A SYSTEMATIC LITERATURE REVIEW (SLR) TO IDENTIFY THE CLINICAL EFFICACY AND SAFETY ASSOCIATED WITH TREATMENTS FOR VIROLOGICALLY SUPPRESSED PEOPLE WITH HIV
Author(s)
Princy N. Kumar, MD1, Antonio E. Urbina, MD2, Arman Papadakis-Sali, DVM3, Yohance Whiteside, PhD4, Hannah Luedke, MSc5, Keith Dunn, PharmD6, Ramani Wonderling, PhD6, Lital Young, MD4, Vaishali Yadav, PhD5, James Jarrett, PhD3, Samir K. Gupta, MD7.
1Georgetown University School of Medicine, Washington, DC, USA, 2Mount Sinai Hospital, New York, NY, USA, 3Gilead Sciences, Stockley Park, United Kingdom, 4Merck & Co. Inc., Rahway, NJ, USA, 5Costello Medical, London, United Kingdom, 6Gilead Sciences, Foster City, CA, USA, 7Indiana University School of Medicine, Indianapolis, IN, USA.
1Georgetown University School of Medicine, Washington, DC, USA, 2Mount Sinai Hospital, New York, NY, USA, 3Gilead Sciences, Stockley Park, United Kingdom, 4Merck & Co. Inc., Rahway, NJ, USA, 5Costello Medical, London, United Kingdom, 6Gilead Sciences, Foster City, CA, USA, 7Indiana University School of Medicine, Indianapolis, IN, USA.
OBJECTIVES: This systematic review (SLR) aimed to identify efficacy and safety evidence for HIV-1 treatments in virologically suppressed people with HIV (PWH), given the advances in HIV treatments since the early ART era and recent approvals of agents for this population.
METHODS: The SLR was conducted in accordance with Cochrane Collaboration guidance. Literature searches were run from January 2000-September 2025 across MEDLINE, Embase and Cochrane Library. Eligible studies were Phase 3/4 randomised controlled trials (RCTs) investigating efficacy and safety/tolerability associated with daily oral dual/triple therapy and long-acting injectables for HIV-1 treatment among virologically suppressed PWH with no history of virologic failure.
RESULTS: A total of 294 publications reporting on 54 unique RCTs in virologically suppressed PWH were included in the SLR, of which 41/54 (~75%) were non-inferiority trials. Most RCTs (n=40/54) evaluated daily oral triple therapy regimens, followed by daily oral dual-therapy combinations (n=24/54). Four studies investigated long-acting injectable treatments, comparing CAB/RPV with oral ART or alternative dosing schedules. Maintenance of viral suppression (<50 copies/mL) was reported by 44/54 studies with % of suppressed patients ranging from 69.8-99.6% in FDA snapshot analyses. Virologic failure/rebound (reported by 44/54 studies) ranged from 0-20% of patients. Mean change from baseline in CD4 cell count ranged from -67-101 cells/µL across 35/54 studies. Discontinuation due to AEs ranged from 0-13% across 44/54 studies. Treatment-related AEs ranged from 0-93% across 34/54 studies; most RCTs reported much lower rates (<25%).
CONCLUSIONS: The majority of identified studies assessed daily oral regimens, with durable viral suppression observed; fewer studies evaluated long-acting injectables. Variability in outcome reporting limited comparability across studies, highlighting the need for more consistent reporting and endpoints that better reflect patient experience as treatment modalities evolve.
METHODS: The SLR was conducted in accordance with Cochrane Collaboration guidance. Literature searches were run from January 2000-September 2025 across MEDLINE, Embase and Cochrane Library. Eligible studies were Phase 3/4 randomised controlled trials (RCTs) investigating efficacy and safety/tolerability associated with daily oral dual/triple therapy and long-acting injectables for HIV-1 treatment among virologically suppressed PWH with no history of virologic failure.
RESULTS: A total of 294 publications reporting on 54 unique RCTs in virologically suppressed PWH were included in the SLR, of which 41/54 (~75%) were non-inferiority trials. Most RCTs (n=40/54) evaluated daily oral triple therapy regimens, followed by daily oral dual-therapy combinations (n=24/54). Four studies investigated long-acting injectable treatments, comparing CAB/RPV with oral ART or alternative dosing schedules. Maintenance of viral suppression (<50 copies/mL) was reported by 44/54 studies with % of suppressed patients ranging from 69.8-99.6% in FDA snapshot analyses. Virologic failure/rebound (reported by 44/54 studies) ranged from 0-20% of patients. Mean change from baseline in CD4 cell count ranged from -67-101 cells/µL across 35/54 studies. Discontinuation due to AEs ranged from 0-13% across 44/54 studies. Treatment-related AEs ranged from 0-93% across 34/54 studies; most RCTs reported much lower rates (<25%).
CONCLUSIONS: The majority of identified studies assessed daily oral regimens, with durable viral suppression observed; fewer studies evaluated long-acting injectables. Variability in outcome reporting limited comparability across studies, highlighting the need for more consistent reporting and endpoints that better reflect patient experience as treatment modalities evolve.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO93
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Infectious Disease (non-vaccine)