Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial.

Autor:	Lawrence DS; Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana. Electronic address: david.s.lawrence@lshtm.ac.uk., Muthoga C; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Meya DB; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; Department of Medicine, School of Medicine, Makerere University, Kampala, Uganda; University of Minnesota, Minneapolis, MN, USA., Tugume L; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda., Williams D; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; University of Minnesota, Minneapolis, MN, USA., Rajasingham R; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; University of Minnesota, Minneapolis, MN, USA., Boulware DR; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; University of Minnesota, Minneapolis, MN, USA., Mwandumba HC; Department of Clinical Science, Liverpool School of Tropical Medicine, Liverpool, UK; Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi; Department of Medicine, Kamuzu University of Health Sciences, Blantyre, Malawi., Moyo M; Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi; Department of Medicine, Kamuzu University of Health Sciences, Blantyre, Malawi., Dziwani EN; Malawi-Liverpool-Wellcome Clinical Research Programme, Blantyre, Malawi., Maheswaran H; Institute of Global Health Innovation, Imperial College London, London, UK., Kanyama C; Lilongwe Medical Relief Trust (University of North Carolina Project), Lilongwe, Malawi; Department of Medicine, University of North Carolina, Chapel Hill, NC, USA., Hosseinipour MC; Lilongwe Medical Relief Trust (University of North Carolina Project), Lilongwe, Malawi; Department of Medicine, University of North Carolina, Chapel Hill, NC, USA., Chawinga C; Lilongwe Medical Relief Trust (University of North Carolina Project), Lilongwe, Malawi., Meintjes G; Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Department of Medicine, University of Cape Town, Cape Town, South Africa., Schutz C; Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Department of Medicine, University of Cape Town, Cape Town, South Africa., Comins K; Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Department of Medicine, University of Cape Town, Cape Town, South Africa., Bango F; Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa), Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Muzoora C; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; Mbarara University of Science and Technology, Mbarara, Uganda., Jjunju S; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda., Nuwagira E; Infectious Diseases Institute, College of Health Sciences, School of Medicine, Makerere University, Kampala, Uganda; Mbarara University of Science and Technology, Mbarara, Uganda., Mosepele M; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Internal Medicine, University of Botswana, Gaborone, Botswana., Leeme T; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Ndhlovu CE; Internal Medicine Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe., Hlupeni A; Internal Medicine Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe., Shamu S; Internal Medicine Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe., Boyer-Chammard T; Institut Pasteur, National Reference Centres, Molecular Mycology Unit and National Reference Centre for Invasive Mycoses and Antifungals, Joint Research Unit 2000, Paris, France; Université de Paris, Necker Pasteur Center for Infectious Diseases and Tropical Medicine, Hôpital Necker Enfants Malades, AssistancePublique-Hôpitaux de Paris, University Hospital Institute Imagine, Paris, France., Molloy SF; Institute of Infection and Immunity, St George's University London, London, UK., Youssouf N; Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Internal Medicine, University of Botswana, Gaborone, Botswana., Chen T; Department of Public Health and Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Institute of Population Health, University of Liverpool, Liverpool, UK., Shiri T; Health Economics and Outcomes Research, Cardiff, UK., Jaffar S; Department of Public Health and Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK., Harrison TS; Institute of Infection and Immunity, St George's University London, London, UK; Clinical Academic Group in Infection and Immunity, St George's University Hospitals NHS Foundation Trust, London, UK; Medical Research Council Centre for Medical Mycology, University of Exeter, Exeter, UK., Jarvis JN; Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Niessen LW; Department of Public Health and Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.
Jazyk:	angličtina
Zdroj:	The Lancet. Global health [Lancet Glob Health] 2022 Dec; Vol. 10 (12), pp. e1845-e1854.
DOI:	10.1016/S2214-109X(22)00450-8
Abstrakt:	Background: HIV-associated cryptococcal meningitis is a leading cause of AIDS-related mortality. The AMBITION-cm trial showed that a regimen based on a single high dose of liposomal amphotericin B deoxycholate (AmBisome group) was non-inferior to the WHO-recommended treatment of seven daily doses of amphotericin B deoxycholate (control group) and was associated with fewer adverse events. We present a five-country cost-effectiveness analysis. Methods: The AMBITION-cm trial enrolled patients with HIV-associated cryptococcal meningitis from eight hospitals in Botswana, Malawi, South Africa, Uganda, and Zimbabwe. Taking a health service perspective, we collected country-specific unit costs and individual resource-use data per participant over the 10-week trial period, calculating mean cost per participant by group, mean cost-difference between groups, and incremental cost-effectiveness ratio per life-year saved. Non-parametric bootstrapping and scenarios analyses were performed including hypothetical real-world resource use. The trial registration number is ISRCTN72509687, and the trial has been completed. Findings: The AMBITION-cm trial enrolled 844 participants, and 814 were included in the intention-to-treat analysis (327 from Uganda, 225 from Malawi, 107 from South Africa, 84 from Botswana, and 71 from Zimbabwe) with 407 in each group, between Jan 31, 2018, and Feb 17, 2021. Using Malawi as a representative example, mean total costs per participant were US$1369 (95% CI 1314-1424) in the AmBisome group and $1237 (1181-1293) in the control group. The incremental cost-effectiveness ratio was $128 (59-257) per life-year saved. Excluding study protocol-driven cost, using a real-world toxicity monitoring schedule, the cost per life-year saved reduced to $80 (15-275). Changes in the duration of the hospital stay and antifungal medication cost showed the greatest effect in sensitivity analyses. Results were similar across countries, with the cost per life-year saved in the real-world scenario ranging from $71 in Botswana to $121 in Uganda. Interpretation: The AmBisome regimen was cost-effective at a low incremental cost-effectiveness ratio. The regimen might be even less costly and potentially cost-saving in real-world implementation given the lower drug-related toxicity and the potential for shorter hospital stays. Funding: European Developing Countries Clinical Trials Partnership, Swedish International Development Cooperation Agency, Wellcome Trust and Medical Research Council, UKAID Joint Global Health Trials, and the National Institute for Health Research. Translations: For the Chichewa, Isixhosa, Luganda, Setswana and Shona translations of the abstract see Supplementary Materials section. Competing Interests: Declaration of interests TSH was the recipient of an investigator award to his institution from Gilead Sciences; speaker fees from Pfizer and Gilead Sciences; and serves as an adviser for F2G. JNJ and GM both declare speaker fees from Gilead Sciences. All other authors declare no competing interests. (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
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