Evaluation of fluvastatin in combination with the standard of care therapy (PEG-IFN/Ribavirin) in Egyptian patients with hepatitis C virus.
OBJECTIVE
Cholesterol biosynthesis suppresses the replication of HCV-1b replicons, thus influencing hepatitis C virus (HCV) natural history. This study aimed at comparing the efficacy and safety of fluvastatin (FLV) as an adjuvant therapy to the standard of care (SOC) therapy, i.e., pegylated interferon (PEG-IFN) and ribavirin, for the treatment of HCV patients.


METHODS
Sixty HCV patients were enrolled and allocated to either group I, who received the triple therapy (fluvastatin + SOC), or group II, who received SOC; the duration for both treatments was 48 weeks. All patients were subjected to pretreatment liver biopsy and monthly biochemical tests (liver profile, CBC), and quantitative HCV-RNA test was performed at weeks 0, 4, 12, 48, and 72.


RESULTS
All virological responses were higher in group I than in group II, with no statistical difference. Group I showed no manifestations of hepatotoxicity.


CONCLUSIONS
Fluvastatin yielded a borderline, significantly higher complete early virological response than SOC; therefore, it is a safe adjuvant to the SOC therapy.
Department of Hepatology and Gastroenterology, Theodor Bilharz Research Institute, Cairo, Egypt. egymarz@yahoo.com.
Moataz S
MS
Seyam
Haitham A
HA
Gabr
Zakaria A
ZA
Salama
Mohammed A
MA
Mokhles
Raghda N
RN
Marzaban
Ahmed F
AF
Soliman
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D001772:Blood Cell Count; D004359:Drug Therapy, Combination; D004534:Egypt; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage*; D005260:Female; D000077340:Fluvastatin; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D016898:Interferon-alpha / Q000008:administration & dosage*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*; D059039:Standard of Care; D016896:Treatment Outcome
D000998:Antiviral Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000077340:Fluvastatin; C100416:peginterferon alfa-2a