PMID- 33355914 OWN - NLM STAT- MEDLINE DCOM- 20210917 LR - 20210917 IS - 1179-2027 (Electronic) IS - 1170-7690 (Print) IS - 1170-7690 (Linking) VI - 39 IP - 3 DP - 2021 Mar TI - Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial). PG - 331-343 LID - 10.1007/s40273-020-00987-3 [doi] AB - OBJECTIVES: Evidence comparing the economic and patient values of the World Health Organization's preferred (dolutegravir 50 mg [DTG]-based) and alternative (low-dose [400 mg] efavirenz [EFV400]-based) first-line antiretroviral regimens is limited. We compared patient-reported outcomes (PROs), costs, and the cost-utility of DTG- versus EFV400-based regimens in treatment-naive HIV-1 adults in the randomised NAMSAL ANRS 12313 trial in Yaounde, Cameroon. METHODS: We used clinical data, PROs, and health resource use data collected in the trial's first 96 weeks (2016-2019). Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale. Other PROs included perceived symptoms, depression, anxiety, and stress. In the 96-week base-case analysis, we estimated the unadjusted and multivariate-adjusted (1) mean costs (in US$, 2016 values) and QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB). Outcomes were extrapolated over 5 and 10 years. Uncertainty was assessed using the cost-effectiveness acceptability curve and scenario and cost-effective price threshold analyses. RESULTS: In the base-case analysis, the NHB (95% confidence interval) for the DTG-based regimen relative to the EFV400-based regimen was 0.056 (- 0.037 to 0.153), corresponding to an 88% probability of DTG being cost-effective. A 10% decrease in this regimen's price (from $5.2 to $4.7/month) would increase its cost-effectiveness probability to 95%. When extrapolating outcomes over 5 and 10 years, the DTG-based regimen had a 100% probability of being cost-effective for a large range of cost-effectiveness thresholds. CONCLUSIONS: At 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02777229. FAU - Bousmah, Marwan-Al-Qays AU - Bousmah MA AD - INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Sante & Traitement de l'Information Medicale, Aix-Marseille University, Marseille, France. FAU - Nishimwe, Marie Liberee AU - Nishimwe ML AD - INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Sante & Traitement de l'Information Medicale, Aix-Marseille University, Marseille, France. AD - ORS PACA, Observatoire Regional de la Sante Provence-Alpes-Cote d'Azur, Marseille, France. FAU - Tovar-Sanchez, Tamara AU - Tovar-Sanchez T AD - Recherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le developpement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France. FAU - Lantche Wandji, Martial AU - Lantche Wandji M AD - ANRS Cameroon Site, Central Hospital of Yaounde, Yaounde, Cameroon. FAU - Mpoudi-Etame, Mireille AU - Mpoudi-Etame M AD - Military Hospital, Yaounde, Cameroon. FAU - Maradan, Gwenaelle AU - Maradan G AD - ORS PACA, Observatoire Regional de la Sante Provence-Alpes-Cote d'Azur, Marseille, France. FAU - Omgba Bassega, Pierrette AU - Omgba Bassega P AD - Cite Verte Hospital, Yaounde, Cameroon. FAU - Varloteaux, Marie AU - Varloteaux M AD - ANRS Cameroon Site, Central Hospital of Yaounde, Yaounde, Cameroon. FAU - Montoyo, Alice AU - Montoyo A AD - ANRS, Paris, France. FAU - Kouanfack, Charles AU - Kouanfack C AD - ANRS Cameroon Site, Central Hospital of Yaounde, Yaounde, Cameroon. AD - Faculty of Medicine and Pharmaceutical Sciences, University of Dshang, Dshang, Cameroon. FAU - Delaporte, Eric AU - Delaporte E AD - Recherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le developpement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France. FAU - Boyer, Sylvie AU - Boyer S AUID- ORCID: 0000-0002-7567-5200 AD - INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Sante & Traitement de l'Information Medicale, Aix-Marseille University, Marseille, France. sylvie.boyer@inserm.fr. CN - New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group LA - eng SI - ClinicalTrials.gov/NCT02777229 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201223 PL - New Zealand TA - Pharmacoeconomics JT - PharmacoEconomics JID - 9212404 RN - 0 (Alkynes) RN - 0 (Benzoxazines) RN - 0 (Cyclopropanes) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - DKO1W9H7M1 (dolutegravir) RN - JE6H2O27P8 (efavirenz) MH - Adult MH - Alkynes MH - Benzoxazines MH - Cameroon MH - Cost-Benefit Analysis MH - Cyclopropanes MH - *HIV Infections/drug therapy MH - Heterocyclic Compounds, 3-Ring MH - Humans MH - Oxazines MH - Piperazines MH - Pyridones PMC - PMC7882571 COIS- All authors report no conflict of interest in relation to this study. FIR - Ayouba, A IR - Ayouba A FIR - Agholeng, A IR - Agholeng A FIR - Butel, C IR - Butel C FIR - Cournil, A IR - Cournil A FIR - Delaporte, E IR - Delaporte E FIR - Eymard-Duvernay, S IR - Eymard-Duvernay S FIR - Granouillac, B IR - Granouillac B FIR - Izard, S IR - Izard S FIR - Lacroix, A IR - Lacroix A FIR - Leroy, S IR - Leroy S FIR - Peeters, M IR - Peeters M FIR - Perrineau, S IR - Perrineau S FIR - Serrano, L IR - Serrano L FIR - Reynes, J IR - Reynes J FIR - Tovar-Sanchez, T IR - Tovar-Sanchez T FIR - Vidal, N IR - Vidal N FIR - Fouda, P J IR - Fouda PJ FIR - Kounfack, C IR - Kounfack C FIR - Mougnoutou, R IR - Mougnoutou R FIR - Olinga, J IR - Olinga J FIR - Omgba, V IR - Omgba V FIR - Tchokonte Ngande, S C IR - Tchokonte Ngande SC FIR - Ymele, B IR - Ymele B FIR - Kambi, A IR - Kambi A FIR - Epoupa Mpacko, C D IR - Epoupa Mpacko CD FIR - Mpoudi-Etame, M IR - Mpoudi-Etame M FIR - Fotso, M IR - Fotso M FIR - Moukoko, R IR - Moukoko R FIR - Nke, T IR - Nke T FIR - Akamba, A IR - Akamba A FIR - Lekelem, S IR - Lekelem S FIR - Omgba Bassega, P IR - Omgba Bassega P FIR - Tongo Fotack, S B IR - Tongo Fotack SB FIR - Ngono, S IR - Ngono S FIR - Tanga, M IR - Tanga M FIR - Ebong, E IR - Ebong E FIR - Edoul Mbesse, G IR - Edoul Mbesse G FIR - Tsongo, M IR - Tsongo M FIR - Mpoudi-Ngole, E IR - Mpoudi-Ngole E FIR - Abong, T IR - Abong T FIR - Ciaffi, L IR - Ciaffi L FIR - Koulla-Shiro, S IR - Koulla-Shiro S FIR - Lantche Wandji, M IR - Lantche Wandji M FIR - Manirakiza, G IR - Manirakiza G FIR - Mimbe, E D IR - Mimbe ED FIR - Tetsa Tata, D IR - Tetsa Tata D FIR - Varloteaux, M IR - Varloteaux M FIR - Boyer, S IR - Boyer S FIR - Bousmah, M-Q IR - Bousmah MQ FIR - Maradan, G IR - Maradan G FIR - Nishimwe, M L IR - Nishimwe ML FIR - Spire, B IR - Spire B FIR - Le, M P IR - Le MP FIR - Peytavin, G IR - Peytavin G FIR - Diallo, A IR - Diallo A FIR - Fournier, I IR - Fournier I FIR - Montoyo, A IR - Montoyo A FIR - Mercier, N IR - Mercier N FIR - Rekacewicz, C IR - Rekacewicz C FIR - Perez Casa, C IR - Perez Casa C FIR - Charpentier, C IR - Charpentier C FIR - Clumeck, N IR - Clumeck N FIR - Flandre, P IR - Flandre P FIR - Ngom Gueye, F IR - Ngom Gueye F FIR - Weiss, L IR - Weiss L FIR - Calmy, A IR - Calmy A FIR - Kouanfack, C IR - Kouanfack C FIR - Hill, A IR - Hill A FIR - Reynes, J IR - Reynes J FIR - Delaporte, E IR - Delaporte E EDAT- 2020/12/29 06:00 MHDA- 2021/09/18 06:00 PMCR- 2020/12/23 CRDT- 2020/12/28 07:44 PHST- 2020/11/20 00:00 [accepted] PHST- 2020/12/29 06:00 [pubmed] PHST- 2021/09/18 06:00 [medline] PHST- 2020/12/28 07:44 [entrez] PHST- 2020/12/23 00:00 [pmc-release] AID - 10.1007/s40273-020-00987-3 [pii] AID - 987 [pii] AID - 10.1007/s40273-020-00987-3 [doi] PST - ppublish SO - Pharmacoeconomics. 2021 Mar;39(3):331-343. doi: 10.1007/s40273-020-00987-3. Epub 2020 Dec 23.