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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 32  |  Issue : 3  |  Page : 928-931

Thyroid in patients receiving new direct-acting antiviral agents for treatment of hepatitis C virus


1 Department of Internal Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Clinical Pathology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
3 Department of Internal Medicine, Ministry of Health, Menoufia, Egypt

Date of Submission09-Nov-2017
Date of Acceptance24-Dec-2017
Date of Web Publication17-Oct-2019

Correspondence Address:
Mukhtar R Al-Shabrawy
Algabriah, El Mahalla El Kubra City, El-Gharbia Governate
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_771_17

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  Abstract 


Objective
The aim was to judge thyroid dysfunction in patients receiving new direct-acting antiviral agents (DAAs) for treatment of hepatitis C pathogen.
Background
Persistent hepatitis C is a gradually progressive disease. DAAs provide high sustained viral response rates and much reduced adverse effects and impaired health-related quality of life during treatment.
Patients and methods
The analysis included 100 patients with persistent hepatitis C contamination with normal thyroid functions before starting treatment with DAAs. After obtaining written informed consent, all patients were analyzed and clinically assessed. Laboratory investigations including complete blood picture, assessment of liver organ and kidney function, thyroid-stimulating hormone, and free thyroxin 4 were done for all patients before the start of the remedy, and by the end of treatment of direct-acting antiviral remedy.
Results
An evaluation of the analyzed patients who were obtaining direct-acting antiviral drugs for treatment of hepatitis C pathogen before and after remedy with respect to the PCR findings proved significant decrease of PCR values after treatment (P = 0.0001). There is no statistically significant difference before and after remedy with new DAA regarding laboratory findings as serum thyroid-stimulating hormone (P = 0.580) and serum free T4 (P = 0.279).
Conclusion
Thyroid function in patients with chronic hepatitis C infection was not afflicted with treatment with new direct-acting antiviral drugs for treatment of hepatitis C virus.

Keywords: antiviral agents, chronic hepatitis C infection, thyroid dysfunction


How to cite this article:
Shaaban MA, Shehab El-Din WA, Nouh MZ, Montaser BA, Al-Shabrawy MR. Thyroid in patients receiving new direct-acting antiviral agents for treatment of hepatitis C virus. Menoufia Med J 2019;32:928-31

How to cite this URL:
Shaaban MA, Shehab El-Din WA, Nouh MZ, Montaser BA, Al-Shabrawy MR. Thyroid in patients receiving new direct-acting antiviral agents for treatment of hepatitis C virus. Menoufia Med J [serial online] 2019 [cited 2019 Nov 21];32:928-31. Available from: http://www.mmj.eg.net/text.asp?2019/32/3/928/268845




  Introduction Top


Persistent hepatitis C virus (HCV) infection is one of the leading factors behind liver organ-related fatality, and in many countries, it is the primary reason behind having a liver organ transplant [1].

Persistent hepatitis C is a gradually progressive disease. Cirrhosis develops in ∼20% of patients over 20–30 years of infection [2].

Egypt has the highest HCV prevalence worldwide [3]. Regarding epidemiologic study, the overall prevalence of HCV infection is estimated to be 10% [4], as HCV was found to have different modes of transmission [5].

The main goal of antiviral treatment is to eliminate the virus, which is thought as a viral RNA that is undetectable by highly delicate methods (lower recognition limit of 15 IU/ml). There is known as to be always a continual viral response [sustained virologic response (SVR)] if this RNA remains undetectable 12 weeks after ceasing treatment [6].

For many years, the standard of care for treatment of chronic hepatitis C had been a combination of pegylated interferon (Peg-IFN) and ribavirin for 48 weeks. However, this combination had many drawbacks including its long course duration, severe adverse effects such as induction of autoimmune phenomena, in addition to its high cost, which makes it not affordable for many patients in limited-resource countries [7]. The side ramifications of IFN remedy on the thyroid gland were reported for the very first time ∼2 decades ago, and since that time, numerous studies have been done in this area [8].

The advent of direct-acting antiviral agents (DAAs) in the few recent years has revolutionized HCV treatment. Peg-IFN and ribavirin have largely been replaced by these highly effective, very well-tolerated DAAs of multiple classes. These new regimens provide higher SVR rate, in addition to higher probability of adherence to treatment, and much reduced adverse effects and impaired health-related quality of life during treatment [9].

