Direct-acting antivirals for hepatitis C First real-life efficacy

Paris, 21 July 2015
Press release
Direct-acting antivirals for hepatitis C
First real-life efficacy data in HIV/HCV co-infected patients
Direct-acting antivirals are revolutionizing the treatment of hepatitis C. Findings from the
ANRS HEPAVIH cohort confirm for the first time their efficacy in HIV/HCV co-infected
patients in a real-life setting. Twelve weeks after discontinuation of treatment, the cure rate
was 93% and the treatment was well tolerated. These results will be presented by Professor
Dominique Salmon (Internal Medicine and Infectious Diseases Department, Hôpital Cochin,
Paris) at the 8th International AIDS Society (IAS) Conference on HIV Pathogenesis,
Treatment and Prevention to be held from 19 to 22 July in Vancouver, Canada.
HIV/HCV co-infection results in faster progression of chronic hepatitis C, with a 2- to 5-fold higher risk
of cirrhosis compared with infection by HCV alone. Moreover, concomitant treatment of HIV and HCV
raises the risk of drug interactions. Clinical trials have shown that the efficacy of direct-acting antivirals
(DAAs) is similar in HIV/HCV co-infected patients and patients infected by HCV alone. It was important
to confirm these results in a real-life setting and now this has been done thanks to the ANRS (France
REcherche Nord&sud Sida-hiv Hépatites). With over 1600 patients in 27 clinical centers, the ANRS
HEPAVIH cohort is one of the world’s largest of HIV/HCV co-infected patients. The aim was to study
the characteristics of treated co-infected patients, as well as access to new anti-HCV drugs, the
response to them and their safety.
Professor Dominique Salmon (Internal Medicine and Infectious Diseases Department, Hôpital Cochin,
Paris) and colleagues analyzed data on 76 co-infected patients of the ANRS HEPAVIH cohort in whom
follow-up was sufficiently long to enable assessment of virologic control. The majority (86%) of patients
showed control of HIV by antiretrovirals, but most presented advanced stage chronic hepatitis C: 80%
had cirrhosis and 78% had experienced failure of a previous treatment. HCV was genotype 1 in 61% of
the patients and genotype 4 in 22%.
These patients had received treatment comprising one or two DAAs, combined or not with ribavirin, for
12 or 24 weeks. After this treatment, 100% of the patients presented a sustained virologic response
(undetectable HCV viral load). However, relapse occurred in 5 cases during the 12 weeks following the
end of treatment. The observed cure rate was therefore 93% and was similar in patients with or without
cirrhosis and did not differ between HCV genotypes or according to whether or not the patients had
received ribavirin or had been treated for 12 or 24 weeks.
The safety of the DAAs was good, as only 38% of patients presented one or more treatment-related
adverse effects (anemia in 30% of cases). Only one patient was obliged to stop treatment prematurely.
“These results confirm for the first time the very good efficacy and safety of DAAs in co-infected
patients followed up in real-life conditions,” explains Professor Salmon. “The efficacy observed was
similar to that reported in clinical trials, whereas in our study population most patients presented
advanced stage chronic hepatitis C. These findings from the ANRS HEPAVIH cohort back up current
recommendations in favor of treatment with DAAs in all co-infected patients, including, and above all,
those with cirrhotic hepatitis.”
The 5 relapses observed in the cohort do, however, emphasize the need for heightened monitoring of
HIV/HCV co-infected patients. “These relapses all occurred once treatment was finished,” points out
Professor Salmon. “So it is vital to set up close monitoring of patients treated with DAAs, even after a
complete virologic response following treatment, and to identify predictors of relapse, in order to avoid
it.”
The Research Agency ANRS (France REcherche Nord&sud Sida-hiv Hépatites) was set up in 1988. It
brings together researchers from different fields and institutions in the developed world and resourcelimited countries to study scientific questions on HIV/AIDS and viral hepatitis. The ANRS funds research
projects approved by international expert committees. It supports projects from conception to completion
and actively participates in communicating the results to ensure that they are used for the benefit of the
populations concerned. Its annual budget of approximately 45 million euros is provided by the ministries
of research and health. In 2012, the ANRS became an autonomous agency of Inserm (French National
Institute of Health and Medical Research).
Abstract
Use of oral DAA-based regimens in HIV-HCV co-infected patients in a real life setting – Interim analysis from the ANRS CO13 HEPAVIH
cohort
D Salmon, K Lacombe, L Esterle, C Gilbert, L Piroth, F Bani Sadr, L Alric, H Aumaitre, E Billaud, J Chas, S Dominguez, A Gervais, C LascouxCombe, P Miaihles, D Neau, I Poizot-Martin, E Rosenthal, D Zucman, F Dabis, P Sogni, L Wittkop. 8th IAS Conference on HIV Pathogenesis,
Treatment and Prevention, 19-22 July 2015, Vancouver (Canada), poster no. TULBPE09.
1
APHP -Hôpital Cochin, Service de Médecine Interne et Pathologie Infectieuse VIH, Paris, France, 2Université Paris Descartes, Paris, France,
APHP -Hôpital Saint Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France, 4Université UPMC, Paris, France, 5Inserm U897 Epidémiologie-Biostatistique, ISPED, Université Bordeaux, Bordeaux, France, 6CHU Dijon, Département d'Infectiologie, Dijon, France, 7CHU Reims
- Hôpital Robert Debré, Service de Médecine interne et de Maladies Infectieuses et Tropicales, Reims, France, 8CHU Toulouse - Hôpital Purpan,
Service de Médecine interne, Toulouse, France, 9CH Perpignan, Service des Maladies Infectieuses et Tropicales, Perpignan, France, 10CHU
Nantes, Service des Maladies Infectieuses et Tropicales, Nantes, France, 11APHP - Hôpital Tenon, Maladies Infectieuses et Tropicales, Paris,
France, 12APHP - Hôpital Henri Mondor, Immunologie clinique et maladies infectieuses, Créteil, France, 13APHP-Hôpital Bichat Claude Bernard,
Maladies infectieuses et tropicales Hépato-gastro-entérologie, Paris, France, 14APHP - Hôpital Saint Louis, Service des Maladies Infectieuses et
Tropicales, Paris, France, 15CHU Lyon, Service des Maladies Infectieuses et Tropicales, Lyon, France, 16CHU Bordeaux, Service des Maladies
Infectieuses et Tropicales, Paris, France, 17APHM-Hôpital Sainte Marguerite, 9Service d'Immuno-Hématologie Clinique, Marseille, France, 18CHU
Nice - Hôpital L'Archet 1, Service de Médecine interne Cancérologie, Nice, France, 19Hôpital Foch, Médecine interne, Suresnes, France,
20
Université de Bordeaux, Inserm U897- Epidémiologie-Biostatistique, ISPED, Bordeaux, France, 21CHU de Bordeaux, Bordeaux, France, 22APHP Hôpital Cochin, Département des maladies du foie - Hépatologie, Paris, France
3
Scientific contact
Vancouver : Pr Dominique Salmon
Email : [email protected]
ANRS contact
[email protected]