Ledipasvir/Sofosbuvir in Adolescents With Chronic Hepatitis C Genotype 4 With and Without Hematological Disorders: Virological Efficacy and Impact on Liver Stiffness

2020 ◽  
Author(s):  
Nahed A Makhlouf ◽  
Mohamed O Abdelmalek ◽  
Mohamed Eltaher Ibrahim ◽  
Nagla H Abu-Faddan ◽  
Abeer E Kheila ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Liver Stiffness ◽  
Hcv Rna ◽  
Genotype 4 ◽  
Hematological Disorders ◽  
Apri Score ◽  
Treatment Naïve ◽  
Patient Groups ◽  
Group 2 ◽  
Chronic Hcv

Abstract Background Egypt has the highest prevalence of hepatitis C virus (HCV) infection. Anti-HCV antibodies were detectable in 3% of children in Upper Egypt. Our aim was to evaluate the efficacy of ledipasvir/sofosbuvir for chronic HCV genotype 4 in adolescents with/without hematological disorders and to determine the effect of sustained virological response (SVR) on liver stiffness. Methods Sixty-five adolescents were recruited. There were 3 patient groups: group 1, 44 treatment-naive without hematological disorders; group 2, 6 previously treated; and group 3, 15 treatment-naive with hematological disorders. All patients received sofosbuvir 400 mg/ledipasvir 90 mg per day for 12 weeks. Serum HCV RNA levels were measured before treatment, at week 12, and at 12 weeks after the end of treatment (SVR12). Liver stiffness and the aspartate aminotransferase–platelet ratio index (APRI) score were estimated at baseline and at SVR12. Results SVR12 was 100%. At SVR12, there was a significant improvement in liver stiffness in all groups. The APRI score showed significant improvements in groups 1 and 3 (P < .001 and P = .004, respectively). The treatment was well tolerated, with minimal and self-limited side effects. Conclusions Treatment of chronic HCV in adolescents using ledipasvir/sofosbuvir was effective, with a cure rate (at SVR12) of 100%. Significant improvement in liver stiffness was found in all groups.

scholarly journals Chronic hepatitis C virus infection: Is there a correlation between HCV genotypes and the level of viremia?

2006 ◽  
Vol 59 (5-6) ◽  
pp. 230-234 ◽  
Author(s):  
Dragan Delic ◽  
Zorica Nesic ◽  
Jasmina Simonovic ◽  
Neda Svirtlih ◽  
Ljubisa Dokic ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Objective Assessment ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Genotype 4 ◽  
Hcv Genotypes ◽  
Genotype 2 ◽  
Chronic Hcv Infection ◽  
Chronic Hcv

Introduction. Hepatitis C virus (HCV) RNA status and HCV genotypes have become extremely important for exact diagnosis, prognosis, duration of treatment and monitoring of antiviral therapy of chronic HCV infection. Material and methods. For the purpose of precise and objective assessment of virologic analyses, such as the determination of the number of virus copies and virus genotypes, 110 patients with chronic HCV infection were tested. Genotyping of HCV isolates and HCV RNA quantification were performed by using the PCR method. Genotype lb infection was verified in 49.1% of patients, genotype 3a infection was found in 28.2%, genotype 4 in 9.1%, genotype 2 in 4.5%, while mixed genotype infections were diagnosed in 9.1% of cases. Results. Patients infected by genotype lb had significantly higher serum HCV RNA level in relation to patients infected by other genotypes (p<0.05). Over 70% of patients infected by genotype lb had more than 2xl06 virus copies in 1 ml of blood, while in genotypes 2, 3a and 4, the percentage was 40%, 38.5% and 30%, respectively. Male patients had approximately 7.7x10.6 virus copies in 1 ml of blood, which was significantly higher in comparison with female patients (2.3xl06 copies/ml; p<0.05). Conclusion. Our results are in concordance with the results of other authors reporting that genotype lb is predominant in Europe, as well as significantly higher incidence of viremia in patients with genotype lb infection in relation to other HCV genotypes. Based on these results, we can conclude that our patients, most commonly, present with severe clinical course of chronic HCV infection and require longer treatment (48 weeks), which causes economic problems. .

scholarly journals Efficiency of a combined peginterferon alpha-2a and ribavarin therapy in intravenous opiate substances abusers with chronic hepatitis C

