Safety, Tolerability, and Efficacy of Sofosbuvir Plus Ribavirin in Elderly Patients Infected with Hepatitis C Virus Genotype 2

Abstract

Background: An interferon-free regimen including sofosbuvir and ribavirin (RBV) for patients with hepatitis C virus (HCV) genotype 2 (G2) infection leads to a drastic improvement of sustained virological response (SVR). However, the safety, tolerability, and efficacy in patients aged 75 or older have not been completely understood. Summary: Fifty-six patients with HCV G2 infection who were treated with sofosbuvir and weight-based dose of RBV were enrolled. Thirty-seven patients aged ≥75 and 19 patients aged ≤74 were classified as the aged and non-aged groups, respectively. The aged group was characterized by significantly more number of women, history of hepatocellular carcinoma, low serum albumin (ALB) level, low hemoglobin (Hb) concentration, low estimated glomerular filtration rate (eGFR), and high fibrosis-4 index (p = 0.0029). Forty-one patients were evaluated for SVR at 12 weeks after the end of therapy (SVR12); of them, all but one completed the treatment scheduled for 12 weeks. The aged group showed lower SVR12 rate than the non-aged group (81.3% for aged and 96.0% for non-aged groups). Although the Hb concentration and eGFR are significantly lower in the aged group throughout the clinical course, all patients in the aged group completed the 12-week treatment with a gradual increase of serum ALB level. Key Messages: The combination of sofosbuvir plus RBV is tolerable and beneficial in patients aged >75. However, intensive management of anemia by dose reduction of RBV is necessary, which could lead to a low SVR12 rate compared to that observed in patients younger than 75 years.

Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose

“…Incidentally, all the few dropouts were attributable to reasons not related to the prescribed therapy. We also consider the safety data of particular significance since this was a frail mostly elderly population, like typical cohorts of cirrhotic patients in the Western world 52,66–68 …”

“…We also consider the safety data of particular significance since this was a frail mostly elderly population, like typical cohorts of cirrhotic patients in the Western world. 52,[66][67][68] However, this research reveals also many possible shortcomings. First, the frequency and severity of AE were estimated on the basis of clinical charts and may partially have been classified…”

Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over

“…Regarding efficacy, Nishida et al[ 12 ] reported that although the difference was not significant, patients ≥ 75-years-old tended to show a lower SVR rate than patients < 75-years-old (81.3%, 13/16 for patients ≥ 75-years-old; 96.0%, 24/25 for patients < 75-years-old)[ 12 ]. Atsukawa et al[ 11 ] showed SVR rates of 98.1% (51/51) for patients ≥ 75-years-old and 96.8% (211/218) for patients < 75-years-old ( P = 0.999)[ 11 ].…”