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.

scholarly journals Virological Factors Associated with Failure to the Latest Generation of Direct Acting Agents (DAA) and Re-Treatment Strategy: A Narrative Review

Viruses ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 432
Author(s):  
Lorenzo Onorato ◽  
Mariantonietta Pisaturo ◽  
Mario Starace ◽  
Carmine Minichini ◽  
Alessandra Di Fraia ◽  
...  
Keyword(s):  
Liver Disease ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Clinical Problem ◽  
Narrative Review ◽  
Factors Associated ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

The availability of all oral direct acting antiviral agents (DAAs) has revolutionized the management of HCV infections in recent years, allowing to achieve a sustained virological response (SVR) in more than 95% of cases, irrespective of hepatitis C Virus (HCV) genotype or staging of liver disease. Although rare, the failure to the latest-generation regimens (grazoprevir/elbasvir, sofosbuvir/velpatasvir, pibrentasvir/glecaprevir) represents a serious clinical problem, since the data available in the literature on the virological characteristics and management of these patients are few. The aim of the present narrative review was to provide an overview of the impact of baseline RASs in patients treated with the latest-generation DAAs and to analyze the efficacy of the available retreatment strategies in those who have failed these regimens.

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 Naturally Occurring Resistance-Associated Variants to Hepatitis C Virus Direct-Acting Antiviral Agents in Treatment-Naive HCV Genotype 6a-Infected Patients

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Zhanyi Li ◽  
Ying Liu ◽  
Ying Zhang ◽  
Xiaoqiong Shao ◽  
Qiumin Luo ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Direct Acting Antiviral ◽  
Naturally Occurring ◽  
Ns5a Region ◽  
Treatment Naïve ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

Background and Objective. The direct-acting antiviral agents (DAAs) antiviral therapy has drastically improved the prognosis of hepatitis C virus (HCV) patients. However, the viral drug resistance-associated variants (RAVs) can limit the efficacy of DAAs. For the HCV-6a is not the predominant prevalent genotype; the data on the prevalence of naturally occurring RAVs in it is scarce. Our study aims to assess the prevalence of RAVs in treatment-naive HCV-6a patients. Methods. Nested PCR assays were performed on 95 HCV-6a patients to amplify HCV viral regions of NS3, NS5A, and NS5B. Results. In NS3/4A region, we detected Q80K in 95.5% isolates (84/88) and D168E in 2.3% isolates (2/88). In NS5A region, we detected Q30R in 93.2% isolates (82/88), L31M in 4.6% isolates (4/88), and H58P in 6.8% isolates (6/88). In NS5B region, we detected A15G in 2.3% isolates (2/88), S96T in 1.1% isolates (1/88), and S282T in 20.7% isolates (17/88) and we detected I482L in 100% isolates (4/4), V494A in 50% isolates (2/4), and V499A in 100% isolates (4/4). Conclusions. RAVs to DAAs preexist in treatment-naive HCV-6a patients. Further studies should address the issue of the impact of RAVs in response to DAA therapies for HCV-6a patients.

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.

Impact of direct-acting antiviral agents-induced SVR on the long-term burden of hepatocellular carcinoma in chronic hepatitis C cirrhosis.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 230-230
Author(s):  
Prowpanga Udompap ◽  
Ajitha Mannalithara ◽  
Donghee Kim ◽  
W. Ray Kim
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Sensitivity Analyses ◽  
Old Patients ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

