Evidence map›Paper›PMID 38702350›Full record

Trial reportScientific reports2024

Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial).

Karine Lacombe, Raoul Moh, Corine Chazallon, Maud Lemoine, Babacar Sylla, Fatoumata Fadiga, Jerôme Le Carrou, Fabienne Marcellin, Charles Kouanfack, Laura Ciaffi and 14 more

Abstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

24 authors.

Karine LacombeInfectious Diseases Department, Inserm IPLESP, UMR-S1136, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, Paris, France. Karine.lacombe2@aphp.fr.
Raoul MohUnité Pédagogique de Dermatologie et Infectiologie, Université Félix Houphouet-Boigny, Abidjan, Côte d'Ivoire.
Corine ChazallonNational Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Bordeaux, France.
Maud LemoineHepatology Unit, Digestive Disease Division, Imperial College London, St Mary's Hospital, London, UK.
Babacar SyllaIMEA, Hôpital Bichat - Claude Bernard, Paris, France.
Fatoumata FadigaProgramme PAC-CI, Site ANRS de Côte d'Ivoire, Abidjan, Côte d'Ivoire.
Jerôme Le CarrouNational Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Bordeaux, France.
Fabienne MarcellinInserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Aix Marseille Univ, Marseille, France.
Charles KouanfackHôpital de Jour, Hôpital Central, Yaoundé, Cameroon.
Laura CiaffiTransVIHMI - IRD UMI233 - INSERM U1175, Université de Montpellier, Montpellier, France.
Michelle Tagni SartreClinique de la Cathédrale, Yaoundé, Cameroon.
Magloire Biwole SidaFaculté de Médecine et des Sciences Biomédicales, Université de Yaoundé 1, Yaoundé, Cameroon.
Alpha DialloService de Pharmacovigilance, ANRS, Paris, France.
Joel GozlanDepartment of Virology, INSERM, UMR_S 938, Centre de Recherche Saint-Antoine, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, Paris, France.
Moussa SeydiService des Maladies Infectieuses et Tropicales, CHNU de Fann, Dakar, Senegal.
Viviane CisséService des Maladies Infectieuses et Tropicales, Centre Régional de Recherche et de Formation, Site ANRS, CHNU de Fann, Dakar, Senegal.
Christine DanelIMEA, Hôpital Bichat - Claude Bernard, Paris, France.
Pierre Marie GirardInfectious Diseases Department, Inserm IPLESP, UMR-S1136, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, Paris, France.
Thomas d'Aquin ToniService de Virologie, Centre de diagnostic et de recherche sur le SIDA, CHU Treichville, Abidjan, Côte d'Ivoire.
Albert MingaCentre National des Donneurs de Sang, Abidjan, Côte d'Ivoire.
Sylvie BoyerHôpital de Jour, Hôpital Central, Yaoundé, Cameroon.
Patrizia CarrieriHôpital de Jour, Hôpital Central, Yaoundé, Cameroon.
Alain AttiaService d'hépatologie, CHU de Yopougon, Abidjan, Côte d'Ivoire.
TAC ANRS12311 Study Group

Funding

French National Agency for Research on HIV and Hepatitis (ANRS)-Emerging Infectious Diseases ANRS 12311
6 · The paper itself

Abstract

Access to Hepatis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multi-country open-label trial TAC ANRS 12311 allowed assessing the feasibility, safety, efficacy of a specific care model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa. Between November 2015 and March 2017, with follow-up until mid 2019, treatment-naïve patients with HCV without decompensated cirrhosis or liver cancer were recruited to receive 12 week-treatment with either sofosbuvir + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosbuvir + velpatasvir + voxilaprevir in case of virological failure. The primary outcome was sustained virological response at 12 weeks after end of treatment (SVR12). Secondary outcomes included treatment adherence, safety and SVR12 in patients who were retreated due to non-response to first-line treatment. The model of care relied on both viral load assessment and educational sessions to increase patient awareness, adherence and health literacy. The study recruited 120 participants, 36 HIV-co-infected, and 14 cirrhotic. Only one patient discontinued treatment because of return to home country. Neither death nor severe adverse event occurred. SVR12 was reached in 107 patients (89%): (90%) in genotype 1 or 2, and 88% in GT-4. All retreated patients (n = 13) reached SVR12. HCV treatment is highly acceptable, safe and effective under this model of care. Implementation research is now needed to scale up point-of-care HCV testing and SVR assessment, along with community involvement in patient education, to achieve HCV elimination in Sub-Saharan Africa.

Indexed as

Antiviral AgentsHepacivirusSofosbuvirAdultAfrica, CentralAfrica, WesternAminoisobutyric AcidsBenzimidazolesBenzopyransCarbamatesCyclopropanesDrug Therapy, CombinationFeasibility StudiesFemaleFluorenesGenotypeAminoisobutyric AcidsAntiviral AgentsBenzimidazolesBenzopyransCarbamatesCyclopropanesFluorenesHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicLeucineProlineQuinoxalinesRibavirinSofosbuvirSulfonamidesvelpatasvirvoxilaprevirAfricaClinical trialHepatitis CHIVSofosvubirViral resistance

Identifiers

PMID38702350
PMCPMC11068860

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Registered trials

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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.