EFFICACY OF SOFOSBUVIR/DACLATASVIR IN CIRRHOTIC AND NON-CIRRHOTIC PATIENTS WITH HCV GENOTYPE 4 INFECTION AT A SPECIALIST HOSPITAL.
Main Article Content
Keywords
Hepatitis, Cirrhosis, Daclatasvir, Sofosbuvir, Sustained virological response
Abstract
Introduction: Untreated Hepatitis C virus infection can lead to cirrhosis, hepatocellular cancer and even death and increases liver disease related morbidity and mortality worldwide. Treatment with Direct Acting Antivirals offer cure over 90% with fewer side effects. Daclatasvir (DCV) and Sofosbuvir (SOF) combination in HCV GT4 infection has imparted higher rates of SVR after treatment with great tolerability.
This study assesses the effectiveness of this regimen in eradication of the HCV GT4 infection in treatment-naïve patients.
Methods: A retrospective study, conducted in our center between June 2017 and December 2020. Treatment protocol was given in treatment-naive HCV GT4 infected cirrhotics and noncirrhotics participants who were later followed for a total of 24 weeks for safety and efficacy of SOF-DCV. Data was analyzed using SPSS, and figures created using MS-Excel.
Results: We analyzed data of 124 participants with HCV GT 4 infection. Mean age was (54.04 +/- 16.39) Treatment regimen was given to 39 cirrhotic (F4) and 85 non-cirrhotic(F0-F3). SVR was seen in 98% of participants with tolerable side effects and improved MELD scores as fall in percentage seen from 46.1% to 40.5% in participant’s with MELD>10.
Discussion: This retrospective study confirms that SOF-DCV is safe and effective treatment regimen in HCV GT4 patients. The findings are consistent with findings of multiple clinical trials. Our study was conducted exclusively on HCV genotype 4 with good number of participants. Treatment completion was followed by high SVR12 rated and improvement in prognostic markers of liver disease in participants with compensated cirrhosis.
Conclusion: SOF-DCV combination showed efficacy in achieving the SVR12 in Child-Pugh B cirrhotic and noncirrhotic population with a favorable safety profile.
References
2. Alswaidi FM, O'Brien SJ. Is there a need to include HIV, HBV and HCV viruses in the Saudi premarital screening program on the basis of their prevalence and transmission risk factors? J Epidemiol Community Health 2010;64:989-97
3. Al Traif I, Al Balwi MA, Abdulkarim I, Handoo FA, Alqhamdi HS, Alotaibi M, et al. HCV genotypes among 1013 Saudi nationals: A multicenter study. Ann Saudi Med 2013;33:10-2
4. Gao M. Antiviral activity and resistance of HCV NS5A replication complex inhibitors. Curr Opin Virol 2013;3:514–20.
5. Sofia MJ, Bao D, Chang W, et al. Discovery of a β-d-20 -deoxy-20 -α-fluoro-20 -β-Cmethyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus. J Med Chem 2010;53:7202–18
6. Jessica Early, Maxted G. Am Fam Physician 2017;95(6).
7. Castéra L, Vergniol J, Foucher J, et al. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005;128(2):343-350.
8. Ziol M, Handra-Luca A, Kettaneh A, et al. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005;41(1):48-54.
9. Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008;48(5):835-847.
10. Ahmed Cordie, Aisha Elsharkawy, Shereen Abdel Alem , Safa Meshaalb, et al Sustained virologic response and changes in liver fibrosis parameters following 12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected patients with HCV genotype 4 infection. Trans R Soc Trop Med Hyg 2020; 114: 232–240
11. Lamiaa N Abdelaty, Ahmed A Elnaggar, Amira A Said, Raghda R S Hussein. Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients: Curr Drug Saf 2020;15(1):53-60
12. Hézode C, Abergel A, ChasJ, Conti F, Cotte L., Tateo M, et al. Sustained virologic response to Daclatasvir and Sofosbuvir with or without Ribavarin, among patients in the French Daclatasvir ATU programme infected with HCV genotypes 4, 5 and 6. EASL meeting 2016 Poster SAT‑131
13. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post‑liver transplantation recurrence. Hepatology 2016;63:1493‑505
14. Sulkowski MS, Gardiner DF, Rodriguez‑Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014;370:211‑21
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Dr. Shivananda Murgod E
King Fahad Specialist Hospital-Buraydah, General Directorate of health affairs in Qassim region, Saudi Arabia, Specialist gastroenterologist,
Dr Sumaira Ahmed
Specialist Gastroenterologist Department of Gastroenterology and Hepatology, King Fahad Specialist Hospital – Buraydah, King Abdullah Rd. An Naziyah SA, 52366,Buraydah, KSA
Dr Ahmed Shoqueer
Specialist Gastroenterologist King Fahad Specialist Hospital-Buraydah, General Directorate of health affairs in Qassim region, Saudi Arabia, Specialist gastroenterologist
Dr. Majed Alharbi
Resident Internal medicine King Fahad Specialist Hospital-Buraydah, General Directorate of health affairs in Qassim region, Saudi Arabia, Specialist gastroenterologist
Dr Nawaf Almutairi
Consultant Gastroenterologist King Fahad Specialist Hospital-Buraydah, General Directorate of health affairs in Qassim region, Saudi Arabia, Specialist gastroenterologist
Dr. Abdullah Alqifari
Consultant Gastroenterologist King Fahad Specialist Hospital-Buraydah, General Directorate of health affairs in Qassim region, Saudi Arabia, Specialist gastroenterologist