Article: The Adverse Effects of Interferon-Free Regimens in 149 816 Chronic Hepatitis C Treated Egyptian Patients—D. Attia, et. al. – Alan Franciscus
SOURCE: Aliment Pharmacol Ther. 2018;00:1–10. https://doi.org/10.1111/apt.14538
Study Aims and Results: This study was conducted to understand the rates of side effects during and after treatment with direct-acting antiviral (DAA) therapy among Egyptian patients. In this retrospective study, a total of 149,816 patients received DAA treatment. The breakdown of type of DAA treatment received included sofosbuvir plus ribavirin (21,835 patients), sofosbuvir plus simeprevir (24,215 pts), sofosbuvir plus daclatasvir (58,477 pts), sofosbuvir, daclatasvir plus ribavirin (45,188), and paritaprevir, ombitasvir plus ribavirin (101 pts). The treatment period was 12 to 24 weeks. The majority of patients treated were male (53%), HCV genotype 4 (90%), and the mean age was 54 years old.
In the analysis, a total of 1.7% of the 149,816 patients treated reported side effects. Of these, 68% were serious which means that slightly more than 1% had serious side effects. The majority of the serious side effects were anemia (low red blood cells) and hyperbilirubinemia (high levels of bilirubin). The two serious side effects were in the patients treated with sofosbuvir plus ribavirin. The combination of sofosbuvir plus daclatasvir had the lowest rate of side effects.
There were 0.02% of people in the analysis treated who developed liver cancer, and .06% died after treatment completion. Patients with cirrhosis showed the highest risk for serious side effects and death.
Conclusions: In this large group of patients treated with various combinations of direct-acting antiviral (DAA) medications the reported side effects were very low. The most common side effects reported were in the group treated with sofosbuvir plus ribavirin.
Editorial Comments: This very large study reaffirms that DAA medications have relatively few side effects with a couple of important caveats:
- The highest rates of side effects were in the therapies that included ribavirin. Anemia is a well-documented side effect of ribavirin. Now, the vast majority of HCV treatment does not include ribavirin.
- The current study reinforces the need to closely monitor people with cirrhosis while they are receiving HCV treatment (and afterward).
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