Antiviral therapies for chronic hepatitis C virus infection with cirrhosis

Table 2 Safety data of antiviral treatments for cirrhotic patients infected with hepatitis C virus

Ref. (name of trial)	Regimen; genotypes; No. of patients (n)	Patient characteristics	AE (serious AE) rate;
			cirrhosis vs non-cirrhosis
Kumada et al[27] (AI447026)	ASV + DCV; G1; n = 222	IFN-intolerant/IFN-ineligible or IFN-non-responders	(9% vs 6%)
Forns et al[19] (PROMISE)	SMV + P/RBV; G1; n = 260	Treatment experienced; relapse	100% vs 92%-93% (1% vs 1%)1
Jacobson et al[30] (POSITRON, FUSION)	SOF + RBV; G2-3; n = 408	IFN-ineligible/IFN-intolerant (POSITRON); IFN-failure (FUSION)	97% vs 88% (7% vs 5%)
		12-wk regimen	86% vs 91% (11% vs 2%)
		16-wk regimen	88% vs 88% (6% vs 2%)
Lawitz et al[35] (COSMOS)	SMV + SOF ± RBV	F0-2; non-responders	87% vs 88% (5% vs 0%)
	for 12 or 24 wk; G1; n = 167	F3-4; non-responders or naïve

¹Comparison between F3-4 and F0-2 (METAVIR score) during the first 12 wk of therapy. AE: Adverse event; ASV: Asunaprevir; DCV: Daclatasvir; G: Genotype; IFN: Interferon; P: Peginterferon; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir.