Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and tolerability of the use of telaprevir in the setting of post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2.

To assess the election rate of postexposure prophylaxis for HCV-related occupational exposures in HCW.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

• MGH or BWH health care workers with exposure through needlestick injury with hollow-bore needles to source patients who are anti-HCV (+) and HCV RNA (+)

• HCW is anti-HCV Ab negative. HCW exposed through needlestick injury with hollow-bore needles to source patients who are anti-HCV (+) and HCV RNA (-), regardless of the RIBA result, will not be eligible for the study. In addition, efforts will be made to identify the source patient's genotype, and if the genotype is unknown, then genotype testing will be performed. If the genotype is 2 or 3, then the HCW exposed to the source patient will not be eligible for the study.

• HCW will be eligible if exposed to a source patient who has a genotype 1, or if the genotype of the source patient is unknown or unable to be ascertained

Exclusion Criteria:

• Exposure to patient with known HCV genotype 2 or 3

• HCV Ab positive

• HCV Ab negative and HCV RNA > 1000 IU/ml

• Active malignancy

• Other condition in the opinion of the investigators or occupational health that makes telaprevir contraindicated in HCW

• Subjects with pre-existing end stage renal impairment or severe hepatic impairment (Child Pugh B or C), and anemia (starting hemoglobin 10 or less) will be excluded.

• Pregnant women will be excluded from the study. All female participants with reproductive potential will undergo a pregnancy test (specifically qualitative urine human chorionic gonadotropin), and those who test positive will not be eligible for study inclusion. Women whom are not pregnant and elect to enroll in the study will be advised that hormonal contraceptives may not be reliable during the study period and for up to two weeks following cessation of the study drug. During this time, female patients of childbearing potential should use two non-hormonal methods of effective birth control, examples of which include a male condom with spermicidal jelly OR female condom with spermicidal jelly (a combination of a male condom and a female condom is not suitable), a diaphragm with spermicidal jelly, a cervical cap with spermicidal jelly, or an intrauterine device (IUD).