Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis

2017 ◽  
Vol 26 (3) ◽  
pp. 275-281 ◽  
Author(s):  
Liana Gheorghe ◽  
Speranta Iacob ◽  
Manuela Curescu ◽  
Ciprian Brisc ◽  
Cristina Cijevschi ◽  
...  
Keyword(s):  
Transient Elastography ◽  
Sustained Viral Response ◽  
Liver Stiffness ◽  
Real Life ◽  
Liver Stiffness Measurement ◽  
Direct Acting Antiviral ◽  
Genotype 1B ◽  
End Of Treatment ◽  
Clinically Significant ◽  
Direct Acting

Background & Aims: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir (OBV/PTV/r+DSV) is one of the elective direct-acting antivirals (DAAs) recommended by international guidelines and the only one covered by the National Insurance System in Romania until November 2016. Our aim was to present the first prospective Romanian cohort evaluating the effectiveness and safety in clinical practice of this 3DAA combination in patients with HCV genotype-1b Child A liver cirrhosis.Methods: 681 patients received OBV/PTV/r+DSV+RBV for 12 weeks and were assessed clinically and biologically at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained viral response, SVR).Results: Per protocol, EOT virological response was 99.8% and SVR12 rate was 99.4%. Adverse events were present in 36.4% of patients. Permanent discontinuation of 3DAA regimen due to side effects was reported in 11 patients (1.6%). In 47.6% (185/389) of patients, Transient Elastography values were >20kPa (defined as clinically significant portal hypertension, CSPH) at baseline. Independent variables associated with CSPH were: baseline cholesterol level (p=0.003), platelet count <120,000/mm³ (p=0.02), MELD score (p=0.01).Liver stiffness measurement has significantly improved between baseline (26.6±12.7kPa) and SVR12 (21.6±11.8kPa) (p<0.0001). The same was true for APRI score (2.66±0.15 at baseline vs 0.85±0.02 at SVR12, p<0.0001) and FIB4 score (5.53±0.28 vs 3.24±0.08, p<0.0001), but not for Lok score (0.57±0.01 vs 0.63±0.01, p<0.0001).Conclusions: We report a high efficacy of the 3DAA regimen in a homogeneous compensated HCV genotype-1b liver cirrhosis population, in a real-life setting. Noninvasive fibrosis scores significantly improved at SVR12.Abbreviations: AE: adverse effect; AFP: alpha feto-protein; CSPH: clinically significant portal hypertension; DAA: direct-acting antiviral; EOT: end of treatment; GT: genotype; HCV: hepatitis C virus; HCC: hepatocellular carcinoma; LSM: liver stiffness measurement; MELD: Model of end stage liver disease; NHIA: National Health Insurance Agency; OBV/PTV/r+DSV: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir; RBV: ribavirin; SAE: serious adverse effect; SVR: sustained viral response; TE: transient elastography.

scholarly journals Assessment of Liver Stiffness Regression and Hepatocellular Carcinoma Risk in Chronic Hepatitis C Patients after Treatment with Direct-Acting Antiviral Drugs

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 210
Author(s):  
Martynas Ridziauskas ◽  
Birutė Zablockienė ◽  
Ligita Jančorienė ◽  
Artūras Samuilis ◽  
Rolandas Zablockis ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Liver Stiffness ◽  
Direct Acting Antiviral ◽  
End Of Treatment ◽  
Increased Risk ◽  
Patients With Diabetes ◽  
Direct Acting

Background and Objectives: Chronic hepatitis C virus infection affects about 71 million people worldwide. It is one of the most common chronic liver conditions associated with an increased risk of developing liver cirrhosis and cancer. The aim of this study was to evaluate changes in liver fibrosis and the risk of developing hepatocellular carcinoma after direct-acting antiviral drug therapy, and to assess factors, linked with these outcomes. Materials and Methods: 70 chronic hepatitis C patients were evaluated for factors linked to increased risk of de novo liver cancer and ≥ 20% decrease of ultrasound transient elastography values 12 weeks after the end of treatment. Results: The primary outcome was an improvement of liver stiffness at the end of treatment (p = 0.004), except for patients with diabetes mellitus type 2 (p = 0.49). Logistic regression analysis revealed factors associated with ≥ 20% decrease of liver stiffness values: lower degree of steatosis in liver tissue biopsy (p = 0.053); no history of interferon-based therapy (p = 0.045); elevated liver enzymes (p = 0.023–0.036); higher baseline liver stiffness value (p = 0.045) and absence of splenomegaly (p = 0.035). Hepatocellular carcinoma developed in 4 (5.7%) patients, all with high alpha-fetoprotein values (p = 0.0043) and hypoechoic liver mass (p = 0.0001), three of these patients had diabetes mellitus type 2. Conclusions: Liver stiffness decrease was significant as early as 12 weeks after the end of treatment. Patients with diabetes and advanced liver disease are at higher risk of developing non-regressive fibrosis and hepatocellular carcinoma even after successful treatment.

