Trial Outcomes & Findings for Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment (NCT NCT01052701)

Results Overview

Ribavirin Triphosphate (RBV-TP) intracellular concentrations.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Day 56

Results posted on

2017-05-01

Participant Flow

Subjects were recruited through general newspaper advertisements, flyers, and referral from providers specializing in hepatitis C

Participant milestones

Participant milestones
Measure	Ribavirin Plus Abacavir Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) plus Daily Abacavir 300 mg orally every 12 hours	Ribavirin Alone Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)
Overall Study STARTED	14	12
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ribavirin Plus Abacavir n=14 Participants Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) plus Daily Abacavir 300 mg orally every 12 hours	Ribavirin Alone n=12 Participants Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	54 years n=99 Participants	50 years n=107 Participants	52 years n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	12 Participants n=107 Participants	25 Participants n=206 Participants
Region of Enrollment United States	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 56

Ribavirin Triphosphate (RBV-TP) intracellular concentrations.

Outcome measures

Outcome measures
Measure	Ribavirin Plus Abacavir n=14 Participants Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) plus Daily Abacavir 300 mg orally every 12 hours	Ribavirin Alone n=12 Participants Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)
Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations	15.87 picomoles per 10^6 cells Standard Deviation 12.82	15.93 picomoles per 10^6 cells Standard Deviation 12.69

SECONDARY outcome

Timeframe: Day 56

Plasma RBV trough concentrations.

Outcome measures

Outcome measures
Measure	Ribavirin Plus Abacavir n=14 Participants Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) plus Daily Abacavir 300 mg orally every 12 hours	Ribavirin Alone n=12 Participants Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)
Plasma RBV Trough Concentrations	2.54 micrograms per milliliter Standard Deviation 1.05	2.60 micrograms per milliliter Standard Deviation 0.62

Adverse Events

Ribavirin Plus Abacavir

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ribavirin Alone

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ribavirin Plus Abacavir n=14 participants at risk Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) or Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) plus Daily Abacavir 300 mg orally every 12 hours	Ribavirin Alone n=12 participants at risk Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)
Hepatobiliary disorders hyperbilirubinemia	14.3% 2/14 • Number of events 2	25.0% 3/12 • Number of events 3
General disorders fatigue	28.6% 4/14 • Number of events 4	0.00% 0/12
Endocrine disorders hyperglycemia	71.4% 10/14 • Number of events 10	66.7% 8/12 • Number of events 8
General disorders insomnia	14.3% 2/14 • Number of events 2	8.3% 1/12 • Number of events 1
Gastrointestinal disorders nausea	7.1% 1/14 • Number of events 1	25.0% 3/12 • Number of events 3
Hepatobiliary disorders transaminitis	35.7% 5/14 • Number of events 5	33.3% 4/12 • Number of events 4
Respiratory, thoracic and mediastinal disorders upper respiratory infection	35.7% 5/14 • Number of events 5	41.7% 5/12 • Number of events 5

Additional Information

Associate Director, Drug Development Unit

Johns Hopkins School of Medicine

Phone: (410) 614-8762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place