Feasability and effectiveness of scaling up hepatitis-C treatment in West and Central Africa: the TAC ANRS 12311 clinical trial

Abstract Background Access to direct-acting antivirals for chronic hepatitis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multicenter open-label trial TAC ANRS 12311 was conducted to assess the feasibility, effectiveness and safety of an implementation model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa.Methods 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.Results 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.Conclusions This model implemented for access to HCV treatment and retreatment of viral failures appeared to be feasible, safe and effective. With the expanded access to HCV generic drugs, scaling up of HCV test-and-treat strategies should now be considered a priority for HCV elimination in Sub-Saharan Africa.