Cost-effectiveness of second-generation direct-acting antiviral agents in chronic HCV infection: a systematic literature review

2019 ◽  
Vol 24 (4) ◽  
pp. 247-259 ◽  
Author(s):  
László Szilberhorn ◽  
Zoltán Kaló ◽  
Tamás Ágh
Keyword(s):  
Cost Effectiveness ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Second Generation ◽  
Antiviral Agents ◽  
Direct Acting Antiviral ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

scholarly journals The efficacy and safety of direct-acting antiviral agents in patients with chronic HCV infection and UGT1A1*28 polymorphism

2020 ◽  
Vol 22 (1) ◽  
pp. 71-80
Author(s):  
S.P. Lukashyk ◽  
I.A. Karpov ◽  
M.G. Siniauskaya ◽  
N.G. Danilenko ◽  
L.A. Anisko ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Antiviral Agents ◽  
Hcv Infection ◽  
Efficacy And Safety ◽  
Svr12 Rate ◽  
Direct Acting Antiviral ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

Objective. To determine the efficacy and safety of direct-acting antiviral agents (DAA) in patients with chronic HCV infection and UGT1A1*28 polymorphism. Materials and Methods. An open-label, non-randomized, observational study to assess efficacy and safety of DAA in patients (n = 143) with chronic hepatitis C (CHC) and liver cirrhosis and UGT1A1*28 polymorphism was performed. A total of 139 patients with chronic HCV infection were included in the efficacy analysis (absence of HCV RNA in blood by PCR) by the rate of sustained virologic response at week 12 (SVR12). Results. The SVR12 rate in patients with CHC and HCV-CP was 92.5% and 87.9%, respectively (p = 0.508), regardless of the presence of UGT1A1*28 polymorphism. The SVR12 rate in patients with chronic HCV infection and (TA)7/(TA)7 was 84.8%, with (TA)6/(TA)7 – 92.2% compared with (TA)6/ (TA)6 – 90,5% (p = 0.518). The rate of SVR12 in patients with CHC and (TA)7/(TA)7 or (TA)6/(TA)7 was 80% and 95%, respectively, with (TA)6/(TA)6 – 95.2%. The rate of SVR12 in patients with liver cirrhosis and (TA)7/(TA)7 or (TA)6/(TA)7 was 92.3% and 87.5%, respectively, with (TA)6/(TA)6 – 85.7%. The rate of SVR12 in patients with 12- and 24-week treatment duration was 88.2% and 96.6%, respectively (p = 0.30). As many as 96.2% of patients with the previous treatment with interferon and ribavirin had SVR12 compared to 88.5% of patients who have not previously taken antiviral drugs (p = 0.486). Grade 1 adverse events (AE) occurred in 24% of patients with chronic HCV infection treated with DAA; two patients developed Grade 4 AE. Conclusions. The treatment with DAA was shown to be effective and safe in patients with chronic HCV infection and UGT1A1*28 polymorphism.

scholarly journals Hematological Changes in HCV Patients Treated with Different Sofosbuvir-Based Regimens

2020 ◽  
pp. 10-17
Author(s):  
Ahmed Abdel Khalek ◽  
Abdel Raouf El-Deib ◽  
Gamal Tawfik ◽  
Nashaat Soliman ◽  
Mohamed Mosaad
Keyword(s):  
Antiviral Agents ◽  
Hemoglobin Level ◽  
Direct Acting Antiviral ◽  
End Of Treatment ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Hematological Changes ◽  
Direct Acting Antiviral Agents

Introduction: Treatment of HCV with direct acting antiviral agents (DAAs) with the different regimen dramatically changed the outcomes of the disease beside its eradication. In the same time hematological concerns as anemia, thrombocytopenia, and leucopenia were a major factor before initiation, or during treatment with the antiviral drugs. Aim: To demonstrate hematological changes during and after treatment with different regimen of DAAs. Methods: Follow up the hematological changes before, during and after treatment for 100 patients with chronic HCV treated with five different sofosbuvir-based regimen; using interferon, ribavirin, simeprevir and daclatasvir. Results: There are no similar linear changes regarding anemia, leucopenia or thrombocytopenia, however, combination therapy using sofosbuvir with simeprevir or daclatasvir significantly increase platelets count, WBCs, and hemoglobin level during and after end of treatment, versus regimens uses sofosbuvir with ribavirin and or interferon that showed significantly decreased hematological values during and after treatment. Conclusion: Sofosbuvir-based regimen has favorable hematological changes in patients with chronic HCV infection during and after treatments especially with sofosbuvir and daclatasvir.

Case 21

2020 ◽  
pp. 137-142
Author(s):  
Will Irving
Keyword(s):  
Antiviral Agents ◽  
Virologic Response ◽  
Hcv Infection ◽  
Direct Acting Antiviral ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Direct Acting ◽  
End Stage ◽  
Hcv Testing ◽  
Direct Acting Antiviral Agents

Chronic hepatitis C (HCV) infection may be completely asymptomatic until the patient presents with complications of end-stage liver disease. Hence, anti-HCV testing should be performed on any patient with risk factors, which includes a raised alanine aminotransferase. Following diagnosis of chronic HCV infection, it is essential to know the genotype of the infecting virus, and whether or not the patient has underlying cirrhosis, as both of these factors will be important in determining the optimal therapeutic regimen. Direct-acting antiviral agents target 3 different viral non-structural proteins. The success of these drugs in achieving sustained virologic response (SVR) in well over 90% of patients in clinical trials has ended the era of interferon-based therapy for this infection. Therapy for most patients comprises one co/multiply-formulated tablet taken orally per day for 8 or 12 weeks.

scholarly journals Virus Elimination by Direct-Acting Antiviral Agents Impacts Glucose Homeostasis in Chronic Hepatitis C Patients

2022 ◽  
Vol 12 ◽  
Author(s):  
Chun-Han Cheng ◽  
Chia-Ying Chu ◽  
Huan-Lin Chen ◽  
I-Tsung Lin ◽  
Chia-Hsien Wu ◽  
...  
Keyword(s):  
Glucose Homeostasis ◽  
Antiviral Agents ◽  
Hcv Infection ◽  
Treatment Experience ◽  
Factors Associated ◽  
Direct Acting Antiviral ◽  
Chronic Hcv Infection ◽  
Hcv Genotype 1 ◽  
Chronic Hcv ◽  
Direct Acting

Background and AimsChronic hepatitis C virus (HCV) infection is associated with dysregulation of glucose homeostasis, including insulin resistance (IR) and type 2 diabetes. However, independent risk factors associated with IR in chronic HCV-infected patients have not been detailly elucidated. Previous data regarding the impact of HCV elimination by direct-acting antiviral agents (DAAs) on glucose homeostasis is insufficient and controversial. This study aimed to analyze the independent factors associated with IR and to evaluate the changes in glucose homeostasis in chronic HCV-infected patients treated with DAAs therapies.MethodsWe screened 704 patients with chronic HCV infection who underwent treatment with interferon-free DAAs. Patients’ baseline characteristics, biochemical and virological data were collected. The outcome measurements were their IR and β-cell function assessed by the homeostasis model assessment (HOMA) method at baseline and 12-weeks post-treatment.ResultsHigh IR (HOMA-IR ≥ 2.5) was observed in 35.1% of the patients. Multivariable logistic regression analysis revealed that body mass index (BMI) >25 kg/m2, treatment experience, elevated baseline levels of alanine aminotransferase (ALT) and triglyceride, as well as Fibrosis-4 score >3.25 were independently associated with high IR. In patients who achieved sustained virological response (SVR), no significant change in mean HOMA-IR was observed from baseline to 12-weeks post-treatment (2.74 ± 2.78 to 2.54 ± 2.20, p = 0.128). We observed a significant improvement in β-cell secretion stress from 121.0 ± 110.1 to 107.6 ± 93.0 (p = 0.015). Subgroup analysis revealed that SVR was associated with a significant reduction in mean HOMA-IR in patients with baseline HOMA-IR ≥ 2.5 (5.31 ± 3.39 to 3.68 ± 2.57, p < 0.001), HCV genotype 1 (3.05 ± 3.11 to 2.62 ± 2.05, p = 0.027), and treatment experience (4.00 ± 3.37 to 3.01 ± 2.49, p = 0.039).ConclusionsThere were several independent factors associated with IR in patients with chronic HCV infection, including obesity, treatment experience, high serum ALT and triglyceride levels, as well as advanced hepatic fibrosis. After viral elimination by DAAs, we observed a significant reduction in mean HOMA-IR in patients with baseline high IR, HCV genotype 1, and treatment experience.

scholarly journals Cost-Effectiveness Analysis of Direct-Acting Antiviral Agents for Occupational Hepatitis C Infections in Germany

2020 ◽  
Vol 17 (2) ◽  
pp. 440
Author(s):  
Melanie Runge ◽  
Magdalene Krensel ◽  
Claudia Westermann ◽  
Dominik Bindl ◽  
Klaus Nagels ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Base Case ◽  
German Statutory Accident Insurance ◽  
Direct Acting Antiviral ◽  
Life Years ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

Around 1% of the world’s population is infected with hepatitis C. The introduction of new direct-acting antiviral agents (DAAs) in 2014 has substantially improved hepatitis C treatment outcomes. Our objective was to evaluate the long-term cost effectiveness of DAAs in health care personnel (HP) with confirmed occupational diseases in Germany. A standardised database from a German statutory accident insurance was used to analyse the cost-effectiveness ratio for the DAA regimen in comparison with interferon-based triple therapies. Taking account of the clinical progression of the disease, a Markov model was applied to perform a base case analysis for a period of 20 years. The robustness of the results was determined using a univariate deterministic sensitivity analysis. The results show that treatment with DAAs is more expensive, but also more effective than triple therapies. The model also revealed that the loss of 3.23 life years can be averted per patient over the 20 years. Compared to triple therapies, DAA treatment leads to a higher sustained virologic response (SVR). Although this results in a decrease of costs in the long term, e.g., pension payments, DAA therapy will cause greater expense in the future due to the high costs of the drugs.

Safety & Efficacy of Directly Acting Antivirals (Sofosbuvir & Daclatasvir) in Treatment of Chronic HCV in HIV-HCV Co-Infected Egyptian Patients

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Kadry Mohamed EL-Saeed ◽  
Inas EL-Khedr ◽  
Christina Alphonse Anwar ◽  
Mahmoud Hassan Al-Sadik Hassan
Keyword(s):  
Antiviral Agents ◽  
Fever Hospital ◽  
Duration Of Treatment ◽  
Direct Acting Antiviral ◽  
Immune Correlates ◽  
Safety Parameters ◽  
Chronic Hcv ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

Abstract Background The introduction of direct-acting antiviral agents, has revolutionized the treatment for chronic HCV with higher cure rates, shorter duration of treatment and more tolerability have been achieved. Objectives The aim of our study is to estimate the efficacy and safety of DAAs in treatment of chronic HCV in patients co-infected with HIV. Patients and Methods This study of previously untreated patients with HCV and HIV co- infection conducted at Abbasia Fever Hospital, from July 2019 to February 2020. Patients included those who are chronic HCV infection and receiving antiretroviral therapy with a CD4 T-lymphocyte count of 200 cells/mL or greater. Serial measurements of safety parameters, virologic and host immune correlates, and adherence were performed during treatment by combination of daclatasvir 90mg and sofosbuvir 400mg+/- ribavirin 800mg daily for 12 weeks. Results In this study, AST & ALT were significantly decreased at end of treatment and 12 weeks after treatment, CD4 count was significantly increased. Otherwise there are no significant changes in both hematological and biochemical laboratory results. The demographic features of the patients and HIV disease characteristics were not predictors of HCV treatment failure. Conclusion More studies on larger numbers of patients are required for proper evaluation of the safety and efficacy of direct acting antiviral agents generally and sofosbuvir plus daclatasvir combination particularly in HIV/HCV coinfected patients. Longer follow-up studies are still recommended to fully understand the impact of sustained virological response on dynamics of liver fibrosis, biochemical profile and rate of relapse.

Favouring modulation of circulating lipoproteins and lipid loading capacity by direct antiviral agents grazoprevir/elbasvir or ledipasvir/sofosbuvir treatment against chronic HCV infection

Gut ◽  
2017 ◽  
Vol 67 (7) ◽  
pp. 1342-1350 ◽  
Author(s):  
Hung-Yu Sun ◽  
Pin-Nan Cheng ◽  
Chiung-Ying Tseng ◽  
Wei-Jen Tsai ◽  
Yen-Cheng Chiu ◽  
...  
Keyword(s):  
Low Density Lipoprotein ◽  
Sustained Virological Response Rate ◽  
Antiviral Agents ◽  
Density Lipoprotein ◽  
Antiviral Agent ◽  
Hcv Infection ◽  
Direct Acting Antiviral ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Direct Acting

ObjectiveLipid homoeostasis is disturbed in patients with HCV infection. Direct-acting antiviral agent (DAA) treatment eradicates chronic HCV viraemia, but the dynamics of lipid components remain elusive. This study investigates the clinical manifestation and mechanistic relevance of plasma triglyceride (TG), cholesterol (Chol), lipoproteins and apolipoproteins (apos) after DAA treatment.DesignTwenty-four patients with chronic genotype 1 (GT1) HCV treated with elbasvir/grazoprevir or ledipasvir/sofosbuvir for 12 weeks, and followed-up thereafter, were recruited. Their TG, Chol, apoAI and apoB levels were quantified in plasma samples and individually fractionated lipoprotein of various classes. Liver fibrosis was evaluated using the FIB-4 Score. The TG and Chol loading capacities were calculated with normalisation to apoB, which represents per very low density lipoprotein (VLDL) and LDL particle unitResultsDAA treatment achieved a sustained virological response rate of 91.7% and reduced the FIB-4 Score. Relative to the baseline, the plasma TG level was reduced but the Chol level increased gradually. Plasma apoB levels and apoB/apoAI ratio were transiently downregulated as early as the first 4 weeks of treatment. The TG and Chol loading capacities in VLDL were elevated by ~20% during the period of DAA treatment and had steadily increased by 100% at follow-up. Furthermore, the TG-to-Chol ratio in VLDL was increased, while the ratio in LDL was reduced, indicating an efficient catabolism.ConclusionThe DAA treatment of patients with chronic hepatitis C might lead to efficient HCV eradication and hepatic improvement concomitantly evolving with favouring lipoprotein/apo metabolisms.

scholarly journals Viekira Pak Induced Fatal Lactic Acidosis: A Case Report of an Unusual Side Effect

2016 ◽  
Vol 2016 ◽  
pp. 1-3 ◽  
Author(s):  
Molham Abdulsamad ◽  
Ariyo Ihimoyan
Keyword(s):  
Lactic Acidosis ◽  
Side Effect ◽  
Antiviral Agents ◽  
Antiviral Agent ◽  
Direct Acting Antiviral ◽  
First Case ◽  
Safety Warning ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

Viekira Pak is a new direct-acting antiviral agent that has an excellent efficacy in treating patients with chronic HCV. FDA released a safety warning that Viekira Pak can cause serious liver injury mostly in patients with underlying advanced liver disease. We report the first case of fatal lactic acidosis presenting 3 days after initiating therapy with Viekira Pak. Although it is very hard to precisely determine the cause of lactic acidosis, our case highlights an unusual side effect that ensued after starting the medication. Given the complexity of drug-drug interactions that can happen with the new direct-acting antiviral agents and the paucity of data regarding coadministration and methods of monitoring, a thorough review should be pursued prior to initiating these medications.

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