Chronic hepatitis C is a leading cause of morbidity and mortality in veterans. Current treatment options have only limited efficacy in veterans and are poorly tolerated. Herpes simplex type 2 virus co-infection commonly occurs in veterans with hepatitis C but is poorly studied. In patients with HIV, treatment of herpes simplex type 2 with well-tolerated oral drugs improves outcomes. We propose to study similar interactions of herpes simplex type 2 in hepatitis C. We also will begin preliminary studies to examine potential interactions of HSV-1 infection in HCV. Because of the varying performance of screening assays for HSV-2, our first aim is to validate a two-step approach for confirming herpes simplex type 2 infection in veterans with HCV. This will allow us to identify accurately persons with HSV-2/HCV infection AND study the effects of HSV-2 on HCV.
In aim 2, we will perform a randomized, double-blind, placebo-controlled clinical trial evaluating the effect of HSV-2 suppression on HCV viral load in patients with genotype 1 hepatitis C virus and herpes simplex type-2 co-infection.
In aim 3, we will examine the effects of HSV-1 suppression on serum hepatitis C viral load in herpes simplex type-1/hepatitis C virus co-infected veterans without evidence of herpes simplex type 2 infection. The VA is the largest single provider of care for persons with hepatitis C in the United States, but the majority of hepatitis C infected veterans are unable to receive or benefit from currently available therapies. This proposal examines a novel approach to delaying hepatitis C progression by suppressing herpes simplex viruses. Evaluating this approach could lead to improved, well-tolerated therapies for HCV in difficult-to-treat populations.

Public Health Relevance

The Department of Veterans Affairs is the largest provider of medical care to persons infected with hepatitis C virus (HCV) in the nation. Current therapies for hepatitis C are poorly tolerated and ineffective in over half of veterans. Viral co-infections influence the natural history of many chronic illnesses, including HCV. Herpes simplex virus-2 (HSV-2) co-infection commonly occurs in hepatitis C infected veterans, but has not been studied. Examining the effects of HSV-2 on the natural history of hepatitis C may lead to improved therapies to prevent or delay the development of advanced liver disease in veterans.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Veterans Administration (IK2)
Project #
5IK2CX000536-03
Application #
8453247
Study Section
Clinical Trials (CLIN)
Project Start
2011-07-01
Project End
2014-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
Indirect Cost
Name
G V Sonny Montgomery VA Medical Center
Department
Type
DUNS #
083443028
City
Jackson
State
MS
Country
United States
Zip Code
39216