title: A pilot study examining the safety and tolerability of valacyclovir in veterans with hepatitis C virus/herpes simplex virus type 2 coinfection.
abstract: BACKGROUND
  We performed a pilot study examining the safety and tolerability of valacyclovir in veterans with herpes simplex virus type 2 and hepatitis C virus (HCV) coinfection.
  
  
  METHODS
  We performed a randomized double-blind, placebo-controlled, crossover clinical trial in U.S. veterans with genotype 1 HCV/herpes simplex virus type 2 coinfection. Patients were randomized 1:1 in blocks of 10 to receive either 1 g twice-daily valacyclovir or matching placebo for 8 weeks followed by a 2-week washout phase with daily placebo. The alternate therapy (valacyclovir or placebo) was given for an additional 8-week period. Safety assessments were performed every 2 weeks. Changes in HCV RNA and alanine aminotransferase (ALT) were estimated using linear mixed models (SAS Proc Mixed).
  
  
  RESULTS
  Thirty patients were enrolled. Valacyclovir was not associated with toxicity or adverse events. ALT levels declined 6% to 10%; mean HCV RNA levels were reduced 24% (1.3 million IU/mL [0.21 log10 IU/mL]) during the valacyclovir phase (P = 0.08) with no carryover effect observed (P = 0.21).
  
  
  CONCLUSIONS
  Valacyclovir 1 g twice daily showed no evidence of hepatotoxicity in U.S. veterans with hepatitis C. A modest reduction in serum levels of ALT and plasma levels of HCV RNA was observed.
authors.affiliation: Veterans Affairs Medical Center (MJB), Jackson, Mississippi; Division of Infectious Diseases (MJB, IS), University of Mississippi Medical Center, Jackson, Mississippi; Center of Biostatistics (AP, IS), University of Mississippi Medical Center, Jackson, Mississippi; Division of Gastroenterology and Hepatology (BMM), University of Alabama at Birmingham, Birmingham, Alabama; and Division of Infectious Diseases (EWK), University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Burton
authors.forename: Alan
authors.initials: A
authors.lastname: Penman
authors.forename: Imran
authors.initials: I
authors.lastname: Sunesara
authors.forename: Brendan M
authors.initials: BM
authors.lastname: McGuire
authors.forename: Edward W
authors.initials: EW
authors.lastname: Hook
mesh_terms: D000212:Acyclovir / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D000410:Alanine Transaminase; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D060085:Coinfection / Q000188:drug therapy; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006561:Herpes Simplex / Q000150:complications / Q000188:drug therapy*; D018258:Herpesvirus 2, Human; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood*; D016896:Treatment Outcome; D000077483:Valacyclovir; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014728:Veterans; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D000410:Alanine Transaminase; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir