scholarly journals Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study

2020 ◽  
Vol 29 (3) ◽  
pp. 385-390
Author(s):  
Liliana Simona Gheorghe ◽  
Carmen Preda ◽  
Laura Iliescu ◽  
Doina Istratescu ◽  
Andreea Elena Chifulescu ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Hepatitis C ◽  
Real Life ◽  
Decompensated Cirrhosis ◽  
Hcv Rna ◽  
Efficacy And Safety ◽  
Decompensated Liver Cirrhosis ◽  
Serious Adverse Events ◽  
Genotype 1B ◽  
Ctp Score

Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) with or without Ribavirin (RBV) has shown good results in terms of efficacy and safety in clinical trials in advanced liver cirrhosis, but real-life data are still needed in order to confirm this profile. We investigated the efficacy and safety of LDV/SOF in a large Romanian population with liver cirrhosis and genotype 1b hepatitis C virus (HCV). Methods: We analyzed a multicentric retrospective cohort enrolling 349 patients with decompensated liver cirrhosis due to HCV who received LDV/SOF±RBV 12/24 weeks (301/48). Patients were included between 2017-2018, all with genotype 1b. Main inclusion criteria were liver cirrhosis and detectable HCV RNA. The cases were followed-up monthly during therapy and 12 weeks after the end of therapy. Results: The cohort included 60% females with a median age of 61, 16% interferon (IFN) pre-treated, 53% with comorbidities, 40/53/7 % with Child Pugh A/B/C, 4% with virus B co-infection and 8% with previously treated hepatocellular carcinoma. Mean initial MELD score was 11.92 (6.82÷ 24.5). Six patients were lost during follow-up. Sustained virologic response (SVR) in intention-to-treat was reported in 85.1%. Predictive factors of SVR in decompensated cirrhosis were female gender (p=0.01), advanced age (p<0.001), lower bilirubin levels (p=0.002) and lower CTP score (p=0.02). In patients with CTP score B or C low bilirubin levels (p=0.003), low INR (p<0.001), increased platelet count (p=0.04), low CTP score (p<0.001), lack of encephalopathy (p=0.02), serum albumin >3.5g/dl (p=0.002) predicted improvement of liver function. Serious adverse events were reported in 16/349 (4.6%), most of them due to severe liver decompensation (9/16). Conclusions: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR.

scholarly journals Efficacy and safety of 12-week sofosbuvir/velpatasvir treatment of patients with decompensated liver cirrhosis caused by hepatitis C virus infection

Kanzo ◽  
2020 ◽  
Vol 61 (5) ◽  
pp. 276-278
Author(s):  
Yoshinari Takaoka ◽  
Kouichi Miura ◽  
Naoki Morimoto ◽  
Satoru Kakizaki ◽  
Tadashi Ikegami ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Virus Infection ◽  
Efficacy And Safety ◽  
Hepatitis C Virus Infection ◽  
Decompensated Liver Cirrhosis

scholarly journals Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older

2019 ◽  
Vol 5 ◽  
pp. 233372141881739 ◽  
Author(s):  
Steven Flamm ◽  
Cheng-Yuan Peng ◽  
Oren Shibolet ◽  
Ronald Nahass ◽  
Peggy Hwang ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Events ◽  
Virologic Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Efficacy And Safety ◽  
Limit Of Quantification ◽  
Serious Adverse Events ◽  
Infected People

Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. Methods: This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Results: Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. Conclusion: The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years.

scholarly journals Evaluation Transplantation of Bone-Derived Mesenchymal Stem Cell in the Patients with Hepatitis C-Related Liver Cirrhosis (Pi lot Study)

2021 ◽  
Vol 11 (2) ◽  
pp. 132-145
Author(s):  
S. P. Lukashyk ◽  
O. V. Aleinikova ◽  
V. M. Tsyrkunov ◽  
I. A. Karpov ◽  
Y. I. Isaykina ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Liver Cirrhosis ◽  
Stem Cell ◽  
Clinical Practice ◽  
Hepatitis C ◽  
Hcv Rna ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Open Label ◽  
Vital Functions

Introduction. Liver cirrhosis (LC) is the final stage in the progression of chronic diffuse diseases. As common, late stages of LC do not respond to conservative treatment methods, so liver transplantation is the most effective method at this stage. Widespread use of transplantation in clinical practice is due to serious obstacles: a shortage of donor organs, transplant rejection, complications during the operation and the postoperative period, as well as the high cost of such an intervention. We consider bone marrow stem cell transplantation as a potential treatment for liver cirrhosis and additional clinical trials for efficacy and safety.The aim of the study was to assess the efficacy and safety of intraparenchymal transplantation of autologous MSCs from the bone marrow for the treatment of patients with cirrhosis of the liver caused by the hepatitis C virus (HCV-LC).Materials and methods. A pilot open-label non-randomized prospective study with the inclusion of 6 patients with HCV-LP. Autologous MSCs were transplanted intraparenchymally into the liver tissue at the rate of 1x106/kg body weight — 1 ml at 5 points.Results. By 6 months after transplantation, there has been a decrease in the level of bilirubin (from 36,4 μmol/L to 27 μmol/L, p=0.03), MELD scores (from 11,5 to 8, p=0.035), and an increase in platelet levels by 3 months (from 83x109 / l to 124,6x109/l, p=0,031) and 6 months (up to 119,5x109/l, p=0,031). By 6 months after transplantation, there has been no statistically significant result in changing on points on the Child-Pugh scale (p=0,181), cytolysis indicators (maintaining elevated levels of ALT (p=0,062) and AST (p=0,844)), replicative activity of the virus (рreservation of HCV RNA in the blood) (p=0,219 ). Moreover, introduction of MSCs by 6 months after transplantation did not lead to resolution of liver cirrhosis and inflammatory infiltration according to light microscopy data, as well as to resolution of sinusoidal capillarization (p=0,586) and PCI transdifferentiation into myofibroblasts (p>0,99) according to immunohistochemical studies. None of the procedures after the transplantation had an increase in body temperature, an increase in laboratory parameters, or changes in vital functions. One patient was admitted to hospital after 6 months. after MSC transplantation, deep vein thrombosis of the right leg was diagnosed.Conclusion. The positive effect of MSCs on the improvement of liver function was noted. There was no effect on the replicative activity of the virus. The continuing activity of the inflammatory process was observed. The used MSC transplantation technique is a safe procedure for patients with HCV-LC severity classes A and B and can be applied in clinical practice.

Platelet Count Improvement after Chronic Hepatitis C Treatment among Cirrhotic Patients Who Achieved Sustained Virological Response: Realworld Results from 2186 Patients in Egypt

2020 ◽  
Vol 20 ◽  
Author(s):  
Rehab Badawi ◽  
Shaimaa Soliman ◽  
Lobna Aboali ◽  
Mahmoud Elkadeem ◽  
Asem Elfert ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Chronic Hepatitis ◽  
Platelet Count ◽  
Hepatitis C ◽  
Sustained Virological Response ◽  
Virological Response ◽  
Hcv Rna ◽  
End Of Treatment ◽  
Pugh Class ◽  
Direct Acting

Background & Aims: This study aimed to assess the changes in platelet counts of patients with liver cirrhosis due to chronic HCV, who achieved sustained virological response (SVR) after taking direct acting antivirals (DAAs) in a large cohort study in Egypt. Methods: This multicenter observational retrospective study was carried out on 2500 chronic hepatitis C virus (HCV) infected patients who achieved (SVR) after treatment with direct acting antiviral drugs (DAA). HCV infection was confirmed by positive PCR for HCV RNA infection. SVR was defined as a negative PCR test for HCV-RNA 12 weeks after completion of DAA therapy. Platelets count was measured before therapy, during therapy, at the end of treatment, and 12 weeks after the end of the treatment. Results: There were 2186 patients enrolled in the study; 1866 (85.4%) were treatment naïve. There were 1006 (46%) males and 1180 (54%) females. Mean age was 50.82± 11.66 years, 2142 (98 %.0) patients achieved SVR, 2118 (96.9%) patients had Child -Pugh class A cirrhosis, and 68 (3.1%) had Child -Pugh class B liver cirrhosis. A significant increase of the platelets count was detected at the end of treatment in comparison to the pretreatment levels (P<0.001), and after achieving SVR (P <0.001) when compared to the pretreatment values. Conclusion: Improvement of platelets count occurs after HCV therapy with DAAS in patients with liver cirrhosis. These results suggested that HCV eradication may have a role in improvement of platelet count.

