Rebetron (interferon α -2b /ribavirin) / Merck (MSD), Bausch Health - LARVOL DELTA

"Are you investigating hypercholesterol caused by rebound from Rebetron treatment for HCV? As a result of the hypercholestremia, I developed CAD and had a CABG x 5. I would happily volunteer, if you are interested! Thank you, Joe Bryan 13102 Alston Rd. Sugar Land TX 77478" (@elwoodbryanjr)

Hepatitis C

Analysis of resistance-associated amino acid variants (RAVs) in non-SVR patients enrolled in a retrospective long-term follow-up analysis of boceprevir Phase 3 clinical studies (AASLD 2011) - Presentation time : Nov 07 4:15 PM - 4:30 PM; P3; N=295; RAVs were detected in 155/295 (53%) of non-SVR patients at virologic failure; 92 of the 155 samples with RAVS (59%) had viruses with multiple (≥2) RAVs; The most frequently detected RAVs varied by genotype; with V36M & R155K GT1A vs. T54A/S, A156S & V170A in GT1B; 54/155 (20%) of patients had viruses with multiple RAVs 6-14 months after the cessation of BOC/P/R therapy; 43/95 (45%) of GT1A patients & 11/32 (34%) Gt1B patients

Biomarker data • Hepatitis C Virus

Predictors of sustained virologic response (SVR) among poor interferon (IFN) responders when boceprevir (BOC) is added to peginterferon alfa-2b/ribavirin (PR) (AASLD 2011) - Presentation time: Nov 06 3:30 PM - 3:45 PM; P=NA, N=NA; Baseline factors associated with SVR were HCV 1 subtype 1b vs 1a for both studies and liver fibrosis F0/1/2 vs F3/4 for SPRINT-2; HCV RNA decline 4 wks following addition of BOC (TW8) was highly predictive of SVR; no patient in either study with <3 log10 decline achieved SVR

Clinical data • Hepatocellular Cancer

Rhabdomyolysis associated with the co-administration of daptomycin and pegylated interferon {alpha}-2b and ribavirin in a patient with hepatitis C (J Antimicrob Chemother) - Abstract not available

Hepatitis C Virus

IL28B Polymorphism and γ-GT/ALT-ratio as predictive factors for interferon-α2a based treatment response in patients with hepatitis c virus genotype 3 infection (AASLD 2011) - P=NA, N=66; IL28B rs12979860 and IL28B rs8099917 genotype distributions were not found to be significantly different between patients with or without SVR; All pts (independently of therapy regime) showed an association with low γ-GT/ALT-ratio for response (p=0.02)

Retrospective analysis • Hepatitis C Virus

Changes in sequences of core region, ISDR and IRRDR of the HCV genotype 1 during and after interferon alpha and ribavirin therapy, and efficacy of retreatment (AASLD 2011) - Presentation time: Nov 06, 8:00 AM - 5:30 PM; P=NA, N=25; The sequences of the core region and ISDR of the HCV genome sometimes change during antiviral therapy, and the change can affect the outcome of retreatment; The baseline variations were, the core aa 70 had changed from sensitive to resistant type in 2 pts, and SVR was not achieved by retreatment; ISDR sequences had changed from resistant to sensitive type in 2 pts and SVR was achieved by retreatment, and from sensitive to resistant type in 3 pts and SVR was not achieved by retreatment & the variations in the IRRDR were resistant type ( <6 mutations) in 6 patients

Clinical data • Hepatitis C Virus

Prolonged combined therapy with pegylated interferon plus ribavirin in chronic hepatitis patients with HCV genotype 2 - a multicentric study to clarify the optimal HCV-RNA negative period during the therapy for the prediction of sustained virological resp (AASLD 2011) - Presentation time: Nov 06 8:00 AM - 5:30 PM; P=NA, N=100; Prolonged combined pegylated interferon plus ribavirin therapy with HCV-RNA- negative period of 17 weeks or more may improve therapeutic outcomes in chronic hepatitis patients with HCV genotype 2

Clinical data • Hepatitis C Virus

The changes of serum complement levels during pegyrated interferon and ribavirin therapy are closely associated with the outcome in patients with chronic hepatitis C (AASLD 2011) - Presentation time: Nov 08 8:00 AM - 12:00 PM; P=NA, N=99; Low levels of C3 and C4, but not CH50 were associated with non-SVR [C3, SVR: 114.3±2.8, non-SVR: 103.0±3.4 mg/dl (p=0.0117), C4, SVR:19.5±0.7, non-SVR: 16.4±0.8 mg/dl (p=0.0033)] among the LPD and immunological markers; Low level of serum C3 before therapy and low response C3 ratio are the predictive markers for resistance to the antiviral therapy

Biomarker data • Hepatitis C Virus

SILEN-C3: Treatment for 12 or 24 weeks with BI201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection (AASLD 2011) - Presentation time: Nov 06 4:15 PM - 4:30 PM; P2; N=159; SILEN-C3; 71.6% & 82.1% of patients in the 12- & 24-week groups achieved eRVR & stopped all treatment at week 24; SVR rates were 63% & 71.8% (not significant) in the 12- and 24-week groups, respectively; Safety & tolerability in the 12- and 24-week groups, respectively, were similar to historical P/R reports, including mild gastrointestinal disorders (57% & 48%), rash or photosensitivity (28% & 25%), & jaundice (3.8% & 5.1%) due to isolated unconjugated hyperbilirubinemia

P2 data • Hepatitis C Virus

Once-daily PSI-7977 plus peg/RBV in treatment-naïve patients with HCV GT1: Robust end of treatment response rates are sustained post-treatment (AASLD 2011) - Presentation time: Nov 08 8:30 AM - 8:45 AM; P2, N=121; PROTON; In the 400mg group, no viral breakthrough or post-treatment relapse occurred in any subject receiving 12 weeks of therapy; In the 200mg group, 3 subjects experienced viral breakthrough while receiving PEG/RBV 4-8 weeks after discontinuing PSI-7977 200mg at Wk12, & 1 subject relapsed 4 weeks after discontinuing all therapy at Wk24

P2 data • Hepatitis C Virus