Real-life Experience of Ledipasvir and Sofosbuvir for HCV Infected Korean Patients: a Multicenter Cohort Study

Overview

Journal Korean J Intern Med

Specialty General Medicine

Date 2022 May 26

PMID 35618302

Authors

Soon Kyu Lee

Sung Won Lee

Hae Lim Lee

Hee Yeon Kim

Chang Wook Kim

Do Seon Song

U Im Chang

Jin Mo Yang

Sun Hong Yoo

Jung Hyun Kwon

Soon Woo Nam

Seok-Hwan Kim

Myeong Jun Song

Jaejun Lee

Hyun Yang

Si Hyun Bae

Ji Won Han

Heechul Nam

Pil Soo Sung

Jeong Won Jang

Jong Young Choi

Seung Kew Yoon

Affiliations

Soon will be listed here.

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.

Citing Articles

Prognosis Following Sustained Virologic Response in Korean Chronic Hepatitis C Patients Treated with Sofosbuvir-Based Treatment: Data from a Multicenter Prospective Observational Study up to 7 Years.

Park Y, Na S, Yoon J, Kim S, Park J, Kim G Medicina (Kaunas). 2024; 60(7).

PMID: 39064561 PMC: 11279039. DOI: 10.3390/medicina60071132.

References

Kim H, Kim K, Choi G, Jang E, Ki M, Choi H . A cost-effectiveness study of universal screening for hepatitis C virus infection in South Korea: A societal perspective. Clin Mol Hepatol. 2021; 28(1):91-104. PMC: 8755471. DOI: 10.3350/cmh.2021.0236. View

. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017; 2(3):161-176. DOI: 10.1016/S2468-1253(16)30181-9. View

Berenguer M, Prieto M, Rayon J, Mora J, Pastor M, Ortiz V . Natural history of clinically compensated hepatitis C virus-related graft cirrhosis after liver transplantation. Hepatology. 2000; 32(4 Pt 1):852-8. DOI: 10.1053/jhep.2000.17924. View

Wong G . Drug-drug interactions with direct-acting antivirals - less is more. Clin Mol Hepatol. 2020; 27(1):81-82. PMC: 7820199. DOI: 10.3350/cmh.2020.0278. View

Pockros P, Reddy K, Mantry P, Cohen E, Bennett M, Sulkowski M . Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology. 2016; 150(7):1590-1598. DOI: 10.1053/j.gastro.2016.02.078. View

Kowdley K, Gordon S, Reddy K, Rossaro L, Bernstein D, Lawitz E . Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014; 370(20):1879-88. DOI: 10.1056/NEJMoa1402355. View

Lim Y, Ahn S, Lee K, Paik S, Lee Y, Jeong S . A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatol Int. 2016; 10(6):947-955. DOI: 10.1007/s12072-016-9726-5. View

Kwok R, Ahn J, Schiano T, Te H, Potosky D, Tierney A . Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients. Liver Transpl. 2016; 22(11):1536-1543. DOI: 10.1002/lt.24614. View

Buggisch P, Vermehren J, Mauss S, Gunther R, Schott E, Pathil A . Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C. J Hepatol. 2017; 68(4):663-671. DOI: 10.1016/j.jhep.2017.11.009. View

10.

Mizokami M, Liu L, Fujiyama N, Littman M, Yuan J, Sekiya T . Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. J Viral Hepat. 2020; 28(1):129-141. DOI: 10.1111/jvh.13395. View

11.

Curry M, Tapper E, Bacon B, Dieterich D, Flamm S, Guest L . Effectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patients. Aliment Pharmacol Ther. 2017; 46(5):540-548. DOI: 10.1111/apt.14204. View

12.

Charlton M, Everson G, Flamm S, Kumar P, Landis C, Brown Jr R . Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015; 149(3):649-59. DOI: 10.1053/j.gastro.2015.05.010. View

13.

Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H . Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis. 2015; 15(6):645-53. DOI: 10.1016/S1473-3099(15)70099-X. View

14.

Park S, Plank L, Suk K, Park Y, Lee J, Choi J . Trends in the prevalence of chronic liver disease in the Korean adult population, 1998-2017. Clin Mol Hepatol. 2019; 26(2):209-215. PMC: 7160351. DOI: 10.3350/cmh.2019.0065. View

15.

Jensen C, Holle L . Ledipasvir-Sofosbuvir: A Once-Daily Oral Treatment Option for Chronic Hepatitis C Virus Genotype 1 Infection. Pharmacotherapy. 2016; 36(5):562-74. DOI: 10.1002/phar.1748. View

16.

. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018; 69(2):461-511. DOI: 10.1016/j.jhep.2018.03.026. View

17.

Lee H, Lee H, Kim B, Chang Y, Jang J, Kim D . Cost-effectiveness of chronic hepatitis C screening and treatment. Clin Mol Hepatol. 2021; 28(2):164-173. PMC: 9013616. DOI: 10.3350/cmh.2021.0193. View

18.

Backus L, Belperio P, Shahoumian T, Loomis T, Mole L . Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patients. Hepatology. 2016; 64(2):405-14. DOI: 10.1002/hep.28625. View

19.

Marcus J, Hurley L, Chamberland S, Champsi J, Gittleman L, Korn D . No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients. Clin Gastroenterol Hepatol. 2018; 16(6):927-935. PMC: 5962408. DOI: 10.1016/j.cgh.2018.03.003. View

20.

Lawitz E, Landis C, Flamm S, Bonacini M, Ortiz-Lasanta G, Huang J . Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study. Lancet Gastroenterol Hepatol. 2020; 5(10):918-926. DOI: 10.1016/S2468-1253(19)30417-0. View