Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-pacific hepatitis C virus genotype 1 non-responders/relapsers

Wattana Sukeepaisarnjaroen, Tri Pham, Tewesak Tanwandee, Saroja Nazareth, Sam Galhenage, Lindsay Mollison, Leanne Totten, Alan Wigg, Rosalie Altus, Anton Colman, Brenda Morales, Sue Mason, Tracey Jones, Nadine Leembruggen, Vince Fragomelli, Cheryl Sendall, Richard Guan, Dede Sutedja, Soek Siam Tan, Yock Young DanYin Mei Lee, Widjaja Luman, Eng Keong Teo, Yin Min Than, Teerha Piratvisuth, Seng Gee Lim

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

AIM: To examined the efficacy and safety of treatment with boceprevir, PEGylated-interferon and ribavirin (PR) in hepatitis C virus genotype 1 (HCVGT1) PR treatmentfailures 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. CONCLUSION: 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.

Original languageEnglish
Pages (from-to)8660-8669
Number of pages10
JournalWorld Journal of Gastroenterology
Volume21
Issue number28
DOIs
Publication statusPublished - 28 Jul 2015
Externally publishedYes

Keywords

  • Chronic hepatitis C
  • Cirrhosis
  • Lead-in
  • Null response
  • Partial response
  • Rapid virological response
  • Relapse
  • Response guided therapy
  • Treatment failure

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    Sukeepaisarnjaroen, W., Pham, T., Tanwandee, T., Nazareth, S., Galhenage, S., Mollison, L., Totten, L., Wigg, A., Altus, R., Colman, A., Morales, B., Mason, S., Jones, T., Leembruggen, N., Fragomelli, V., Sendall, C., Guan, R., Sutedja, D., Tan, S. S., ... Lim, S. G. (2015). Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-pacific hepatitis C virus genotype 1 non-responders/relapsers. World Journal of Gastroenterology, 21(28), 8660-8669. https://doi.org/10.3748/wjg.v21.i28.8660