Body mass index increase and weight gain among people living with HIV-1 initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide in the United States

Émond, Bruno; Rossi, Carmine; Côté-Sergent, Aurélie; Bookhart, Brahim; Anderson, David; Lefèbvre, Patrick; Lafeuille, Marie-Hélène; Donga, Prina

doi:10.1080/03007995.2021.2007006

Cited by 15 publications

(6 citation statements)

References 60 publications

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“…In addition, no significant changes in body weight and BMI were observed at 24 weeks. This finding et al 22 but was consistent with another study. 23 In Emond et al's study, patient weight changes were statistically significant only at 36 weeks.…”

Section: (B) (A)supporting

confidence: 90%

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

Kong,

Xie,

et al. 2023

Immunity Inflam & Disease

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BackgroundProspective studies examining long‐term therapeutic outcomes of the Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC/FTC/TAF in HIV‐infected individuals in southwest China.MethodsThis was a single‐center, prospective study enrolling ART‐naïve (n = 32) and ART‐experienced (n = 177) HIV‐infected patients administered BIC/FTC/TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of Electronic Patient Reporting Outcome (ePRO) were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at Week 24.ResultsAt Week 24, 87.5% and 95.5% of ART‐naïve and ART‐experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in ART‐naïve and ART‐experienced patients increased significantly by 163.5 cells/μL (p = .002) and 55.0 cells/μL (p = .022), respectively. By Week 24, no patients had discontinued the BIC/FTC/TAF treatment due to adverse events. Based on ePRO data, ART‐naïve and ART‐experienced patients at Week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC/FTC/TAF.ConclusionBIC/FTC/TAF reduces the viral load in ART‐naïve patients with high viral load as well as ART‐experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC/FTC/TAF. This study also revealed a very low incidence for BIC/FTC/TAF drug‐related side effects.

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Section: (B) (A)supporting

confidence: 90%

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

Kong,

Xie,

et al. 2023

Immunity Inflam & Disease

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show abstract

“…In addition, no signi cant changes in body weight and BMI were observed at 24 weeks. This nding contradicted Emond et al [22] but was consistent with another study [23]. In Emond et al's study, patient weight changes were statistically signi cant only at 36 weeks.…”

Section: Discussionsupporting

confidence: 57%

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Kong

Xie

et al. 2023

Preprint

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Background: Prospective studies examining long-term therapeutic outcomes of the BIC+FTC+TAF regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC+FTC+TAF in HIV-infected individuals in southwest China. Methods: This was a single-center, prospective study enrolling treatment-naïve (n=32) and treatment-experienced (n=177) HIV-infected patients administered BIC+FTC+TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of ePRO were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at week 24. Results: At week 24, 87.5% and 95.5% of treatment-naïve and treatment-experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in treatment-naïve and treatment-experienced patients increased significantly by 163.5 cells/μL (P=0.002) and 55.0 cells/μL (P=0.022), respectively. By week 24, no patients had discontinued the BIC+FTC+TAF treatment due to adverse events. Based on ePRO data, treatment-naïve and treatment-experienced patients at week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC+FTC+TAF. Conclusion: BIC+FTC+TAF reduces the viral load in treatment-naïve patients with high viral load as well as treatment-experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC+FTC+TAF. This study also revealed a very low incidence for BIC+FTC+TAF drug-related side effects.

