Seemingly Unrelated Regression Analysis of the Cost and Health-Related Quality of Life Outcomes of the REVAMP Randomized Clinical Trial

Tamlyn A Rautenberg; Shu Kay Ng; Gavin George; Mahomed-Yunus S Moosa; Suzanne M McCluskey; Rebecca F Gilbert; Selvan Pillay; Isaac Aturinda; Kevin L Ard; Winnie Muyindike; Nicholas Musinguzi; Godfrey Masette; Melendhran Pillay; Pravi Moodley; Jaysingh Brijkumar; Rajesh T Gandhi; Brent Johnson; Henry Sunpath; Mwebesa B Bwana; Vincent C Marconi; Mark J Siedner

doi:10.1016/j.vhri.2022.12.006

Seemingly Unrelated Regression Analysis of the Cost and Health-Related Quality of Life Outcomes of the REVAMP Randomized Clinical Trial

Value Health Reg Issues. 2023 May:35:42-47. doi: 10.1016/j.vhri.2022.12.006. Epub 2023 Feb 28.

Authors

Tamlyn A Rautenberg¹, Shu Kay Ng², Gavin George³, Mahomed-Yunus S Moosa⁴, Suzanne M McCluskey⁵, Rebecca F Gilbert⁶, Selvan Pillay⁷, Isaac Aturinda⁸, Kevin L Ard⁵, Winnie Muyindike⁸, Nicholas Musinguzi⁸, Godfrey Masette⁸, Melendhran Pillay⁹, Pravi Moodley¹⁰, Jaysingh Brijkumar¹¹, Rajesh T Gandhi¹², Brent Johnson¹³, Henry Sunpath¹⁴, Mwebesa B Bwana¹⁵, Vincent C Marconi¹⁶, Mark J Siedner¹⁷

Affiliations

¹ Centre for Applied Health Economics, Griffith University, Brisbane, QLD, Australia; Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; Allied Health Services, Metro North Hospital and Health Service, Brisbane, QLD, Australia. Electronic address: [email protected].
² Centre for Applied Health Economics, Griffith University, Brisbane, QLD, Australia.
³ Health Economics and HIV Research Division, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa; Division of Social Medicine and Global Health, Lund University, Lund, Sweden.
⁴ School of Clinical Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
⁵ Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
⁶ Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
⁷ School of Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
⁸ Department of Internal Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.
⁹ Department of Virology, National Health Laboratory Service, Durban, South Africa.
¹⁰ Department of Virology, National Health Laboratory Service, Durban, South Africa; Department of Virology, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
¹¹ Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
¹² Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹³ Department of Biostatistics and Computation Biology, University of Rochester, Rochester, NY, USA.
¹⁴ Department of Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
¹⁵ Mbarara University of Science and Technology, Mbarara, Uganda.
¹⁶ Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA; Department of Global Health, Rollins School of Public Health, Atlanta, GA, USA.
¹⁷ Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA; School of Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa; Department of Internal Medicine, Mbarara University of Science and Technology, Mbarara, Uganda; Department of Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa; Africa Health Research Institute, KwaZulu-Natal, South Africa.

Abstract

Objective: This study aimed to evaluate the 9-month cost and health-related quality of life (HRQOL) outcomes of resistance versus viral load testing strategies to manage virological failure in low-middle income countries.

Methods: We analyzed secondary outcomes from the REVAMP clinical trial: a pragmatic, open label, parallel-arm randomized trial investigating resistance versus viral load testing for individuals failing first-line treatment in South Africa and Uganda. We collected resource data, valued according to local cost data and used the 3-level version of EQ-5D to measure HRQOL at baseline and 9 months. We applied seemingly unrelated regression equations to account for the correlation between cost and HRQOL. We conducted intention-to-treat analyses with multiple imputation using chained equations for missing data and performed sensitivity analyses using complete cases.

Results: For South Africa, resistance testing and opportunistic infections were associated with statistically significantly higher total costs, and virological suppression was associated with lower total cost. Higher baseline utility, higher cluster of differentiation 4 (CD4) count, and virological suppression were associated with better HRQOL. For Uganda, resistance testing and switching to second-line treatment were associated with higher total cost, and higher CD4 was associated with lower total cost. Higher baseline utility, higher CD4 count, and virological suppression were associated with better HRQOL. Sensitivity analyses of the complete-case analysis confirmed the overall results.

Conclusion: Resistance testing showed no cost or HRQOL advantage in South Africa or Uganda over the 9-month REVAMP clinical trial.

Keywords: cost-effectiveness; health economics; resistance testing; seemingly unrelated regression; virological failure.

Publication types

Randomized Controlled Trial

MeSH terms

Anti-HIV Agents* / therapeutic use
Humans
Quality of Life
Südafrika

Substances

Anti-HIV Agents

Grants and funding

R01 AI124718/AI/NIAID NIH HHS/United States