TY - JOUR
T1 - Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks
AU - Feld, Jordan J.
AU - Moreno, Christophe
AU - Trinh, Roger
AU - Tam, Edward
AU - Bourgeois, Stefan
AU - Horsmans, Yves
AU - Elkhashab, Magdy
AU - Bernstein, David E.
AU - Younes, Ziad
AU - Reindollar, Robert W.
AU - Larsen, Lois
AU - Fu, Bo
AU - Howieson, Kevin
AU - Polepally, Akshanth R.
AU - Pangerl, Andreas
AU - Shulman, Nancy S.
AU - Poordad, Fred
N1 - Funding Information:
JJ Feld: Grant/Research Support: AbbVie, Boehringer Ingelheim, Gilead, Janssen, Merck; Scientific consulting/Advisory Board: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, Theravance. C Moreno: Speaker/Advisor: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, MSD; Research Grant: AbbVie, Gilead, Janssen, MSD, Novartis, Roche. E Tam: Consultant/Advisory board: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Merck, Pendopharm, Roche, Vertex; Grant/Research Support: AbbVie, BMS, Boehringer Ingelheim, Gilead, Idenix, Janssen, Merck, Novartis, Pendopharm, Roche, Vertex. S Bourgeois: Research Support: Janssen, Merck, Roche; Consultant: AbbVie, Bristol-Myers Squibb, Gilead, Janssen. Y Horsmans: Consultant: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck. M Elkhashab: Grant/Research Support: AbbVie, Bristol-Myers Squibb, EISAI, Gilead, GlaxoSmithKline, Merck, Roche; Advisory Board: AbbVie, Bristol-Myers Squibb, Gilead, Merck. DE Bernstein: Research Support: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck; Consultant/Speaker: AbbVie, Gilead, Janssen, Merck. Z Younes: Grant/Research Support: AbbVie, Bristol-Myers Squibb, Gilead, Idenix, Janssen, Merck, Roche, Tibotec, Vertex; Speaker: AbbVie, Gilead, Vertex; Advisor: Gilead. RW Reindollar: Research support: AbbVie, Bristol-Myers Squibb, Cepheid, Gilead, Intercept, Janssen; Consultant/Speaker: AbbVie, Bristol-Myers Squibb, Gilead, Janssen. F Poordad: Grant/Research Support: AbbVie, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Medarex, Medtronic, Merck, Novartis, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Vertex, ZymoGenetics; Speaker: Gilead, Kadmon, Merck, Onyx/Bayer, Genentech, GlaxoSmithKline, Salix, Vertex; Consultant/Advisor: AbbVie, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, GlobeImmune, Idenix, Merck, Novartis, Tibotec/Janssen, Theravance, Vertex. R Trinh, L Larsen, B Fu, K Howieson, AR Polepally, A Pangerl, and NS Shulman: Employees of AbbVie and may hold stock or options.
Funding Information:
The authors thank AbbVie employees Sandrine Schermack, PhD, Nishi Pachnina (clinical operations), Janean Rullman, RN, BSN (clinical safety), and Tami Pilot-Matias, PhD (clinical virology) for study support. Medical writing support was provided by Douglas E. Dylla, PhD, of AbbVie.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - Background & Aims Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Methods Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ≥10 g/dl, albumin ≥2.8 g/dl, platelet count ≥25 × 109/L, creatinine clearance ≥30 ml/min, and Child-Pugh score ≤6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Results Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90 × 109/L, and 17% with albumin <3.5 g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. Conclusions The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.
AB - Background & Aims Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Methods Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ≥10 g/dl, albumin ≥2.8 g/dl, platelet count ≥25 × 109/L, creatinine clearance ≥30 ml/min, and Child-Pugh score ≤6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Results Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90 × 109/L, and 17% with albumin <3.5 g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. Conclusions The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.
KW - 3D
KW - Cirrhosis
KW - Direct-acting antivirals
KW - TURQUOISE-III
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U2 - 10.1016/j.jhep.2015.10.005
DO - 10.1016/j.jhep.2015.10.005
M3 - Article
C2 - 26476290
AN - SCOPUS:84954286001
VL - 64
SP - 301
EP - 307
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 2
ER -