Background: With the advent of highly effective direct antiviral agents against chronic hepatitis C (CHC) and the recent World Health Organization commitment, HCV elimination has become realistic. However, in sub-Saharan Africa (SSA) the HCV epidemic remains a neglected issue and access to care and treatment is almost inexistent. The TAC ANRS 12311 trial is an international multicenter open label trial aimed to assess the feasibility, efficacy and safety of q combination of interferon-free DAA in HCV-infected patients in the SSA setting.
Methods: Adult patients with treatment-naïve CHC were recruited in Senegal, Côte d''Ivoire and Cameroon. Patients without decompensated cirrhosis received a 12 week-combination of sofosbuvir plus weight-based ribavirin (SOF+RBV) if infected with genotype (GT) 2 or sofosbuvir/ ledipasvir (SOF+LDV) if infected with GT1 or 4. This trial included 120 participants (40 per GT). We present here the outcomes in the first 110 participants (GT-1, n=33; GT-2, n=40; GT-4, n=37).
Results: Among the participants (male 55%, median age 58 years [IQR 48-63], median plasma HCV-RNA 6.0 logIU/mL [IQR 5.5 -6.5]), 32 were HIV-coinfected (median CD4: 624/mm3, IQR 442-844), all with plasma HIV-RNA< 200 copies/Ml. Eleven patients were cirrhotic (APRI score>2). All but one patient completed the 12-week treatment course, and the remaining one discontinued treatment for personal reason (travel abroad). No patient died or was lost to follow-up. No severe adverse event occurred. Four patients had a haemoglobin decrease between 85 and 100 g/L, and two had a consequent reduction of RBV dosage. HCV-RNA was measured at week 24 (documenting SVR12) and 98/110 (89%) had undetectable viral load (threshold of detectability 12 or 25 IU/mL): 29 (88%) in GT-1, 36 (90%) in GT-2, and 33 (89%) in GT-4. Three out of 12 failing patients were cirrhotic at baseline. Viral strains of failing patients are currently been sequenced.
Conclusions: In this interim analysis, HCV treatment appeared to be feasible, safe and effective in sub-Saharan Africa including in HIV co-infected patients. With the growing access to HCV drugs at generic price worldwide, it is time to prompt scaling up of HCV care and management in Africa.