Evidence synthesis evaluating body weight gain among people treating HIV with antiretroviral therapy - a systematic literature review and network meta-analysis

Kanters, Steve; Renaud, Françoise; Rangaraj, Ajay; Zhang, Kenneth; Limbrick‐Oldfield, Eve H.; Hughes, Monica; Ford, Nathan; Vitória, Marco

doi:10.1016/j.eclinm.2022.101412

Cited by 55 publications

(32 citation statements)

References 35 publications

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“…Our results are consistent with the literature which unanimously confirms weight gain following TAF introduction, in addition to that due to INSTIs, in people starting a first treatment as well as in those changing treatment with a suppressed viral load, and in randomized clinical trials as well as in large cohorts [1–5, 8]. Our study, due to its rigorous methodology, reinforces the probability of a direct responsibility of TAF in the weight gain following TDF replacement.…”

Section: Discussionsupporting

confidence: 91%

Weight gain following the single substitution of tenofovir disoproxil fumarate by tenofovir alafenamide in HIV‐infected people from the French Dat'AIDS cohort: A propensity score‐matched analysis

et al. 2023

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Objectives To minimize confounding factors, we aimed to describe the changes in weight and body mass index (BMI) following the single substitution of tenofovir disoproxil fumarate (TDF) by tenofovir alafenamide (TAF) in people living with HIV (PLWH). Methods We designed a retrospective study in a large French cohort. We included all HIV‐suppressed adults under TDF + emtricitabine + rilpivirine or elvitegravir/cobistat, who experienced a first switch from TDF to TAF, while other antiretrovirals remained unchanged (Switch group). We compared this population to a propensity score‐matched Control group (1:1) who stayed on the same TDF‐based regimen. Changes were evaluated after 6 (M6) and 12 months (M12). Results Some 1260 and 468 PLWH were evaluable per group at M6 and M12, respectively. In the Switch group, there was a mean (95% confidence interval [95% CI]) weight gain of +1014 g (+826 to +1201) at M6 (p < 0.0001) and +1365 g (+910 to +1820) at M12 (p < 0.0001), as compared with baseline. Meanwhile, there was no significant weight gain at M6 (+139 g [−50 to +328]) and M12 (−32 g [−413 to +350]) in the matched Control group. Similarly, mean BMI increased significantly in the Switch group at M6 (+0.35, 95% CI: +0.29 to +0.41, p < 0.0001) and M12 (+0.49, 95% CI: +0.32 to +0.65, p < 0.0001), while it was stable at M6 (+0.05, 95% CI: −0.01 to +0.12, p = 0.11) and M12 (+0.01, 95% CI: −0.12 to +0.14, p = 0.89) in the No Switch group. Conclusions Although modest, there is a significant weight gain following the substitution of TDF by TAF. This should be anticipated in certain at‐risk populations.

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Section: Discussionsupporting

confidence: 91%

Weight gain following the single substitution of tenofovir disoproxil fumarate by tenofovir alafenamide in HIV‐infected people from the French Dat'AIDS cohort: A propensity score‐matched analysis

et al. 2023

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“…There was also an increase in the proportion of participants classified as overweight or obese in this population [33]. Continued monitoring of weight gain and associated metabolic outcomes in children and adolescents on TAF is critical in light of findings in adults, showing increased weight gain with TAF compared with other NRTIs [42].…”