scholarly journals Predictors of Response to 24-Week Telaprevir-Based Triple Therapy for Treatment-Naïve Genotype 1b Chronic Hepatitis C Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Hiroshi Abe ◽  
Akihito Tsubota ◽  
Noritomo Shimada ◽  
Masanori Atsukawa ◽  
Keizo Kato ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Virological Response ◽  
Multivariate Logistic Regression Analysis ◽  
Hcv Rna ◽  
Rapid Virological Response ◽  
Related Factors ◽  
Genotype 1B ◽  
Predictors Of Response ◽  
Treatment Naïve ◽  
Intent To Treat

We evaluated the genetic variation in rs8099917, substitutions in core amino acid (aa) 70, and the number of aa substitutions in the interferon sensitivity-determining region (ISDR) on the prediction of sustained virological response (SVR) in treatment-naïve hepatitis C virus (HCV) genotype 1b (G1b) patients. This multicenter study involved 150 Asian treatment-naïve patients infected with HCV G1b who received 12 weeks of telaprevir in combination with 24 weeks of peginterferon-α-2b and ribavirin. The baseline and treatment-related factors potentially associated with SVR were determined by multivariate logistic regression analysis. Virological response was analyzed on an intent-to-treat basis. Cessation of the therapy due to adverse effects occurred in only 2 patients, who discontinued the trial at 10 weeks and at 2 weeks due to cerebral infarction and renal impairment, respectively. Among the 150 patients in whom the final virological response was determined, only genotype TT in rs8099917 was identified as a pretreatment predictor (P= 7.38 × 10−4). Achievement of a rapid virological response (RVR), defined as undetectable HCV RNA at week 4 of treatment, was identified as an after-starting-treatment predictor (P= 2.47 × 10−5). However, neither a substitution in core aa 70 nor the number of substitutions in the ISDR affected treatment outcome.

scholarly journals Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1048
Author(s):  
Virginia Solitano ◽  
Maria Corina Plaz Torres ◽  
Nicola Pugliese ◽  
Alessio Aghemo
Keyword(s):  
Hepatitis C ◽  
Previous Treatment ◽  
World Health ◽  
Current Evidence ◽  
Decompensated Cirrhosis ◽  
Drug Side Effects ◽  
Efficacy And Safety ◽  
Current Scenario ◽  
Health Organization ◽  
Direct Acting

Direct-acting antivirals (DAA) have revolutionized the treatment of patients with chronic hepatitis C virus (HCV) infection, possibly leading to HCV elimination by 2030 as endorsed by the World Health Organization (WHO). However, some patients belonging to the so-called unique or special populations are referred to as difficult-to-treat due to unreached sustained virological response, potential drug side effects or interactions or co-morbidities. Several years after the DAA introduction and on the basis of excellent findings in terms of efficacy and safety, some doubts arise around the exact meaning of the special population designation and whether this group of patients actually exists. The aim of this review is to discuss and analyze current evidence on the management and treatment of the so-called “unique populations”. We placed particular emphasis on patients with decompensated cirrhosis, chronic kidney disease (CKD), coinfections, rare genotypes, and previous treatment failure, in order to provide physicians with an updated overview of the actual problems and needs in the current scenario.

Efficacy and safety of elbasvir plus grazoprevir combination therapy in Japanese patients infected with hepatitis C virus genotype 1b

2018 ◽  
Vol 49 (3) ◽  
pp. 256-263 ◽  
Author(s):  
Yasue Takeuchi ◽  
Norio Akuta ◽  
Hitomi Sezaki ◽  
Fumitaka Suzuki ◽  
Shunichiro Fujiyama ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Combination Therapy ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Virus Genotype ◽  
Genotype 1B

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.

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