Effectiveness and safety of Sofosbuvir and Daclatasvir in Treatment-Naïve non-Cirrhotic Hepatitis C Patients. A Prospective Study
DOI:
https://doi.org/10.47489/szmc.v40i2.948Keywords:
Hepatitis C, Sofosbuvir, Daclatasvir, Antiviral Agents, Viral LoadAbstract
Background: Hepatitis C virus (HCV) infection remains a major global health concern, particularly in South Asia, where genotype 3 is most common. When compared to interferon therapy, the introduction of direct-acting antivirals (DAAs), such as sofosbuvir and daclatasvir, has resulted in significantly higher cure rates and fewer or no side effects.
Objective: This research aimed to evaluate the safety and effectiveness of the sofosbuvir–daclatasvir combination in non-cirrhotic, treatment-naïve individuals with chronic HCV infection.
Methods: This prospective observational research was conducted from May to November 2025 at the medical outpatient department of Allied Hospital in Faisalabad. Convenience sampling was used to select 85 HCV RNA-positive individuals (20–60 years old) without cirrhosis. Daclatasvir (60 mg) and sofosbuvir (400 mg) were administered daily for 12 weeks to each patient. The effectiveness of the therapy was assessed using the sustained virological response at 12 weeks following the conclusion of treatment (SVR-12). Data analysis was done using SPSS version 23. For quantitative data, mean ± standard deviation was employed, whereas for qualitative variables, frequencies and percentages were used. Associations were evaluated using the chi-square test, with p < 0.05 being deemed statistically significant.
Results: The respondents were 63.5% male and 36.5% female, with an average age of 45.2 ± 8.1 years. The average BMI was 29.4 ± 3.5 kg/m². 82.4% (n = 70) of patients attained SVR-12 at 12 weeks after therapy, but 17.6% (n = 15) were still HCV RNA positive. Age, gender, BMI, and baseline viral load did not significantly correlate with treatment response (p>0.05). Fatigue (27.0%), headache (18.9%), and nausea (16.5%) were the most often reported side effects, the majority of which were minor. No significant adverse effects were observed.
Conclusion: The combination of sofosbuvir and daclatasvir is an effective and well-tolerated treatment option for treatment-naïve, non-cirrhotic patients with chronic hepatitis C, supporting its continued use in routine clinical practice, particularly in resource-limited settings.
References
Nadeem, S., Haide, A., Maryum, H., Fatima, M., Waqas, U., Maryum, F., & Baig, U. (2023). Validation of statistical quality controls to improve HCV detection: An efficient approach for accurate diagnosis. Annals of Hematology & Blood Disorders, 1(1). https://doi.org/10.33582/annhematolblooddisord.2023.1002
Khan, A., Nadir, A., Mushtaq, M. H., Junaid, K., Khan, A. M., Ali, H., Waqar, F., Khan, T. A., & Khan, A. A. (2020). Molecular epidemiology and genotype distribution of hepatitis C in Pakistan: A multicenter cross-sectional study. Infection, Genetics and Evolution, 84, 104372. https://doi.org/10.1016/j.meegid.2020.104372
Mahmud, S., Kanaani, Z. A., & Abu-Raddad, L. J. (2019). Characterization of the hepatitis C virus epidemic in Pakistan. BMC Infectious Diseases, 19(1), 1–11. https://doi.org/10.1186/s12879-019-4403-7
Wu, N., Rao, H., Yang, W., Gao, Z., Yang, R., Fei, R., Gao, Y., Qian, J., & Wei, L. (2020). Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chinese Medical Journal, 133(3), 253–259. https://doi.org/10.1097/cm9.0000000000000629
Shah, N. J., Kadla, S., Dar, M., Khan, B., Shah, A., Pathania, R., & Parveen, S. (2020). Outcome of hepatitis C patients in a community with predominant genotype 3 with standard-of-care treatment before and after advent of direct-acting antivirals: A retrospective-cum-prospective study. Indian Journal of Pharmacology, 52(5), 372–377. https://doi.org/10.4103/ijp.ijp_516_18
Yousaf, A., Ghafoor, A., Fatima, N., & Danish, M. (2021). Gender-specific frequency distribution of hepatitis C virus genotypes in Punjab province, Pakistan: A clinically significant descriptive cross-sectional study. Cureus.