scholarly journals Efficacy and Tolerability of Daclatasvir/Sofosbuvir (Datex) in Patients with HIV-HCV Co-infection

2020 ◽  
Vol 15 (3) ◽  
Author(s):  
Narjes Shokatpour ◽  
Shahnaz Sali ◽  
Batool Daneshpazhouh ◽  
Masoud Mardani
Keyword(s):  
Antiviral Agents ◽  
Real Life ◽  
Virologic Response ◽  
Cd4 Count ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Real Life Setting ◽  
End Of Treatment ◽  
Direct Acting ◽  
Iv Drug Use

Background: Treatment of hepatitis C virus (HCV) infection with direct-acting antiviral agents in patients with HCV/human immunodeficiency virus (HIV) co-infection remains controversial due to drug interactions with antiretroviral therapy (ART). Objectives: In this study, we assessed the efficacy and tolerability of daclatasvir/sofosbuvir (DCV/SOF) in patients with HIV-HCV co-infection in the real-life setting in Iran. Methods: A total of 44 patients with HCV-HIV co-infection (genotypes 1, 3, and 4) were treated with DCV/SOF±RBV (ribavirin) (dose-adjusted DCV for concomitant ART). Assessment of risk factors, sustained virologic response at 12 weeks after the end of treatment (SVR12), safety, and serum CD4 count was performed. Results: Most patients were male (95.2%). Four patients were HCV treatment-experienced cases, and 15 had cirrhosis or advanced fibrosis. The most common genotype was 3 (53.5%), followed by 1 (44.2%) and 4 (2.3%). HIV-1 RNA < 50 copies/mL and CD4 count > 250 cells/mm3 were observed in 81.8% and 79.1% of patients, respectively. The highest risk factor was a history of IV drug use (81.8%), followed by using a common syringe (77.3%) and tattooing (70.5%). All patients with or without cirrhosis (100%) completed the HCV treatment course and achieved SVR12. Also. 92.6% of patients on ART had CD4 count > 250 cells/mm3 at the end of treatment. The HCV treatment regimen was well-tolerated. Moreover, 15.9% of patients experienced adverse events (AEs), including anorexia, nausea, diarrhea, palpitations, and anxiety. No serious AEs or discontinuation due to AEs were reported. Conclusions: Our study showed excellent tolerability and efficacy of DCV/SOF±RBV in HIV-HCV co-infected patients with or without cirrhosis.

scholarly journals Regression of liver fibrosis and hepatocellular carcinoma development after HCV eradication with oral antiviral agents

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Hae Won Yoo ◽  
Jun Yong Park ◽  
Sang Gyune Kim ◽  
Young Kul Jung ◽  
Sae Hwan Lee ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Transient Elastography ◽  
Antiviral Agents ◽  
Sustained Viral Response ◽  
Liver Stiffness ◽  
Pegylated Interferon ◽  
Historical Cohort ◽  
Direct Antiviral Agents ◽  
Direct Acting ◽  
Over Time

AbstractWe prospectively investigated the changes of liver stiffness (LS) and the occurrence of hepatocellular carcinoma (HCC) after hepatitis C virus (HCV) eradication using direct antiviral agents (DAA) over three years. LS measurement using transient elastography and serum fibrosis surrogate markers before treatment and at 48, 96, 144 weeks after starting direct-acting antivirals (DAA) according to the protocol were evaluated. Patients were also compared with historical cohort treated with pegylated interferon (peg-IFN). Sustained viral response (SVR) was observed in 95.8%. LS value in the patients achieving SVR significantly decreased over time (19.4 ± 12.9 kPa [baseline], 13.9 ± 9.1 kPa [48 weeks], 11.7 ± 8.2 kPa [96 weeks], 10.09 ± 6.23 [144 weeks], all p < 0.001). With matched analysis, the decrease in LS value was significantly larger in DAA group than peg-IFN group at both 48 weeks (29% vs. 9%) and 96 weeks (39% vs. 17%). The incidence of HCC was not significantly different between DAA and peg-IFN groups (5.5% vs. 5.4%) at 144 weeks. HCV eradication with DAA can lead to improvement of liver stiffness over time. The regression of fibrosis was greater in the group with DAA than peg-IFN.Clinical trials registration: ClinicalTrials.gov (NCT02865369).

scholarly journals Diagnostic Performance of APRI and FIB-4 for Confirming Cirrhosis in Indonesian HIV/HCV Co-infected Patients

