scholarly journals Efficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis C

2019 ◽  
Vol 91 (8) ◽  
pp. 67-74
Author(s):  
E A Klimova ◽  
E Z Burnevich ◽  
V P Chulanov ◽  
D A Gusev ◽  
O O Znoyko ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Efficacy And Safety ◽  
Hcv Genotype ◽  
Genotype 1B ◽  
Safety Population ◽  
Viral Hepatitis C ◽  
Treatment Naïve ◽  
The Mean ◽  
Almost All ◽  
Direct Acting

Aim. Evaluate efficacy and safety of a combination of direct - acting antivirals narlaprevir/ritonavir with daclatasvir in patients with viral hepatitis C. Materials and methods. The study enrolled adult patients with HCV genotype 1b infection without demonstrated NS5A resistance - associated substitutions Y93C/H/N/S and/or L31F/M/V/I. Patients were treated with narlaprevir 200 mg QD, ritonavir 100 mg QD and daclatasvir 60 mg QD. Treatment duration was 12 weeks. Proportion of patients achieving sustained virological response 12 weeks after treatment (SVR12) was the primary efficacy endpoint. Results and discussion. In total, 105 (75.0%) patients were treatment with the study combination. Patients’ age varied from 21 to 69 years, the mean age being 43.2±10.9 years. There were slightly more women (55.2%), and 69 patients (65.7%) had comorbidities. SVR 12 was 89.5% (95% CI 82.0-94.7%). In 10 of 11 patients with treatment failures NS5A resistance - associated substitutions in residues 31 and/or 93 were found, as well as less clinically relevant substitutions L28M, P58S, R30Q, Q62K. Adverse events (AEs) were found in less than one half of patients (45 patients, or 42.9% in the safety population). Almost all recorded AEs were mild to moderate. Conclusion. Efficacy of treatment with a combination of narlaprevir/ritonavir and daclatasvir in treatment - naïve patients with HCV genotype 1b was close to 90%. This combination was found to be safe and well - tolerated.

scholarly journals Treatment of hepatitis C virus infection with direct-acting antiviral agent-based regimens in Iranian patients with hereditary bleeding disorders

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Heidar Sharafi ◽  
Bita Behnava ◽  
Alireza Azizi-saraji ◽  
Ali Namvar ◽  
Ali Anvar ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Antiviral Agent ◽  
Previous Treatment ◽  
Virologic Response ◽  
Bleeding Disorders ◽  
Hcv Genotype ◽  
Direct Acting Antiviral ◽  
Treatment Naïve ◽  
Hcv Genotype 1 ◽  
Direct Acting

Abstract Background Chronic hepatitis C (CHC) is one of the most important comorbidities in patients with hereditary bleeding disorders (HBD). The present study aimed at evaluating the effectiveness of direct-acting antiviral agent (DAA)-based interferon-free HCV antiviral regimens in patients with HBD. Patients and methods The present study was performed on the patients with HBD and CHC between 2015 and 2019. Sofosbuvir-based interferon-free regimens with or without ribavirin were prescribed to treat HCV infection. The main endpoint of the study was to determine the sustained virologic response (SVR), assessed 12 weeks after the completion of treatment. Results A total of 147 patients with a mean age of 41.1 years were enrolled in the study; 4.1% of them were co-infected with HIV, 25.2% had cirrhosis, and 76.9% of them were diagnosed with hemophilia A. HCV genotype-1 includes the largest number (68.1%) of patients. 46.3% of patients were treatment-naïve and others had a treatment history with interferon-based regimens. Out of 147 patients, 15 patients were lost to follow-up during treatment or for SVR evaluation or discontinued treatment. 132 subjects completed treatment and were evaluated for SVR, 12 weeks after the completion of treatment. All of the patients achieved SVR 12 (SVR rate: 100%, 95% CI 97.2–100%). Conclusion Hepatitis C DAA-based regimens are the effective treatments for CHC in patients with HBD, regardless of the treatment modifiers such as previous treatment experience, cirrhosis, HIV co-infection, and HCV genotype.

scholarly journals A Hepatitis C Virus-Associated Cirrhotic Patient Developing Interstitial Pneumonia during the Course of Antiviral Therapy with Ombitasvir/Paritaprevir/Ritonavir

2017 ◽  
Vol 11 (2) ◽  
pp. 369-376 ◽  
Author(s):  
Kazuo Tarao ◽  
Kouzo Yamada
Keyword(s):  
Computed Tomography ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Interstitial Pneumonia ◽  
Total Duration ◽  
Drug Discontinuation ◽  
Chest Computed Tomography ◽  
Hcv Genotype ◽  
Genotype 1B ◽  
Direct Acting

Oral direct-acting antivirals (DAAs) are the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the first agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. More recently, ombitasvir/paritaprevir/ritonavir is also recommended as a potent therapy for HCV genotype 1b. Among the adverse events associated with these oral DAAs, interstitial pneumonia is one of the most severe ones. Regarding treatment with daclatasvir plus asunaprevir or sofosbuvir plus ledipasvir, a few cases have already been reported in a postmarketing surveillance. Recently, we have encountered a HCV-associated genotype 1b cirrhosis patient who developed interstitial pneumonia during treatment with ombitasvir/paritaprevir/ritonavir and who recovered after drug discontinuation without corticosteroid therapy. Interstitial pneumonia was confirmed by chest x-ray and chest computed tomography. The serum KL-6 level was elevated to 1,180 U/mL. The total duration of the drug administration was 7 weeks, and she achieved SVR24. This is the first detailed report in the literature on the development of interstitial pneumonia during treatment with ombitasvir/paritaprevir/ritonavir. When dry cough appeared in the treatment with DAAs, chest computed tomography and the evaluation of serum KL-6 level were recommended.

scholarly journals Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Yinan Yao ◽  
Ming Yue ◽  
Jie Wang ◽  
Hongbo Chen ◽  
Mei Liu ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Efficacy And Safety ◽  
Genotype 1 ◽  
Hcv Genotype ◽  
Link Type ◽  
End Of Treatment ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Hcv Genotype 1

Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with or without RBV for 12 or 18 weeks. The sustained virological response (SVR) 12 weeks after end of treatment was calculated for overall and subgroups. Results. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93–96) patients achieved SVR12, 95% (95% CI: 92–96) for treatment-naive and 96% (95% CI: 92–98) for previously treated patients, respectively. Treatment duration and treatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%–29%), headache (20%), nausea (8%–14%), and asthenia (4%–12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving grazoprevir plus elbasvir plus RBV had treatment-related serious AEs. Conclusions. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.

scholarly journals Efficacy and safety of sofosbuvir plus ribavirin in treatment-naive chronic hepatitis c genotype 3 patients of South Punjab, Pakistan

2020 ◽  
Vol 8 (12) ◽  
pp. 4242
Author(s):  
Qazi Masroor Ali ◽  
Syed Hashim Raza ◽  
Ali Imran ◽  
Saba Anjum ◽  
Maria Masroor
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Hcv Rna ◽  
Efficacy And Safety ◽  
Genotype 3 ◽  
Hcv Genotype ◽  
End Of Treatment ◽  
Treatment Naïve ◽  
Hcv Genotype 3 ◽  
Chronic Hcv

