A pilot study examining the safety and tolerability of valacyclovir in veterans
with hepatitis C virus/herpes simplex virus type 2 coinfection.
Author(s): Burton MJ(1), Penman A, Sunesara I, McGuire BM, Hook EW 3rd.
Affiliation(s): Author information:
(1)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.
Publication date & source: 2014, Am J Med Sci. , 348(6):455-9
INTRODUCTION: 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.
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