Real‐world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan

Abstract

Background and Aim Infection with hepatitis C virus (HCV) genotype (GT) 6 is uncommon in Taiwan, and reports of ledipasvir/sofosbuvir (LDV/SOF) treatment for GT6 are few. This study evaluates the effectiveness and safety of LDV/SOF in treating chronic hepatitis C (CHC) patients with GT6 infection. Methods CHC patients that were infected with GT6 and treated for 12 weeks with LDV/SOF at two hospitals were enrolled. All patients were followed for an additional 12 weeks after the completion of LDV/SOF treatment. Demographics, HCV viral load, lipid and sugar profiles, and adverse events were recorded and reviewed. Results A total of 127 patients were enrolled. Cirrhosis was found in 68.2% of them. Sustained virological response (SVR), determined by per‐protocol analysis, was 97.6%. The SVR rates for cirrhosis versus non‐cirrhosis (96.5% vs 100%, P = 0.229) and low versus high viral load (cutoff value: 106 IU/mL; 100% vs 95.6%, P = 0.108) were similar. Following HCV clearance, significantly lower glycosylated hemoglobin was present both in patients with or without diabetes mellitus. Twenty‐three (18.1%) patients exhibited adverse events, and each adverse event presented with an incidence of 0.8% to 3.1%. Neuropsychiatric symptoms were the most common. During treatment, 18 patients (14.2%) had alanine aminotransferase elevations consistent with more than grade 1 abnormalities, and none had signs of decompensation. Renal function remained unchanged. Conclusion The high SVR and excellent safety of LDV/SOF treatment for GT6 CHC patients suggest that LDV/SOF is a favorable option for treating GT6 CHC patients in Taiwan and Asia.

Factors associated with treatment failure of direct‐acting antivirals for chronic hepatitis C: A real‐world nationwide hepatitis C virus registry programme in Taiwan

“…Apart from other study cohorts, the current study population possessed several unique characteristics; more than one‐third of the patients had liver cirrhosis, and the cohort represented the largest sample size with HBV dual infection. Until now, reports regarding DAA treatment in CHC patients were performed only in single centres or with limited patient numbers in Taiwan, 8‐16 which precluded the identification of reasons for failing to achieve SVR. By adopting the nationwide, multicentre database, we identified certain factors associated with virological failure in Taiwanese patients, including poor DAA adherence; possessing high baseline viral loads, active HCC and hepatic decompensation; and the use of DCV/ASV and SOF/RBV.…”

“…Apart from other study cohorts, the current study population possessed several unique characteristics; more than one-third of the patients had liver cirrhosis, and the cohort represented the largest sample size with HBV dual infection. Until now, reports regarding DAA treatment in CHC patients were performed only in single centres or with limited patient numbers in Taiwan, [8][9][10][11][12][13][14][15][16] West with the use of more potent DAAs. 39,40 The issue regarding the treatment efficacy of DAAs in HCC patients has been extensively explored.…”

“…4,6 The Taiwan National Health Insurance (NHI) programme started to reimburse DAAs in 2017, and more than 75 000 CHC patients received DAAs until the end of 2019. 7 Although several real-world data regarding DAA treatment have been reported in Taiwan, [8][9][10][11][12][13][14][15][16] all were on a single-centre or small-scale basis, which failed to address potential causes of virological failure due to limited sample size. Nationwide data depicting the treatment efficacy and tolerability of CHC patients receiving DAA in Taiwan are still lacking, especially data from special populations.…”

Geographic Variation of Indigenous Hepatitis C Virus Subtypes 6g and 6w in an Endemic Area of Southern Taiwan

“…14 The e cacy of pan-genotypic DDAs might be suboptimal for these local endemic subtypes as clinical trials covered mainly the global epidemic genotypes/subtypes. [14][15][16][17] Moreover, the geographic differences in distribution of HCV genotypes and subtypes could re ect the epidemiological history of the virus, 18 understanding these local endemic subtypes could help to improve public health strategies to prevent further transmission and spreading.…”

Hepatitis C Virus Subtypes Novel 6g-Related Subtype and 6w Could Be Indigenous in Southern Taiwan with Characteristic Geographic Distribution

“…Even in the era of interferon-free, pan-genotypic direct acting antivirals (DAAs), some rare subtypes might harbor intrinsic resistance to DAAs [ 1 ]. The efficacy of pan-genotypic DDAs might be suboptimal for these local endemic subtypes, as clinical trials covered mainly the global epidemic genotypes/subtypes only [ 1 , 2 , 3 , 4 ]. Moreover, the geographic differences in distribution of HCV genotypes and subtypes could reflect the epidemiological history of the virus [ 5 ].…”