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Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin ( QUARTZ II ‐ III )
Author(s) -
Shafran S. D.,
Shaw D.,
Charafeddine M.,
Agarwal K.,
Foster G. R.,
Abunimeh M.,
PilotMatias T.,
Pothacamury R. K.,
Fu B.,
Cohen E.,
Cohen D. E.,
Gane E.
Publication year - 2018
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12782
Subject(s) - ombitasvir , sofosbuvir , paritaprevir , ritonavir , ribavirin , medicine , cirrhosis , gastroenterology , hepatitis c , hepatitis c virus , virology , viral load , virus , antiretroviral therapy
Summary The efficacy and safety of an investigational combination of ombitasvir/paritaprevir/ritonavir ( OBV / PTV /r) plus sofosbuvir ( SOF ) ± ribavirin ( RBV ) in patients with HCV genotype 2 or 3 infection with or without cirrhosis was evaluated. Patients with HCV genotype 3 infection without cirrhosis were randomized to receive OBV / PTV /r + SOF ± RBV for 12 weeks; OBV / PTV /r + SOF + RBV was administered to genotype 3‐infected patients with cirrhosis for 12 weeks and to genotype 2‐infected patients without cirrhosis for either 6 or 8 weeks. Efficacy was assessed by sustained virologic response [ HCV RNA <25 IU / mL ] 12 weeks post‐treatment ( SVR 12). Safety was assessed in all treated patients. In patients with genotype 3 infection with or without cirrhosis treated with 12 weeks of OBV / PTV /r + SOF ± RBV , the overall SVR 12 rate was 98% (50/51), with no virologic failures. Patients with genotype 2 infection treated with OBV / PTV /r + SOF + RBV had SVR 12 rates of 90% (9/10) and 44% (4/9) following 8‐ and 6‐week treatment durations, respectively; failure to achieve SVR 12 for these patients was due to relapse without baseline or treatment‐emergent resistance‐associated substitutions. Thus, the investigational combination of OBV / PTV /r with SOF ± RBV was well tolerated and achieved high SVR rates with no virologic failures in patients with genotype 3 infection. Combining direct‐acting antivirals with complementary mechanisms of action and different viral targets may be an effective treatment strategy that may allow for shorter durations of therapy.