Sofosbuvir-based antiviral therapy provided highly treatment efficacy, safety, and good tolerability for Taiwanese chronic hepatitis C patients with decompensated cirrhosis

Abstract

Background: For patients with hepatitis C virus (HCV)-related decompensated cirrhosis, poor prognosis was documented due to the development of portal hypertension-related complications and hepatocellular carcinoma. Sofosbuvir-based direct-acting antiviral agents (DAAs) has revolutionized the treatment landscape of HCV, particularly in this subpopulation. To date, real-world efficacy, tolerability, and safety profiles for Taiwanese HCV-related decompensated cirrhosis treated by DAAs have not been reported. Methods: Between December 2015 and June 2020, 50 consecutive HCV-related Child-Turcotte-Pugh (CTP) classes B or C cirrhotics treated by sofosbuvir-based DAAs (with daclatasvir: 7, with ledipasvir: 32, with velpatasvir: 10, with ledipasvir then shifted to velpatasvir: 1) were enrolled. Forty-seven (94%) patients used DAAs in combination with low-dose ribavirin. SVR 12 was defined by undetectable HCV RNA (<15 IU/mL) at treatment end and 12 weeks after the completion of therapy. Results: The mean age of the enrolled patients was 68.1 ± 11.2 years, 18% of the patients were CTP class C, and the baseline HCV RNA level was 5.42 ± 1.2 log 10 IU/mL. The genotype distribution was as follows: 1a: 3; 1b: 34; 2: 9; 6: 3; and one patient with an unclassified HCV genotype. After DAAs treatment, the rates of undetectable HCV RNA at week 4 and at the end of the treatment were 88.9% and 98.0%, respectively. Subjective adverse events were reported by 42.0% of the patients, but they were generally mild and could be relieved by medications. One patient did not finish therapy due to sepsis with multiple organ dysfunction. The overall SVR 12 rate was 96.0% (CTP class B: 97.6%, CTP class C: 88.9%). A significant improvement in hepatic functional reserve was noted after successful antiviral therapy. Conclusion: For patients with HCV-related decompensated cirrhosis, which has been considered a contraindication for interferon-based therapy, sofosbuvir-based all-oral DAAs provided high treatment efficacy, acceptable safety, and good tolerability.

Analyzing risk factors and developing a stratification system for hepatocellular carcinoma recurrence after interferon-free direct-acting antiviral therapy in chronic hepatitis C patients

“…The development of highly effective, IFN-free, all-oral DAAs has revolutionized HCV treatment, offering high rates of SVR in a very short time, broader candidacy even for patients with decompensated cirrhosis, and very few side effects compared to IFN-based therapy. [9][10][11][12] In addition, a substantially lower risk of liver-related events has been reported in patients with CHC successfully treated with DAAs. 36 Consequently, clinicians The bold value merely indicates that the p-value is statistically significant, but it is not necessary; it can also be presented without bold.…”

“…DAAs have exhibited superior safety profiles and shorter treatment duration, even for advanced liver disease stages, including decompensated cirrhosis, yielding a remarkable SVR rate exceeding 95%. [9][10][11][12] Although two studies published in 2016 raised concerns about the high risk of HCC occurrence and recurrence after DAA therapies, 13,14 most recent studies have not supported that DAA therapy increases the risk of HCC recurrence. [15][16][17][18][19][20][21][22] In addition, a meta-analysis of six studies encompassing 1105 patients who received DAAs vs 1912 controls either untreated or undergoing peg-IFN-α-based regimens with follow-up ranging from 1.25 to 4 years concluded that DAA therapy was correlated with a substantial 64% decrease in HCC recurrence compared to untreated controls.…”

Residual risk of hepatocellular carcinoma development for chronic hepatitis C patients treated by all oral direct-acting antivirals with sustained virological response

“…Additionally, previous research has shown that CHC patients with decompensated cirrhosis have lower SVR rates with DAAs, which also impacts patient outcomes. 50,51 Given this, it may be worthwhile and cost-effective to screen and treat our CHC patients with DAAs at an earlier stage.…”

Sofosbuvir-based direct-acting antivirals for patients with decompensated hepatitis C virus–related cirrhosis

“…We read with great interest the original contribution regarding the safety and tolerability of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) for patients with decompensated hepatitis C virus (HCV)-related cirrhosis in Taiwan by Su et al 1 Although the authors performed a comprehensive literature review and patient assessment in their report, several other recent studies from Taiwan also corroborate the authors' findings about caring for patients with HCV in this special clinical setting.…”