HCV treatment: results of the first clinical trial in Africa
The preliminary results of the ANRS TAC trial show that direct-acting antivirals (DAAs) against hepatitis C can be as effective in resource-limited countries as in the developed world. This argues for broad access to DAAs in resource-limited countries, notably in sub-Saharan Africa where the HCV epidemic has been neglected. Dr Karine Lacombe (Inserm UMR-S707, SMIT, CHU St-Antoine – AP-HP, Paris, IMEA) will present these results in an oral communication on 24 July, during the 9th Conference on HIV Science (IAS 2017), organized by the International AIDS Society and the ANRS in Paris from July 23rd to 26th 2017.
Over the last 3 years, direct-acting antivirals (DAAs) have revolutionized the treatment of chronic hepatitis C, enabling a cure in over 90 % of patients, whatever their HIV status (co-infection or not) or the severity of liver disease. DAAs are, however, scarce among HCV-infected people in resource-limited settings, because of their cost. The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) has conducted the first trial designed to assess the efficacy and safety of new anti-HCV treatments in sub-Saharan countries.
The ANRS 12311 TAC trial was lanched in October 2015 in three West African countries: Cameroon, Ivory Coast, and Senegal. Run by Dr Karine Lacombe (Inserm UMR-S707, SMIT, CHU St-Antoine – AP-HP, Paris, IMEA) and Prof Alain Attia (CHU Yopougon, Abidjan, Côte d’Ivoire), this trial included 120 patients with chronic hepatitis C who had never been treated for this infection. Each of the three most frequent HCV genotypes (1, 2 and 4) were represented by 40 patients. Patients with genotype 2 HCV were treated with the DAA sofobuvir, plus ribavirin; those with genotype 1 or 4 HCV were given a combination of 2 DAAs (sofobuvir and ledipasvir) in the form of a single tablet. Treatment lasted 12 weeks.
The preliminary results presented today relate to 110 patients, 32 of whom were HIV/HCV-co-infected and 11 of whom had hepatitis C at the stage of compensated cirrhosis. After 24 weeks of follow-up, the interim analysis found a sustained 89 % virologic response in all patients. One patient discontinued treatment after 8 weeks of follow-up, yet was nonetheless cured. No severe adverse effect was observed.
Dr Karine Lacombe considers that these results show that "the treatment of chronic hepatitis C by DAAs is entirely possible in the African context, with good adherence, good safety, and a laboratory follow-up that poses no particular difficulty. The efficacy achieved is very close to that seen in the developed countries, including in HIV/HCV co-infected patients." Professor François Dabis, Director of the ANRS, adds: "We lacked data on the efficacy of these drugs in resource-limited countries. The first results of the ANRS TAC trial now argue strongly that access to DAAs should be extended without delay to HCV-infected patients in Africa and, more generally, in all resource-limited countries."
Treatment of chronic hepatitis C genotype 1, 2 and 4 in patients with or without HIV and living in Central or West Africa: the TAC ANRS 12311 trial. Karine Lacombe1, Raoul Moh2, Corine Chazallon3, Jerôme Lecarrou3, Babacar Sylla4, Maud Lemoine5, Charles Kouanfack6, Laura Ciaffi6, Fatoumata Fadiga2, Nicolas Rouveau7, Joel Gozlan8, Moussa Seydi9, Viviane Cissé9, Christine Danel2, Pierre Marie Girard1, Alain Attia10 and the TAC ANRS 12311 study group
1Inserm UMR-S1136, Université Paris VI – APHP, France. 2MEREVA, PACCI Abidjan, Côte D’ivoire. 3ISPED, Bordeaux, France. 4IMEA, Paris, France. 5Imperial College, London, UK, 6Hôpital Central, Site ANRS, Yaoundé, Cameroun. 7ANRS, Paris, France. 8Service de virologie, Hôpital St Antoine, APHP, Paris, France. 9Service de maladies infectieuses - CRCF, Hôpital Fann, Dakar, Sénégal. 10Service d’hépatologie, CHU Yopougon, Abidjan, Côte d’Ivoire.