Volume 139, Issue 6, Pages 1972-1983 (December 2010) Induction Pegylated Interferon Alfa-2a and High Dose Ribavirin Do Not Increase SVR in Heavy Patients With HCV Genotype 1 and High Viral Loads  K. Rajender Reddy, Mitchell L. Shiffman, Maribel Rodriguez–Torres, Hugo Cheinquer, Djamal Abdurakhmanov, Igor Bakulin, Viacheslav Morozov, Giovanni Faria Silva, Natalia Geyvandova, Carol Stanciu, Michael Rabbia, Michael McKenna, James A. Thommes, Stephen A. Harrison  Gastroenterology  Volume 139, Issue 6, Pages 1972-1983 (December 2010) DOI: 10.1053/j.gastro.2010.08.051 Copyright © 2010 AGA Institute Terms and Conditions

Figure 1 Flow of patients in the trial. Gastroenterology 2010 139, 1972-1983DOI: (10.1053/j.gastro.2010.08.051) Copyright © 2010 AGA Institute Terms and Conditions

Figure 2 Virologic response during treatment and follow-up, as well as relapse rate during follow-up. (A) RVR is defined as undetectable HCV RNA in serum (<15 IU/mL) by week 4. (B) cEVR is defined as undetectable HCV RNA in serum by week 12. (C) SVR is defined as undetectable HCV RNA in serum at the end of untreated follow-up (study week 72). (D) Relapse is defined as detection of HCV RNA in serum during the 24-week untreated follow-up period in a patient who was HCV RNA negative at the end of treatment. Two patients (one in group A and one in group D) who were HCV RNA negative at the end of treatment subsequently tested HCV RNA positive at week 12 of untreated follow-up and then HCV RNA negative at week 24 of untreated follow-up. By definition, these patients experienced both a relapse and an SVR and are considered as such. Gastroenterology 2010 139, 1972-1983DOI: (10.1053/j.gastro.2010.08.051) Copyright © 2010 AGA Institute Terms and Conditions

Figure 3 SVR according to (A) baseline steatosis score, (B) baseline NAS, (C) baseline HOMA-IR score, (D) baseline body weight, (E) exposure to peginterferon alfa-2a, and (F) exposure to ribavirin. Treatment exposure was calculated as the percentage of the total target dose administered after physician-initiated dose reductions for laboratory abnormalities and adverse events. Gastroenterology 2010 139, 1972-1983DOI: (10.1053/j.gastro.2010.08.051) Copyright © 2010 AGA Institute Terms and Conditions

Figure 4 Multiple logistic regression analysis of baseline host and viral factors associated with SVR. Only adherent patients (n = 767), defined as those who received ≥80% of the planned doses of both study drugs, were included. ALT, alanine aminotransferase; NAFLD, nonalcoholic fatty liver disease. Gastroenterology 2010 139, 1972-1983DOI: (10.1053/j.gastro.2010.08.051) Copyright © 2010 AGA Institute Terms and Conditions