Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study

Abstract

Background/aims: To evaluate the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) therapy in hepatitis C virus (HCV)-infected Korean patients in a real clinical setting.

Methods: A total of 273 patients who received LDV/SOF therapy between May 2016 and February 2021 were consecutively enrolled and analyzed. A per-protocol analysis was performed to evaluate the virologic response.

Results: Seventy-five percent were infected with genotype 1, and 25% were infected with genotype 2. A hundred eightyone (66.3%) patients had chronic hepatitis, 74 (27.1%) had compensated cirrhosis, eight (2.9%) had decompensated cirrhosis, and 10 (3.7%) had undergone liver transplantation. Undetectable HCV RNA at week 4 was achieved in 90.2% (231/256) of patients, 99.2% (250/252) achieved the end of treatment response, and 98.1% (202/206) achieved sustained virologic response at 12 weeks post-treatment (SVR12). According to liver function, the SVR12 rates were 99.3% (135/136) in chronic hepatitis, 96.4% (53/55) in compensated cirrhosis, and 100% (6/6) in decompensated cirrhosis. The SVR12 rates according to the genotype were 98.2% (167/170) for genotype 1 and 97.2% (35/36) for genotype 2. An 8-week LDV/SOF treatment in treatment-naïve chronic hepatitis patients with HCV RNA < 6,000,000 IU/mL at baseline resulted in 100% (23/23) SVR12 rates. Overall, LDV/SOF was tolerated well, with a 0.7% (2/273) discontinuation rate due to adverse events that were unrelated to LDV/SOF.

Conclusion: LDV/SOF is effective and safe for treating HCV-infected Korean patients with high SVR12 rates.

Keywords: Genotype; Hepatitis C virus; Ledipasvir; Sofosbuvir; Sustained virologic response.

Figure 1

The rates of (A) rapid virologic response (RVR), end of treatment response (ETR), and sustained virological response 12 weeks after end of treatment (SVR12) for the per protocol population after ledipasvir/sofosbuvir treatment and (B) SVR12 according to the genotype (GT) and prior treatment (Tx) status. HCV, hepatitis C virus; LLOQ, lower limit of quantification.

Figure 2

The rate of sustained virological response 12 weeks after end of treatment (SVR12) according to (A) the treatment duration in treatment-naïve genotype (GT) 1 patients with hepatitis C virus (HCV) RNA < 6 million IU/mL, (B) the liver cirrhosis (LC) and liver transplantation status, and (C) comorbidities in patients with HCV infection. LLOQ, lower limit of quantification; CH, chronic hepatitis; PSLT, post-status liver transplantation; DM, diabetes mellitus; HTN, hypertension; CKD, chronic kidney disease.