Systematic Literature Review and Meta-Analysis (SLR/MA) of Integrase Strand Transfer Inhibitors (INSTI)-based Single-Tablet Regimens (STR) versus Multiple-Tablet Regimens (MTR) for the Treatment of Adult People with HIV (PWH)
Author(s)
Mary J. Christoph, PhD, MPH1, Uche Mordi, MS, PharmD1, Woodie Zachry, PhD1, Joshua Gruber, PhD, MPH1, Kristen Haloski, PharmD1, Seojin Park, PharmD, MS1, Megan Chen, MSPH1, Jan Tužil, MSc, PhD2, Mirella Dudzic, MPharm2, Krzysztof Lach, MPH2;
1Gilead Sciences, Inc., Foster City, CA, USA, 2Maple Health Group, New York, NY, USA
1Gilead Sciences, Inc., Foster City, CA, USA, 2Maple Health Group, New York, NY, USA
Presentation Documents
OBJECTIVES: SLR/MAs have shown STRs are associated with improved outcomes in PWH compared to MTRs. Despite being preferred therapy, no SLRs have focused on INSTI-based regimens.
METHODS: Full-texts, abstracts, and posters from clinical trials and real-world studies published between 2013-2023 were searched in MEDLINE/PubMed, EMBASE, and relevant congresses (PROSPERO ID: CRD42024525515). Eligible estimates of adherence, persistency, and discontinuation in adult PWH treated with INSTI-based STR/MTRs were combined via frequentist random-effect meta-analysis, and heterogeneity (I2) was explored in subgroups.
RESULTS: In 3 retrospective studies, the pooled rate ratio (RR) of adherence favored STR vs. MTR (1.64; 95% confidence interval [CI] 1.46-1.83; I2=0%), irrespective of adherence definition, whereas in one double-blind trial no difference in adherence was seen (RR=1.02; 95% CI 0.77-1.35). In 7 retrospective studies assessing persistency, the pooled odds ratio (OR) favored STR vs. MTR (1.97; 95% CI 1.68-2.32; I2=66%); the increased persistency effect was stronger in PWH using Bictegravir/Emtricitabine/Tenofovir (B/F/TAF, 3.55; 95% CI 2.20-5.71). In 6 retrospective studies, the pooled hazard ratio (HR) of discontinuation was higher for MTR vs. STR (1.55; 95% CI 1.41-1.71). The increased discontinuation for MTRs was stronger in treatment-naïve (TN) vs. treatment-experienced (TE) PWH (p<0.01) and for B/F/TAF vs. all STRs (3.80; 95% CI 2.55-5.66). In 3 prospective studies, RR of discontinuation was higher for MTRs vs. STRs (4.43; 95% CI 1.62-12.09; I2=96%). The increased discontinuation effect for MTRs was stronger in TN vs. TE PWH (p<0.01) and for B/F/TAF (7.90; 95% CI 4.04-15.43). In 4 non-inferiority trials, the RR of discontinuation was comparable between MTR and STR (0.83; 95% CI 0.55-1.26; I2 =0%), irrespective of previous treatment or regimen.
CONCLUSIONS: INSTI-based STR compared to MTR performed similarly in clinical trials but demonstrated significantly better outcomes in real-world settings.
METHODS: Full-texts, abstracts, and posters from clinical trials and real-world studies published between 2013-2023 were searched in MEDLINE/PubMed, EMBASE, and relevant congresses (PROSPERO ID: CRD42024525515). Eligible estimates of adherence, persistency, and discontinuation in adult PWH treated with INSTI-based STR/MTRs were combined via frequentist random-effect meta-analysis, and heterogeneity (I2) was explored in subgroups.
RESULTS: In 3 retrospective studies, the pooled rate ratio (RR) of adherence favored STR vs. MTR (1.64; 95% confidence interval [CI] 1.46-1.83; I2=0%), irrespective of adherence definition, whereas in one double-blind trial no difference in adherence was seen (RR=1.02; 95% CI 0.77-1.35). In 7 retrospective studies assessing persistency, the pooled odds ratio (OR) favored STR vs. MTR (1.97; 95% CI 1.68-2.32; I2=66%); the increased persistency effect was stronger in PWH using Bictegravir/Emtricitabine/Tenofovir (B/F/TAF, 3.55; 95% CI 2.20-5.71). In 6 retrospective studies, the pooled hazard ratio (HR) of discontinuation was higher for MTR vs. STR (1.55; 95% CI 1.41-1.71). The increased discontinuation for MTRs was stronger in treatment-naïve (TN) vs. treatment-experienced (TE) PWH (p<0.01) and for B/F/TAF vs. all STRs (3.80; 95% CI 2.55-5.66). In 3 prospective studies, RR of discontinuation was higher for MTRs vs. STRs (4.43; 95% CI 1.62-12.09; I2=96%). The increased discontinuation effect for MTRs was stronger in TN vs. TE PWH (p<0.01) and for B/F/TAF (7.90; 95% CI 4.04-15.43). In 4 non-inferiority trials, the RR of discontinuation was comparable between MTR and STR (0.83; 95% CI 0.55-1.26; I2 =0%), irrespective of previous treatment or regimen.
CONCLUSIONS: INSTI-based STR compared to MTR performed similarly in clinical trials but demonstrated significantly better outcomes in real-world settings.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
SA41
Topic
Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine)