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TREATMENT OF CHRONIC HEPATITIS C GT1,2,4 IN AFRICA: FINAL RESULTS OF ANRS TAC TRIAL
Karine Lacombe1, Raoul Moh2, Corine Chazallon3, Babacar Sylla4, Maud Lemoine5, Charles Kouanfack6, Eric Tchoumi Leuwat6, Magloire Biwole Sida6, Fatoumata Fadiga2, Michèle Tagni-Sartre6, Viviane Marie Pierre Cisse1, Lawson-Ananissoh Laté Mawuli2, Pierre-Marie Girard1, Alain Attia2
1INSERM, Paris, France,2PAC-CI Program, Abidjan, Côte d’Ivoire,3INSERM, Bordeaux, France,4IMEA, Paris, France,5Imperial College London, London, UK,6IRD, Montpellier, France
With the advent of highly effective oral therapy for hepatitis C virus (HCV) infection and the recent World Health Organization commitment, HCV elimination has become a realistic goal. However, in sub-Saharan Africa 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 interferon-free therapy in HCV-infected patients in the sub-Saharan African setting.
Adult patients with treatment-naïve chronic hepatitis C were recruited in Senegal, Côte d'Ivoire and Cameroon. Patients without decompensated cirrhosis received either 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 in total (40 in each GT group). The primary endpoint was the sustained virological response (threshold of detectability 12 or 25 IU/mL), observed 12 weeks after the end of treatment (SVR12).
Of the 120 participants (male 54%, median age 58 years [IQR 49 –63], median plasma HCV-RNA 6.0 log IU/Ml [IQR 5.5 –6.6]), 36 were HIV-coinfected (median CD4: 624/mm3, IQR 442 - 844), all with plasma HIV-RNA<200 copies/Ml. 14 (12%) patients had APRI score > 2 (F4) at baseline. All but one patient completed the 12-week treatment course, and the remaining one discontinued treatment for personal reason (travel abroad) but reached SVR12. No patient died or was lost to follow-up. 8 (7%) patients had an adverse event of grade 3 or 4 During treatment, 3 patients had a decrease in haemoglobin level between 70 and 94 g/L, one of whom with a consequent reduction of RBV dosage. 37 cases of arterial hypertension were documented, 35 being pre-existing conditions and the 2 others unrelated to HCV drugs. HCV-RNA was measured at week 24 (documenting SVR12) in 119 patients, of whom 107 (90%) had undetectable viral load including 36 (90%) in GT-1, 36 (90%) in GT-2, and 35 (90%) in GT-4. 3 out of the 12 failing patients had an APRI score>2 (F4) at baseline.
HCV treatment with SOF+RBV in GT-2 or SOF+LDV in GT-1 or GT-4 infected patients is 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 treatment in Africa.