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

Abstract

Objective

Evidence suggests that integrase strand transfer inhibitors (INSTIs) are associated with greater weight gain than other antiretrovirals. This real-world study compares weight/body mass index (BMI) change between insured US patients with human immunodeficiency virus (HIV-1) initiating a protease inhibitor (PI) or INSTI.

Methods

A retrospective longitudinal study was conducted using Decision Resources Group’s Real World Data Repository (7/17/2017-6/1/2019). Adult patients with HIV-1 who initiated a new PI or INSTI on or after 7/17/2018 (index date) and had ≥12 months of continuous pre-index clinical activity were included. Baseline characteristics were balanced using inverse probability of treatment weighting. The proportion of patients with ≥5% weight/BMI increases and mean weight/BMI change from pre- to post-index were compared using odds ratios (ORs) and mean differences (MDs).

Results

20,367 patients (9993 PI, 10,374 INSTI) were included (mean age = 50 years; ∼30% females). Pre- and post-index weight and BMI measurements were available in 429 and 430 PI patients, and 397 and 383 INSTI patients, respectively (mean time between index and post-index measurements: ∼7 months). The PI cohort was 39%/49% less likely to experience ≥5% weight/BMI increase than the INSTI cohort, respectively (OR [≥5% weight gain] = 0.61; p = .014; OR [≥5% BMI gain] = 0.51; p < .001). Mean weight/BMI gain was significantly lower in the PI cohort than the INSTI cohort (weight MD = –1.90 kg [–4.19 lbs], BMI MD = –0.61kg/m²; both p < .001).

Conclusions

Relative to INSTI, patients initiating a new PI were less likely to experience ≥5% weight/BMI gain post-index. Additionally, mean weight/BMI gain was lower in the PI than in the INSTI cohort.

Keywords:

• HIV
• protease inhibitors
• integrase inhibitors
• weight gain
• body mass index
• electronic health records
• observational study

Transparency

Declaration of funding

This study was supported by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design, interpretation of results, manuscript preparation, and publication decisions.

Declaration of financial/other relationships

WC and PD are employees of Janssen Scientific Affairs, LLC; HH is an employee of Janssen Research & Development, LLC, and all are stockholders of Johnson & Johnson. ACS, CR, PL, MHL, and BE are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work. A peer reviewer discloses that their institution received a research grant from Janssen. The peer reviewers have no other relevant financial or other relationships to disclose.

Author contributions

All authors were involved in the following aspects of the research: the conception and design of the study, or analysis and interpretation of the data; drafting of the paper and revising it critically for intellectual content; and the decision to submit the manuscript for publication. All authors agree to be accountable for all aspects of the work.

Acknowledgements

Medical writing assistance was provided by Loraine Georgy, PhD, an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Janssen Scientific Affairs, LLC