Cost-effectiveness protocol for treating adult HIV-infected patients with Kaposi sarcoma in resource-limited settings: a phase III, randomized, open-label, non-inferiority study of paclitaxel and pegylated liposomal doxorubicin.

BACKGROUND: This paper presents the rationale and plan for a cost-effectiveness analysis conducted alongside an open-label, prospective, randomized, two-arm, multicenter, non-inferiority study by the Consortium for Advancing the Prevention and Management of Cancer in People with HIV (AMC) in sub-Saharan Africa. The study compares two commonly used chemotherapy agents, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD), administered intravenously with concomitant antiretroviral therapy (ART) for the treatment of adult persons living with Human Immunodeficiency Virus (HIV) (PLWH) with severe Kaposi sarcoma (KS) according to WHO guidelines. The two regimens are commonly used in high-resource settings but have not been formally compared in lower-resource settings. METHODS: This study uses a decision-tree model to evaluate the cost-effectiveness of PTX versus PLD for treating severe KS in adults living with HIV. A health system perspective and a two-year time horizon will be applied. Costs, including medications, labs, and hospitalizations, will be estimated using micro-costing and time-and-motion analyses. Health outcomes will be measured in Quality Adjusted Life years using PROMIS 29 + 2 utility scores. Sensitivity analyses will include Daily adjusted life years and Years of Life Lost. DISCUSSION: This research will provide valuable insights into the cost-effectiveness of these treatments in managing KS. The results of this analysis will have important implications for healthcare providers and policymakers, offering guidance on the optimal treatment approach for HIV-infected individuals with KS. TRIAL REGISTRATION: This study (NCT05411237) is registered on ClinicalTrials.gov, sponsored by the Consortium for Advancing the Prevention and Management of Cancer in People with HIV. It was first posted on June 9, 2022, with the latest update on January 29, 2025. The trial was prospectively registered before participant enrollment. Estimated primary completion is December 2027, with full completion in September 2028.