Background: To evaluate the efficacy and safety of sofosbuvir (SOF) plus ribavirin (RIB) in naive patients with chronic HCV genotype 3. The study design was open label, quasi experimental study. The study was conducted at Medical Outpatient Department of Medical Unit-1, Bahawal Victoria Hospital, affiliated with Quaid e Azam Medical College (QAMC), Bahawalpur, from April 2016 to June 2019.Methods: A total of 627 treatment-naive patients, aged above 18 years, with chronic Hepatitis C virus (HCV) genotype 3 infection were enrolled. SOF as 400 mg once a day plus weight-based RIB (1000 mg/day <75 kg and 1200 mg/day >75 kg) was given to all the study participants for 24 weeks. Qualitative polymerase chain reaction (PCR) for HCV ribonucleic acid (RNA) were done at 4 weeks to note the rapid virological response (RVR) whereas end of treatment response (ETR) was recorded at 24 weeks and sustained virological response (SVR) was noted 3 months after completion of treatment.Results: By 4th week, PCR of 524 (83.6%) patients was available, out of which, 492 (93.9%) had undetectable HCV RNA. By the end of treatment (24 weeks), PCR of 401 (64.0%) patients was available, out of which, 393 (98.0%) had undetectable HCV RNA. Data of 291 (46.4%) patients was available for SVR, 274 (94.1%) had undetectable HCV RNA. Weakness and fatigue turned out to be the commonest side effects, observed in 236 (37.6%) patients.Conclusions: Sofosbuvir was found to have good efficacy and safety in the local population of South Punjab having treatment-naïve chronic HCV genotype 3 infection.

scholarly journals Changes in hepatic fibrosis and vitamin D levels after viral hepatitis C eradication using direct-acting antiviral therapy

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Supachaya Sriphoosanaphan ◽  
Kessarin Thanapirom ◽  
Sirinporn Suksawatamnuay ◽  
Panarat Thaimai ◽  
Sukanya Sittisomwong ◽  
...  
Keyword(s):  
Vitamin D ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Hepatic Fibrosis ◽  
Liver Stiffness ◽  
Clinical Trial Registry ◽  
Viral Hepatitis C ◽  
Vitamin D Levels ◽  
The Mean ◽  
Direct Acting

Abstract Background Vitamin D (VD) is important in hepatic fibrogenesis in animal models and human studies. VD deficiency is associated with liver fibrosis progression. Metabolic dysfunction of the liver, as an intermediate organ for VD metabolism, contributes partly to this deficiency. We hypothesized that improving hepatic fibrosis and inflammation in chronic hepatitis C (CHC) patients after eradication with direct-acting antivirals (DAA) would increase 25-hydroxyVD [25(OH)VD] levels. Methods Eighty CHC patients (17 chronic hepatitis, and 63 cirrhosis) were enrolled. Baseline characteristics, hepatitis C viral load (VL), genotypes, liver enzymes and liver stiffness measurements (LSM) were assessed at baseline. Blood samples for 25(OH)VD and the procollagen type III N-terminal peptide (P3NP) were collected at baseline, 24 and 48 weeks. LSMs were re-evaluated at 48 weeks. Serum 25(OH)VD levels < 30 ng/mL were defined as VD insufficiency/deficiency. Paired t-tests were used for statistical analyses. Results Among 80 patients, the mean age was 57.7 ± 10.5 years, and 52.5% were men. The mean VL was 6.1 ± 0.7 logIU/mL with genotype 1 predominance (55%). All patients achieved sustained virological response. The alanine aminotransferase levels decreased from 79.9 ± 53.3 U/L at baseline to 25.7 ± 17.2 and 22.3 ± 11.0 U/L at 24 and 48 weeks, respectively (p < 0.001). The mean LSM decreased from 19.2 ± 15.3 to 11.7 ± 8.0 kPa at 48 weeks (p < 0.001). The P3NP levels decreased from 43.6 ± 22.0 ng/mL before treatment to 35.7 ± 21.1 and 29.4 ± 15.0 ng/mL at 24 and 48 weeks, respectively (p < 0.001). The proportions of VD insufficiency/deficiency were 72.5%, 91.3%, and 86.5% at baseline, 24 and 48 weeks, respectively. The 25(OH)VD levels decreased from 26.3 ± 10.7 ng/mL at baseline to 20.8 ± 8.1 and 20.8 ± 8.5 ng/mL at 24 and 48 weeks, respectively (p < 0.001). Conclusions Curative treatment with DAA attenuated the liver stiffness and inflammation but did not improve VD levels. Over 80% of patients remained VD insufficient/deficient. Whether VD replacement during and after DAA therapy can improve hepatic fibrosis remains unclear. Trial registration The Thai Clinical Trial Registry as TCTR20161025001 (31 October 2016). http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2136.

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