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A pilot study examining the safety and tolerability of valacyclovir in veterans with hepatitis C virus/herpes simplex virus type 2 coinfection.

The American journal of the medical sciences (2014-08-28)
Mary J Burton, Alan Penman, Imran Sunesara, Brendan M McGuire, Edward W Hook
ABSTRACT

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. 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). 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). 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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
L -缬氨酸, reagent grade, ≥98% (HPLC)
Sigma-Aldrich
L -缬氨酸, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, 98.5-101.0%
Supelco
阿昔洛韦, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
阿昔洛韦, ≥99% (HPLC), powder
SAFC
L -缬氨酸
阿昔洛韦, European Pharmacopoeia (EP) Reference Standard
Supelco
L-缬氨酸, Pharmaceutical Secondary Standard; Certified Reference Material
USP
阿昔洛韦, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
L -缬氨酸, BioUltra, ≥99.5% (NT)
缬氨酸, European Pharmacopoeia (EP) Reference Standard
Supelco
L -缬氨酸, certified reference material, TraceCERT®
Sigma-Aldrich
伐昔洛韦 盐酸盐 水合物, ≥98% (HPLC), solid
USP
伐昔洛韦 盐酸盐, United States Pharmacopeia (USP) Reference Standard
伐昔洛韦 盐酸盐, European Pharmacopoeia (EP) Reference Standard
伐昔洛韦 盐酸盐, European Pharmacopoeia (EP) Reference Standard