Safety and efficacy of directly acting antivirals in patient with hcv infection on haemodialysis

1. Efficacy and Safety of Directly Acting Antivirals in
Patients with Hepatitis C Infection on Hemodialysis
MODERATOR :- DR.POOJA NAIK
SENIOR RESIDENT ,KIMS KOPPAL
STUDENT:-DR.SRINIVAS JAYANTHUR
1ST YEAR POSTGRADUATE STUDENT
KIMS KOPPAL

2. • PUBLISHED IN :- Journal of Association of Physicians of India
• PUBLISHED ON :- APRIL 25, 2023
AUTHORS; Manisha Sahay, Priyashree, Kiranmai Ismal, K Anuradha , Jyoti Lakshmi
STUDY TYPE:- PROSPECTIVE COHORT STUDY
• STUDY DURATION ; January 2019 to December 2020
• STUDY PLACE :-Trial was conducted at Tertiary care hospital

3.  INTRODUCTION
 NEED FOR THE STUDY
 METHODOLOGY
 RESULTS
 DISCUSSION
 LIMITATIONS
 STRENGTHS OF THE STUDY
 CONCLUSION
 CRITICAL ANALYSIS

4. INTRODUCTION
The prevalence of hepatitis C virus (HCV) is high among patients on maintenance hemodialysis
(MHD) due to nosocomial transmission of infection and multiple blood transfusions during HD
Apart from the increased liver-related morbidity and higher cardiovascular risk in dialysis, the
persistence of infection after kidney transplantation is associated with increased mortality and graft
dysfunction
With the advent of newer direct-acting antivirals (DAA), the treatment of HCV infection has become
simple, finite, and impressively effective with sustained virological response (SVR) rates of >95%.

5. NEED FOR THE STUDY
To study the efficacy of full dose Sofusbivir in Endstage renal disease patients on MHD

6. METHODOLOGY
•STUDY DESIGN:-
•The data were analyzed descriptively using percentages, means, and standard deviations.
•Tests of significance were performed using independent student t-tests and χ2 analyses as
appropriate for the variables used in the comparisons

7. METHODOLOGY
STUDY POPULATION:-
Inclusion criteria :-
All patients above 15 years of age with HCV infection with ESRD who were undergoing MHD

8. METHODOLOGY
•STUDY POPULATION:-
Exclusion criteria:-
•Coninfected with HBV, HIV
•Patients on Antiepileptics,immunosuppresants,chemotheraupetic drugs and antiarrythmic
•Previous h/o treatment with DAA/interferon
•Pregnant woman
•

9. METHODOLOGY
•STATISTICAL ANALYSIS:
•The level of significance was set at 0.05
•All analyses were done with the Statistical Package for the Social Sciences for Windows (version
16; SPSS, Chicago, Illinois).

10. RESULT
A total of 54 patients with chronic kidney disease (CKD) on MHD with HCV were studied in this period of 2 years.
Hypertension was present in 83.3% patients and a history of coronary artery disease was present in 7.4%
HCV genotype 1 was the most common, seen in 75.9% followed by genotype 3–24.07% of the patients.
The median HCV RNA load (performed by Quantiplus HCV RT-PCR kit) was 2,83,894.5 IU/mL with a range of 18.7–
7834124 IU/mL
Fibrosis of liver assessment with FibroScan showed 55.5% (n = 30) had fibrosis and 16.6% (n = 09) patients had cirrhosis.
Patients with the presence of fibrosis or cirrhosis 72.2% were treated with FDC of sofosbuvir and velpatasvir. The
remaining 27.7% of patients received sofosbuvir and daclatasvir

11. RESULT
Among this, all patients who received sofosbuvir + velpatasvir achieved SVR-12.
Two patients (4.1%) in the sofosbuvir + daclatasvir group did not achieve SVR-12.
Six patients succumbed in the study period before the measurement of SVR-12.
All deaths were related to severe COVID-19 infection with multiorgan dysfunction.

12. Baseline characterstics of participants in
the study trial

13. Changes associated Various parameters

14. COMPARISON OF EFFICACY FINDINGS OF VARIOUS
STUDIES

15. DISCUSSION
Although HCV infection is curable in the general population, there is still hesitancy in treating patients with MHD in this part of the world
due to the nonavailability of recommended drugs and the fear of renal adverse events.
In this study, National hepatitis C guidelines were followed in the management of HCV infection in ESRD patients on MHD
Our study showed an SVR of 95.6% with only two patients not attaining SVR. Both patients had genotype 1 with no fibrosis and were
treated with daclatasvir
 Initial studies have shown the worsening of renal function with sofosbuvir rbased regimens in patients with moderate renal insufficiency.14
However, it is difficult to attribute it to drug per se and may be related to the natural dynamic course of CKD itself
It is important to note that the adverse events were more common in patients with advanced liver disease and patients with prior treatment
failure who may require a longer duration of treatment or the addition of ribavirin
Due to the lower number of patients in DAA failed cases (n = 2), a multivariate analysis could not be performed to find predictors for
nonattainment of SVR

16. LIMITATIONS
Small sample size
Single-center study,
Nonestimation of sofosbuvir and its metabolites to correlate side effects

17. CONCLUSION
The use of full-dose sofosbuvir with velpatasvir or daclatasvir with excellent efficacy
and safety in patients with ESRD on MHD

18. FUNDING
None

19. REFERENCES
1. Jadoul M, Bieber BA, Martin P, et al. Prevalence, incidence, and risk factors for hepatitis C
virus infection in hemodialysis patients. Kidney Int 2019;95(4):939–9472
2.. Jasuja S, Gupta AK, Choudhry R, et al. Prevalence and associations of hepatitis C viremia in
hemodialysis patients at a tertiary care hospital. Indian J Nephrol 2009;19(2):62–67.5.
3 Agarwal SK, Dash SC, Irshad M. Hepatitis C infection during haemodialysis in India. J Assoc
Physicians India 1999;47(12):1139–11436.
4. Fabrizi F, Martin P, Dixit V, et al. Meta-analysis: effect of hepatitis C virus infection on
mortality in dialysis. Aliment Pharmacol Ther 2004;20(11-12):1271–1277
5.. National Guidelines for Diagnosis and Management of viral Hepatitis, Issued by the Govt of
India, Ministry of. Health & Family Welfare 2018.

20. REFERENCES(cont..)
6.Hundemer GL, Sise ME, Wisocky J, et al. Use of sofosbuvir-based direct-acting antiviral
therapy for hepatitis C viral infection in patients with severe renal insufficiency. Infect Dis (Lond)
2015;47(12):924–929

21. CRITICAL ANALYSIS
Title
Materials & Methods
Results
Limitations
Discussion & Conclusion
General considerations & implications

22. THANK YOU