Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy

Summary

Hepatitis C is a common and potentially serious disease. However, there are treatments that can cure it. That's why it's so important to detect the hepatitis C virus (HCV) and treat those affected. Today, many hepatitis C sufferers in Cameroon (and elsewhere) remain untreated.

The aim of this research is therefore to evaluate a simplified screening and treatment strategy (developed specifically for the Cameroonian context) in comparison with a standard strategy (based on usual care), in order to improve access to hepatitis C treatment in Cameroon. If the results of this research are positive, this strategy could be recommended to health authorities in Cameroon and other comparable countries.

Conditions

• Hepatitis C Virus Infection

Interventions

DRUG

ACCESS+ strategy Epclusa 400/100 Oral Tablet

The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg once daily for 12 weeks), (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).

DRUG

ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet

The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100mg) once daily for 12 weeks, (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).

DRUG

Standard Strategy Vosevi 400/100/100 Oral Tablet

In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.

DRUG

Standard Strategy Epclusa 400/100 Oral Tablet

In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.

Sponsors & Collaborators

• IRD, Epidemiologie et Prevention, Montpelier, France

  collaborator UNKNOWN

• SESSTIM (IRD, Inserm, Université Aix-Marseille)

  collaborator UNKNOWN

• Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER)

  collaborator UNKNOWN

• Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun

  collaborator UNKNOWN

• PharmAccess

  collaborator UNKNOWN

• Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France

  collaborator UNKNOWN

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-12-31

Completion

2028-06-30