Trial Outcomes & Findings for Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV) (NCT NCT00892697)

Results Overview

Intrahepatic viral kinetics, plasma viral kinetics,

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Day-7, Day 1, Day 4,

Results posted on

2015-03-20

Participant milestones
Measure	Telaprevir/Peg-IFN/RBV 15 subjects received Telaprevir in combination with pegylated interferon and ribavirin. Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

Baseline characteristics by cohort
Measure	Telaprevir/Peg-IFN/RBV n=15 Participants 15 subjects received Telaprevir in combination with pegylated interferon and ribavirin. Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	50 years n=39 Participants
Sex: Female, Male Female	5 Participants n=39 Participants
Sex: Female, Male Male	10 Participants n=39 Participants
Region of Enrollment United States	15 participants n=39 Participants

Timeframe: Day-7, Day 1, Day 4,

Intrahepatic viral kinetics, plasma viral kinetics,

Outcome measures
Measure	Telaprevir/Peg-IFN/RBV n=15 Participants 15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care. Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). Additional 5 subjects be on standard of therapy.
Intrahepatic and Plasma HCV Viral Kinetics Plasma HCV RNA predose	6.5 log transformed copies/ml Standard Deviation 0.8
Intrahepatic and Plasma HCV Viral Kinetics Plasma HCV RNA 10 hrs	4.9 log transformed copies/ml Standard Deviation 0.9
Intrahepatic and Plasma HCV Viral Kinetics Plasma HCV RNA day 4	3.2 log transformed copies/ml Standard Deviation 0.6
Intrahepatic and Plasma HCV Viral Kinetics Liver HCV RNA predose	4.2 log transformed copies/ml Standard Deviation 1.2
Intrahepatic and Plasma HCV Viral Kinetics Liver HCV RNA 10 hrs	4.0 log transformed copies/ml Standard Deviation 1.3
Intrahepatic and Plasma HCV Viral Kinetics Liver HCV RNA day 4	3.9 log transformed copies/ml Standard Deviation 1.2

Timeframe: Day 1, Day 4, Day 15, Week 8

Intrahepatic and plasma telaprevir concentration ratios

Outcome measures
Measure	Telaprevir/Peg-IFN/RBV n=15 Participants 15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care. Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). Additional 5 subjects be on standard of therapy.
Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir telaprevir liver/plasma conc ratio day 1	0.72 telaprevir liver to plasma conc ratio Interval 0.4 to 1.01
Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir telaprevir liver/plasma conc ratio day 4	0.47 telaprevir liver to plasma conc ratio Interval 0.33 to 0.78
Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir telaprevir liver/plasma conc ratio day 15	0.57 telaprevir liver to plasma conc ratio Interval 0.34 to 0.76
Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir telaprevir liver/plasma conc ratio week 8	0.61 telaprevir liver to plasma conc ratio Interval 0.42 to 0.84

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Telaprevir/PEG-IFN/RBV n=15 participants at risk 15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care. Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). Additional 5 subjects be on standard of therapy.
Nervous system disorders Subarachnoid hemorrhage	6.7% 1/15 • Number of events 1 • Participants were followed for up to 24 weeks post treatment cessation.

Other adverse events
Measure	Telaprevir/PEG-IFN/RBV n=15 participants at risk 15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care. Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). Additional 5 subjects be on standard of therapy.
Nervous system disorders Subarachnoid hemorrhage	6.7% 1/15 • Number of events 1 • Participants were followed for up to 24 weeks post treatment cessation.

University at Buffalo

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