Trial Outcomes & Findings for Dutch Acute HCV in HIV Study (DAHHS) (NCT NCT01912495)

Results Overview

The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Boceprevir 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dutch Acute HCV in HIV Study (DAHHS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boceprevir/Peginterferon/Ribavirin n=57 Participants Boceprevir with Peginterferon and Ribavirin
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment Netherlands	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 41 patients had a RVR4

The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.

Outcome measures

Outcome measures
Measure	Boceprevir, Peginterferon and Ribavirin n=41 Participants 12 week Boceprevir, Peginterferon and Ribavirin
Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.	41 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Total intention to treat population

The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy

Outcome measures

Outcome measures
Measure	Boceprevir, Peginterferon and Ribavirin n=57 Participants 12 week Boceprevir, Peginterferon and Ribavirin
SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).	49 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.

The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment

Outcome measures

Outcome measures
Measure	Boceprevir, Peginterferon and Ribavirin n=5 Participants 12 week Boceprevir, Peginterferon and Ribavirin
SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.	5 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.

The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.

Outcome measures

Outcome measures
Measure	Boceprevir, Peginterferon and Ribavirin n=5 Participants 12 week Boceprevir, Peginterferon and Ribavirin
SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.	5 participants

SECONDARY outcome

Timeframe: 72 weeks

Population: data were not collected during this study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 weeks

Population: 57 patients started treatment and were at risk

only serious adverse events are recorded in this secondary endpoint

Outcome measures

Outcome measures
Measure	Boceprevir, Peginterferon and Ribavirin n=57 Participants 12 week Boceprevir, Peginterferon and Ribavirin
Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.	3 participants

Adverse Events

Boceprevir

Serious events: 3 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Boceprevir n=57 participants at risk 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
Cardiac disorders Myocardial infarction	1.8% 1/57
Vascular disorders transient ischemic attack	1.8% 1/57
General disorders anemia	1.8% 1/57

Other adverse events

Other adverse events
Measure	Boceprevir n=57 participants at risk 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
Blood and lymphatic system disorders Anemia	82.5% 47/57
Blood and lymphatic system disorders anemia	12.3% 7/57

Additional Information

B.J.A.Rijnders

Erasmus MC

Phone: 0031107034529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place