2009 ◽  
Vol 66 (10) ◽  
pp. 791-795 ◽  
Author(s):  
Maja Jovanovic ◽  
Ljiljana Konstantinovic ◽  
Velimir Kostic ◽  
Miodrag Vrbic ◽  
Lidija Popovic
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Combined Therapy ◽  
Hcv Infection ◽  
Special Treatment ◽  
Hcv Rna ◽  
Significant Difference ◽  
Patient Groups ◽  
Chronic Hcv

Background/Aim. The most important ethiology factor of chronic liver disease that progresses into terminal insufficiency is hepatitis C virus (HCV) infection. Intravenous (iv) drug abuse is the main cause for spreading HCV. Thus the therapy for such patients is of extreme importance in reducing the incidence of the disease. The aim of the study was to establish efficacy of a combined therapy with peginterferon alpha-2a and ribavirin in iv opiate substances abusers having chronic HCV infection in relation to sex, age, genotype and level of fibrosis and duration of HCV infection before the treatment. Methods. Thirty one iv opiate substances abusers with chronic hepatitis C (HHC) were enrolled in the examination. The patients were divided according to the genotype into two groups. The patients with genotypes 1 and 4 (n = 18) were treated for 48 weeks, while those with genotypes 2 and 3 (n = 13) for 24 weeks. PCR HCV RNA, genotype determination and liver biopsy were done to each patient. Results. A stabile virological response was achieved in 93.5% of the patients, so the therapy demonstrated statistically significant efficacy i. v. opiate substances abusers with HHC (p < 0.001). There was no statistically significant difference in therapeutic response among patient groups formed according to the genotype, sex, duration of the disease and level of fibrosis (p > 0.05). Conclusion. Therapy of of iv opiate substances abusers with HHC has its specificities, and these patients need special treatment. Efficacy of the therapy was equivalent in patient groups formed according to the sex, genotype, level of fibrosis and duration of HCV infection. A combined therapy with peginterferon alfa 2a and ribavirin has high level of success in the treatment of these patients.

scholarly journals Effect of using Direct Acting Antivirals on the Synthetic Liver Functions in Treatment-Naïve Patients with Chronic Hepatitis C Virus Infection Genotype 4

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
K Hamdy ◽  
N Ibrahim ◽  
E Safwat ◽  
A Elrefaei
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Total Bilirubin ◽  
Post Treatment ◽  
Genotype 4 ◽  
End Of Treatment ◽  
Treatment Naïve ◽  
Group 3 ◽  
Chronic Hcv ◽  
Direct Acting

Abstract Background and aim of the study Interferon-free direct-acting antivirals (DAAs) combination therapies, including sofosbuvir (SOF), daclatasvir (DCV) and paritaprevir -r/ombitasvir therapy with or without ribavirin, eradicate chronic hepatitis C virus (HCV) in a high percentage of patients, but its impact on improvement of synthetic liver function is unclear. The aim of this study was to evaluate the effect of DAAs on the synthetic functions of the liver in treatment- naïve chronic HCV genotype 4 patients who treated by different regimens of DAAs for 12 weeks and achieved a sustained virological response at 12 weeks after treatment completion (SVR 12). Patients and Methods From September 2017 to March 2018, 150 treatment- naïve chronic HCV genotype 4 Egyptian patients received different DAAs regimens for 12 weeks were enrolled for this prospective cohort study, to evaluate the effect of DAAs on serum albumin, total bilirubin, INR, prothrombin concentration and platelets count at the end of treatment (WK12) and at week 12 post treatment in comparison to baseline. Patients were categorized to three groups; Group 1 (easy to treat) included 60 patients treated by SOF/DAC regimen, Group 2 (Difficult to treat) included 60 patients treated by SOF/DAC + ribavirin regimen and Group 3 included 30 chronic HCV patients with chronic kidney disease (eGFR ≤ 30 ml/min and Haemoglobin level &gt;10g/dl) treated by Qurevo (paritaprevir-r/ombitasvir) + ribavirin and all included patients were treated for 12 weeks and achieved a sustained virological response at week 12 post treatment (SVR 12). Results There was a statistically highly significant improvement of serum albumin, total bilirubin, PC and INR (P = 0.001) among groups 1 and 2 patients at both time points _the end of treatment and WK12 post treatment_ (except for s. total bilirubin; P value was 0.11 at the end of treatment as compared to baseline). Platelets count showed a statistically highly significant improvement (P = 0.001) at both time points among group 1 patients, however among groups 2 and 3, it showed a statistically highly significant decline at the end of treatment (P = 0.001) as compared to baseline then showed a statistically highly significant improvement at WK12 post treatment (P = 0.001) among group 2 patients and (P = 0.027) among group 3 patients as compared to baseline value. Among group 3 cases there was a statistically significant improvement of serum albumin (P = 0.001) and PC (P = 0.025) at WK12 post treatment as compared to baseline. Conclusion In conclusion, based on analysis of all laboratory parameters in this study, we can conclude that direct acting antiviral therapy (DAAs) is effective in improvement of synthetic liver functions in chronic hepatitis C genotype 4 patients who achieved a sustained virological response.

scholarly journals HIV Coinfection Predicts Failure of Ledipasvir/Sofosbuvir in Treatment-Naïve Noncirrhotic Patients With HCV Genotype 1

2019 ◽  
Vol 6 (5) ◽  
Author(s):  
Juan Berenguer ◽  
José Luis Calleja ◽  
María Luisa Montes ◽  
Ángela Gil ◽  
Ana Moreno ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Hiv Infection ◽  
Treatment Failure ◽  
Sustained Viral Response ◽  
Liver Stiffness ◽  
Hcv Rna ◽  
Multivariable Logistic Regression Model ◽  
Direct Acting Antiviral ◽  
Treatment Naïve ◽  
Direct Acting

Abstract Background The efficacy of licensed direct-acting antiviral (DAA) regimens is assumed to be the same for hepatitis C virus (HCV)–monoinfected patients (HCV-Mono) and HIV/HCV-coinfected patients (HCV-Co). However, the high sustained viral response (SVR) rates of DAA regimens and the small number of HIV-infected patients included in registration trials have made it difficult to identify predictors of treatment failure, including the presence of HIV. Methods We compared treatment outcomes for ledipasvir/sofosbuvir (LDV/SOF) against HCV G1 in treatment-naïve HCV-Mono and HCV-Co without cirrhosis in a prospective registry of individuals receiving DAAs for HCV. Results Up to September 2017, a total of 17 269 patients were registered, and 1358 patients (1055 HCV-Mono/303 HCV-Co) met the inclusion criteria. Significant differences between HCV-Mono and HCV-Co were observed for age, gender, and G1 subtype distribution. Among HCV-Co, 99.0% were receiving antiretroviral therapy. SVR rates for LDV/SOF at 8 weeks did not differ significantly between HCV-Mono and HCV-Co (96.9% vs 94.0%; P = .199). However, the SVR rate for LDV/SOF at 12 weeks was significantly higher for HCV-Mono than HCV-Co (97.2% vs 91.8%; P = .001). A multivariable logistic regression model including age, sex, liver stiffness, G1 subtype, HCV-RNA, HIV, and treatment duration showed the factors associated with treatment failure to be male sex (adjusted odds ratio [aOR], 2.49; 95% confidence interval [CI], 1.27–4.91; P = .008) and HIV infection (aOR, 2.23; 95% CI, 1.13–4.38; P = .020). Conclusions The results of this large prospective study analyzing outcomes for LDV/SOF against HCV G1 in treatment-naïve noncirrhotic patients suggest that HIV infection is a predictor of treatment failure in patients with chronic hepatitis C.

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.

Outcomes of Treatment and Predictors of Response to Sofosbuvir Plus Simeprevir in Hepatitis C Virus with Genotype-4 Infection

2020 ◽  
Vol 20 (3) ◽  
pp. 389-395 ◽  
Author(s):  
Ossama A. Ahmed ◽  
Mohamed A Elsebaey ◽  
Mohamed Hassan A. Fouad ◽  
Mahmoud Elkadeem ◽  
Rehab Badawi ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Treatment Plan ◽  
Albumin Level ◽  
Hcv Rna ◽  
Open Label ◽  
Genotype 4 ◽  
Hcv Genotype ◽  
Direct Acting Antiviral ◽  
Chronic Hcv

