title: Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-Pacific hepatitis C virus genotype 1 non-responders/relapsers.
abstract: OBJECTIVE
  To examined the efficacy and safety of treatment with boceprevir, PEGylated-interferon and ribavirin (PR) in hepatitis C virus genotype 1 (HCVGT1) PR treatment-failures in Asia.
  
  
  METHODS
  The Boceprevir Named-Patient Program provided boceprevir to HCVGT1 PR treatment-failures. Participating physicians were invited to contribute data from their patients: baseline characteristics, on-treatment responses, sustained virological response at week 12 (SVR12), and safety were collected and analysed. Multivariate analysis was performed to determine predictors of response.
  
  
  RESULTS
  150 patients were enrolled from Australia, Malaysia, Singapore and Thailand (Asians = 86, Caucasians = 63). Overall SVR12 was 61% (Asians = 59.3%, Caucasians = 63.5%). SVR12 was higher in relapsers (78%) compared with non-responders (34%). On-treatment responses predicted SVR, with undetectable HCVRNA at week 4, 8 and 12 leading to SVR12s of 100%, 87%, and 82% respectively, and detectable HCVRNA at week 4, 8 and 12, leading to SVR12s of 58%, 22% and 6% respectively. Asian patients were similar to Caucasian patients with regards to on-treatment responses. Patients with cirrhosis (n = 69) also behaved in the same manner with regards to on-treatment responses. Those with the IL28B CC genotype (80%) had higher SVRs than those with the CT/TT (56%) genotype (P = 0.010). Multivariate analysis showed that TW8 and TW12 responses were independent predictors of SVR. Serious adverse events occurred in 18.6%: sepsis (2%), decompensation (2.7%) and blood transfusion (14%). Discontinuations occurred in 30.7%, with 18.6% fulfilling stopping rules.
  
  
  CONCLUSIONS
  Boceprevir can be used successfully in PR treatment failures with a SVR12 > 80% if they have good on-treatment responses; however, discontinuations occurred in 30% because of virological failure or adverse events.
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Wattana
authors.initials: W
authors.lastname: Sukeepaisarnjaroen
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Tri
authors.initials: T
authors.lastname: Pham
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Tewesak
authors.initials: T
authors.lastname: Tanwandee
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Saroja
authors.initials: S
authors.lastname: Nazareth
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Sam
authors.initials: S
authors.lastname: Galhenage
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Mollison
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Leanne
authors.initials: L
authors.lastname: Totten
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Alan
authors.initials: A
authors.lastname: Wigg
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Rosalie
authors.initials: R
authors.lastname: Altus
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Anton
authors.initials: A
authors.lastname: Colman
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Brenda
authors.initials: B
authors.lastname: Morales
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Sue
authors.initials: S
authors.lastname: Mason
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Tracey
authors.initials: T
authors.lastname: Jones
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Nadine
authors.initials: N
authors.lastname: Leembruggen
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Vince
authors.initials: V
authors.lastname: Fragomelli
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Sendall
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Richard
authors.initials: R
authors.lastname: Guan
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Dede
authors.initials: D
authors.lastname: Sutedja
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Soek Siam
authors.initials: SS
authors.lastname: Tan
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Yock Young
authors.initials: YY
authors.lastname: Dan
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Yin Mei
authors.initials: YM
authors.lastname: Lee
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Widjaja
authors.initials: W
authors.lastname: Luman
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Eng Kiong
authors.initials: EK
authors.lastname: Teo
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Yin Min
authors.initials: YM
authors.lastname: Than
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Teerha
authors.initials: T
authors.lastname: Piratvisuth
authors.affiliation: Wattana Sukeepaisarnjaroen, Srinagarind Hospital, Chiangmai 40002, Khon Kaen, Thailand.
authors.forename: Seng Gee
authors.initials: SG
authors.lastname: Lim
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia / Q000453:epidemiology; D044466:Asian People; D001315:Australia / Q000453:epidemiology; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000821:virology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011392:Proline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000627:therapeutic use; D013997:Time Factors; D017211:Treatment Failure; D019562:Viral Load; D044465:White People
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: Chronic hepatitis C; Cirrhosis; Lead-in; Null response; Partial response; Rapid virological response; Relapse; Response guided therapy; Treatment failure