The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: A randomized controlled trial

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• 作者：Jean-Marc Chapplain ; Eric Bellissant ; Dominique Guyader ; Jean-Michel Molina ; Isabelle Poizot-Martin ; Philippe Perr¨¦ ; Gilles Pialoux ; Bruno Turlin ; Catherine Mouchel ; Alain Renault ; Christian Michelet ; ANRS HC-12 Study Group
• 关键词：HIV/HCV co-infection ; Liver fibrosis ; Metavir fibrosis score ; Peg-interferon ; Randomized controlled trial
• 刊名：Journal of Infection
• 出版年：2013
• 出版时间：October, 2013
• 年：2013
• 卷：67
• 期：4
• 页码：313-321
• 全文大小：426 K

文摘

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Summary

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 ¦Á-2a at 180?¦Ìg/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/mm³; 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 ¦Á-2a over 96 weeks in HIV/HCV co-infected patients, who were non-responders to HCV treatment, did not change liver fibrosis.

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