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

作者：Sogni Philippe^*; Gilbert Camille; Lacombe Karine; Piroth Lionel; Rosenthal Eric; Miailhes Patrick; Gervais Anne; Esterle Laure; Chas Julie; Poizot Martin Isabelle; Dominguez Stephanie; Simon Anne; Morlat Philippe; Neau Didier; Zucman David; Bouchaud Olivier; Lascoux Combe Caroline; Bani Sadr Firouze; Alric Laurent; Goujard Cecile; Vittecoq Daniel; Billaud Eric; Aumaitre Hugues; Boue Franois; Valantin Marc Antoine; Dabis Francois; Salmon Dominique; Wittkop Linda

来源：Clinical Infectious Diseases, 2016, 63(6): 763-770.

DOI：10.1093/cid/ciw379

• human immunodficiency virus (HIV)
• hepatitis C virus (HCV)
• cirrhosis
• direct-acting antiviral treatment
• virologic response

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/mu L; 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.

• 出版日期2016-9-15