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Aust Prescr. 2017 June; 40(3): 90.
Published online 2017 June 1. doi:  10.18773/austprescr.2017.036
PMCID: PMC5478404

Safety concerns with the direct-acting antivirals for hepatitis C

Simone Strasser’s summary of hepatitis C treatment in general practice deserves comment.1

Although the rate of sustained virologic response to direct-acting antivirals is impressive, this is only a surrogate. Interferon-based regimens were proven to have efficacy on the rate of progression to cirrhosis and the incidence of hepatocellular carcinoma. Expectation with direct-acting antivirals cannot replace the results of either long-term randomisation on clinically relevant benefits and harms or post-marketing surveillance programs. Indeed, safety concerns are beginning to come to light.2 Moreover, an unusual occurrence of hepatocellular carcinoma among patients with direct-acting antiviral therapy has been reported.3 The finding needs more basic data to be analysed but the fourfold increase in serum vascular endothelial growth factor during antiviral therapy is alarming.4

Simone Strasser rightly stressed the importance of treating comorbid factors such as alcohol use and obesity in patients with hepatitis C. However, she overlooked the case of smoking, which is an independent and dose-related cause of hepatocellular carcinoma. In a large European study of patients with hepatocellular carcinoma, the population-attributable fraction for tobacco use was 47.6%. This was more than twice the population-attributable fraction for hepatitis C (at 20.9%), which was the second most attributed risk factor.5

REFERENCES

1. Strasser SI. Managing hepatitis C in general practice. Aust Prescr 2017;40:64-9. 10.18773/austprescr.2017.017 [PMC free article] [PubMed] [Cross Ref]
2. US Food and Drug Administration. FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni) or Sovaldi in combination with another direct acting antiviral drug. 2015 Mar 24. www.fda.gov/Drugs/ DrugSafety/ucm439484.htm [cited 2017 May 1]
3. Ravi S, Axley P, Jones D, Kodali S, Simpson H, McGuire BM, et al. Unusually high rates of hepatocellular carcinoma after treatment with direct-acting antiviral therapy for hepatitis C related cirrhosis. Gastroenterology 2017;152:911-2. 10.1053/j.gastro.2016.12.021 [PubMed] [Cross Ref]
4. Villani R, Facciorusso A, Bellanti F, Tamborra R, Piscazzi A, Landriscina M, et al. DAAs rapidly reduce inflammation but increase serum VEGF level: a rationale for tumor risk during anti-HCV treatment. PLoS One 2016;11:e0167934. 10.1371/journal.pone.0167934 [PMC free article] [PubMed] [Cross Ref]
5. Trichopoulos D, Bamia C, Lagiou P, Fedirko V, Trepo E, Jenab M, et al. Hepatocellular carcinoma risk factors and disease burden in a European cohort: a nested case-control study. J Natl Cancer Inst 2011;103:1686-95. 10.1093/jnci/djr395 [PMC free article] [PubMed] [Cross Ref]

Articles from Australian Prescriber are provided here courtesy of NPS MedicineWise