An assessment of weight change associated with the initiation of a protease or integrase strand transfer inhibitor in patients with human immunodeficiency virus

Chow, Wing; Donga, Prina; Côté-Sergent, Aurélie; Rossi, Carmine; Lefèbvre, Patrick; Lafeuille, Marie-Hélène; Émond, Bruno; Hardy, Hélène

doi:10.1080/03007995.2020.1775074

Cited by 19 publications

(23 citation statements)

References 44 publications

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“…Of note, these prior EMR studies only accounted for the impact of the third agent, and not the NRTI backbone used, on weight changes among these populations. 14,15 Thus, the present EMR study adds to the literature by showing that the use of different NRTIs and their doses may also be associated with variations in weight gain among real-world populations, although findings should also be interpreted in light of the specific third agent used.…”

Section: Discussionmentioning

confidence: 69%

“…The present study, with its focus on the NRTI backbone, builds on other contemporary real-world studies in the US which have shown differential weight gain related to the third agent of ART regimens (eg, INSTI vs PI) among PLWH in routine clinical practice. Recently, a retrospective longitudinal study by Chow et al 14 using administrative claims linked to EMR data found that over a mean follow-up period of 7 months, the PI cohort was 39% and 49% less likely to experience ≥5% weight and BMI increase than the INSTI cohort, respectively. Similarly, another recent study of treatment-naïve or virologically suppressed stable switchers by Emond et al 15 using administrative claims linked to EMR found that patients initiated on BIC/FTC/TAF (an INSTI-based STR) had greater weight and BMI increases over a 1-year follow-up period than patients initiated on DRV/c/FTC/TAF (a PIbased STR).…”

Section: Discussionmentioning

confidence: 99%

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Real-World Analysis of Weight Gain and Body Mass Index Increase Among Patients with HIV-1 Using Antiretroviral Regimen Containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Neither in the United States

Émond

Rossi

Rogers

et al. 2022

JHEOR

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Background: While some studies among patients with HIV-1 suggest that antiretroviral therapy (ART) regimens containing tenofovir alafenamide (TAF) may be associated with greater weight gain than those not containing TAF, no studies have assessed the relationship between TAF doses and weight change. Objectives: To evaluate weight-related outcomes among patients with HIV-1 in the United States initiating ART containing different nucleoside reverse transcriptase inhibitors and doses. Methods: A retrospective longitudinal study was conducted using Decision Resources Group’s electronic medical records (July 17, 2017-March 1, 2020). Adult patients with HIV-1 initiating ART (index date) containing TAF 25 mg, TAF 10 mg, tenofovir disoproxil fumarate (TDF), or neither TAF nor TDF on or after July 17, 2018, were included. Changes in weight and body mass index (BMI) from pre-index to 3, 6, 9, and 12 months post-index were compared between cohorts using mean differences obtained from ordinary least squares models adjusted for baseline characteristics. Time-to-weight and BMI increase ≥5% were compared using Cox models adjusted for baseline characteristics. Results: Among 1652 eligible patients (TAF 25 mg, n=710; TAF 10 mg, n=303; TDF, n=219; non-TAF/TDF, n=420), the majority (83.2%-99.5%) initiated an integrase strand transfer inhibitor, except for the TDF cohort (45.2%). Patients initiating TAF 25 mg had greater weight or BMI increase across all time points compared with patients initiating TAF 10 mg, TDF, or non-TAF/TDF regimens (mean differences in weight or BMI changes between cohorts at 12 months post-index ranged from 0.78 kg [1.72 lb] to 1.34 kg [2.95 lb] and from 0.77 kg/m2 to 1.95 kg/m2, respectively), although findings were not statistically significant for all comparisons. Compared with TAF 25 mg, time-to-weight and BMI increase ≥5% in the other treatment cohorts were longer (hazard ratios ranged from 0.77 to 0.94), although findings were generally not statistically significant. Conclusions: Among a population of patients predominantly initiating integrase strand transfer inhibitors, increases in weight and BMI post-ART initiation were common and appeared to be higher and occur more rapidly among patients receiving TAF 25 mg compared with lower TAF doses or other nucleosides. When considering long-term health consequences, weight gain is an important factor to consider when selecting an ART regimen.

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Real-World Analysis of Weight Gain and Body Mass Index Increase Among Patients with HIV-1 Using Antiretroviral Regimen Containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Neither in the United States

Émond

Rossi

Rogers

et al. 2022

JHEOR

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“…29 A similar real-world study using a different database reported a higher risk of 5% weight gain for INSTI vs. PI initiators overall (1.5 kg greater weight gain for INSTI), but the differences did not reach statistical significance among females, perhaps due to smaller sample size. 30 In a pooled analysis of 8 clinical trials, Sax et al reported approximately 1.5 kg greater mean weight gain for INSTIs vs. PIs, with female and African Americans/Black patients having greater risk of ≥10% weight gain. 20 Similarly, a recent prospective, observational study by Kline et al of military personnel with HIV reported that overweight African American men initiating INSTI-based regimens had greater mean BMI increase at 2 years than overweight White men (1.85 kg/m 2 /yr, P = 0.007).…”

Section: Discussionmentioning

confidence: 99%

Real-World Assessment of Weight Change in African American Females and Hispanics with HIV-1 After Initiating Integrase Strand-Transfer Inhibitors or Protease Inhibitors

Chen

Anderson

Pericone

et al. 2022

JHEOR

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Background: Studies have shown an increase in weight among people living with HIV (PLWH) who initiated integrase strand transfer inhibitors (INSTI). However, weight gain with INSTI-based regimens vs other regimens in females or racial/ethnic minorities is poorly understood. Objective: This study assessed differences in weight gain among treatment-naïve, female, African Americans and Hispanics after initiating INSTI-based vs protease inhibitor (PI)-based regimens. Methods: This retrospective, observational cohort study included data from the Optum® deidentified Electronic Health Record Database. Female African Americans or Hispanics initiating INSTI- or PI-based regimens between January 1, 2015, and December 31, 2018 (first prescription was index date), with ≥12-month baseline and follow-up periods, ≥1 weight measure during each period, and no prior antiretroviral (ARV) use were included. Inverse probability of treatment weighting was used to reduce selection bias and improve cohort comparability. Multivariable models were used to compare absolute weight/body mass index (BMI) changes and proportion of patients with weight/BMI increases from pre- to post-index (last measure between the 4th and 12th months post-index). Results: Weighted cohorts included 3407 African American females (INSTI, 1704; PI, 1703) and 3711 Hispanics (INSTI, 1865; PI, 1846) PLWH. Mean time to follow-up weight measure was ~9.5 months. Among female African Americans, INSTI initiators had a 1.5 kg greater mean weight gain (2.1 kg vs 0.6 kg; P = 0.033), and a higher proportion with ≥5% weight gain (32% vs 29%; odds ratio [OR]=1.2; 95% CI [1.0-1.4]) than PI initiators. Among Hispanics, INSTI and PI initiators had similar mean increases in weight (2.1 and 1.8 kg, respectively), but INSTI initiators had a higher proportion with ≥5% weight gain (31% vs 27%; OR=1.2; 95% CI [1.1-1.4]). Female African American INSTI initiators were more likely to shift from normal or overweight to a worse BMI classification. Hispanic INSTI initiators were less likely to shift from normal BMI to overweight but more likely to shift from normal or overweight to obese. Conclusion: In a real-world setting, INSTI-based regimens were associated with greater weight gain for treatment-naïve female African Americans, compared with PI-based regimens. Differences between regimens were less consistent for Hispanics. These results may inform ARV choice for PLWH who are at risk for ARV-related weight gain.

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“…Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir Recent evidence suggests that initial combination antiretroviral therapy (cART), including integrase strand transfer inhibitors (INSTIs), is associated with greater weight gain than initial regimens including other antiretroviral classes, and this correlation has led to an increasing concern, because international guidelines recommend the INSTI-based regimens as the preferred first-line treatment for HIV infection [1][2][3].…”

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confidence: 99%

Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir

Calza

Borderi

Colangeli

et al. 2022

Aids

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Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir Recent evidence suggests that initial combination antiretroviral therapy (cART), including integrase strand transfer inhibitors (INSTIs), is associated with greater weight gain than initial regimens including other antiretroviral classes, and this correlation has led to an increasing concern, because international guidelines recommend the INSTI-based regimens as the preferred first-line treatment for HIV infection [1][2][3].An unexpected excess in weight gain has been reported mostly in the course of dolutegravir-based treatments [3][4][5], but a comparison in weight gain associated with dolutegravir and bictegravir-based cART is still lacking.We performed a retrospective, observational, cohort analysis of HIV-1-infected adult patients naive to antiretroviral therapy and initiating a first antiretroviral treatment in our Division of Infectious Diseases from June 2018 through June 2020. Patients starting the coformulated antiretroviral regimen abacavir/lamivudine/dolutegravir (ABC/3TC/DOL) or tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC), and with a follow-up of at least 12 months were enrolled into the study.Demographic, clinical and laboratory data were extracted from the medical records and included weight, BMI, waist circumference, lipids, glucose and insulin. BMI classes were 18 kg/m 2 or less (class I), 18.1-25 kg/m 2 (class II), 25.1-30 kg/m 2 (class III) and more than 30 kg/m 2 (class IV). The homeostasis model assessment-estimated insulin resistance (HOMA-IR) index was calculated multiplying fasting plasma insulin (mUI/l) by fasting plasma glucose (mg/dl), then dividing by the constant 405, and insulin resistance is defined by HOMA-IR more than 2.5 [6].Study inclusion criteria were met by 141 patients who were enrolled in the study: 68 patients starting abacavir/ lamivudine/dolutegravir (ABC/3TC/DOL group) and 73 starting tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC group). Demographic, clinical and laboratory characteristics of study patients at baseline were comparable in both groups and are summarized in Table 1.The baseline mean (AE SD) weight was 72.8 (AE 10.7) kg, waist circumference 87.9 (AE 14.9) cm and BMI 24.3 (AE 3.6) kg/m 2 . In detail, BMI was 18 kg/m 2 or less (class I) in eight (5.7%) patients, ranging between 18 and 25 kg/m 2 (class II) in 79 (56%), ranging between 25 and 30 kg/m 2 (class III) in 35 (24.8%), and more than 30 kg/m 2 (class IV) in 19 (13.5%). Patients with baseline HOMA-IR index more than 2.5 were five (7.3%) in ABC/3TC/DOL group and four (5.5%) in TAF/FTC/BIC group.

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An assessment of weight change associated with the initiation of a protease or integrase strand transfer inhibitor in patients with human immunodeficiency virus

Cited by 19 publications

References 44 publications

Real-World Analysis of Weight Gain and Body Mass Index Increase Among Patients with HIV-1 Using Antiretroviral Regimen Containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Neither in the United States

Real-World Analysis of Weight Gain and Body Mass Index Increase Among Patients with HIV-1 Using Antiretroviral Regimen Containing Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Neither in the United States

Real-World Assessment of Weight Change in African American Females and Hispanics with HIV-1 After Initiating Integrase Strand-Transfer Inhibitors or Protease Inhibitors

Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir

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