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“…Research on the consequence of ART use on cardiometabolic outcomes has started to emerge recently [11,[27][28][29][30][31], owing to growing evidence on the association of some ART with weight gain [7][8][9][32][33][34][35]. In a US analysis of INSTI-associated metabolic changes in virally controlled women enrolled in the longitudinal Women's Interagency HIV Study (WIHS), PLWH who switched to or added an INSTI to their ART regimen had significant increases in HbA1c and blood pressure relative to those who remained on a non-INSTI ART regimen after a median follow-up of approximately 2 years [11].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, obesity and elevated body mass index (BMI) are well‐established risk factors for cardiometabolic disease [ 45 , 46 ], and significantly greater weight/BMI increases have been reported among PLWH treated with INSTI versus non‐INSTI regimens [ 9 , 32 , 35 ]. These observations may have important clinical implications for PLWH, as it has been shown that weight gain conferred an even greater risk of incident diabetes mellitus among PLWH than among HIV‐negative individuals [ 47 ].…”

Section: Discussionmentioning

confidence: 99%

Incidence of cardiometabolic outcomes among people living with HIV‐1 initiated on integrase strand transfer inhibitor versus non‐integrase strand transfer inhibitor antiretroviral therapies: a retrospective analysis of insurance claims in the United States

et al. 2023

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Introduction Integrase strand transfer inhibitor (INSTI)‐containing antiretroviral therapy (ART) has been associated with weight gain, though there is limited information on associations between ART‐related weight gain and cardiometabolic outcomes among people living with HIV‐1 (PLWH). We, therefore, evaluated risks of incident cardiometabolic outcomes following INSTI versus non‐INSTI‐based ART initiation in the United States. Methods We conducted a retrospective study using IBM MarketScan Research Databases (12 August 2012−31 January 2021). Treatment‐naïve PLWH initiating ART (index date) on/after 12 August 2013 (approval date of the first second‐generation INSTI, dolutegravir) were included and censored at regimen switch/discontinuation, end of insurance eligibility or end of data availability. We used inverse probability of treatment weights constructed with baseline (12 months pre‐index) characteristics to account for differences between INSTI‐ and non‐INSTI‐initiating cohorts. Doubly robust hazard ratios (HRs) obtained from weighted multivariable Cox regression were used to compare time to incident cardiometabolic outcomes (congestive heart failure [CHF], coronary artery disease, myocardial infarction, stroke/transient ischemic attack, hypertension, type II diabetes, lipid disorders, lipodystrophy and metabolic syndrome) by INSTI‐initiation status. Results Weighted INSTI (mean age = 39 years, 23% female, 70% commercially insured, 30% Medicaid insured) and non‐INSTI (mean age = 39 years, 24% female, 71% commercially insured, 29% Medicaid insured) cohorts included 7059 and 7017 PLWH, respectively. The most common INSTI‐containing regimens were elvitegravir‐based (43.4%), dolutegravir‐based (33.3%) and bictegravir‐based (18.4%); the most common non‐INSTI‐containing regimens were darunavir‐based (31.5%), rilpivirine‐based (30.4%) and efavirenz‐based (28.3%). Mean±standard deviation follow‐up periods were 1.5±1.5 and 1.1±1.2 years in INSTI‐ and non‐INSTI‐initiating cohorts, respectively. INSTI initiators were at a clinically and significantly increased risk of experiencing incident CHF (HR = 2.12, 95% confidence interval [CI] = 1.08−4.05; p = 0.036), myocardial infarction (HR = 1.79, 95% CI = 1.03−5.65; p = 0.036) and lipid disorders (HR = 1.26, 95% CI = 1.04−1.58; p = 0.020); there was no evidence of an increased risk for other individual or composite outcomes. Conclusions Over a short average follow‐up period of <2 years, INSTI use among treatment‐naïve PLWH was associated with an increased risk of several cardiometabolic outcomes, such as CHF, myocardial infarction and lipid disorders, compared to non‐INSTI use. Further research accounting for additional potential confounders and with longer follow‐up is warranted to more accurately and precisely quantify the impact of INSTI‐containing ART on long‐term cardiometabolic outcomes.

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Body mass index increase and weight gain among people living with HIV-1 initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide in the United States

Cited by 15 publications

References 60 publications

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

Incidence of cardiometabolic outcomes among people living with HIV‐1 initiated on integrase strand transfer inhibitor versus non‐integrase strand transfer inhibitor antiretroviral therapies: a retrospective analysis of insurance claims in the United States

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