HCV Post-Exposure Prophylaxis for Health Care Workers

Purpose

This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.

Condition

  • Hepatitis C

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive - Healthcare worker must be HCV Ab-

Exclusion Criteria

  • HCV Ab positive - HCV Ab negative and HCV RNA greater than 1000 IU/ml - Active malignancy - Positive urine pregnancy test

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment with Sofosbuvir/Velpatasvir 		14 days of treatment with Sofosbuvir/Velpatasvir tablet
  • Drug: Sofosbuvir/Velpatasvir Treatment for 14 days
    14 day therapy with Sofosbuvir/Velpatasvir
    Other names:
    • Epclusa

More Details

Status
Withdrawn
Sponsor
Massachusetts General Hospital

Study Contact

Detailed Description

The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles