Hepatitis C, Chronic Clinical Trial
Official title:
Boceprevir-based Triple Therapy to Rescue HCV Genotype 1/HBV Dually Infected Patients Refractory to Peginterferon Plus Ribavirin Combination Therapy
The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.
Liver disease, especially viral hepatitis, is an important public health issue, which
frequent leads to liver cirrhosis, hepatocellular carcinoma (HCC) and liver-related death.
Around 340 to 400 million persons are infected with hepatitis B virus (HBV) and 130 to 210
million persons are infected with hepatitis C virus (HCV) worldwide, In Taiwan, the
prevalence of HBV infection is 15-20%, and the prevalence of HCV infection is 2-5% in general
population. Moreover, there are some HCV-hyperendemic areas in southern Taiwan with anti-HCV
prevalence rate of as high as 30-40%.
HBV/HCV dual infections is not uncommon in HBV epidemic areas, such as Southeastern Asia,
with a prevalence rate of 1.1% in southern Taiwan. Recent study showed that the risk of HCC
incidence is even higher among HBV/HCV co-infected persons than those with HBV or HCV
mono-infection, indicating the importance of disease control in this clinical setting.
The PEG-IFN/RBV has been effective in the treatment of HCV-dominant, treatment-naïve patients
with HCV/HBV dual infections. For treatment-naive HCV genotype 1 (HCV GT1)/HBV co-infected
patients, 48 weeks of peginterferon (PEG-IFN) plus ribavirin (RBV) could achieve an HCV
sustained virological response (SVR) rate of 72%, which was comparable to 77% for patients
with HCV GT1 monoinfection. For treatment-naive HCV GT2 or GT3 /HBV co-infected patients, 24
weeks of PEG-IFN plus RBV could achieve an HCV SVR rate of 83%, which was comparable to 84%
for patients with HCV GT2/3 monoinfection . Furthermore, PEG-IFN plus RBV combination therapy
could enhance seroclearance of hepatitis B surface antigen (HBsAg) with an HBsAg loss rate of
upto 11%. Nevertheless, there is about 30% of HCV GT1/HBV and 20% of HCV GT2 or 3/HBV
co-infected patients refractory to current PEG-IFN/RBV combination therapy, which remains at
high risk of HCC and liver-related death.
Boceprevir is an oral antiviral drug, which is NS3/4A protease inhibitor. Boceprevir has been
approved for treating HCV GT1 infection by Food and Drug Administration (FDA) on 11 May 2011.
For HCV GT1 mono-infected patients who refractory to previous PEG-IFN plus RBV combination
therapy, becoprevir combined with PEG-IFN/RBV triple therapy can improve the treatment
efficacy. The SVR rate of becoprevir-based triple therapy is about 3 times when compared to
patients who received PEG-IFN with RBV dual therapy [14].The investigators , therefore,
hypothesize that boceprevir plus PEG-IFN/RBV is effective in treating HCV GT1/HBV dually
infected patients who are refractory to previous PEG-IFN/RBV combination therapy.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03740906 -
Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting
|
||
Terminated |
NCT02465203 -
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
|
Phase 3 | |
Completed |
NCT02262728 -
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
|
Phase 2 | |
Completed |
NCT01429792 -
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
|
Phase 4 | |
Completed |
NCT02541409 -
Directly Observed Therapy for HCV in Chennai, India
|
Phase 2 | |
Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
Withdrawn |
NCT01608737 -
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
|
Phase 3 | |
Completed |
NCT01399619 -
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
|
Phase 3 | |
Completed |
NCT01435226 -
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
Completed |
NCT01435044 -
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
|
Phase 2 | |
Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
Completed |
NCT01447446 -
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
|
N/A | |
Terminated |
NCT01168856 -
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
|
N/A | |
Completed |
NCT00793793 -
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
|
Phase 1 | |
Completed |
NCT00725751 -
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
|
N/A | |
Completed |
NCT00375661 -
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
|
Phase 4 | |
Completed |
NCT00377182 -
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
|
Phase 2 | |
Completed |
NCT00217139 -
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
|
Phase 2 | |
Completed |
NCT00723632 -
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
|
N/A |