EFFICACY OF SOFOSBUVIR AND DACLATASVIR IN COMPENSATED CHRONIC HEPATITIS C INFECTION: A SINGLE CENTER, OPEN-LABEL AND PROOF OF CONCEPT STUDY

2021 ◽  
pp. 27-30
Author(s):  
Manisha Thakur ◽  
Anurag Chauhan ◽  
Prashant Jambunathan ◽  
Shikha Awasthi ◽  
Thilagavathi K ◽  
...  

AIMS AND OBJECTIVES: The advent of directly acting agents for the treatment of Hepatitis C infection has forever transformed our understanding and management of viral infections. With over 95 % patients achieving a sustained viral response at 12 weeks with some of these newly inducted agents, the prospect of eradicating the Hepatitis C virus seems like an achievable target, which makes this one of the most important discoveries in modern medicine. We studied the combination of Sofosbuvir and Daclatasvir in patients with chronic hepatitis C infection (Genotype 3) to assess the rates of sustained virological response at 12 weeks. We studied 67 treatment naive METHODS: patients with compensated chronic hepatitis C infection (genotype 3). They were all started on Tab Sofosbuvir 400 mg daily and Tab Daclatasvir 60 mg once daily for 12 weeks and followed up for a total of 24 weeks, which includes a treatment duration and observation period of 12 weeks each. The patients were monitored with HCV RNA levels at one, three and six months, with as many evaluations of liver function and routine hemogram. Our results show that 70.5% (p<0.05) achieved a rapid vi RESULTS: rological response, 88.5% (p<0.05) achieved an end of treatment response and, similarly, an impressive 88.05% (p<0.05) showed a sustained virological response at the end of 12 weeks. One patient who developed a psoriasiform rash discontinued the medication and was excluded from the analysis, as duration of treatment had not been completed. No major dose related adverse events were reported. Sofosbuvir and Daclatasvir is an acceptable, well tolerated regimen for treatment naive, CONCLUSIONS: compensated patients with genotype 3 infection. Based on our observations and data, we recommend this as the rst line DAA for patient with compensated genotype 3 infection until medications with higher SVR 12 are available in the Indian market.

Author(s):  
Shabir Shiekh ◽  
Shafat Lone ◽  
Zafar Wani ◽  
Zafar Kawoosa ◽  
Showkat A. Kadla

Abstracts Objectives: Direct acting antivirals (DAAs) have dramatically changed our approach towards management of chronic hepatitis C by yielding a high sustained virological response (SVR). Genotype-3 is the most common genotype found in Kashmir (Northern India) besides having an aggressive nature with increased risk of steatosis and hepatocellular carcinoma. We assessed the efficacy and safety of sofosbuvir plus valpatasvir based therapy in chronic hepatitis C genotype-3 infection in Kashmiri population. Aims and objectives: An observational, prospective, open label, hospital based study was carried over a period of two years which included 230 treatment naïve chronic hepatitis-C genotype-3 patients. Patients were divided in two groups. Group-A: Non-cirrhotics who received sofosbuvir (400 mg daily) with valpatasvir (100 mg) in fixed–dose combination for 12 weeks. Group B included CPT class A cirrhotics who received sofosbuvir (400mg daily) with valpatasvir (100 mg daily) and weight based ribavarin for 12 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. Results and observations: We observed 98.57 % (138/140) SVR 12 in non-cirrhotics who received valpatasvir plus sofosbuvir treatment regimen. Cirrhotics who received Sofosbuvir plus valpatasvir with ribavirin observed SVR of 96.6 % (87/90). All patients tolerated the drug regimens well without any serious adverse effect. Conclusion: Once daily oral Sofosbuvir plus valpatasvir based fixed dose rerimen is highly efficient and safe in treatment of both cirrhotics and non-cirrhotic hepatitis C patients. Keywords: Direct acting antivirals; sustained virological response; Genotype; chronic hepatitis C


2019 ◽  
Vol 70 (11) ◽  
pp. 3964-3966
Author(s):  
Ioan Sergiu Micu ◽  
Marilena Musat ◽  
Yousef Al Hamidi ◽  
Andrada Dumitru ◽  
Anca Rogoveanu ◽  
...  

