Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03299049 (A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed), which is not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed
Who cites it
74 citing papers in PubMed, 3 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Pooled it
- Virologic Failure and Emergent Integrase Strand Transfer Inhibitor Drug Resistance With Long-Acting Cabotegravir for HIV Treatment: A Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Pooled it
- Pooled it
- Sustained Virologic Suppression After Discontinuation of Long-acting Cabotegravir/Rilpivirine: A Two-case Series Highlighting Unexpected Heterogeneity in Pharmacokinetics and Viral Control.Open forum infectious diseases · 2026Trial
- Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Subcutaneous injections of cabotegravir plus rilpivirine long-acting in virally suppressed adults with HIV-1.AIDS (London, England) · 2025Trial
- Thigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With HIV-1: A Substudy of the Phase 3b ATLAS-2M Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV.Clinical pharmacology in drug development · 2025Trial
- Trial
- Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy With Cabotegravir + Rilpivirine Long-Acting Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in the Phase 3b SOLAR Study.AIDS and behavior · 2025Trial
- Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials.The Journal of infectious diseases · 2024Trial
- Trial
- Feasibility, Fidelity, and Effectiveness of Administering Long-Acting Cabotegravir + Rilpivirine in Infusion Centers in the United States: Findings From the Phase 4 GLACIER Implementation Study.Journal of the International Association of Providers of AIDS CareTrial
- Real-World Safety and Effectiveness of Cabotegravir in People Living with HIV: Interim Report of a Post-marketing Surveillance in Japan.Advances in therapy · 2026Article
- Effectiveness, Sex Differences, and Patient Experience in Real-World Use of Long-Acting Cabotegravir and Rilpivirine: Results from a Prospective Study.Infectious diseases and therapy · 2026Article
- Evaluation of Real-World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir/Lamivudine Fixed-Dose Combination in Treatment-Naive and Pretreated People Living With HIV Who are Virologically Suppressed, in Routine Clinical Care in France: Results From the CARAVEL Study.Open forum infectious diseases · 2026Article
- Article
- Long-Acting Injectable Antiretroviral Therapies for HIV Treatment and Prevention: Clinical Pharmacology, Recent Advances and Future Opportunities.Journal of clinical pharmacology · 2026Review
- Effect of Non-nucleoside Resistance-Associated Mutations on the Effectiveness of Long-Acting Cabotegravir + Rilpivirine Therapy: Insights From the Real-World RELATIVITY Cohort.Open forum infectious diseases · 2026Article
- Determinants of long-acting cabotegravir plus rilpivirine discontinuation in real-world HIV care: insights from the relativity cohort.AIDS (London, England) · 2026Article
14 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
25 authors at 14 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete, long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. Here, we report the antiretroviral therapy as long acting suppression (ATLAS)-2M study week 152 results.
methodsATLAS-2M is a phase 3b, randomized, multicenter study assessing the efficacy and safety of CAB+RPV LA every 8 weeks (Q8W) versus every 4 weeks (Q4W). Virologically suppressed (HIV-1 RNA <50 copies/mL) individuals were randomized to receive CAB+RPV LA Q8W or Q4W. Endpoints included the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and <50 copies/mL, incidence of confirmed virologic failure (CVF; 2 consecutive measurements ≥200 copies/mL), safety, and tolerability.
resultsA total of 1045 participants received CAB+RPV LA (Q8W, n = 522; Q4W, n = 523). CAB+RPV LA Q8W demonstrated noninferior efficacy versus Q4W dosing, with 2.7% (n = 14) and 1.0% (n = 5) of participants having HIV-1 RNA ≥50 copies/mL, respectively, with adjusted treatment difference being 1.7% (95% CI: 0.1-3.3%), meeting the 4% noninferiority threshold. At week 152, 87% of participants maintained HIV-1 RNA <50 copies/mL (Q8W, 87% [n = 456]; Q4W, 86% [n = 449]). Overall, 12 (2.3%) participants in the Q8W arm and 2 (0.4%) in the Q4W arm had CVF. Eight and 10 participants with CVF had treatment-emergent, resistance-associated mutations to RPV and integrase inhibitors, respectively. Safety profiles were comparable, with no new safety signals observed since week 48.
conclusionsThese data demonstrate virologic suppression durability with CAB+RPV LA Q8W or Q4W for ∼3 years and confirm long-term efficacy, safety, and tolerability of CAB+RPV LA as a complete regimen to maintain HIV-1 virologic suppression.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.