To our knowledge, there are no studies that have assessed new immediate antiviral agents. Consequently, our study purpose is to evaluate the incidence and risk factors for thyroid dysfunction during treatment of patients with persistent hepatitis C with DAAs.


  Patients and Methods Top


The study was approved by Ethical Committee of Menoufia Faculty of Medicine, and written prepared consent with justification about the reason, methods, results, and troubles was obtained from each participant. The present research included 100 patients with persistent hepatitis C pathogen with normal thyroid functions through the period from August 2016 to November 2016.

Inclusion criteria included the following: age group greater than 18 years of both sexes, and patients identified as having hepatitis C. Exclusion conditions included the following: patients with background of pre-existing thyroid disease, patients with malignant diseases, or autoimmune diseases, patients with severe cardiac or pulmonary disease, patients presently using immunosuppressant and/or steroids, pregnant females, and patients with severe renal disease and hematological disorders.

All patients were clinically examined to analyze other systems and find out any associated conditions. Laboratory investigations included liver function and kidney function estimation using Hitachi 912 chemistry analyzer (Roche Diagnostics GmbH, Mannheim, Germany), also serum level of thyroid-stimulating hormone (TSH), and free thyroxin 4 (T4) were identified before the start of remedy and by the end of treatment of direct-acting antiviral remedy using Cobas e411 automated analyzer (Roche Diagnostics GmbH).


  Statistics Analysis Top


The collected data were organized, tabulated, and statistically analyzed using SPSS software (statistical package for the sociable sciences, version 19; SPSS Inc., Chicago, Illinois, USA). For quantitative data, the mean and SD were identified. For qualitative data, which describe a categorical group of data, comparability between two groups was done using χ2-test. Value was used at P value less than 0.05 for interpretation of results of assessments of value [10].


  Results Top


Of 100 patients, 61 (61%) were men and 39 (39%) were women. The mean age of the researched patients was 40 years [Table 1].
Table 1: Age and sex of the studied patients receiving new direct-acting antiviral agents (Sofosbuvir and Daclatasvir) for treatment of hepatitis C virus

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A comparison among the list of studied patients receiving new DAAs for treatment of hepatitis C infection before and after remedy regarding PCR findings demonstrated statistically significant difference, as SVR was evident in 94% of patients [Figure 1].
Figure 1: PCR findings among the studied patients receiving new direct-acting antiviral agents for treatment of hepatitis C virus.

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A comparison among the list of studied patients receiving new DAAs for treatment of hepatitis C infection before and after remedy regarding laboratory findings revealed statistically high significant dissimilarities regarding serum albumin (P = 0.0001), international normalized ratio level (P = 0.0001), and serum serum glutamic pyruvic transaminase (P = 0.0001) [Table 2].
Table 2: Laboratory data among the studied hepatitis C virus patients before and after receiving new direct-acting antiviral agents (Sofosbuvir and Daclatasvir)

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A comparison among the list of studied patients before and after remedy regarding thyroid function revealed statistically no significant dissimilarities regarding serum TSH (P = 0.580) and serum free T4 (P = 0.279) [Table 3].
Table 3: Thyroid function test among the studied patients with hepatitis C virus before and after receiving new direct-acting antiviral agents (Sofosbuvir and Daclatasvir)

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  Discussion Top


In our research, with respect to sex, men represented higher percentage of the enrolled patients. This is in accordance with the findings of Xianghong and his colleagues [11] as they found that that most patients are males, with the male/female ratio is 3:7, which could be explained by differences in exposure to risk factors [12].

A comparison among the list of studied patients receiving new DAAs for treatment of hepatitis C infection before and after remedy regarding PCR findings demonstrated statistically significant difference. Lawitz et al. [13] found that on-treatment treatment regimens including sofosbuvir response was high, with 99% of patients showing response by the end of treatment.

A comparison among the list of studied patients receiving new DAAs for treatment of hepatitis C infection before and after remedy regarding PCR findings demonstrated statistically significant difference. Lawitz et al. [13] found that on-treatment treatment regimens including sofosbuvir response was high, with 99% of patients showing response by the end of treatment.

