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 HCV Core Antigen as an alternative test to Quantitative HCV RNA for assessment of SVR in Chronic HCV infected patients treated with Direct Acting Antiviral agents

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
S M Mohamed ◽  
N I Musa ◽  
R S Ghait ◽  
B M Abdelrhiem
Keyword(s):  
Antiviral Agents ◽  
Virologic Response ◽  
Hcv Infection ◽  
Core Antigen ◽  
Hcv Rna ◽  
Viral Kinetics ◽  
Direct Acting Antiviral ◽  
Hcv Core Antigen ◽  
End Of Treatment ◽  
Direct Acting

Abstract Background and aims Widespread use of direct-acting antiviral (DAA) agents to treat patients with hepatitis C virus (HCV) infection has reduced the need for monitoring of HCV-RNA levels, because viral kinetics do not predict sustained virologic response (SVR) to these drugs. However, the performance of cheaper tests, such as the assay to quantify HCV core antigen (HCV Ag), has not been determined. This study was aimed at investigating the accuracy of the HCV Ag test in predicting which patients receiving DAAs will achieve SVR at week 12 (SVR12). Methods We performed a prospective study on 90 patients, chronically infected with HCV, receiving DAAs therapy from different NCCVH centers in Cairo during the period from August 2017 to June 2018. We collected blood samples and measured the levels of HCV core Ag and HCV-RNA at baseline and 12 weeks after end of treatment. We compared the ability of these assays to predict which patients would have SVR12. Results The median baseline level of HCV-RNA was 1688529.6 ± 994697.3 IU/ml (range, 312700 IU/ml to 3491100 IU/ml) and HCV Ag was 179.2 ± 83.5 pg/ml (range, 33.5 pg/ml to 315.6 pg/ml). HCV Ag became undetectable in 92.2% 12 weeks after the end of treatment. HCV-RNA became undetectable in 87.8% at the end of treatment (P&lt;.0001). 79 out of 90 patients (87.8%) achieved an SVR12; the test for HCV Ag identified 63.6% of these patients. Conclusions Tests that measure HCV Ag monitor efficacy of DAA therapy for HCV infection as well as assays that measure HCV-RNA, and hence could be recommended for clinical practice.

scholarly journals Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study

2020 ◽  
Author(s):  
Kristina M Brooks ◽  
Jose R Castillo-Mancilla ◽  
Mary Morrow ◽  
Samantha MaWhinney ◽  
Sarah E Rowan ◽  
...  
Keyword(s):  
Drug Use ◽  
Linear Models ◽  
Virologic Response ◽  
Directly Observed Therapy ◽  
Hcv Treatment ◽  
Open Label ◽  
Direct Acting Antiviral ◽  
Intention To Treat ◽  
Adherence Data ◽  
Direct Acting

Abstract Background HCV treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. Here, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and/or alcohol. Methods INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18-70 years. Participants were randomized to wireless (WOT, Wisepill®) or video-based directly observed therapy (vDOT, Emocha®). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing ≥1 dose(s) between visits were examined using generalized linear models. Results Sixty participants received ≥1 ledipasvir/sofosbuvir dose (47 HIV/HCV, 13 HCV only; 78% male; 22% Black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. SVR by intention-to-treat was 86.7% (52/60) and as-treated was 94.5% (52/55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median (IQR [range]) total adherence was 96% (85-100% [30-101%]) and between-visit adherence was 100% (86-100% [0-107%]). Odds [95% CI] of missing ≥1 dose between visits increased with HIV coinfection (2.94 [1.37, 6.32], p=0.006), Black race (4.09 [1.42, 11.74], p=0.009), methamphetamine use (2.51 [1.44, 4.37], p=0.0.001) and cocaine use (2.12 [1.08, 4.18], p=0.03), and decreased with marijuana use (0.34 [0.17, 0.70], p=0.003) and vDOT (0.43 [0.21, 0.87], p=0.02). Conclusions PWUD achieved high SVR rates with high, but variable, ledipasvir/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.

DI-062 Sustained virologic response rates of new direct acting antiviral agents for HCV

2016 ◽  
Vol 23 (Suppl 1) ◽  
pp. A145.2-A146
Author(s):  
C Caballero Requejo ◽  
M Onteniente Candela ◽  
JJ Franco Miguel ◽  
M Garcia Coronel ◽  
A Trujillano Ruiz ◽  
...  
Keyword(s):  
Sustained Virologic Response ◽  
Antiviral Agents ◽  
Response Rates ◽  
Virologic Response ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

scholarly journals Resolution of HCV-Autoimmune Hepatitis Overlap Syndrome With Antiviral TreatmentA Paired Liver Biopsy Study

2019 ◽  
Vol 152 (6) ◽  
pp. 735-741
Author(s):  
Juan Putra ◽  
Thomas D Schiano ◽  
M Isabel Fiel
Keyword(s):  
Autoimmune Hepatitis ◽  
Plasma Cells ◽  
Antiviral Agents ◽  
Virologic Response ◽  
Overlap Syndrome ◽  
High Power Field ◽  
Direct Acting Antiviral ◽  
Before And After ◽  
Liver Biopsies ◽  
Direct Acting

Abstract Objectives To evaluate histologic changes occurring in patients having chronic hepatitis C and autoimmune hepatitis overlap (HCV-AIH), and who achieved virologic cure using direct-acting antiviral agents (DAA). Methods Characteristics of HCV-AIH patients who underwent paired liver biopsies before and after receiving DAA treatment from 2011 to 2018 were evaluated. Results Five HCV-AIH patients (three male; mean age, 60.4 years) underwent paired liver biopsies (average interval, 2.3 years) before and after achieving cure with DAA treatment. All patients showed virologic response, while four showed decreased inflammation, and three cases showed features of fibrosis regression. Immunohistochemical staining demonstrated significant decrease in plasma cell count in three patients (20.6 vs 11.9 plasma cells/high power field; P = .02, t test). Conclusions Histologic improvements in inflammation and fibrosis are noted in most HCV-AIH patients after DAA treatment, suggesting that the autoimmune component of the HCV-AIH overlap syndrome is merely a secondary phenomenon of viral infection.

scholarly journals Sustained Viral Response in a Hepatitis C Virus-Infected Chimpanzee via a Combination of Direct-Acting Antiviral Agents

2010 ◽  
Vol 55 (2) ◽  
pp. 937-939 ◽  
Author(s):  
David B. Olsen ◽  
Mary-Ellen Davies ◽  
Larry Handt ◽  
Kenneth Koeplinger ◽  
Nanyan Rena Zhang ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Antiviral Agents ◽  
Sustained Viral Response ◽  
Virologic Response ◽  
Proof Of Concept ◽  
Viral Response ◽  
Direct Acting Antiviral ◽  
Infected Chimpanzee ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

ABSTRACTEfforts to develop novel, interferon-sparing therapies for treatment of chronic hepatitis C (HCV) infection are contingent on the ability of combination therapies consisting of direct antiviral inhibitors to achieve a sustained virologic response. This work demonstrates a proof of concept that coadministration of the nucleoside analogue MK-0608 with the protease inhibitor MK-7009, both of which produced robust viral load declines as monotherapy, to an HCV-infected chimpanzee can achieve a cure of infection.

scholarly journals Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C: Real-life Data

2021 ◽  
Vol 27 (2) ◽  
pp. 42-48
Author(s):  
Ayhan Balkan ◽  
Yasemin Balkan ◽  
Abdullah Emre Yıldırım ◽  
Buğra Tolga Konduk ◽  
Sezgin Barutçu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Antiviral Agents ◽  
Real Life ◽  
Direct Acting Antiviral ◽  
Life Data ◽  
Real Life Data ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents
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