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Time to viral suppression is not related to achievement of SVR 12 in HCV GT 1‐infected patients treated with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin
Author(s) -
Alqahtani S.,
Ozaras R.,
Isakov V.,
Wyles D.,
Ferenci P.,
Feld J. J.,
Calinas F.,
Gschwantler M.,
Gane E.,
Crawford D.,
Jacobson I. M.,
Dumas E. O.,
King M.,
Sulkowski M.
Publication year - 2017
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.12641
Subject(s) - ombitasvir , paritaprevir , dasabuvir , ritonavir , medicine , ribavirin , virology , gastroenterology , hepatitis c virus , viral load , virus , antiretroviral therapy
Summary High rates of sustained virologic response at post‐treatment week 12 ( SVR 12) were achieved in six phase 3 trials of ombitasvir ( OBV , an NS 5A inhibitor), paritaprevir (an NS 3/4A protease inhibitor) co‐dosed with ritonavir ( PTV /r) + dasabuvir ( DSV , an NS 5B RNA polymerase inhibitor) (ie, 3D regimen) with or without ribavirin ( RBV ) in adults with chronic genotype ( GT ) 1 hepatitis C virus ( HCV ) infection. We assessed whether time to first HCV RNA value below the lower limit of quantification in patients with and without cirrhosis was associated with achievement of SVR 12. Data were analysed from GT 1‐infected patients enrolled in six phase 3 studies of 3D ± RBV . Patients who experienced non‐virologic failure were excluded from analysis. HCV RNA was determined using the Roche COBAS TaqMan RT ‐ PCR assay (lower limit of quantification, LLOQ =25 IU / mL ). SVR 12 was analysed by week of first HCV RNA suppression, defined as HCV RNA < LLOQ . The analysis included a total of 2027 patients. Cumulative proportions of subjects with initial HCV RNA suppression < LLOQ at weeks 1, 2, 4 and 6 were 31%, 81%, 99% and 100%, respectively. SVR 12 was achieved by 98%, 97%, 98% and 92% of patients with initial suppression at Weeks 1, 2, 4 and 6, respectively ( P =.42, trend test). Across six phase 3 trials of 3D ± RBV , most patients achieved viral suppression by week 2. Time to viral suppression was not associated with subsequent achievement of SVR 12, suggesting that on‐treatment virologic monitoring may not be necessary with this regimen.