Evidence map›Paper›PMID 33355914›Full record

ArticlePharmacoEconomics2021

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).

Marwân-Al-Qays Bousmah, Marie Libérée Nishimwe, Tamara Tovar-Sanchez, Martial Lantche Wandji, Mireille Mpoudi-Etame, Gwenaëlle Maradan, Pierrette Omgba Bassega, Marie Varloteaux, Alice Montoyo, Charles Kouanfack and 3 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in PharmacoEconomics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02777229 (A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.3field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02777229 phase3completednot on this map

A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2016 to 2021Enrolled616ConditionsHIV-1 InfectionArmsDolutegravir 50 mg, Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg, Efavirenz 400 mg
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

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  8. Cost-effectiveness analysis of nivolumab plus ipilimumabTherapeutic advances in medical oncology · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 2 countries.

Marwân-Al-Qays BousmahINSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France.
Marie Libérée NishimweINSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France.
Tamara Tovar-SanchezRecherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le développement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France.
Martial Lantche WandjiANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.
Mireille Mpoudi-EtameMilitary Hospital, Yaoundé, Cameroon.
Gwenaëlle MaradanORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.
Pierrette Omgba BassegaCité Verte Hospital, Yaoundé, Cameroon.
Marie VarloteauxANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.
Alice MontoyoANRS, Paris, France.
Charles KouanfackANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.
Eric DelaporteRecherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le développement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France.
Sylvie BoyerINSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France. sylvie.boyer@inserm.fr.ORCID 0000-0002-7567-5200
New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group
Inserm · FRCentral Hospital of Yaoundé · CMARPE PACA · FRUniversité de Dschang · CM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesEvidence 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 Yaoundé, Cameroon.

methodsWe 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.

resultsIn 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.

conclusionsAt 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa.

trial registrationClinicalTrials.gov Identifier: NCT02777229.

Indexed as

HIV InfectionsAdultAlkynesBenzoxazinesCameroonCost-Benefit AnalysisCyclopropanesDolutegravirHeterocyclic Compounds, 3-RingHumansOxazinesPiperazinesPyridonesAlkynesBenzoxazinesCyclopropanesDolutegravirefavirenzHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridones

Identifiers

PMID33355914
PMCPMC7882571
OpenAlexW3117774116

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.