Liver enzymes, aspartate aminotransferase and alanine aminotransferase, are known to have clinical significance in viral hepatitis and other forms of liver disease associated with hepatic necrosis [14]. In our analysis, albumin, serum glutamic pyruvic transaminase, and international normalized ratio were significantly improved by the end of treatment. This is in line with the findings of Elsharkawy et al. [15], as they noted decline in alanine aminotransferase and aspartate aminotransferase values after treatment, which may indicate the significant role of DAAs in improving hepatic inflammatory changes induced by viral infection. This constitutes one of the goals of therapy of chronic HCV as stated in the European Association for the Study of the Liver guidelines published in 2015 [16].

In our research, we found that there was no significant difference regarding TSH and free T4, before and after treatment with new DAA. In accordance with our findings, Pastore et al. [17] suggested that the availability of interferon-free combined treatment with DAAs for HCV is very promising, to ameliorate the patient compliance and to reduce the development of thyroid autoimmunity.


  Conclusion Top


Thyroid function in patients with persistent hepatitis C infections was not damaged with treatment with new DAAs for treatment of HCV.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 2014; 61(Suppl 1):S45–S57.  Back to cited text no. 1
    
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Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015: implications for future policy on prevention and treatment. Liver Int 2017; 37:45–53.  Back to cited text no. 4
    
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Ford N, Kirby C, Singh K, Mills EJ, Cooke G, Kamarulzaman A, et al. Chronic hepatitis C treatment outcomes in low- and middle-income countries: a systematic review and meta-analysis. Bull World Health Organ 2012; 90:540–550.  Back to cited text no. 7
    
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Mazziotti G, Sorvillo F, Morisco F, Carbone A, Rotondi M, Stornaiuolo G, et al. Serum insulin-like growth factor I evaluation as a useful tool for predicting the risk of developing hepatic-cellular carcinoma in patients with hepatitis C virus-related cirrhosis: a prospective study. Cancer 2002; 95:2539–2545.  Back to cited text no. 8
    
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Younossi ZM, Stepanova M, Nader F, Lam B, Hunt S. The patient's journey with chronic hepatitis C from interferon plus ribavirin to interferon- and ribavirin-free regimens: a study of health-related quality of life. Aliment Pharmacol Ther 2015; 42:286–295.  Back to cited text no. 9
    
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Goodman SN. Toward evidence-based medical statistics: the P- value fallacy. Ann Intern Med 1999; 130:995–1004.  Back to cited text no. 10
    
11.
Xianghong G, Guanping C, Fenghua Y, Jiayin W. Changes in platelet functional parameters and CD62 P expression in liver cirrhosis. Afr Health Sci 2013; 13:1079–1083.  Back to cited text no. 11
    
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Sherlock S, Dooley J. Malignant liver tumour. In: Sherlock S, Dooley J, editors. Disease of the liver and biliary system. 11th ed. Oxford, UK: Blackwell Science; 2002. 537–561.  Back to cited text no. 12
    
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Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013; 13:401–408.  Back to cited text no. 13
    
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Akhtar E, Manne V, Saab S. Cirrhosis regression in hepatitis C patients with sustained virological response after antiviral therapy. Liver Int 2015; 35:30–36.  Back to cited text no. 14
    
15.
Elsharkawy A, Eletreby R, Fouad R, Soliman Z, Abdallah M, Negm M, et al. Impact of different sofosbuvir based treatment regimens on the biochemical profile of chronic hepatitis C genotype 4 patients. Expert Rev Gastroenterol Hepatol 2017; 11:773–778.  Back to cited text no. 15
    
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European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C. J Hepatol 2015; 63:199–236.  Back to cited text no. 16
    
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Pastore F, Martocchia A, Stefanelli M, Prunas P, Giordano S, Toussan L, et al. Hepatitis C virus infection and thyroid autoimmune disorders: a model of interactions between the host and the environment. World J Hepatol 2016; 8:83–91.  Back to cited text no. 17
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]



 

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Abstract
Introduction
Patients and Methods
Statistics Analysis
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