Quality of life of HIV-infected patients who switch antiretroviral medication due to side effects or other reasons

Abstract

Objective: The objective of this study was to investigate changes in health-related quality of life (HRQOL) among HIV patients following switch from a first- to second-line antiretroviral therapy (ART) regimen.

Research design and methods: This was an observational study of adult HIV patients in the US at 35 academic and community health centers. Patients were required to be switching an antiretroviral regimen for the first time at the enrollment visit. Patients were assigned to a study cohort based on whether the switch was due to treatment-related side effects or for any other reason as reported by their physician. Patients completed the Medical Outcomes Study–Human Immunodeficiency Virus (MOS-HIV) health survey, the Depression, Anxiety, and Stress Scale Short Form (DASS-21), and the Human Immunodeficiency Virus Treatment Satisfaction Questionnaire–status (HIVTSQs) at the enrollment visit (baseline) and a follow-up survey was completed approximately 4 weeks later. The within cohort change in survey measures from baseline to follow-up was assessed by two-sample paired t-test.

Results: Patients who switched their ART regimen due to treatment-related side effects (n = 50) had statistically significant improvements (p < .05, baseline to follow-up) in mean Physical and Mental Health Summary scores (MOS-HIV scale) and in all three HIVTSQ summary scores. Patients who switched for other reasons (n = 44) did not experience statistically significant improvements in these same measures.

Conclusions: HIV patients whose regimen was switched due to treatment-related side effects experienced an improvement in QOL following the switch. Physicians should take the potential impact on QOL into consideration when deciding on a switch in ART regimen, particularly when patients are intolerant of their current treatment. The results are based on a patient survey and may have been influenced by recall and response bias.

Keywords:

• Antiretroviral therapy
• HIV
• QOL
• Side effects

Transparency

Declaration of funding

This study was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.

Declaration of financial/other relationships

E.M.M. has disclosed that he was an employee and shareholder of Merck Sharp & Dohme Corp. at the time this study was conducted. P.T.J., A.G.H., and T.B. have disclosed that they are employed by Optum. Optum was paid by Merck Sharp & Dohme Corp. to conduct this study. A.W.W. has disclosed that he was a consultant to Merck Sharp & Dohme Corp. for selection of PRO measures. He is also a consultant to BMS, Genentech, Johnson & Johnson, Otsuka, and Pfizer.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Jesse Potash, Optum, provided medical writing assistance. Michael Saag, University of Alabama at Birmingham, provided input on study protocol development.