https://doi.org/10.7759/cureus.17480
Meanwell, N. A., & Belema, M. (2019). The discovery and development of daclatasvir: An inhibitor of the hepatitis C virus NS5A replication complex. In M. Sofia (Ed.), HCV: The journey from discovery to a cure (Topics in Medicinal Chemistry, Vol. 32). Springer, Cham. https://doi.org/10.1007/7355_2018_47
Butt, Z., & Shah, S. M. A. (2019). Daclatasvir plus sofosbuvir with or without ribavirin in patients with chronic hepatitis C genotype 3a in a Pakistani population: A real-world experience. Pakistan Journal of Medical Sciences, 35(2), 409–413. https://doi.org/10.12669/pjms.35.2.668
Wyles, D., Poordad, F., Wang, S., Alric, L., Felizarta, F., Kwo, P., Maliakkal, B., Gordon, S. C., Reddy, K. R., Bernstein, D., et al. (2017). Glecaprevir/pibrentasvir for 8 or 12 weeks in HCV genotype 3 without cirrhosis: An integrated analysis. Journal of Hepatology, 67(2), 263–271. https://doi.org/10.1016/j.jhep.2017.03.021
Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study.Hepatology. 2015;61(4):1127–1135. https://doi.org/10.1002/hep.27726
Foster GR, Irving WL, Cheung MC, Walker AJ, Hudson BE, Verma S, et al. Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol. 2016;64(6):1224–1231.
https://doi.org/10.1016/j.jhep.2016.01.029
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. New Engl J Med. 2014;370:211–221. https://doi.org/10.1056/NEJMoa1306218
Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, et al.Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV infection and advanced liver disease. Hepatology. 2016;63(5):1430–1441 https://doi.org/10.1002/hep.28467
Curry MP, O’Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al.
Sofosbuvir and daclatasvir for treatment of HCV infection in patients with advanced liver disease.Gastroenterology. 2015;149(3):649–659. https://doi.org/10.1053/j.gastro.2015.05.010
European Association for the Study of the Liver (EASL). EASL recommendations on treatment of hepatitis C.J Hepatol. 2020;73(5):1170–1218. https://doi.org/10.1016/j.jhep.2020.08.018
World Health Organization.Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection.WHO. 2018 update. https://doi.org/10.2471/BLT.18.021600
Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Cornberg M, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, for treatment of HCV genotype 3 infection. J Hepatol. 2016;64(6):1349–1356. https://doi.org/10.1016/j.jhep.2016.01.035
Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT-450/r–ombitasvir and dasabuvir with ribavirin for hepatitis C genotype 1 infection. New Engl J Med. 2014;370:1973–1982.
https://doi.org/10.1056/NEJMoa1402869
Feld JJ, Jacobson IM, Hézode C, Asselah T, Ruane PJ, Gruener N, et al. Sofosbuvir and velpatasvir for HCV genotype 1–6 infection. New Engl J Med. 2015;373:2599–2607. https://doi.org/10.1056/NEJMoa1512610
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al.Sofosbuvir for hepatitis C genotype 2 or 3 infection New Engl J Med. 2013;368:1867–1877. https://doi.org/10.1056/NEJMoa1214854
Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3.New Engl J Med. 2014;370:1993–2001. https://doi.org/10.1056/NEJMoa1316145
Butt Z, Shah SMA, Ahmad W, Javed A, Khan AA. Daclatasvir plus sofosbuvir with or without ribavirin in patients with chronic hepatitis C genotype 3a in a Pakistani population: A real-world experience. Pak J Med Sci. 2019;35(2):409-413. doi:10.12669/pjms.35.2.668
European Association for the Study of the Liver (EASL). EASL recommendations on treatment of hepatitis C: Final update. J Hepatol. 2020;73(5):1170-1218. 1. doi:10.1016/j.jhep.2020.08.018
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