Weight gain after antiretroviral therapy initiation in people living with HIV in the United States: analyses of electronic medical records and prescription claims

Abstract

Background

Treatment guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimens for treatment naïve people living with HIV (PLWH) in the United States (US). This retrospective database study compared weight changes following initiation of INSTI-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or protease inhibitor (PI)-based ART in treatment-naïve PLWH.

Methods

Adult (≥18 years) PLWH initiated on INSTI, NNRTI, or PI plus ≥2 nucleoside reverse transcriptase inhibitors (NRTI) between 1 January 2014 to 31 August 2019 were identified in IQVIA’s Ambulatory Electronic Medical Records (AEMR) linked to prescription drug claims (LRx). Weight changes over up to 36 months (M) of follow-up were compared among PLWH on INSTI- vs. NNRTI- and PI-based ART separately using non-linear mixed effect models, adjusting for demographics and baseline clinical characteristics.

Results

The INSTI, NNRTI, and PI cohorts included 931, 245, and 124 PLWH, respectively. For all three cohorts, the majority were male (78.2–81.2%) and overweight/obese (53.6–61.6%) at baseline; 40.8–45.2% of the groups were African American. The INSTI vs. NNRTI/PI cohorts were younger (median age: 38 years vs. 44 years/46 years), had lower weight at ART initiation (mean: 80.9 kg vs. 85.7 kg/85.0 kg), and had higher TAF usage during follow-up (55.6% vs. 24.1%/25.8%; all p < .05). Multivariate models showed higher weight gain among PLWH in INSTI vs. NNRTI and PI cohorts during treated follow-up (estimated weight gain after 36 M: 7.1 kg vs. 3.8 kg and 3.8 kg, both p < .05).

Conclusion

Study findings highlight the need to monitor an increase in weight and potential metabolic complications among PLWH starting ART with INSTI.

Keywords:

• Weight gain
• integrase inhibitors
• treatment naïve
• antiretroviral therapy

Transparency

Declaration of funding

This work was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc, Rahway, NJ, USA.

Declaration of financial/other relationships

Girish Prajapati is an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc, Rahway, NJ, USA. Aimee Near, Jenny Tse, and Xiaohui Zhao are employed by IQVIA, which received funding from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc, Rahway, NJ, USA to conduct this study. Princy Kumar reports grant/research support from GSK, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc, Rahway, NJ, USA, and Gilead; stock ownership with Merck & Co., Inc., Rahway, NJ, USA, Pfizer, Johnson & Johnson, GSK, and Gilead; and service as consultant/advisory board member with AMGEN, GSK, Merck & Co., Inc., Rahway, NJ, USA, and Gilead.

Results in part were presented at the 2022 AIDS meeting, Montreal, Canada, 29 July–2 August 2022.

A reviewer on this manuscript has disclosed that they have received a research grant from Gilead Science. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

Conception and design of study: Girish Prajapati, Xiaohui Zhao, Jenny Tse, and Aimee M. Near. Acquisition of data, analysis, and interpretation of data: Girish Prajapati, Xiaohui Zhao, Jenny Tse, Aimee M. Near, and Princy N. Kumar. Drafting and revising the manuscript: Girish Prajapati, Xiaohui Zhao, Jenny Tse, Aimee M. Near, and Princy N. Kumar. All authors approved the final manuscript version to be submitted.

Acknowledgements

The authors thank Wei-Ti Huang and Hangcheng Liu of IQVIA for statistical expertise during the analysis of data of this study.

Data availability statement

The data that support the findings of this study are available from IQVIA but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.

Ethics statement

Not applicable. This was a retrospective database study using de-identified data compliant with the US Health Insurance Portability and Accountability Act of 1996. Therefore, ethics approval from the Institutional Review Board (IRB) was not required for this study.