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All-oral DAA regimens in HIV-HCV coinfected cirrhotic patients are efficient and safe. Real-life results from the prospective ANRS CO13 – HEPAVIH cohort.

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Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaître H, Boué F, Valantin MA, Dabis F, Salmon D, Wittkop L,


Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaître H, Boué F, Valantin MA, Dabis F, Salmon D, Wittkop L, (click to view)

Sogni P, Gilbert C, Lacombe K, Piroth L, Rosenthal E, Miailhes P, Gervais A, Esterle L, Chas J, Poizot-Martin I, Dominguez S, Simon A, Morlat P, Neau D, Zucman D, Bouchaud O, Lascoux-Combe C, Bani-Sadr F, Alric L, Goujard C, Vittecoq D, Billaud E, Aumaître H, Boué F, Valantin MA, Dabis F, Salmon D, Wittkop L,

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2016 6 17() pii

Abstract
BACKGROUND
 Cirrhotic HIV-HCV coinfected patients have long been considered as difficult-to-treat patients, and real-life efficacy and tolerance data with all-oral DAA (direct acting antiviral) combinations in these patients are scarce.

METHODS
 Cirrhotic HIV-HCV coinfected patients enrolled in the ANRS CO13 HEPAVIH cohort initiating an all-oral DAA regimen were consecutively included. A negative HCV-RNA at FU-W12 or thereafter was assumed as a sustained virological 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 a median age 53.2 years; 74.6% male; CDC A/B/C: 37/31/32%; Child-Pugh A/B/C: 91/8/1%; 87% with HIV-RNA <50 copies/mL; 99% on ARV, median CD4: 489/mm(3); naïve of HCV treatment in 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% CI: 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 naïve compared to 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. CONCLUSION
 In this prospective real-life cohort, all-oral DAA regimens were well tolerated and associated with a high virological efficacy in cirrhotic HIV-HCV coinfected patients. This should not alleviate the surveillance for liver-related events in these patients.

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