Advanced liver fibrosis effects on the response to sofosbuvir‐based antiviral therapies for chronic hepatitis C

Morio, Kei; Imamura, Michio; Kawakami, Yoshiiku; Nakamura, Yuki; Hatooka, Masahiro; Morio, Reona; Fujino, Hatsue; Nakahara, Takashi; Murakami, Eisuke; Tsuge, Masataka; Hiramatsu, Akira; Hayes, C. Nelson; Miki, Daiki; Ochi, Hidenori; Katamura, Yoshio; Arataki, Keiko; Moriya, Takuya; Ito, Hiroyuki; Tsuji, Keiji; Kohno, Hiroshi; Waki, Koji; Tamura, Toru; Nakamura, Toshio; Chayama, Kazuaki

doi:10.1002/jmv.25267

Cited by 12 publications

(11 citation statements)

References 26 publications

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“…The antiviral effect of DAAs is lower for patients with cirrhosis compared to patients with chronic hepatitis. 18 Among the patients with cirrhosis, patients with decompensated cirrhosis have a lower susceptibility to DAA therapy compared to those with compensated cirrhosis. 19 The SVR12 rate in this study was 85% (28 of 33 patients) based on intention to treat analysis, which is lower than in other recent studies of DAA-treated patients with chronic hepatitis or compensated cirrhosis.…”

Section: Discussionmentioning

confidence: 99%

“…Advanced liver fibrosis is known to be associated with refractoriness to DAA treatment in HCV‐infected patients. The antiviral effect of DAAs is lower for patients with cirrhosis compared to patients with chronic hepatitis 18 . Among the patients with cirrhosis, patients with decompensated cirrhosis have a lower susceptibility to DAA therapy compared to those with compensated cirrhosis 19 .…”

Section: Discussionmentioning

confidence: 99%

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Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Ohya

Imamura

Teraoka

et al. 2020

Hepatology Research

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Aim: Combination therapy with sofosbuvir (SOF) plus velpatasvir (VEL) is approved for patients with hepatitis C virus (HCV)-related decompensated cirrhosis. We analyzed the real-world efficacy of SOF/VEL therapy. Methods: Thirty-three patients with HCV-related decompensated cirrhosis (25 and eight patients with Child B and C, respectively) were treated with SOF/VEL for 12 weeks. The HCV non-structural protein (NS)5A and NS5B drug resistance-associated substitutions (RASs) were determined by direct sequencing. Result: Thirty-two of 33 patients completed the treatment, but the remaining patient discontinued the therapy during third week of the treatment due to aggravation of hepatic encephalopathy. Serum HCV-RNA became negative during the treatment in all patients but relapsed after the end of therapy in five patients. In total, 28 out of 33 patients (85%) achieved sustained vi-rological response 12 weeks following completion of treatment (SVR12). The SVR12 rate was 96% in patients with Child B, but significantly lower, at 50%, in patients with Child C (P<0.05). In genotype 1b HCV-infected patients, all eight patients without baseline NS5A RASs, but only three of seven patients with RASs, achieved SVR12. Multivariate analysis identified Child B (odds ratio, 35.8 for Child C; P=0.045) as an independent predictor of SVR12. Median serum albumin levels significantly increased only in patients who achieved SVR12. Child-Pugh scores improved in 16 of 28 patients (57%) following achievement of SVR12. Conclusion: The effect of SOF/VEL therapy is lower for patients with Child C. Improvement of hepatic function is expected after viral eradication with SOF/VEL therapy in patients with decompensated cirrhosis.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Ohya

Imamura

Teraoka

et al. 2020

Hepatology Research

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“…26 A recent Japanese multicenter cohort study revealed an SVR rate of 90.8% in patients with high FIB-4, which was significantly lower compared to 98.1% of those with low FIB-4 after SOF+RBV therapy. 27 The reason for the universally high SVR rate in NC (97.6%) or cirrhotic (99.1%) Korean patients might be the longer treatment duration for cirrhosis compared to that of Japanese patients who were only allowed 12 weeks of treatment due to reimbursement limitations for SOF-based treatment in Japan. Moreover, four decompensated cirrhotic patients showed SVR rate of 100% without any significant adverse event.…”

Section: Discussionmentioning

confidence: 99%

Real-Life Effectiveness and Safety of Sofosbuvir-Based Therapy in Genotype 2 Chronic Hepatitis C Patients in South Korea, with Emphasis on the Ribavirin Dose

