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Observational Study
. 2016 Sep 15;63(6):763-770.
doi: 10.1093/cid/ciw379. Epub 2016 Jun 17.

All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus-coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13-HEPAVIH Cohort

Philippe Sogni  1   2   3 , Camille Gilbert  4 , Karine Lacombe  5   6 , Lionel Piroth  7   8 , Eric Rosenthal  9   10 , Patrick Miailhes  11 , Anne Gervais  12 , Laure Esterle  4 , Julie Chas  13 , Isabelle Poizot-Martin  14 , Stéphanie Dominguez  15 , Anne Simon  16 , Philippe Morlat  17   18 , Didier Neau  18   19 , David Zucman  20 , Olivier Bouchaud  21   22 , Caroline Lascoux-Combe  23 , Firouzé Bani-Sadr  24   25 , Laurent Alric  26   27 , Cécile Goujard  28   29 , Daniel Vittecoq  29   30 , Eric Billaud  31 , Hugues Aumaître  32 , François Boué  29   33 , Marc-Antoine Valantin  34 , François Dabis  4   35   36 , Dominique Salmon  3   37 , Linda Wittkop  4   35   36
Affiliations
Observational Study

All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus-coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13-HEPAVIH Cohort

Philippe Sogni et al. Clin Infect Dis. .

Abstract

Background: Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected patients with cirrhosis have long been considered to be difficult to treat, and real-life efficacy and tolerance data with all-oral direct-acting antiviral (DAA) combinations in these patients are scarce.

Methods: Cirrhotic HIV/HCV-coinfected patients enrolled in the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) CO13 HEPAVIH cohort initiating an all-oral DAA regimen were consecutively included. A negative HCV RNA result at 12 weeks of follow-up or thereafter was assumed as a sustained virologic response (SVR12). Adjusted exact logistic regression was used to study factors associated with treatment outcome.

Results: We included 189 patients who initiated an all-oral DAA regimen with the following characteristics: median age 53.2 years; 74.6% male; Centers for Disease Control and Prevention classification A/B/C: 37%/31%/32%; Child-Pugh class A/B/C: 91%/8%/1%; 87% with HIV RNA <50 copies/mL; 99% on antiretrovirals; median CD4 count: 489 cells/µL; HCV treatment naive 29%; HCV genotype 1/2/3/4: 58%/4%/17%/21%. Sofosbuvir (SOF) + daclatasvir ± ribavirin (RBV) was used in 123 patients, SOF + RBV in 30, SOF + simeprevir in 11, and SOF + ledipasvir in 23. An SVR12 was reported in 93.1% of the patients (95% confidence interval, 88.5%-96.3%). In adjusted analyses, no difference was found between 12 or 24 weeks of treatment, in patients receiving RBV or not, and in treatment-naive vs experienced patients. Premature stop of DAA was reported for 8 patients. One patient died during treatment (unknown cause), and 12 other patients developed liver-related events.

Conclusions: In this prospective real-life cohort, all-oral DAA regimens were well tolerated and associated with a high virologic efficacy in cirrhotic HIV/HCV-coinfected patients. This should not alleviate the surveillance for liver-related events in these patients.

Keywords: cirrhosis; direct-acting antiviral treatment; hepatitis C virus (HCV); human immunodficiency virus (HIV); virologic response.

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