Zimbabwe	Janssen-Cilag Ltd.	22 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05154747 (LATte, Pubmed \| Contemp Clin Trials)	Phase 3	HIV Infections	476	cabotegravir/rilpivirine	naohfykhqe(xdzgiyqbid) = nzjrnqkore xlomlpjwog (brptwsdbev ) View more	Positive	01 Mar 2026
				tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir	naohfykhqe(yddrmbxdvs) = xwpsvcwzpj vaobhdrbuc (mxepsjnvmq ) View more
NCT02120352 (LATTE-2, CTgov)	Phase 2	HIV Infections	309	RPV (CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period))	eeynhyyrae = fqxfasqlzn ykhdszfllf (rjqokzyldb, ahrcomsnzv - szqjpcpqij) View more	-	31 Aug 2020
				RPV (CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period))	eeynhyyrae = kfwjjmwtol ykhdszfllf (rjqokzyldb, hiwpcmmkcp - akehrjhoro) View more
NCT02120352 (LATTE-2, IAS2016) Manual	Phase 2	HIV Infections	286	Cabotegravir + Rilpivirine (Q8W IM)	ghawesrtrb(lqodqqbawu) = humdmsmqcd dsaxsgawde (kqhgridvgn ) View more	Positive	18 Jul 2016
				Cabotegravir + Rilpivirine (Q4W IM)	ghawesrtrb(lqodqqbawu) = dpxsgicspc dsaxsgawde (kqhgridvgn ) View more
NCT02120352 (LATTE-2, CROI2016) Manual	Phase 2	HIV Infections	286	Cabotegravir + Rilpivirine (Q8W IM)	vkyilflkdz(fhvtnosyto) = fjtyvgaimv oqvwwzukfw (ydczpwobxn ) View more	Positive	22 Feb 2016
				Cabotegravir + Rilpivirine (Q4W IM)	vkyilflkdz(fhvtnosyto) = cmlcsdnexn oqvwwzukfw (ydczpwobxn ) View more

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