Section: Resultsmentioning

confidence: 99%

Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review

et al. 2023

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Introduction: Tenofovir alafenamide (TAF) is approved for paediatric use in fixed-dose combination tablets, but efficacy and safety data in children are limited. We conducted a systematic review on the efficacy/effectiveness and safety of TAF in infants, children and adolescents living with HIV. Methods: We searched MEDLINE, Embase, the Cochrane Library, clinical trial registries, reference lists and relevant conferences to identify literature published January 2009-March 2021. We included clinical trials and observational studies assessing the efficacy/effectiveness or safety of TAF through ≥6 months of treatment in participants aged 0-19 years. Results and discussion: Overall 3626 abstracts and 371 full papers were screened. Four single-arm, innovator-funded trials (341 participants) and a pooled analysis of those trials were identified. All four trials included treatment-experienced and virally suppressed children or adolescents. One trial also included treatment-naïve adolescents with baseline viral load >1000 copies/ml. The risk of bias was rated as low in one study and unclear in the other three owing to missing data on study design (all conference presentations). At 48 weeks, 92% (46/50) of treatment-naïve participants were virally suppressed (one trial). Among treatment-experienced participants with viral load at 48 weeks, 214 of 224 participants were virally suppressed. Across the studies, one grade 3/4 adverse event was considered drug-related (intermediate uveitis). There were three discontinuations for adverse events (grade 2 anxiety and insomnia, grade 1 iridocyclitis [drug-related] and grade 1 pulmonary tuberculosis [unrelated to treatment]). One accidental death occurred across the four studies. In the pooled analysis of 223 participants, the median change in bone mineral density z-score (height-and age-adjusted) from baseline to 48 weeks was −0.12 (interquartile range [IQR] −0.46, 0.17) to 0.05 (IQR not reported) for spine, and −0.09 (IQR −0.33, 0.07) to 0.09 (IQR not reported) for total body less head. Weight-for-age z-scores increased by 0.25 from baseline to 48 weeks. Conclusions: Four single-arm trials were identified in this systematic review, with initial evidence suggesting good viral suppression and no obvious safety concerns in children and adolescents on TAF-containing regimens over 24-48 weeks. However, further comparative and longer-term safety data are needed in children and adolescents, including on weight and metabolic changes.

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“…Furthermore, a recent analysis of eight phase III clinical trials, including 5,680 ART-naive participants, reported that 17.3% of them had a weight gain of ≥10% from baseline, and the weight gain was greater among those taking INSTIs (3.24 kg) than NNRTIs (1.93 kg) and PIs (1.72 kg) ( 28 ). Female gender and African origin were factors associated with weight gain ( 29 ). The studies conducted in the Asian population reported that factors such as low initial CD4 counts and starting treatment with DTG/TAF/FTC were associated with weight gain ( 30 ).…”

Section: Discussionmentioning

confidence: 99%

Lipid profiles of people with human immunodeficiency virus with dyslipidemia after switching from efavirenz to dolutegravir

Khemla

Meesing

Sribenjalux

et al. 2023

dti

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Introduction: Human immunodeficiency virus (HIV) infection and the long-term use of antiretroviral therapy, especially efavirenz (EFV)-based regimens, impact lipid profiles due to insulin resistance and lead to a higher risk of metabolic diseases. Dolutegravir (DTG) is an integrase inhibitor with better lipid profiles than EFV. However, data on treatment experience in Thailand are limited. The primary outcome was lipid profile changes at 24 weeks after switching therapy. Methods: We conducted a prospective, open-label, cohort study in people with HIV aged ≥18 years who had undergone at least 6 months of EFV-based therapy, had HIV-1 ribonucleic acid levels <50 copies/mL for ≥6 months before switching, and were diagnosed with dyslipidemia or had risk factors for atherosclerosis cardiovascular disease based on modified National Cholesterol Education Program Adult Treatment Panel III guidelines. Results: Sixty-four patients were enrolled. The mean age (standard deviation [SD]) was 48.20 ± 10.46 years, and 67.19% were male. At week 24, there were decreases from baseline in mean total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides. However, mean body weight and waist circumference had increased. Conclusions: DTG resulted in better lipid profiles after switching from EFV-based therapy, suggesting that this switch could benefit patients with a high risk of cardiovascular disease. However, it is essential to note that weight gain and increased waist circumference were also observed.

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Evidence synthesis evaluating body weight gain among people treating HIV with antiretroviral therapy - a systematic literature review and network meta-analysis

Cited by 55 publications

References 35 publications

Weight gain following the single substitution of tenofovir disoproxil fumarate by tenofovir alafenamide in HIV‐infected people from the French Dat'AIDS cohort: A propensity score‐matched analysis

Weight gain following the single substitution of tenofovir disoproxil fumarate by tenofovir alafenamide in HIV‐infected people from the French Dat'AIDS cohort: A propensity score‐matched analysis

Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review

Lipid profiles of people with human immunodeficiency virus with dyslipidemia after switching from efavirenz to dolutegravir

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