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2017 ; 52
(4
): 294-301
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gab.com Text
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Anti-Nuclear Cytoplasmic Antibody-Associated Vasculitis: A Probable Adverse
Effect of Sofosbuvir Treatment in Chronic Hepatitis C Patients
#MMPMID28515509
Ahmad YK
; Tawfeek S
; Sharaf-Eldin M
; Elbatea HE
; Kobtan A
; El-Kalla F
; Badawi R
; Abd-Elsalam S
Hosp Pharm
2017[Apr]; 52
(4
): 294-301
PMID28515509
show ga
Background: Egypt has the largest hepatitis C virus (HCV) epidemic worldwide.
Sofosbuvir is an antiviral drug acting by inhibition of the HCV NS5B polymerase.
It has shown high efficacy in combination with several other drugs and has a low
reported rate of side effects. Objective: The aim of this prospective cohort
study was to assess the safety of sofosbuvir-based treatment regimens used to
treat chronic hepatitis C infections and to detect any side effects of sofosbuvir
not previously reported. Methods: We studied treatment side effects in 3,000
patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24
weeks or treated by pegylated interferon, sofosbuvir, and ribavirin triple
therapy for 12 weeks. The endpoint of the study was the end of treatment.
Results: Hyperbilirubinemia occurred frequently during treatment in both groups.
Treatment was discontinued in 72 cases due to hepatic decompensation and drug
complications; 8 of the cases had deep vein thrombosis (DVT) and 7 had cerebral
ischemia. Surprisingly, 177/3,000 (5.9%) patients presented with abnormal
bleeding, 85 of whom had a vasculitic skin rash. Conclusion: We report the
occurrence of previously nonrecorded side effects with sofosbuvir, namely DVT and
bleeding disorders associated with anti-nuclear cytoplasmic antibody
(ANCA)-associated vasculitis (AAV).We believe this to be the first report of
sofosbuvir-induced AAV skin lesions and bleeding disorders.