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Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

NCT03512210 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-02-04

Study results available
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Summary

To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the \~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.

Conditions

Interventions

DRUG

Sofosbuvir/Velpatasvir (SOF/VEL)

400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.

OTHER

Minimal Monitoring (MINMON) Strategy

MINMON Strategy: 1. No pre-treatment HCV genotyping 2. Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry 3. No scheduled on-treatment laboratory monitoring or clinic visits 4. Remote contact with participants at week 4 and week 22

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Sunil Solomon, MBBS, PhD, MPH · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2020-07-30
Completion
2021-02-28
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Puerto Rico
  • South Africa
  • Thailand
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512210 on ClinicalTrials.gov