Effectiveness of Ledipasvir-Sofosbuvir 12 Weeks After Hepatitis C Virus Genotype 1 Infection and the Factors Associated With Sustained Virologic Response: A Retrospective Study.

Autor:	Alshoaibi IA; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Al-Gamli A; Pharmacy, University of Science and Technology, Ibb, YEM., Abdullah M; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Abdo B; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Alzanen KH; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Alhakamy M; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Al-Namer M; Internal Medicine, School of Medicine, Ibb University, Ibb, YEM., Ahmed F; Urology, School of Medicine, Ibb University, Ibb, YEM., Tamesh M; Pharmacy, University of Science and Technology, Ibb, YEM., Mahdi W; Pharmacy, University of Science and Technology, Ibb, YEM., Abdo Z; Pharmacy, University of Science and Technology, Ibb, YEM., Mohammed M; General Practice, School of Medicine, Ibb University, Ibb, YEM.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Aug 30; Vol. 16 (8), pp. e68249. Date of Electronic Publication: 2024 Aug 30 (Print Publication: 2024).
DOI:	10.7759/cureus.68249
Abstrakt:	Background: The combination of ledipasvir and sofosbuvir (LDV/SOF) has been licensed to treat genotype 1 hepatitis C virus infection (HCV) with a 12-week regimen. However, there is scant data from Yemen regarding this combination regimen. Here, we investigate sustained virologic responses (SVR) 12 weeks after HCV treatment with LDV/SOF regimens and the factors that contribute to SVR failure. Material and Method: A retrospective cross-sectional study was conducted at Althora General Hospital in Ibb, Yemen, from June 1, 2019, to October 31, 2022, on 53 cases with HCV genotype 1 infection who received combined therapy of LDV/SOF and completed treatment for 12 weeks. The clinical characteristics and treatment follow-up were obtained from patient medical records. Factors associated with SVR failure were investigated in univariate analysis with odds ratio (OR) and 95% confidence interval (CI). Result: The mean age was 50 ± 15.3 years, and most cases were female (n=36, 67.9%). Comorbidities were diabetes, hypertension, and fatty liver, which were represented in 12 (22.6%), nine (17.0%), and eight (15.1%) cases, respectively. A total of 13 (24.5%) patients had compensated liver cirrhosis, while the remaining 40 patients (75.5%) were non-cirrhotic healthy individuals. The baseline viral load (HCV RNA) was more than 800000 IU/mL in 21 patients (39.6%). Early virological response (ERV) was achieved in 51 patients (96.2%). After treatment, 46 of the patients (86.8%) achieved SVR at Week 12, while failure occurred in two patients (3.8%) and relapse occurred in five patients (9.4%). Blood liver enzymes, including alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase, returned to normal, with statistically significant improvements in non-cirrhotic healthy persons than compensated liver cirrhosis individuals (p= 0.006, 0.006, and 0.010; respectively). Factors associated with SVR failure were older age (OR:1.13; 95% CI: 1.03-1.30, p=0.009), presence of liver cirrhosis (OR: 5.48; 95% CI: 1.04-28.98, p=0.031), having diabetes (OR: 6.33; 95% CI: 1.19-37.93, p= 0.019), baseline higher viral load (OR: 2.27; 95% CI: 0.45-12.73, p<0.001), and not achieving EVR (OR:7.63; 95% CI: 3.77- 17.78, p= 0.009). Conclusion: In this study, we found that LDV/SOF regimens are effective against HCV genotype one infection, allowing for the expansion of 12-week treatment for suitable patients in clinical settings. Additionally, older age, liver cirrhosis, diabetes, higher pretreatment viral load, and non-completion of EVR were associated with SVR failure. However, due to the small number of HCV genotype 1 infected individuals in this study, more corporate data is required to get a clear conclusion. Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Ibb University Institutional Ethics Committee issued approval IBBUNI. AC. YEM. 2024.01.77. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Alshoaibi et al.)
Databáze:	MEDLINE
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