Open Label Study of 8 vs. 12 Weeks of Ledipasvir/Sofosbuvir in Genotype 6 Treatment Naïve or Experienced Patients

Nguyen, Mindie H.; Trinh, Huy N.; Do, Son; Nguyen, Thuan T.; Nguyen, Pauline; Henry, Linda

doi:10.1038/ajg.2017.399

Cited by 20 publications

(29 citation statements)

References 25 publications

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“…The recommendations for HCV GT6 without cirrhosis were SOF plus LDV, SOF plus VEL, SOF plus DCV in accordance with the Asian Pacific Association for the Study of the Liver (APASL) guidelines, and SOF plus LDV, SOF plus VEL, GLE/PIB according to the 2018 EASL and American Association for the Study of Liver Diseases (AASLD) guidelines . A 12‐week regimen of SOF plus LDV without ribavirin given to patients with HCV GT6 yielded an SVR12 rate of 95%‐96% . In another phase 3 clinical trial, the SVR12 rate was 100% (41/41) for HCV GT6 patients after 12 weeks of SOF plus VEL treatment, which is in agreement with our results.…”

Section: Discussionmentioning

confidence: 99%

“…The most likely routes of HCV transmission are intravenous drug use, iatrogenic exposure from conventional medical care or traditional remedies such as acupuncture, cupping, tattooing and piercings . Clinical evidence supporting the use of DAAs for GT 6 HCV therapy has increased, and the rates of SVR rates are high . The European Association for the Study of the Liver (EASL) recommendations for the treatment of HCV GT6 are currently sofosbuvir (SOF) plus ledipasvir, SOF plus velpatasvir (VEL) and SOF plus daclatasvir (DCV) .…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real‐world experience of a retrospective study

Jiang

Wang

et al. 2018

Journal of Viral Hepatitis

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Summary Optional treatments for patients with chronic hepatitis C virus (HCV) genotype (GT) 6 infection have not been extensively studied. This study aimed to evaluate the safety and efficacy of sofosbuvir (SOF)‐based direct‐acting antiviral agents (DAAs) for HCV GT6. We performed a retrospective study at the West China Hospital of Sichuan University in Southwest China from January 2016 to May 2017. Our study screened 130 treatment‐naïve patients with chronic HCV GT6 and without liver cirrhosis. A total of 60 HCV GT6 patients were ultimately enrolled. All patients received SOF‐based DAAs therapy, including SOF 400 mg plus daclatasvir (DCV) 60 mg daily or SOF 400 mg plus velpatasvir (VEL) 100 mg daily for 12 weeks. The sustained virological response 12 weeks after treatment (SVR12) was 100% (60/60) in treatment‐naïve patients with HCV GT6, including 100% (37/37) of patients receiving SOF plus DCV therapy and 100% (23/23) of patients receiving SOF plus VEL therapy. Measurements of liver stiffness were significantly decreased in patients at week 12 (P = 0.014) and week 24 (P < 0.001) of DAAs treatment compared to baseline values. The serum biomarker aspartate aminotransferase‐to‐platelet ratio index (APRI) and fibrosis‐4 score were also significantly reduced at week 12 and week 24 compared to before treatment (both P < 0.001). SOF‐based therapy was well‐tolerated, and no serious adverse events were reported. In conclusion, SOF plus DCV and SOF plus VEL were safe and achieved a high SVR12 rate for treatment‐naïve patients with HCV GT6 without liver cirrhosis.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real‐world experience of a retrospective study

Jiang

Wang

et al. 2018

Journal of Viral Hepatitis

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“…These findings have been corroborated in several large real-world observational and registry studies ranging from 600 to 14,000 patients 32–40. The efficacy of LDV/SOF for treating adults with CHC from other genotypes has also been supported by multiple Phase II trials,41–47 a Japanese Phase III trial, and real-world data from a French cohort 31…”

Section: Ldv/sof Use In Adultsmentioning

confidence: 64%

Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

Yang

Goel

Ahmed

2018

AHMT

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Chronic infection with hepatitis C virus (HCV) affects an estimated 0.1%–2% of the pediatric population in the United States. While the clinical course in young children is indolent, adolescents who contract HCV have a disease course similar to adults, with a 26-fold increased risk of chronic liver disease-associated mortality, hepatocellular carcinoma, and need for curative liver transplantation. Furthermore, adolescent patients are entering childbearing age and carry a risk of passing HCV to their offspring via vertical transmission. Pegylated-interferon (PEG-IFN) with ribavirin was previously the only treatment option for pediatric patients with chronic hepatitis C (CHC), but the high likelihood of adverse reactions and subcutaneous route of administration limited its use and efficacy. Recently, the direct-acting antivirals (DAAs) ledipasvir (LDV) and sofosbuvir (SOF) were approved for adolescents with CHC. This review discusses the natural history of CHC in pediatric patients, data supporting LDV/SOF in adolescents, and ongoing studies evaluating DAAs in pediatric patients.

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“…Most involved fewer than 50 patients. They also presented a wide variation of treatment results, and the SVR rates ranged from 64.1% to 100% . In contrast, this study enrolled patients with a single HCV GT and the most GT6 CHC patients of any study in the literature; it was also conducted in a real‐world setting.…”

Section: Discussionmentioning

confidence: 99%

“…They also presented a wide variation of treatment results, and the SVR rates ranged from 64.1% to 100%. [19][20][21][22][23][24][25] In contrast, this study enrolled patients with a single HCV GT and the most GT6 CHC patients of any study in the literature; it was also conducted in a real-world setting. Therefore, the analysis of the realworld effectiveness and safety of DAA treatment for GT6 CHC in this study provides an important and useful reference not only for Taiwan but also for Southeast Asia.…”

Section: Discussionmentioning

confidence: 99%

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

Chen

Lee

Chiu

et al. 2019

J of Gastro and Hepatol

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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.

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Open Label Study of 8 vs. 12 Weeks of Ledipasvir/Sofosbuvir in Genotype 6 Treatment Naïve or Experienced Patients

Abstract: LDV/SOF FDC for 8 or 12 weeks was safe and effective for patients without cirrhosis or prior treatment failure as well as for patients with cirrhosis and/or prior treatment failure, respectively.

Cited by 20 publications

References 25 publications

Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real‐world experience of a retrospective study

Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real‐world experience of a retrospective study

Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

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

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