N/A Completed N=713

Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)

Hepatitis C Chronic

Source: ClinicalTrials.gov NCT01544582 ↗

Enrolled (actual)

713

Serious AEs

17.1%

Results posted

Sep 2016

Primary outcomePrimary: Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern) — 43.9; 45.2; 10.9 percentage of participants

Summary

This is an observational prospective follow-up study to assess the utilization of boceprevir and the management of pre-specified health outcomes of interest (HOIs) under conditions of routine clinical care in participants with chronic hepatitis C (CHC) genotype 1. As an observational prospective study, this study is not intended to change the participant/physician relationship, nor influence the physician's drug prescription or therapeutic management of the participant. No individual administration of any therapeutic or prophylactic agent is assigned in this protocol, and there are no procedures required as part of this protocol. Physician choice of the drug used to treat the participant is based on clinical judgment alone.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)	43.9; 45.2; 10.9	—
PRIMARY Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight	77.7; 77.0; 71.7	—
PRIMARY Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height	170.8; 170.8; 171.0	—
PRIMARY Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)	26.5; 26.5; 24.7	—
PRIMARY Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype	107; 120; 33; 147; 148; 30	—
PRIMARY Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load	101; 94; 35; 182; 197; 39	—
PRIMARY Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score	97; 61; 30; 1; 3; 0	—
PRIMARY Percentage of Anemia Episodes Managed by at Least One Clinical Intervention	79.3; 72.5; 69.9; 75.0; 20.7; 27.5	—
PRIMARY Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes	52.4; 46.0; 43.9; 66.7; 52.4; 20.0	—
PRIMARY Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention	36.7; 33.6; 18.5; 0.0; 63.3; 66.4	—
PRIMARY Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes	27.3; 46.2; 75.0; NA; 0.0; 0.0	—
PRIMARY Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention	42.3; 35.8; 32.1; 0.0; 57.7; 64.2	—
PRIMARY Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes	30.0; 42.1; 11.1; NA; 0.0; 5.3	—
PRIMARY Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention	100.0; 100.0; 96.3; 0.0; 0.0; 3.7	—
PRIMARY Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes	100.0; 42.9; 65.4; 0.0; 28.6; 23.1	—
SECONDARY Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash	1.185; 3.302; 3.001; 5.122; 1.305; 1.656	—

Eligibility Criteria

Inclusion Criteria

Documented chronic hepatitis C (CHC) genotype-1 infection
Untreated or failed previous therapy
Initiated a new treatment regimen after the study implementation date at their site
Agrees to participate in the study by giving written informed consent

Exclusion Criteria

Taking part in a clinical trial or in any study where a participant is receiving care outside of normal clinical practice for Hepatitis C Virus (HCV)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01544582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.