Real-World Experience with Two-Drug Regimens in HIV-1-Infected Patients Beyond the Indication of Clinical Trials: 48 Weeks' Results

Pardo, Ana Arancón; Palomino, Marta Moreno; Jiménez-Nácher, Inmaculada; Moreno, Francisco; Fernández, María Angeles González; González‐García, Juan; Ambrosio, Alícia Herrero

doi:10.1089/aid.2021.0041

Cited by 4 publications

(2 citation statements)

References 17 publications

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“… 33 Further, DTG plus lamivudine as dual therapy has demonstrated success in achieving VLS and cost-effectiveness in numerous studies. 37 , 38 Clinician hesitancy to changing ART can have dire consequences to patients, 39 and these findings will help to quell concerns that preexisting NRTI RAMs may adversely affect the ability of DTG to achieve VLS in CALHIV, and empower providers in LMICs to confidently switch their pediatric and adolescent patients to DTG.…”

Section: Discussionmentioning

confidence: 99%

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

Bacha

Dlamini

Anabwani³

et al. 2023

Pediatric Infectious Disease Journal

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Background: Despite encouraging results from clinical trials and in highincome countries, large-scale data on the effectiveness and safety of dolutegravir (DTG) in children and adolescents living with HIV (CALHIV) are lacking in low-and middle-income countries (LMICs). Methods: Retrospective analysis was performed among CALHIV 0-19 years old and weighing greater than or equal to 20 kg who received DTG from 2017 to 2020 at sites in Botswana, Eswatini, Lesotho, Malawi, Tanzania and Uganda to determine effectiveness, safety and predictors of viral load suppression (VLS) among CALHIV using DTG, including through single drug substitutions (SDS). Results: Among 9419 CALHIV using DTG, 7898 had a documented post-DTG VL, and VLS post-DTG was 93.4% (7378/7898). VLS for antiret-roviral therapy (ART) initiations was 92.4% (246/263), and VLS was maintained for the ART-experienced [92.9% (7026/7560) pre-vs. 93.5% (7071/7560) post-DTG; P = 0.14). Among previously unsuppressed, 79.8% (426/534) achieved VLS with DTG. Only 5 patients reported a Grade 3 or 4 adverse event (0.057 per 100 patient-years) requiring DTG discontinuation. History of protease inhibitor-based ART [odds ratio (OR) = 1.53; 95% confidence interval (CI): 1.16-2.03], care in Tanzania (OR = 5.45; 95% CI: 3.41-8.70), and being 15-19 years old (OR = 1.31; 95% CI: 1.03-1.65) were associated with gain of VLS post-DTG. Predictors of VLS on DTG included VLS before DTG (OR = 3.87; 95% CI: 3.03-4.95) and using the once-daily, single tab tenofovir-lamivudine-DTG regimen (OR = 1.78; 95% CI: 1.43-2.22). SDS maintained VLS [95.9% (2032/2120) pre-vs. 95.0% (2014/2120) post-SDS with DTG; P = 0.19], and 83.0% (73/88) of unsuppressed gained VLS using SDS with DTG. Conclusions: We found DTG to be highly effective and safe within our cohort of CALHIV in LMICs. These findings can empower clinicians to prescribe DTG confidently to eligible CALHIV.

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Section: Discussionmentioning

confidence: 99%

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

Bacha

Dlamini

Anabwani³

et al. 2023

Pediatric Infectious Disease Journal

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“…Therefore, the demand for two-drug regimens (2DRs) is increasing to minimize drug exposure, reduce drug-drug interactions, and alleviate side effects. Dolutegravir (DTG)-based 2DRs are attractive because of the following advantages: a high barrier to resistance, low risk of drug-drug interactions, and daily dosing schedule [3,4]. For these reasons, studies on the effects, efficacy, and side effects of 2DRs using DTG as an anchor are rapidly progressing [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Real-World Effectiveness, Tolerability, and Safety of Dolutegravir/Lamivudine in Korea

Lee

Kim

Lee

et al. 2022

Viruses

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Most studies on the real-world effectiveness and safety of dolutegravir/lamivudine (DTG/3TC) have been conducted in Western countries, and Asian reports are lacking. We evaluated the effectiveness and safety of DTG/3TC in Korean adult people living with HIV (PLWH). This retrospective study was conducted from July 2020 to July 2022 at a tertiary hospital in Korea. Those who were followed up for more than 12 months were included. We analyzed the baseline characteristics, effectiveness, resistant profiles, body weights, metabolic parameters, and safety of DTG/3TC treatment in 151 PLWH, dividing them into the treatment-naïve group and the switching group. The median DTG/3TC treatment durations in the treatment-naïve and switching groups were 507.5 and 525.0 days. In the treatment-naïve group, the viral RNA titer was undetectable at 6 and 12 months in 95% of patients. In the switching group, virologic suppression was well-maintained. Meanwhile, the creatinine levels were slightly elevated in both groups compared to baseline. Five participants complained of mild side effects, such as indigestion, constipation, diarrhea, and fatigue. However, no patient stopped treatment during the follow-up period. Since there was no virological failure or serious complications observed in this study, DTG/3TC may be a good treatment option for PLWH in Korea.

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Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature

Grau

Miró

Olalla

et al. 2022

Expert Review of Anti-infective Therapy

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Real-World Experience with Two-Drug Regimens in HIV-1-Infected Patients Beyond the Indication of Clinical Trials: 48 Weeks' Results

Cited by 4 publications

References 17 publications

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

Real-World Effectiveness, Tolerability, and Safety of Dolutegravir/Lamivudine in Korea

Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature

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