Real-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience

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dc.authoridAtalay, Roni/0000-0002-3781-5110
dc.authoridKani, Haluk Tarik/0000-0003-0042-9256
dc.authoridsen, ilker/0000-0001-6230-5457
dc.authoridDanis, Nilay/0000-0002-3939-3089
dc.authoridCOSAR, Arif Mansur/0000-0002-4472-2895
dc.authoridGuzelbulut, Fatih/0000-0003-4889-208X
dc.authoridAkin, Mete/0000-0003-2393-7990
dc.contributor.authorDegertekin, Bulent
dc.contributor.authorDemir, Mehmet
dc.contributor.authorAkarca, Ulus S.
dc.contributor.authorKani, Haluk Tarik
dc.contributor.authorUcbilek, Enver
dc.contributor.authorYildirim, Emre
dc.contributor.authorGuzelbulut, Fatih
dc.date.accessioned2024-09-18T20:26:34Z
dc.date.available2024-09-18T20:26:34Z
dc.date.issued2020
dc.departmentHatay Mustafa Kemal Üniversitesien_US
dc.description.abstractBackground/Aims: This study aimed to evaluate the real-life efficacy and tolerability of direct-acting antiviral treatments for patients with chronic hepatitis C (CHC) with/without cirrhosis in the Turkish population. Material and Methods: A total of 4,352 patients with CHC from 36 different institutions in Turkey were enrolled. They received ledipasvir (LDV) and sofosbuvir (SOF)+/- ribavirin (RBV) ombitasvir/paritaprevir/ritonavir +/- dasabuvir (PrOD)+/- RBV for 12 or 24 weeks. Sustained virologic response (SVR) rates, factors affecting SVR, safety profile, and hepatocellular cancer (HCC) occurrence were analyzed. Results: SVR12 was achieved in 92.8% of the patients (4,040/4,352) according to intention-to-treat and in 98.3% of the patients (4,040/4,108) according to per-protocol analysis. The SVR12 rates were similar between the treatment regimens (97.2%-100%) and genotypes (95.6%-100%). Patients achieving SVR showed a significant decrease in the mean serum alanine transaminase (ALT) levels (50.90 +/- 54.60 U/L to 17.00 +/- 14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51 +/- 4.54 to 7.32 +/- 3.40) (p<0.05). Of the patients, 2 were diagnosed with HCC during the treatment and 14 were diagnosed with HCC 37.0 +/- 16.0 weeks post-treatment. Higher initial MELD score (odds ratio [OR]: 1.92, 95% confidence interval [CI]: 1.22-2.38; p=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95% CI: 1.31-2.28; p=0.038), and higher serum ALT levels (OR: 1.38, 95% CI: 1.21-1.83; p=0.042) were associated with poor SVR12. The most common adverse events were fatigue (12.6%), pruritis (7.3%), increased serum ALT (4.7%) and bilirubin (3.8%) levels, and anemia (3.1%). Conclusion: LDV/SOF or PrOD +/- RBV were effective and tolerable treatments for patients with CHC and with or without advanced liver disease before and after liver transplantation. Although HCV eradication improves the liver function, there is a risk of developing HCC.en_US
dc.description.sponsorshipTurkish Association for the Study of The Liver (TASL)en_US
dc.description.sponsorshipThe present study was supported by The Turkish Association for the Study of The Liver (TASL).en_US
dc.identifier.doi10.5152/tjg.2020.20696
dc.identifier.endpage893en_US
dc.identifier.issn2148-5607
dc.identifier.issue12en_US
dc.identifier.pmid33626001en_US
dc.identifier.scopus2-s2.0-85101318838en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage883en_US
dc.identifier.trdizinid453250en_US
dc.identifier.urihttps://doi.org/10.5152/tjg.2020.20696
dc.identifier.urihttps://search.trdizin.gov.tr/tr/yayin/detay/453250
dc.identifier.urihttps://hdl.handle.net/20.500.12483/10405
dc.identifier.volume31en_US
dc.identifier.wosWOS:000621603800007en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakTR-Dizinen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAvesen_US
dc.relation.ispartofTurkish Journal of Gastroenterologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectHCVen_US
dc.subjecttreatmenten_US
dc.subjectdirect-acting antiviralen_US
dc.subjectTurkeyen_US
dc.titleReal-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experienceen_US
dc.typeArticleen_US

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