2020 ◽  
Author(s):  
Evy Yunihastuti ◽  
Bramantya Wicaksana ◽  
Adrian Wiraguna ◽  
Ainum Jhariah Hidayah ◽  
Fhadilla Amelia ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Gold Standard ◽  
Diagnostic Performance ◽  
Transient Elastography ◽  
Liver Stiffness ◽  
High Specificity ◽  
Tertiary Hospital ◽  
Direct Acting Antiviral ◽  
Apri Score ◽  
Direct Acting

Abstract BackgroundAfter successful of antiretroviral therapy, highly effective direct acting antiviral (DAA) make HCV elimination reasonable in HIV/HCV co-infected patients. However, in achieving this target, there are still barriers to start DAA treatment, particularly in the area of liver fibrosis assessment that determine the duration of therapy. We aimed to assess the diagnostic performance of APRI and FIB-4 for diagnosing cirrhosis in HIV/HCV co-infected patients using hepatic transient elastography (TE) as gold standard.MethodThis is an retrospective study on HIV/HCV co-infected patients who concomitantly performed hepatic TE measurement, APRI, and FIB-4 evaluation before HCV treatment initiation at a tertiary hospital in Jakarta from 2014 to 2019. Sensitivity, specificity and diagnostic accuracy of indirect biomarkers for liver stiffness measurement (LSM) ≥ 12.5 kPa was determined by receiver operator characteristics curves. Results233 HIV/HCV co-infected patients on stable antiretroviral therapy were included, of whom 91.5% were male with mean age of 37 (SD 5) years. Only 28.7% of patients were classified as cirrhosis (F4). Using TE as gold standard (≥12.5 kPa), the low threshold of APRI (1) had specificity 95%, sensitivity 48.4%, correctly classified 81.6% of patients, with moderate performance, AUROC at 0.72 (95% CI 0.63-0.80). The optimal cut-off of FIB-4 was 1.66 [specificity 92.5%, sensitivity 53.1%, AUROC at 0.73 (95% CI 0.65-0.81)] and correctly classified 81.1% of the patients.ConclusionAPRI score > 1 and FIB-4 score > 1.66 had moderate performance with high specificity in diagnosing cirrhosis. These biochemical markers could be used while TE is not available.

scholarly journals Diagnostic Performance of APRI and FIB-4 for Confirming Cirrhosis in Indonesian HIV/HCV Co-infected Patients

2020 ◽  
Author(s):  
Evy Yunihastuti ◽  
Bramantya Wicaksana ◽  
Andrian Wiraguna ◽  
Ainum Jhariah Hidayah ◽  
Fhadilla Amelia ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Gold Standard ◽  
Diagnostic Performance ◽  
Transient Elastography ◽  
Liver Stiffness ◽  
High Specificity ◽  
Tertiary Hospital ◽  
Direct Acting Antiviral ◽  
Apri Score ◽  
Direct Acting

Abstract Background After successful of antiretroviral therapy, highly effective direct acting antiviral (DAA) make HCV elimination reasonable in HIV/HCV co-infected patients. However, in achieving this target, there are still barriers to start DAA treatment, particularly in the area of liver fibrosis assessment that determine the duration of therapy. We aimed to assess the diagnostic performance of APRI and FIB-4 for diagnosing cirrhosis in HIV/HCV co-infected patients using hepatic transient elastography (TE) as gold standard.Method This is a retrospective study on HIV/HCV co-infected patients who concomitantly performed hepatic TE measurement, APRI, and FIB-4 evaluation before HCV treatment initiation at a tertiary hospital in Jakarta from 2014 to 2019. Sensitivity, specificity and diagnostic accuracy of indirect biomarkers for liver stiffness measurement (LSM) ≥ 12.5 kPa was determined by receiver operator characteristics curves. Results 223 HIV/HCV co-infected patients on stable antiretroviral therapy were included, of whom 91.5% were male with mean age of 37 (SD 5) years. Only 28.7% of patients were classified as cirrhosis (F4). Using TE as gold standard (≥12.5 kPa), the low threshold of APRI (1) had specificity 95%, sensitivity 48.4%, correctly classified 81.6% of patients, with moderate performance, AUC at 0.72 (95% CI 0.63-0.80). The optimal cut-off of FIB-4 was 1.66 [specificity 92.5%, sensitivity 53.1%, AUC at 0.73 (95% CI 0.65-0.81)] and correctly classified 81.1% of the patients.Conclusion APRI score > 1 and FIB-4 score > 1.66 had moderate performance with high specificity in diagnosing cirrhosis. These biochemical markers could be used while TE is not available.

Sign in / Sign up

Export Citation Format

Share Document