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 13, 14 Julie Chas 15 Isabelle Poizot-Martin 16 Stéphanie Dominguez 17 Anne Simon 18 Philippe Morlat 19, 20 Didier Neau 21, 20 David Zucman 22 Olivier Bouchaud 23, 24 Caroline Lascoux-Combe 25 Firouze Bani-Sadr 26 Laurent Alric 27, 28 Cécile Goujard 29 Daniel Vittecoq 30 Eric Billaud 31 Hugues Aumaitre 32 François Boue 33 Marc-Antoine Valantin 34 François Dabis 13, 14 Dominique Salmon 35, 3 Linda Wittkop 13, 3
* Corresponding author
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.
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Philippe Sogni, Camille Gilbert, Karine Lacombe, Lionel Piroth, Eric Rosenthal, et al.. 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. Clinical Infectious Diseases, Oxford University Press (OUP), 2016, 63 (6), pp.763-770. ⟨10.1093/cid/ciw379⟩. ⟨inserm-01993207⟩

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