Trial Outcomes & Findings for HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin (NCT NCT01718301)

Results Overview

Achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

Week 24

Results posted on

2025-08-24

Participant Flow

Started 21/06/2013 and finished 04/12/2013

Participant milestones

Participant milestones
Measure	Boceprevir + Ribavirin + Peginterferon Participants received 4 weeks of Peginterferon/Ribavirin (lead-in), followed by response-guided therapy with Boceprevir added. Cirrhotic patients received a fixed 44-week regimen. Boceprevir 800 mg three times a day (v.o.) in combination with Peginterferon (alfa-2b or alfa-2a) and Ribavirin
Overall Study STARTED	102
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boceprevir Plus Peginterferon/Ribavirin to Retreat HCV Genotyp n=98 Participants boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
Age, Continuous	44 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Region of Enrollment Spain	98 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All patients who received at least one dose of study medication were included in the efficacy analysis. Patients with detectable HCV RNA at week 12 were discontinued per protocol-defined futility criteria.

Achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.

Outcome measures

Outcome measures
Measure	Boceprevir + Ribavirin + Peginterferon n=98 Participants boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin boceprevir Ribavirin Peginterferon alfa-2a Peginterferon alfa-2b
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment Number of participants achieving SVR	66 Participants
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment Number of participants not achieving SVR	32 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12

Proportion of participants with undetectable HCV RNA (\<15 IU/mL) at weeks 2, 4, 8, and 12 during treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

The proportion of subjects with undetectable HCV-RNA at follow-up week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 72

The proportion of randomized subjects with undetectable HCV-RNA at 72 weeks after randomization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to study completion (up to 72 weeks)

Safety: number of adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)

Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).

Outcome measures

Outcome data not reported

Adverse Events

Boceprevir + Ribavirin + Peginterferon

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Boceprevir + Ribavirin + Peginterferon n=98 participants at risk Side effects leading to drug discontinuation appeared in 6 patients.
Blood and lymphatic system disorders Anemia	6.1% 6/98 • Number of events 6

Other adverse events

Other adverse events
Measure	Boceprevir + Ribavirin + Peginterferon n=98 participants at risk Side effects leading to drug discontinuation appeared in 6 patients.
Psychiatric disorders Headache	1.0% 1/98 • Number of events 1

Additional Information

Dr Josep Mallolas Masferrer

Infetious disesases

Phone: 932275400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place