1. Volume 148, Issue 2, Pages 355-366.e1 (February 2015)
Daclatasvir Plus Peginterferon and Ribavirin Is Noninferior to Peginterferon and Ribavirin Alone, and Reduces the Duration of Treatment for HCV Genotype 2 or 3 Infection 
Gregory J. Dore, Eric Lawitz, Christophe Hézode, Stephen D. Shafran, Alnoor Ramji, Harvey A. Tatum, Gloria Taliani, Albert Tran, Maurizia R. Brunetto, Serena Zaltron, Simone I. Strasser, Nina Weis, Wayne Ghesquiere, Samuel S. Lee, Dominique Larrey, Stanislas Pol, Hugh Harley, Jacob George, Scott K. Fung, Victor de Lédinghen, Peggy Hagens, Fiona McPhee, Dennis Hernandez, David Cohen, Elizabeth Cooney, Stephanie Noviello, Eric A. Hughes 
Gastroenterology 
Volume 148, Issue 2, Pages e1 (February 2015)
DOI: /j.gastro
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2. Figure 1
Patient disposition. The disposition of patients through the study is shown. The final modified intention-to-treat analysis included all patients who initiated treatment regardless of withdrawals or other events before the end of the follow-up period. One patient in the 12-week cohort, 3 patients in the 16-week cohort, and 2 patients in the placebo cohort did not enter follow-up evaluation because of withdrawal of consent, loss to follow-up evaluation, or patient requested to discontinue. Four of the 5 patients in the placebo arm who discontinued follow-up evaluation for the reason of “other” did so to transition into a re-treatment study; 1 patient left the country. DCV, daclatasvir.
Gastroenterology  , e1DOI: ( /j.gastro )
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3. Figure 2
Virologic responses. Mean HCV-RNA levels ± 80% confidence intervals through treatment week 12 are shown for patients with (A) genotype 2 and (B) genotype 3. Initial responses in the daclatasvir arms were similar across genotypes, and greater than those in the placebo arms. DCV, daclatasvir.
Gastroenterology  , e1DOI: ( /j.gastro )
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4. Supplementary Figure 1
Study design. Patients were assigned randomly (1:1:1) to 1 of 3 treatment groups: daclatasvir + peg-alfa/RBV for 12 weeks; daclatasvir + peg-alfa/RBV for 16 weeks; or placebo + peg-alfa/RBV for 24 weeks. Patients in the daclatasvir groups who achieved a PDR discontinued all treatment at the protocol-defined end point (week 12 or week 16). Daclatasvir recipients without PDR discontinued daclatasvir at week 12 and received an additional 12 weeks of placebo + peg-alfa/RBV. PDR was defined as HCV-RNA level less than the LLOQTND or TD (target detected), detected at week 4 and <LLOQTND at week 10. All patients in the placebo group received 24 weeks of therapy. DCV, daclatasvir.
Gastroenterology  , e1DOI: ( /j.gastro )
Copyright © 2015 AGA Institute Terms and Conditions