Serum markers in monitoring the effect of Sofosbuvir-based treatments in HCV genotype 4

Author(s): Hyam Roshdy

Abstract

Background: Hepatitis C virus (HCV) infection and its consequent complications are undeniably a public health burden worldwide, particularly in Egypt. Even though Sofosbuvir (SOF), a direct-acting antiviral (DAA), has revolutionized the treatment of chronic HCV infection, treatment with pegylated interferon (PEG-IFN) in combination with ribavirin (RBV) is considered the standard of care for treatment in countries with limited medical resources.

 Aim: This study aimed to monitor the efficacy and safety of sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (Peg-INF-α), in Egyptian patients with chronic HCV genotype 4 (GT4).

Subjects:  Between the year 2015-2016, 165 patients infected with HCV GT4 were enrolled in this prospective study. Eligible patients received the recommended doses of SOF and RBV for 24 weeks (Dual treatment), or SOF+ RBV + PEG-IFN-α-2a for 12 weeks (Triple treatment). All patients were followed up for 24 weeks after the end of therapy. The primary outcome was the number of patients who achieved sustained virologic response (SVR24), and the secondary outcome was the occurrence of adverse events.

Results: The highest SVR rates were attained with the triple group (93.4%), corresponding to 79.3% in the dual group. Patients who failed to treatment (Non-SVR), had higher baseline PDGF in both groups, higher TNF- in the duel group, and lower TSH in the Triple group, and were considered as weak prognostic markers. We investigated the ability of the serum markers to monitor patients during therapy depending on the intra-individual biochemical variations.  Adverse effects included decrease in hemoglobin and white blood cells, together with an increase in creatinine, ferritin, and TSH. These adverse effects were well tolerated and there was no need for discontinuation or dose reduction of treatment regimens. The favorable effects besides high SVR24 included normalization of liver indices, correction of hypolipidemia, together with a decrease in TNF-α.

Conclusion: Results of sofosbuvir???based therapies achieved better SVR24 rates with the addition of PEG-INF. We recommend that monitoring the effects of treatment should be based on the intra-individual variations.

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