Trial Outcomes & Findings for A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3 (NCT NCT01364090)

Last Updated: 2019-11-18

Results Overview

The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

36 weeks

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Shortened Treatment Duration (12 Weeks) Subjects with undetectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Standard Treatment Duration (24 Weeks) Subjects with detectable HCV RNA after four weeks of therapy will continue on pegylated interferon alfa 2b (PEG-IFN) and ribavirin (RBV) until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Discontinued Prior to Week 4 Participants who discontinued therapy prior to week 4 HCV RNA assessment and were therefore not placed in either study arms.
Overall Study STARTED	61	26	6
Overall Study COMPLETED	58	12	0
Overall Study NOT COMPLETED	3	14	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment Duration (24 Weeks) n=26 Participants Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Shortened Treatment Duration (12 Weeks) n=61 Participants Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Discontinued Prior to RVR n=6 Participants Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.	Total n=93 Participants Total of all reporting groups
Age, Continuous	40 years n=99 Participants	41 years n=107 Participants	50 years n=206 Participants	41 years n=7 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	12 Participants n=107 Participants	1 Participants n=206 Participants	16 Participants n=7 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	49 Participants n=107 Participants	5 Participants n=206 Participants	77 Participants n=7 Participants

PRIMARY outcome

Timeframe: 36 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Standard Treatment Duration (24 Weeks) n=26 Participants Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Shortened Treatment Duration (12 Weeks) n=61 Participants Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Discontinued Prior to RVR n=6 Participants Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
Treatment Efficacy	10 Participants	51 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Evaluate the adherence (\>80 of PEG-IFN, \>80% of RBV, \>80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.

Outcome measures

Outcome data not reported

Adverse Events

Standard Treatment Duration (24 Weeks)

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Shortened Treatment Duration (12 Weeks)

Serious events: 6 serious events

Other events: 60 other events

Deaths: 0 deaths

Discontinued Prior to RVR

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Standard Treatment Duration (24 Weeks) n=26 participants at risk Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Shortened Treatment Duration (12 Weeks) n=61 participants at risk Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.	Discontinued Prior to RVR n=6 participants at risk Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
General disorders Fatigue	53.8% 14/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	54.1% 33/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	16.7% 1/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
General disorders Influenza like illness	50.0% 13/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	31.1% 19/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	66.7% 4/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Nervous system disorders Headache	53.8% 14/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	34.4% 21/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	0.00% 0/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Gastrointestinal disorders Nausea	19.2% 5/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	42.6% 26/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	33.3% 2/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Musculoskeletal and connective tissue disorders Myalgia	26.9% 7/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	29.5% 18/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	16.7% 1/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Metabolism and nutrition disorders Decreased appetite	23.1% 6/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	31.1% 19/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	0.00% 0/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Psychiatric disorders Insomnia	15.4% 4/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	24.6% 15/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	0.00% 0/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Gastrointestinal disorders Vomiting	19.2% 5/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	18.0% 11/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	33.3% 2/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Blood and lymphatic system disorders Anaemia	19.2% 5/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	19.7% 12/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	0.00% 0/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
Skin and subcutaneous tissue disorders Dry Skin	19.2% 5/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	19.7% 12/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	0.00% 0/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.
General disorders Injection site erythema	15.4% 4/26 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	13.1% 8/61 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.	83.3% 5/6 • Adverse events were collected from the date of signing the consent until 24 weeks post-treatment. Laboratory abnormalities only recorded as AEs if it caused a Serious Adverse Event (SAE), resulted in discontinuation/modification of study treatment or required treatment with, or modification to, concomitant medication. Pre-existing conditions/diseases that occurred during the study were not considered as adverse events unless they changed in frequency or severity. Participants were assessed at each study visit for adverse events.

Additional Information

Dr. Jason Grebely

Viral Hepatits Clinical Research Program - The Kirby Institute - UNSW Sydney

Phone: +61 2938 50957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place