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.authorid0000-0001-8945-2385
dc.contributor.authorDeğertekin, Bülent
dc.contributor.authorDemir, Mehmet
dc.contributor.authorAkarca, Ulus S.
dc.contributor.authorKani, Haluk Tarık
dc.contributor.authorÜçbilek, Enver
dc.contributor.authorYıldırım, Emre
dc.contributor.authorGüzelbulut, Fatih
dc.contributor.authorBalkan, Ayhan
dc.contributor.authorVatansever, Sezgin
dc.contributor.authorDanış, Nilay
dc.contributor.authorDemircan, Melek
dc.contributor.authorSoylu, Aliye
dc.contributor.authorYaraş, Serkan
dc.contributor.authorKartal, Aysun
dc.contributor.authorKefeli, Ayşe
dc.contributor.authorGündüz, Feyza
dc.contributor.authorYalçın, Kendal
dc.contributor.authorErarslan, Elife
dc.contributor.authorAladağ, Murat
dc.contributor.authorHarputluoğlu, Murat
dc.contributor.authorÖzakyol, Ayşegül
dc.contributor.authorTemel, Tuncer
dc.contributor.authorAkarsu, Mesut
dc.contributor.authorSümer, Hale
dc.contributor.authorAkın, Mete
dc.contributor.authorAlbayrak, Bülent
dc.contributor.authorŞen, İlker
dc.contributor.authorAlkım, Hüseyin
dc.contributor.authorUyanıkoğlu, Ahmet
dc.contributor.authorIrak, Kader
dc.contributor.authorÖztaşkın, Sinem
dc.contributor.authorUğurlu, Çağrı Burak
dc.contributor.authorGüneş, Şevkican
dc.contributor.authorGürel, Selim
dc.contributor.authorNuriyev, Kenan
dc.contributor.authorİnci, İsmail
dc.contributor.authorKaçar, Sabite
dc.contributor.authorDinçer, Dinç
dc.contributor.authorDoganay, Levent
dc.contributor.authorGöktürk, Hüseyin Savaş
dc.contributor.authorMert, Ali
dc.contributor.authorCoşar, Arif Mansur
dc.contributor.authorDursun, Hakan
dc.contributor.authorAtalay, Roni
dc.contributor.authorAkbulut, Sabiye
dc.contributor.authorBalkan, Yasemin
dc.contributor.authorKöklü, Hayrettin
dc.contributor.authorŞimşek, Halis
dc.contributor.authorÖzdoğan, Osman
dc.contributor.authorÇoban, Mehmet
dc.contributor.authorPoturoğlu, Şule
dc.contributor.authorAyyıldız, Talat
dc.contributor.authorYapalı, Suna
dc.contributor.authorGünşar, Fulya
dc.contributor.authorAkdoğan, Meral
dc.contributor.authorÖzenirler, Seren
dc.contributor.authorAkyıldız, Murat
dc.contributor.authorSezgin, Orhan
dc.contributor.authorÖzdoğan, Osman
dc.contributor.authorKaymakoğlu, Sabahattin
dc.contributor.authorBeşışık, Fatih
dc.contributor.authorKarasu, Zeki
dc.contributor.authorİdilman, Ramazan
dc.date.accessioned2021-03-04T08:37:46Z
dc.date.available2021-03-04T08:37:46Z
dc.date.issued2020
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı
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.
dc.description.sponsorshipTurkish Association for the Study of The Liver (TASL)en_US
dc.identifier.citationDeğertekin, B., Demir, M., Akarca, U. S., Kani, H. T., Üçbilek, E., Yıldırım, E. ... İdilman, R. (2020). Real-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir +/- Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology, 31(12), 883-893. https://dx.doi.org/10.5152/tjg.2020.20696
dc.identifier.doi10.5152/tjg.2020.20696
dc.identifier.endpage893
dc.identifier.issn1300-4948
dc.identifier.issn2148-5607
dc.identifier.issue12
dc.identifier.scopusqualityQ3
dc.identifier.startpage883
dc.identifier.urihttps://dx.doi.org/10.5152/tjg.2020.20696
dc.identifier.urihttps://hdl.handle.net/20.500.12511/6598
dc.identifier.volume31
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherAVES
dc.relation.ispartofTurkish Journal of Gastroenterologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectHCV
dc.subjectTreatment
dc.subjectDirect-Acting Antiviral
dc.subjectTurkey
dc.titleReal-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir +/- Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience
dc.typeArticle

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