Chronic viral infections affecting the liver represents a global burden for medical comunities. More than 170 million individuals are infected chronically with hepatitis C virus (HCV), this accounting about 2�3% of the world�s population. Despite numerous progresses aquired in viral pahogenesis and treatment, chronic hepatitis C management is influenced by a multitude of factors. Interleukin IL-28 beta subunit (IL28B) demonstrated to be involved in both sustained virological response (SVR) to treatment, but even with spontaneous viral clearance without any therapy. In the era of direct antiviral agents (DAAs) we aimed to find out what was the real influence of IL28B phenotypes over the response to Peg-IFN and Ribavirin treatment in patients with chronic hepatitis C, many of theses being non-responders or relapsers, and as consequence, to optimize the referal of patients to more expensive and efficient treatments. In a retrospectively manner, we analyzed the IL28B phenotype and its influence over the rapid viral response (RVR), early viral response (EVR) and sustained viral response (SVR), in 250 patients HCV treated patients. We made correlations between the treatment response rates and the IL28B polymorphism.TT phenotype was correlated negatively with all parameters studied, while CC phenotype was correlated with the best response rates. We concluded that IL28B phenotypes interfere with the EVR and SVR rates, IL28B phenotype being an independent prognostic factor for antiviral treatment response in our patient groups, and according to this characteristics, we created the premise to optimize the patients referal to expensive therapies as DAAs.


Author(s):  
Mushtaq Laway ◽  
Shabir Shiekh ◽  
Shafat Sideeq ◽  
Zafar Wani ◽  
Peerzada Mohd Shafi

Introduction: Hepatitis C virus (HCV) infection represents a major healthcare challenge in both industrialized and developing countries. The standard treatment for hepatitis C virus (HCV) infection has been interferon-based over many years with less than satisfactory cure rate and many side-effects. Directly acting antivirals (DAAs) have promise for a treatment regimen free of interferons with much better cure rate and minimal side-effects. Aims and Objectives: To evaluate efficacy and safety of an oral interferon-free regimen, sofosbuvir plus ribavirin in the treatment in genotype 3 chronic hepatitis C patients. Materials and Methods: 200 treatment naïve chronic hepatitis C genotype 3 patients of either sex with age more than 18 years were enrolled in the study. Sofosbuvir 400 mg once daily plus Ribavarin weight-based was given to all the patients. Duration of treatment was 24 weeks and 12 weeks to cirrhotics and non-cirrhotics respectively. Data analysis was performed using the IBM SPSS version 22. Results and Observations: In this prospective study the total number of patients was two hundred (n=200). The mean age (in years) of patients was 44.2 ± 14.7. The number of male patients was 112 (56 %) and 88   (44 %) were females. The number of cirrhotic patients was 70 while 130 were non-cirrhotic. On comparison on the basis of sustained virological response at twelve weeks of the completion of treatment (SVR12) we observed that treatment naïve cirrhotic patients had  SVR 12 of  92.8 %  while in the non cirrhotic patients SVR 12= was 96.9 % . Adverse effects were insignificant and none of the patients dropped out because of side effects. Conclusion: The sofosbuvir and ribavirin based therapy showed very good rates of sustained virological response in chronic hepatitis C genotype 3 patients irrespective of the state of fibrosis. In addition it was found to be cost effective, safe and very well-tolerated. Keywords: Hepatitis C; Genotype 3; directly acting antivirals, Sofosbuvir, Sutained virologic response (SVR).


2009 ◽  
Vol 2009 ◽  
pp. 1-5
Author(s):  
Ioannis S. Elefsiniotis ◽  
Christos Pavlidis ◽  
Elena Vezali ◽  
Theodoros Mariolis-Sapsakos ◽  
Sotirios Koutsounas ◽  
...  

Aim. To evaluate the impact of hepatitis B core antibody (anti-HBc) seropositivity in sustained virological response (SVR) rates in treatment-naïve, chronic hepatitis C (CHC) patients with high pretreatment viral load (>800000 IU/mL).Methods. 185 consecutive CHC patients (14.4% cirrhotics, 70.2% prior intravenous drug users) treated with pegylated interferon-a2b plus ribavirin, for 24 or 48 weeks based on viral genotype, were retrospectively analyzed. SVR was confirmed by undetectable serum HCV-RNA six months after the end of treatment schedule.Results. Thirty percent of CHC/HBsAg-negative patients were anti-HBc-positive. Anti-HBc positivity was more prevalent in cirrhotic, compared to noncirrhotic patients (76.9% versus 19.5%,P<.05). Serum HBV-DNA was detected in the minority of anti-HBc-positive patients (1.97%). Overall, 62.1% of patients exhibited SVR, while 28.6% did not; 71.4% of non-SVRs were infected with genotype 1. In the univariate analysis, the anti-HBc positivity was negatively associated with treatment outcome (P=.065). In the multivariate model, only the advanced stage of liver disease (P=.015) and genotype-1 HCV infection (P=.003), but not anti-HBc-status (P=.726), proved to be independent predictors of non-SVR.Conclusion. Serum anti-HBc positivity does not affect the SVR rates in treatment-naïve CHC patients with high pretreatment viral load, receiving the currently approved combination treatment.


Kanzo ◽  
2006 ◽  
Vol 47 (12) ◽  
pp. 550-557 ◽  
Author(s):  
Haruo Nakayama ◽  
Toshiaki Ojima ◽  
Masao Kusano ◽  
Kazunori Endo ◽  
Masaharu Takahashi ◽  
...  

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