Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial).

Journal: JHEP reports : innovation in hepatology

Volume: 5

Issue: 3

Year of Publication: 

Affiliated Institutions:  Aix Marseille Univ, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Marseille, France. Department of Metabolism, Digestion and Reproduction, Division of Digestive Diseases, Section of Hepatology and Gastroenterology, St Mary's Hospital, Imperial College, London, UK. Hôpital de Jour, Hôpital Central de Yaoundé, Cameroon. Service des Maladies Infectieuses et Tropicales, CHU Fann, Dakar, Senegal. Service d'hépatologie, CHU Yopougon, Abidjan, Cote d'Ivoire. Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, IPLESP, Paris, France.

Abstract summary 

Patient-reported outcomes (PROs) are poorly documented for patients with chronic hepatitis C on direct-acting antiviral (DAA) treatment in low-to-middle-income countries. We documented PROs during and after DAA treatment in participants of the TAC ANRS 12311 trial (West and Central Africa).Trial participants received a 12-week regimen containing either sofosbuvir plus ribavirin (HCV genotype 2, n = 40), or sofosbuvir plus ledipasvir (HCV genotypes 1 and 4, n = 80). Health-related quality of life (SF-12), fatigue (Piper Fatigue scale), and self-reported symptoms (35-symptom list) were assessed at enrolment (Week (W) 0), during treatment (W2, W4, W8 and W12) and after treatment (W24 and W36). These PROs were compared between W0 and W36 (Wilcoxon signed-rank or McNemar tests). Mixed-effects linear regression models helped identify correlates of physical and mental quality of life component summaries (PCS and MCS) in a longitudinal analysis.Most PROs were significantly improved 24 weeks after treatment end (W36), without significant differences between treatment groups. For the post-treatment period, multivariable analysis showed significant increases in PCS for patients with cirrhosis and in MCS for patients in the sofosbuvir plus ribavirin group. A higher number of self-reported symptoms at W0 was associated with lower PCS and MCS, older age and cirrhosis with lower PCS, and male sex and HCV cure with higher PCS.Sofosbuvir-based DAA therapy was associated with a significant improvement in PROs 6 months after treatment end in patients with chronic HCV infection from Central and West Africa. These findings may guide HCV treatment providers in low-to-middle-income countries to deliver pre-treatment information concerning the benefits of DAAs beyond viral eradication.NCT02405013.Perceptions and experiences ( "patient-reported outcomes") of patients with chronic hepatitis C receiving direct-acting antivirals (DAAs) are poorly documented in the African setting. This study shows significant improvements in health-related quality of life, fatigue, and self-reported symptoms 24 weeks after the end of a 12-week sofosbuvir-based DAA regimen in 120 patients from Central and West Africa. These findings substantially add to the body of knowledge about DAA therapy in the African setting. Treatment providers should be encouraged to inform patients of the benefits of DAAs beyond viral eradication, to increase treatment adherence and retention in care.

Authors & Co-authors:  Marcellin Fabienne F Mourad Abbas A Lemoine Maud M Kouanfack Charles C Seydi Moussa M Carrieri Patrizia P Attia Alain A Protopopescu Camelia C Lacombe Karine K Boyer Sylvie S

Study Outcome 

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Statistics
Citations :  WHO . Advocacy Brief; May 2016. Combating hepatitis B and C to reach elimination by 2030. 2016.
Authors :  10
Identifiers
Doi : 100665
SSN : 2589-5559
Study Population
Male
Mesh Terms
Other Terms
DAA, direct-acting antiviral;EOT, end-of-treatment;HRQL, health-related quality of life;LMICs, low-to-middle income countries;MCS, mental component summary;MOS SF-12, Medical Outcomes Study 12-item short-form general health survey;MOS, Medical Outcomes Study;PCS, physical component summary;PROs, patient-reported outcomes;SOF/LDV, sofosbuvir plus ledipasvir;SOF/RBV, sofosbuvir plus ribavirin;SVR, sustained virological response;W, week;WHO, World Health Organization;West Africa;direct-acting antivirals;health-related quality of life;hepatitis C;symptoms
Study Design
Study Approach
Country of Study
Publication Country
Netherlands