1 Division of Infectious Diseases, San Gerardo Hospital - ASST Monza, Monza, Italy.
2 Medical School, University of Milano-Bicocca, Milan, Italy.
3 Center of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
4 Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.
5 Infectious Diseases, Ospedale Luigi Sacco - ASST Fatebenefratelli Sacco, Milano, Italy.
6 Infectious Diseases, Spedali Civili - ASST Brescia, Brescia, Italy.
7 ASST Papa Giovanni XXIII, Bergamo HCV Network, Bergamo, Italy.
8 Ospedale di Legnano - ASST Ovest Milano, Legnano, Italy.
9 Infectious Diseases, San Raffaele Scientific Institute IRCCS, Milano, Italy.
10 Vita-Salute San Raffaele University, Milan, Italy.
11 Hepatitis Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
12 Ospedale San Paolo - ASST Santi Paolo e Carlo, Milano, Italy.
13 Division of Infectious Diseases, Ospedale di Busto Arsizio - ASST Valle Olona, Busto Arsizio, Italy.
14 Infectious Diseases, Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, Italy.
15 Division of Infectious Diseases, ASST Cremona, Cremona, Italy.
16 Internal Medicine and Hepatology, Humanitas Research Hospital IRCCS and Humanitas University, Rozzano, Italy.
17 Ospedale di Circolo e Fondazione Macchi Varese - ASST Sette Laghi, Infectious Diseases, Università dell'Insubria, Varese, Italy.
18 ASST Bergamo Ovest, Treviglio, Italy.
19 Ospedale San Giuseppe, University of Milan, Milano, Italy.
20 Bergamo HCV Network, Zingonia, Italy.
21 Internal Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.
22 Sant'Anna - ASST Lariana, Como, Italy.
23 Division of Infectious Diseases, ASST Lecco, Lecco, Italy.
24 Ospedale Como - Valduce, Como, Italy.
25 Policlinico San Pietro, Bergamo HCV Network, Ponte San Pietro, Italy.
26 San Carlo Hospital - ASST Santi Paolo e Carlo, Milano, Italy.
27 ASST Garda, Gavardo, Italy
28 Gastro-Hepato-Pancreatic Surgery and Liver Transplant Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
29 Ospedale di Vizzolo Predabissi - ASST Melegnano e Martesana, Vizzolo Predabissi, Italy.
30 UO Gastroenterologia ed Endoscopia Digestiva, Epatologia, Fondazione Ospedaliera Poliambulanza, Rete HCV Brescia, Brescia, Italy.
31 Division of Gastroenterology, San Gerardo Hospital - ASST Monza, Monza, Italy.
32 Ospedale di Cernusco sul Naviglio - ASST Melegnano e Martesana, Cernusco sul Naviglio, Italy.
33 ASST Bergamo Est, Bergamo HCV Network, Clusone, Italy.
34 ASkST Bergamo Est, Bergamo HCV Network, Lovere, Italy.
35 ASST Bergamo Est, Bergamo HCV Network, Seriate, Italy.
36 QUOVADIS Associazione no-profit, Padova, Italy.
BACKGROUND & AIMS: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap.
METHODS: Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression.
RESULTS: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P = .065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P = .007) and lower median pretreatment Log10 HCV-RNA (5.87 vs 6.20, P = .001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12.
CONCLUSIONS: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.