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<title lang=en>The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: a randomized controlled trial.</title>
<creator>Chapplain, Jean-Marc</creator>
<creator>Bellissant, Eric</creator>
<creator>Guyader, Dominique</creator>
<creator>Molina, Jean-Michel</creator>
<creator>Poizot-Martin, Isabelle</creator>
<creator>Perré, Philippe</creator>
<creator>Pialoux, Gilles</creator>
<creator>Turlin, Bruno</creator>
<creator>Mouchel, Catherine</creator>
<creator>Renault, Alain</creator>
<creator>Michelet, Christian</creator>
<contributor>Service des maladies infectieuses et réanimation médicale ; Université de Rennes 1 (UR1) - Hôpital Pontchaillou</contributor>
<contributor>Department of Clinical Pharmacology ; Institut National de la Santé et de la Recherche Médicale (INSERM) - University Hospital, Rennes 1 University, Rennes</contributor>
<contributor>Centre d'Investigation Clinique [Rennes] (CIC) ; Université de Rennes 1 (UR1) - Hôpital Pontchaillou - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Service d'hépato- gastro-entérologie ; Université de Rennes 1 (UR1) - Hôpital Pontchaillou - CHU Pontchaillou [Rennes]</contributor>
<contributor>Service des Maladies Infectieuses et Tropicales ; Assistance publique - Hôpitaux de Paris (AP-HP) - Groupe Hospitalier Saint-Louis-Lariboisière- Fernand-Widal - Université Paris Diderot - Paris 7 (UPD7)</contributor>
<contributor>Service d'immuno-hématologie clinique (CISIH) ; Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )</contributor>
<contributor>Internal Medicine Department, CHG ; CHG</contributor>
<contributor>Département d'Anatomie et Cytologie Pathologiques ; Hôpital Pontchaillou - CHU Pontchaillou [Rennes]</contributor>
<contributor>Institut de recherche, santé, environnement et travail [Rennes] (Irset) ; Université d'Angers (UA) - Université des Antilles et de la Guyane (UAG) - Université de Rennes 1 (UR1) - École des Hautes Études en Santé Publique [EHESP] (EHESP) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )</contributor>
<contributor>French National Agency for AIDS; Viral Hepatitis</contributor>
<description>International audience</description>
<source>ISSN: 0163-4453</source>
<source>Journal of Infection</source>
<publisher>WB Saunders</publisher>
<identifier>hal-00875067</identifier>
<identifier>https://hal.archives-ouvertes.fr/hal-00875067</identifier>
<source>https://hal.archives-ouvertes.fr/hal-00875067</source>
<source>Journal of Infection, WB Saunders, 2013, 67 (4), pp.313-21. 〈10.1016/j.jinf.2013.05.007〉</source>
<identifier>DOI : 10.1016/j.jinf.2013.05.007</identifier>
<relation>info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jinf.2013.05.007</relation>
<identifier>PUBMED : 23800784</identifier>
<relation>info:eu-repo/semantics/altIdentifier/pmid/23800784</relation>
<language>en</language>
<subject lang=en>HIV/HCV co-infection</subject>
<subject lang=en>Liver fibrosis</subject>
<subject lang=en>Metavir fibrosis score</subject>
<subject lang=en>Peg-interferon</subject>
<subject lang=en>Randomized controlled trial</subject>
<subject>[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases</subject>
<type>info:eu-repo/semantics/article</type>
<type>Journal articles</type>
<description lang=en>OBJECTIVE: We hypothesized that, in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) co-infected patients who did not respond to peg-interferon and ribavirin, a maintenance therapy with peg-interferon could induce fibrosis regression. METHODS: This was a randomized study with two parallel groups. HIV/HCV co-infected patients received peg-interferon α-2a at 180 μg/week or remained on observation for 96 weeks. The primary endpoint was the percentage of patients who experienced a decrease of at least one point in their Metavir fibrosis score between initial and final liver biopsies. Secondary endpoints included plasma fibrosis markers at week 96, occurrence of HCV-related complications, and survival. RESULTS: A total of 52 patients were randomized (peg-interferon: 25; control: 27) including 18 with cirrhosis. The median (interquartile range) age was 44 (40-46) years, and 69% were male. A total of 64% had ALT levels >1.5 normal values, and the CD4 cell count was 391 (296-537) cells/mm(3); 67% of patients had HIV RNA <200 copies/mL at entry. The main endpoint was assessed in 41 patients. Response rates were 3/20 (15%) and 4/21 (19%) in the peg-interferon and control groups, respectively (p = 0.99). There was no significant difference between peg-interferon and control groups on plasma fibrosis markers at the final visit. Severe liver-related complications were observed in 2 and 5 patients in peg-interferon and control groups, respectively. Three deaths were observed, all in the control group. CONCLUSIONS: A maintenance therapy with peg-interferon α-2a over 96 weeks in HIV/HCV co-infected patients, who were non-responders to HCV treatment, did not change liver fibrosis. ClinicalTrials.gov Identifier: NCT00122616.</description>
<contributor>ANRS HC-12 Study Group</contributor>
<date>2013-10</date>
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