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Rebetol Intron A (Ribavirin / Interferon Alfa-2B) - Summary

 
 



CONTRAINDICATIONS AND WARNINGS

Combination REBETOL/INTRON A therapy is contraindicated in females who are pregnant and in the male partners of females who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination REBETOL/INTRON A therapy. Females of childbearing potential and males must use two reliable forms of effective contraception during treatment and during the 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species studied. See CONTRAINDICATIONS and WARNINGS. REBETOL monotherapy is not effective for the treatment of chronic hepatitis C and should not be used for this indication. See WARNINGS.

Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. See WARNINGS, and ADVERSE REACTIONS.

 

SUMMARY

REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog with antiviral activity.

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

Previously Untreated Patients Adults with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who were previously untreated with alpha interferon therapy were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive REBETOL Capsules 1200 mg/day (1000 mg/day for patients weighing </=75 kg) plus INTRON A Injection 3 MIU TIW or INTRON A Injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. The International study did not contain a 24-week INTRON A plus placebo treatment arm. The US study enrolled 912 patients who, at baseline, were 67% male, 89% caucasian with a mean Knodell HAI score (I+II+III) of 7.5, and 72% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 799 patients (65% male, 95% caucasian, mean Knodell score 6.8, and 58% genotype 1).

Study results are summarized in TABLE 3.

TABLE 3. Virologic and Histologic Responses: Previously Untreated Patients *
US Study International Study
24 weeks
of treatment
48 weeks
of treatment
24 weeks
of treatment
48 weeks
of treatment
INTRON A
plus
REBETOL
(N=228)
INTRON A
plus
Placebo
(N=231)
INTRON A
plus
REBETOL
(N=228)
INTRON A
plus
Placebo
(N=225)
INTRON A
plus
REBETOL
(N=265)
INTRON A
plus
REBETOL
(N=268)
INTRON A
plus
Placebo
(N=266)
Virologic
Response
-Responder1 65 (29) 13 (6) 85 (37) 27 (12) 86 (32) 113 (42) 46 (17)
-Nonresponder 147 (64) 194 (84) 110 (48) 168 (75) 158 (60) 120 (45) 196 (74)
-Missing data 16 (7) 24 (10) 33 (14) 30 (13) 21 (8) 35 (13) 24 (9)
Histologic
Response
-Improvement2 102 (45) 77 (33) 96 (42) 65 (29) 103 (39) 102 (38) 69 (26)
-No improvement 77 (34) 99 (43) 61 (27) 93 (41) 85 (32) 58 (22) 111 (41)
-Missing data 49 (21) 55 (24) 71 (31) 67 (30) 77 (29) 108 (40) 86 (32)
*Number (%) of patients
1 Defined as HCV RNA below limit of detection using a research-based RT-PCR assay at end of treatment and during follow-up period.
2 Defined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of >/=2 points.

Of patients who had not achieved HCV RNA below the limit of detection of the research-based assay by week 24 of REBETOL/INTRON A treatment, less than 5% responded to an additional 24 weeks of combination treatment.

Among patients with HCV genotype 1 treated with REBETOL/INTRON A therapy who achieved HCV RNA below the detection limit of the research-based assay by 24 weeks, those randomized to 48 weeks of treatment had higher virologic responses compared to those in the 24-week treatment group. There was no observed increase in response rates for patients with HCV nongenotype 1 randomized to REBETOL/INTRON A therapy for 48 weeks compared to 24 weeks.

Relapse Patients Patients with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who had relapsed following one or two courses of interferon therapy (defined as abnormal serum ALT levels) were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive REBETOL 1200 mg/day (1000 mg/day for patients weighing </=75 kg) plus INTRON A 3 MIU TIW or INTRON A plus placebo for 24 weeks followed by 24 weeks of off-therapy follow-up. The US study enrolled 153 patients who, at baseline, were 67% male, 92% caucasian with a mean Knodell HAI score (I+II+III) of 6.8, and 58% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 192 patients (64% male, 95% caucasian, mean Knodell score 6.6, and 56% genotype 1).

Study results are summarized in TABLE 4.

TABLE 4. Virologic and Histologic Responses: Relapse Patients *
US Study International Study
INTRON A
plus
REBETOL
(N=77)
INTRON A
plus
Placebo
(N=76)
INTRON A
plus
REBETOL
(N=96)
INTRON A
plus
Placebo
(N=96)
Virologic
Response
-Responder1 33 (43) 3 (4) 46 (48) 5 (5)
-Nonresponder 36 (47) 66 (87) 45 (47) 91 (95)
-Missing data 8 (10) 7 (9) 5 (5) 0 (0)
Histologic
Response
-Improvement2 38 (49) 27 (36) 49 (51) 30 (31)
-No improvement 23 (30) 37 (49) 29 (30) 44 (46)
-Missing data 16 (21) 12 (16) 18 (19) 22 (23)
*Number (%) of patients
1 Defined as HCV RNA below limit of detection using a research-based RT-PCR assay at end of treatment and during follow-up period.
2 Defined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of >/=2 points.

Virologic and histologic responses were similar among male and female patients in both the previously untreated and relapse studies.


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NEWS HIGHLIGHTS

Media Articles Related to Rebetol Intron A (Ribavirin)

One in four hepatitis C patients denied initial approval for drug treatment
Source: Liver Disease / Hepatitis News From Medical News Today [2015.08.28]
Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine...

Expression of a single gene lets scientists easily grow hepatitis C virus in the lab
Source: Liver Disease / Hepatitis News From Medical News Today [2015.08.19]
Worldwide, 185 million people have chronic hepatitis C. Since the late 1980s, when scientists discovered the virus that causes the infection, they have struggled to find ways to grow it in human...

more news >>

Published Studies Related to Rebetol Intron A (Ribavirin)

The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis. [2014]
without cirrhosis... CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly

[Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease]. [Article in Chinese] [2014]
with hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol can be effectively and safely used for treating

[Effects of ribavirin aerosol on viral exclusion of patients with hand-foot-mouth disease]. [Article in Chinese] [2014]
treatment of hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol has multiple advantages of lower dose, quicker

Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1. [2014]
infection... CONCLUSIONS: Daclatasvir combined with alfa-2a/ribavirin in treatment-naive

A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for HCV genotype 1 infection. [2014]
infection... CONCLUSIONS: Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin

more studies >>

Clinical Trials Related to Rebetol Intron A (Ribavirin)

Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252) [Completed]
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671) [Completed]
Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) [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) PegIntron 1. 5 g/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1g/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 g/wk plus COPEGUS 1000-1200 mg/day.

Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212) [Terminated]
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.

Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206) [Terminated]
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

more trials >>


Page last updated: 2015-08-28

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