Trial Outcomes & Findings for Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients (NCT NCT00018031)

Results Overview

HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects. Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Day 3 and Day 28

Results posted on

2014-10-01

Participant Flow

Patients were all recruited from other NIAID HIV clinical trials and from the nearby Maryland, Virginia and the District of Columbia HIV clinics

Open label study. The participants were only excluded if they did not meet eligibility criteria, such as pregnancy, availability to make frequent clinic visits and able to meet laboratory safety criteria as described in the clinical protocol.

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2b, Ribavirin Weekly Injection (Peginterferon alfa-2b) Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously Oral Pills (Ribavirin) Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peg-interefron Alfa 2b, Ribavirin n=36 Participants Weekly Injection Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously Oral Pills Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 and Day 28

Population: Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed

HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects. Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2b, Ribavirin n=23 Participants Weekly Injection (Peginterferon alfa-2b) Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously Oral Pills (Ribavirin) Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response	8 participants with post treatment svr

Adverse Events

Peg-interefron Alfa 2b, Ribavirin

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peg-interefron Alfa 2b, Ribavirin n=36 participants at risk Weekly Injection Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously Oral Pills Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma	2.8% 1/36 • Number of events 1
Eye disorders Vision Changes	2.8% 1/36 • Number of events 1
Psychiatric disorders Unusual affect or behavior	2.8% 1/36 • Number of events 1

Other adverse events

Other adverse events
Measure	Peg-interefron Alfa 2b, Ribavirin n=36 participants at risk Weekly Injection Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously Oral Pills Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
Investigations Anemia	16.7% 6/36 • Number of events 7
General disorders Fatigue	8.3% 3/36 • Number of events 4
Investigations Neutropenia	41.7% 15/36 • Number of events 43

Additional Information

Dr. Shyam Kottilil

NIAID/NIH

Phone: 301-435-036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place