Jang

Kim

et al. 2020

Gut and Liver

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Background/Aims: Sofosbuvir (SOF)-based therapy has been used in Korean patients with chronic hepatitis C virus (HCV) infection since January 2016. This study aimed to investigate the real-life effectiveness and safety of SOF-based therapy in genotype 2 HCV infection. Methods: From January to December 2016, 458 genotype 2 HCV-infected patients who received ≥1 dose of SOF-based therapy were consecutively enrolled in seven tertiary hospitals. Sustained virologic response (SVR) rates and safety were determined by intention-to-treat (ITT) and per-protocol (PP) analyses. Results: The mean age of the patients was 61.0 years; 183 (40%) were male, and 13.1% showed a high viral load (>6,000,000 IU/ mL). Among the 378 treatment-naïve patients, the SVR rates were 94.2% (ITT) and 96.7% (PP). Among the 80 treatmentexperienced patients, the SVR rates were 96.3% (ITT) and 98.7% (PP). Patients with a relatively high fibrosis-4 index score (>3.25) had similar SVR rates to those with a relatively low score (p=0.756). A total of 314 patients (68.6%) were treated with a reduced ribavirin dose at the prescriber's discretion, but they showed similar SVR rates to those treated with the weight-based dose (ITT: 95.5% and 92.3%, PP: 97.4% and 96.3%, respectively). Adverse events were observed in 191 patients (41.7%), including 86 (18.8%) with anemia, but only one (0.2%) discontinued antiviral therapy due to nausea. Conclusions: SOF-based therapy showed high real-life efficacy and tolerability in Korean patients with genotype 2 chronic HCV infection, regardless of previous antiviral treatment experience and fibrosis score. A reduced ribavirin dose can be considered in this patient cohort.

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“…Advanced liver fibrosis or cirrhosis or baseline NS5A resistance-associated substitution Y93H may responsible for the failure of the virologic response, owing to its interference with responses to DAA therapy affect virological response to DAAs therapy. [ 29 , 30 ] Furthermore, SOF based pangenotypic DAAs therapy also achieved high SVR12 rate in CHC patients with hypertension or diabetes of our cohort. Another pangenotypic DAA, GLE/PIB also yield high SVR12 rates in CHC patients with HCV GT 1 to 6 with or without cirrhosis, ranging from 91% to 100%.…”

Section: Discussionmentioning

confidence: 52%

Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination

Li¹,

Jiang

et al. 2020

Medicine

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Several new, pangenotypic direct-acting antiviral agents (DAAs) have been approved, may reduce the need for genotyping to guide therapy decisions for patients with chronic hepatitis C (CHC). This study aimed to investigate the efficacy and safety of Sofosbuvir (SOF)-based pangenotypic DAAs therapy for CHC patients without genotype (GT determination in the real-world practice. This retrospective cohort study included treatment-naïve CHC patients without GT determination, who received SOF-based DAAs therapy, including 400 mg SOF plus 60 mg daclatasvir (DCV) daily or 400 mg SOF plus 100 mg velpatasvir (VEL) daily for 12 or 24 weeks. Clinical and laboratory data, including sustained virologic response (SVR), were obtained at baseline, end of treatment (EOT), 12 weeks after EOT, and 48 weeks after EOT. A total of 95 CHC patients, including 30 (31.58%) had liver cirrhosis were enrolled. SVR rates after 12 weeks of treatment (SVR12) was 96.84% (92/95), including 96.20% (76/79) of patients receiving SOF plus DCV and 100% (16/16) of patients receiving SOF plus VEL. For 92 patients achieving an SVR12, no virological relapse was observed at 48 weeks after EOT. Furthermore, serum evaluation of liver fibrosis aspartate aminotransferase-to-platelet ratio index and Fibrosis-4 score were decreased significantly at EOT and 12 weeks after EOT, compared to pre-treatment values (both P < .05). Treatment was well-tolerated by our patients. SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study. This may provide a potential simple strategy for CHC treatment without GT determination.

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Advanced liver fibrosis effects on the response to sofosbuvir‐based antiviral therapies for chronic hepatitis C

Abstract: Both older and younger patients respond similarly to DAA therapy. Advanced liver fibrosis affects the virological response to sofosbuvir-based therapy.

Cited by 12 publications

References 26 publications

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Real-Life Effectiveness and Safety of Sofosbuvir-Based Therapy in Genotype 2 Chronic Hepatitis C Patients in South Korea, with Emphasis on the Ribavirin Dose

Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination

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