Rebetol (Ribavirin) - Summary

REBETOL SUMMARY

REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-(beta)-D-ribofuranosyl-1 H -1,2,4-triazole-3-carboxamide.

REBETOL (ribavirin, USP) Capsules and Oral Solution are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy.

REBETOL Capsules are indicated in combination with PEG-INTRON (peginterferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

The safety and efficacy of REBETOL Capsules or Oral Solution with interferons other than INTRON A or PEG-INTRON products have not been established.

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NEWS HIGHLIGHTS

Media Articles Related to Rebetol (Ribavirin)

AASLD: Treating Before Transplant Cuts HCV Recurrence (CME/CE)
Source: MedPage Today Gastroenterology [2009.11.06]
BOSTON (MedPage Today) -- In patients with advanced liver disease related to hepatitis C, a course of pegylated interferon and ribavirin (Rebetol) before liver transplant may help them avoid recurrence of infection, a researcher said here.

InterMune Announces Modification To On-Going Phase 2b Study Of ITMN-191 In Patients With Chronic HCV Infection
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.18]
InterMune, Inc. (Nasdaq: ITMN) announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified. The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study.

SCYNEXIS' SCY-635 Demonstrates Positive Antiviral Activity In Combination With Approved And Investigational Anti-HCV Agents
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.04]
Drug discovery company SCYNEXIS, Inc. presented positive data from an in vitro study evaluating the antiviral activity of SCY-635 in combination with approved and investigational non-nucleoside polymerase inhibitors, nucleoside polymerase inhibitors, protease inhibitors, ribavirin and interferon alpha 2b. SCY-635 exhibited additive to synergistic antiviral activity when combined with each of the six compounds tested and all combinations exhibited greater-than-anticipated antiviral activity.

Bristol-Myers Squibb And ZymoGenetics Present Final Phase 1b Results For PEG-Interferon Lambda In Hepatitis C
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.03]
Bristol-Myers Squibb Company (NYSE: BMY) and ZymoGenetics, Inc. (NASDAQ: ZGEN) today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients. The poster included data on 56 patients in the study. Antiviral activity was observed at all dose levels tested.

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Published Studies Related to Rebetol (Ribavirin)

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naive patients with chronic hepatitis C: ViSER1 results. [2009.09]
Pegylated interferon (peg-IFN) and ribavirin (RBV) are effective in eradicating the hepatitis C virus in more than half of patients. However, anemia arising from RBV-induced hemolysis can prompt dose reductions and lower sustained virologic response (SVR) rates... These results suggest fixed-dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C; a weight-based dosing trial of viramidine is currently under way.

Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. [2009.08.06]
BACKGROUND: Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared... CONCLUSIONS: In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770.) 2009 Massachusetts Medical Society

Predictability of sustained virological response to pegylated interferon alpha-2b Plus ribavirin therapy by week-8 viral response in HIV-positive patients with chronic hepatitis C virus infection. [2009.07]
Chronic hepatitis C is frequent and aggressive in HIV-positive patients. Identification of early predictors of response to anti-HCV therapy is needed for a lower rate of response and higher discontinuations, compared to HCV mono-infected subjects...

Effect of dietary purines on the pharmacokinetics of orally administered ribavirin. [2009.06]
Ribavirin is found to be absorbed in the intestine through the human concentrative nucleoside transporter 2 (hCNT2). Cellular uptake of ribavirin was strongly inhibited by purine nucleoside in an in vitro study...

Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results. [2009.06]
CONCLUSION: Retreatment of PEG-IFN and RBV nonresponders with CIFN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores.

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Clinical Trials Related to Rebetol (Ribavirin)

Peg-Ifn Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED) [Completed]
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1. 5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Extended Treatment With PEG-Intron and Rebetol in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685AM3) [Active, not recruiting]
This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron plus Rebetol in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.

Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)(COMPLETED) [Completed]
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy [Completed]
HRN-003 STUDY SYNOPSIS

OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.

OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks.

STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy.

DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1. 5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.

EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study medication doses will be obtained.

SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity of adverse experiences and progression of disease, as measured by HCV viral load.

STUDY DESIGN

This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. Patients will be stratified according to their response to the previous course of therapy (i. e. non-reponse or relapse virologic pattern

This is a multi-center, randomized, open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period.

Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1. 5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.

- Group A: PEGIntron weight -adjusted dose (1. 5 mg/kg) by subcutaneous injection weekly

+ ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).

- Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80

KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an additional 48 weeks (Total therapy x 48 weeks).

REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy [Completed]
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

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