230 Background: Sustained virological response (SVR) has been associated with decreased morbidity and mortality from hepatitis C virus (HCV) infection. Data are sparse, however, about the long-term benefits of direct-acting antiviral agents (DAAs) in terms of risk reduction for hepatocellular carcinoma (HCC). We estimate the impact of SVR on the HCC incidence in the DAA era when SVR is achieved nearly universally even in patients with advanced fibrosis and cirrhosis. Methods: We constructed a Markovian model of 50-year-old patients with compensated HCV cirrhosis (n=1,000) to model the incidence of HCC over 20-years of follow-up. We compared 2 cohorts: 1) SVR following DAA therapy and 2) no SVR (natural history). In the latter, HCC would develop at an annual rate of 4.2% and patients would die as a result of end stage liver disease (ESLD) according to their MELD (=6 at baseline). In the former, MELD score would not increase, the HCC risk would decrease and, in some patients, cirrhosis would regress. Results: The table summarizes the 20-year outcome in the two cohorts. In the cohort without SVR, HCC would occur in 33% and 63% would die of ESLD. In the SVR cohort, the proportion of HCC would increase to 37% as the number of subjects at HCC risk would increase, as a result of a dramatic reduction in deaths from ESLD. In the univariate sensitivity analyses, the cumulative HCC incidence was mainly influenced by the rate at which the risk of HCC is decreased after SVR, followed by the change in cirrhosis regression rate. Conclusions: Although HCC risk would decrease after SVR in a given individual patient with cirrhosis, on the population level, highly effective DAA therapy may lead to a paradoxical increase in the burden of HCC. These data underscore the important of (1) HCC surveillance in patients with cirrhosis even after SVR and (2) DAA intervention before cirrhosis develops. [Table: see text]

Statins use corrects the impact of direct acting antiviral agents on lipid profile in hepatitis C virus patients

2020 ◽  
Vol 73 ◽  
pp. S607
Author(s):  
Andrea Dalbeni ◽  
Anna Mantovani ◽  
Diego Faccincani ◽  
Michele Bevilacqua ◽  
Filippo Cattazzo ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Lipid Profile ◽  
Antiviral Agents ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

scholarly journals The impact of direct-acting antiviral agents on liver and kidney transplant costs and outcomes

2018 ◽  
Vol 18 (10) ◽  
pp. 2473-2482 ◽  
Author(s):  
D. A. Axelrod ◽  
M. A. Schnitzler ◽  
T. Alhamad ◽  
F. Gordon ◽  
R. D. Bloom ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Antiviral Agents ◽  
Direct Acting Antiviral ◽  
Liver And Kidney ◽  
Direct Acting ◽  
The Impact ◽  
Direct Acting Antiviral Agents

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.

scholarly journals Attitude and Practices Regarding Use of Direct Acting Antiviral Agents (DAAs) in the Treatment of Hepatitis C among Health Care Practitioners “A Survey-based Study”

2021 ◽  
pp. 133-140
Author(s):  
Nadia Saifullah ◽  
Dabeeran Zehra ◽  
Ambreen Wasim ◽  
Samia Saifullah ◽  
Urooj Zafar ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Side Effects ◽  
Antiviral Agents ◽  
Age Groups ◽  
Survey Study ◽  
World Population ◽  
Duration Of Treatment ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

Approximately 3% of the world population has been known to be infected with HCV. Hepatitis C virus is a major etiological factor behind the development of liver diseases such as cirrhosis and hepatocellular carcinoma. Interferon-based therapy has remained as the mainstay treatment for HCV for decades. Owing to the unavoidable side effects of interferon, direct-acting antivirals (DAAs) have been approved recently for the treatment of HCV-infected patient. These drugs have brought revolution in the management of HCV because of their favorable side effects profiles and enhanced rates of sustained virological response. We conducted a questionnaire-based survey study to assess the knowledge and current practices among specialists and senior post graduate trainees regarding treatment of HCV with DAAs. The questionnaire was based on latest WHO guidelines for treating HCV. The results obtained were collected and tabulated. Majority (95%) of physicians were between the age of 21-30 years and mostly (69.6%) were females. Almost three fourth of the practitioners were aware of direct-acting antiviral agents (DAAs) and 70.2% agreed that they reduce the duration of treatment along with low bill burden along with lesser side effects. In this study, we could see that the participants’ knowledge and practices regarding use of DAAs, preference over interferon therapy and recommended combinations for different age groups was appreciable, however there is still a gap of knowledge among doctors regarding treatment of HCV with DAAs which needs to be filled with the help of proper health educational programs and training.

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