Trial Outcomes & Findings for Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255) (NCT NCT00725751)

Last Updated: 2015-10-02

Results Overview

For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.

Recruitment status

COMPLETED

Target enrollment

353 participants

Primary outcome timeframe

24 to 48 weeks

Results posted on

2015-10-02

Participant Flow

353 participants were enrolled on the study; 348 were treated.

Participant milestones

Participant milestones
Measure	PegIFN-2b/Ribavirin With Substitution Therapy Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
Overall Study STARTED	90	258
Overall Study COMPLETED	56	150
Overall Study NOT COMPLETED	34	108

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=90 Participants Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy n=258 Participants Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	Total n=348 Participants Total of all reporting groups
Age, Continuous	32.38 years STANDARD_DEVIATION 9.51 • n=5 Participants	42.26 years STANDARD_DEVIATION 12.62 • n=7 Participants	39.71 years STANDARD_DEVIATION 12.64 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	96 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	162 Participants n=7 Participants	223 Participants n=5 Participants
Region of Enrollment Austria	90 participants n=5 Participants	258 participants n=7 Participants	348 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 to 48 weeks

Population: Participants who received at least one dose of PegIFN-2b/ribavirin

Outcome measures

Outcome measures
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=90 Participants Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy n=258 Participants Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin	56 participants	150 participants

SECONDARY outcome

Timeframe: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)

Population: All treated participants.

SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.

Outcome measures

Outcome measures
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=90 Participants Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy n=258 Participants Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
Number of Participants Who Achieved Sustained Virologic Response (SVR)	42 participants	111 participants

SECONDARY outcome

Timeframe: Day 1

Population: Participants who received at least one dose of antiviral treatment.

This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.

Outcome measures

Outcome measures
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=348 Participants Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy	90 participants	—

Adverse Events

PegIFN-2b/Ribavirin With Substitution Therapy

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

PegIFN-2b/Ribavirin Without Substitution Therapy

Serious events: 10 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=90 participants at risk Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy n=258 participants at risk Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
Blood and lymphatic system disorders Anaemia	0.00% 0/90 All participants who received at least one dose of study therapy.	1.2% 3/258 • Number of events 3 All participants who received at least one dose of study therapy.
Blood and lymphatic system disorders Blood disorder	1.1% 1/90 • Number of events 1 All participants who received at least one dose of study therapy.	0.00% 0/258 All participants who received at least one dose of study therapy.
Ear and labyrinth disorders Vertigo	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
General disorders Accidental death	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
Infections and infestations Staphylococcal sepsis	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
Nervous system disorders Cerebrovascular accident	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
Nervous system disorders Epilepsy	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.
Renal and urinary disorders Nephrolithiasis	0.00% 0/90 All participants who received at least one dose of study therapy.	0.39% 1/258 • Number of events 1 All participants who received at least one dose of study therapy.

Other adverse events

Other adverse events
Measure	PegIFN-2b/Ribavirin With Substitution Therapy n=90 participants at risk Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)	PegIFN-2b/Ribavirin Without Substitution Therapy n=258 participants at risk Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)
General disorders Fatigue	8.9% 8/90 • Number of events 8 All participants who received at least one dose of study therapy.	4.7% 12/258 • Number of events 12 All participants who received at least one dose of study therapy.
General disorders Influenza like illness	11.1% 10/90 • Number of events 10 All participants who received at least one dose of study therapy.	5.4% 14/258 • Number of events 15 All participants who received at least one dose of study therapy.
Investigations Weight decreased	5.6% 5/90 • Number of events 5 All participants who received at least one dose of study therapy.	2.3% 6/258 • Number of events 6 All participants who received at least one dose of study therapy.
Nervous system disorders Headache	5.6% 5/90 • Number of events 5 All participants who received at least one dose of study therapy.	1.9% 5/258 • Number of events 5 All participants who received at least one dose of study therapy.
Psychiatric disorders Depression	5.6% 5/90 • Number of events 5 All participants who received at least one dose of study therapy.	2.7% 7/258 • Number of events 7 All participants who received at least one dose of study therapy.
Skin and subcutaneous tissue disorders Alopecia	8.9% 8/90 • Number of events 8 All participants who received at least one dose of study therapy.	2.7% 7/258 • Number of events 7 All participants who received at least one dose of study therapy.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place