Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotypes 1‐4 and 6 in Myanmar: Real‐world experience

Hlaing, Naomi Khaing Than; Mitrani, Robert; Aung, Si Thu; Phyo, Wah Wah; Serper, Marina; Kyaw, A. M. M.; Bwa, Aung Hlaing; Win, Khin Maung; Reddy, K. Rajender

doi:10.1111/jvh.12721

Cited by 31 publications

(51 citation statements)

References 35 publications

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“…The results herein demonstrate that LDV/SOF achieved an excellent SVR rate, as determined by ITT and PP analysis, cirrhosis status, or viral load. In the literature, the lowest SVR rate came from Myanmar and was explained by the high percentage (41%) of cirrhotic patients and distribution of subtypes of GT6 . In this study, high percentage (68%) of cirrhosis patients and similar SVR rates between cirrhosis and non‐cirrhosis patients were observed.…”

Section: Discussionsupporting

confidence: 69%

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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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Section: Discussionsupporting

confidence: 69%

“…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%

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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“…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%

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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“…A real-world experience with sofosbuvir-based DAA regimens reported rash in up to 2.6% (n 5 344) of patients: 6% with sofosbuvir, PEG-IFN, plus ribavirin; 0% with sofosbuvir plus ribavirin; and 0% with sofosbuvir and daclatasvir/ledipasvir with or without ribavirin. (7) Two other realworld studies did not report any rash related to sofosbuvir-based regimens. (8,9) Interestingly, these studies failed to provide the morphologic description of the rash associated with the DAAs.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the literature on the incidence of rash due to sofosbuvir alone is limited. A real‐world experience with sofosbuvir‐based DAA regimens reported rash in up to 2.6% (n = 344) of patients: 6% with sofosbuvir, PEG‐IFN, plus ribavirin; 0% with sofosbuvir plus ribavirin; and 0% with sofosbuvir and daclatasvir/ledipasvir with or without ribavirin . Two other real‐world studies did not report any rash related to sofosbuvir‐based regimens .…”

Section: Discussionmentioning

confidence: 99%

Sofosbuvir induced steven Johnson Syndrome in a patient with hepatitis C virus‐related cirrhosis

Verma

Sawatkar

Singh

2017

Hepatology Communications

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Sofosbuvir is an imperative drug used in treatment regimens for hepatitis C virus (HCV). It is considered relatively safe with fewer adverse effects than other treatments. Here, we report a rare and potentially serious, dermatologic, adverse effect following the use of sofosbuvir. A 35‐year‐old man with genotype 3‐related HCV cirrhosis presented with decompensated ascites and jaundice following 7 weeks of therapy with peginterferon alpha‐2a and oral ribavirin. After peginterferon withdrawal and stabilization, oral sofosbuvir and ribavirin were started; 10 days later, he developed itching over the trunk and legs, followed by multiple papules and vesicles over an erythematous base. Over the next 15 days, the rash progressed with the formation of blisters and peeling skin. Simultaneously, the oral mucosa and lips developed crusting and painful erosions. Considering drug‐induced Steven John Syndrome (SJS), sofosbuvir and ribavirin were withdrawn and the patient was treated with topical emollients, steroids, and supportive care. The lesions improved over the next 4 weeks, with some residual hyperpigmentation. Rechallenge with sofosbuvir alone at one eighth the dose resulted in similar skin and mucosal lesions after 2 months; these lesions also improved after sofosbuvir withdrawal. The Algorithm of Drug Causality for Epidermal Necrolysis score was 7, which suggested sofosbuvir as the very probable drug resulting in SJS in our patient. Conclusion: The appearance of SJS following sofosbuvir use is an important and potentially fatal complication from a drug that serves as the backbone of several HCV treatment regimens. Treating physicians must use sofosbuvir with caution and consider withholding or discontinuing this drug in patients with such severe dermatologic manifestations. (Hepatology Communications 2018;2:16–20)

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Safety and efficacy of sofosbuvir‐based direct‐acting antiviral regimens for hepatitis C virus genotypes 1‐4 and 6 in Myanmar: Real‐world experience

Abstract: DAA therapy ±PEG-IFN achieved high SVR rates. Genotype 6 patients had a low SVR to 12 weeks of LDV and SOF raising the need for other regimens, RBV or longer treatment duration in this population.

Cited by 31 publications

References 35 publications

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

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

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

Sofosbuvir induced steven Johnson Syndrome in a patient with hepatitis C virus‐related cirrhosis

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