Background & Aims: Treatment plan of chronic HCV infection has dramatically improved after the introduction of different groups of Direct-Acting Antiviral (DAA) drugs. These drugs have been found to be safe and effective. Sofosbuvir (SOF) plus simeprevir (SMV) regimen has been shown to be tolerable and effective in treatment of patients with HCV genotype 1. The aim of the study was to evaluate the safety and the efficacy of combined sofosbuvir plus simeprevir treatment in genotype 4 chronic HCV patients. Methods: This open-label multicenter prospective study was carried out on 381 Egyptian patients with chronic hepatitis C virus- infection. Treatment experienced and treatment-naive patients were included. Subjects administrated a regimen of sofosbuvir (400 mg/ day) plus semiprevir (150 mg /day) for twelve weeks. Sustained Virological Response (SVR) was confirmed by undetectable HCV RNA by quantitative PCR 3 months after the end of the treatment. Results: 97.6% (372 /381) of patients had SVR. None of the studied clinical and demographic characteristics were associated with the SVR status. However, patients who failed to achieve SVR showed low albumin level and high total leucocyte. The most common side effects of the studied regimen were headache, fatigue, itching, photosensitivity, and cough. Conclusion: Twelve weeks’ regimen of sofosbuvir plus simeprevir was considered to be safe and tolerable in the treatment of HCV genotype 4; also it was associated with high SVR (97.6%).

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 Serum Inter-Alpha-Trypsin Inhibitor Heavy Chain 4 (ITIH4) in Children with Chronic Hepatitis C: Relation to Liver Fibrosis and Viremia

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Mostafa M. Sira ◽  
Behairy E. Behairy ◽  
Azza M. Abd-Elaziz ◽  
Sameh A. Abd Elnaby ◽  
Ehab E. Eltahan
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Liver Fibrosis ◽  
Chronic Hepatitis C ◽  
Heavy Chain ◽  
Trypsin Inhibitor ◽  
Clinical Laboratory ◽  
Treatment Naïve ◽  
Liver Fibrogenesis ◽  
Chronic Hcv

Liver fibrosis and viremia are determinant factors for the treatment policy and its outcome in chronic hepatitis C virus (HCV) infection. We aimed to investigate serum level of inter-alpha-trypsin inhibitor heavy chain 4 (ITIH4) and its relation to liver fibrosis and viremia in children with chronic HCV. ITIH4 was measured by ELISA in 33 treatment-naive children with proved chronic HCV and compared according to different clinical, laboratory and histopathological parameters. Liver histopathological changes were assessed using Ishak score and compared with aspartate transaminase-to-platelet ratio (APRI) and FIB-4 indices as simple noninvasive markers of fibrosis. ITIH4 was measured in a group of 30 age- and sex-matched healthy controls. ITIH4 was significantly higher in patients than in controls (54.2±30.78 pg/mL versus 37.21±5.39 pg/mL; P=0.021). ITIH4, but not APRI or FIB-4, had a significant direct correlation with fibrosis stage (P=0.015, 0.961, and 0.389, resp.), whereas, the negative correlation of ITIH4 with HCV viremia was of marginal significance (P=0.071). In conclusion, ITIH4 significantly correlated with higher stages of fibrosis indicating a possible relation to liver fibrogenesis. The trend of higher ITIH4 with lower viremia points out a potential antiviral properties and further studies in this regard are worthwhile.

scholarly journals Spontaneous Clearance of Chronic HCV: The Key Ending Left in the Dark

2019 ◽  
Vol 7 (10) ◽  
pp. 1657-1659
Author(s):  
Nikola Hristov Mumdzhiev ◽  
Daniela Valerieva Radicheva ◽  
Mariana Penkova Radicheva ◽  
Rumen Valchev Tenev ◽  
Zlatina Dimitrova Vasileva
Keyword(s):  
Hepatitis C ◽  
Hcv Rna ◽  
Spontaneous Clearance ◽  
Hepatitis C Infection ◽  
Positive Serology ◽  
Mild Disease ◽  
Spontaneous Hcv Clearance ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Special Circumstances

BACKGROUND: Hepatitis C is the second leading cause of liver cirrhosis and hepatocellular carcinoma. Although the discovery of direct-acting agents made the disease curable, HCV elimination can be achieved solely by the host’s immunologic arsenal. CASE REPORT: We report the case of a 29-year-old woman with chronic hepatitis C infection - elevated transaminases, positive serology. HCV was detectable on two occasions, and histology showed mild disease - A1F1. Upon follow up and without any treatment, the patient achieved spontaneous clearance confirmed by two consecutive undetectable HCV RNA tests. Spontaneous HCV clearance rarely occurs – 0.5% per person-year. This is sometimes accompanied by special circumstances like additional disease or medical interventions. Host factors like gender and interleukin-28B polymorphisms have been known to contribute to clearance. Viral factors like HCV RNA levels are also a factor. The characteristics of host-viral interplay – age of acquisition and fibrosis stage – cannot be overlooked. CONCLUSION: All of the abovementioned factors contribute to the complex immunological interaction between virus and host and the result, although rarely can be spontaneous clearance.

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