HCV Post-Exposure Prophylaxis for Health Care Workers

Mass General Brigham

Status and phase: Withdrawn; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir/Velpatasvir Treatment for 14 days

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03313414

2017P001661

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment with Sofosbuvir/Velpatasvir

Experimental group

Description:

14 days of treatment with Sofosbuvir/Velpatasvir tablet

Treatment:

Drug: Sofosbuvir/Velpatasvir Treatment for 14 days