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

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.contributor.authorBalkan, Ayhan
dc.contributor.authorVatansever, Sezgin
dc.contributor.authorDanis, Nilay
dc.contributor.authorDemircan, Melek
dc.contributor.authorSoylu, Aliye
dc.contributor.authorYaras, Serkan
dc.contributor.authorKartal, Aysun
dc.contributor.authorKefeli, Ayse
dc.contributor.authorGunduz, Feyza
dc.contributor.authorYalcin, Kendal
dc.contributor.authorErarslan, Elife
dc.contributor.authorAladag, Murat
dc.contributor.authorHarputluoglu, Murat
dc.contributor.authorOzakyol, Aysegul
dc.contributor.authorTemel, Tuncer
dc.contributor.authorAkarsu, Mesut
dc.contributor.authorSumer, Hale
dc.contributor.authorAkin, Mete
dc.contributor.authorAlbayrak, Bulent
dc.contributor.authorSen, Ilker
dc.contributor.authorAlkim, Huseyin
dc.contributor.authorUyanikoglu, Ahmet
dc.contributor.authorIrak, Kader
dc.contributor.authorOztaskin, Sinem
dc.contributor.authorUgurlu, Cagri Burak
dc.contributor.authorGunes, Sevkican
dc.contributor.authorGurel, Selim
dc.contributor.authorNuriyev, Kenan
dc.contributor.authorInci, Ismail
dc.contributor.authorKacar, Sabite
dc.contributor.authorDincer, Dinc
dc.contributor.authorDoganay, Levent
dc.contributor.authorGokturk, Huseyin Savas
dc.contributor.authorMert, Ali
dc.contributor.authorCosar, Arif Mansur
dc.contributor.authorDursun, Hakan
dc.contributor.authorAtalay, Roni
dc.contributor.authorAkbulut, Sabiye
dc.contributor.authorBalkan, Yasemin
dc.contributor.authorKoklu, Hayrettin
dc.contributor.authorSimsek, Halis
dc.contributor.authorOzdogan, Osman
dc.contributor.authorCoban, Mehmet
dc.contributor.authorPoturoglu, Sule
dc.contributor.authorAyyildiz, Talat
dc.contributor.authorYapali, Suna
dc.contributor.authorGunsar, Fulya
dc.contributor.authorAkdogan, Meral
dc.contributor.authorOzenirler, Seren
dc.contributor.authorAkyildiz, Murat
dc.contributor.authorSezgin, Orhan
dc.contributor.authorOzdogan, Osman
dc.contributor.authorKaymakoglu, Sabahattin
dc.contributor.authorBesisik, Fatih
dc.contributor.authorKarasu, Zeki
dc.contributor.authorIdilman, Ramazan
dc.contributor.authorInter, T.A.S.L. Viral Hepatitis Special
dc.date.accessioned2023-02-21T12:42:45Z
dc.date.available2023-02-21T12:42:45Z
dc.date.issued2020-01-01
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
dc.description.abstractp=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95\% CI: 1.31-2.28
dc.description.abstractp=0.038), and higher serum ALT levels (OR: 1.38, 95\% CI: 1.21-1.83
dc.description.abstractp=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.issue12
dc.description.issueDEC
dc.description.pages883-893
dc.description.volume31
dc.identifier.doi10.5152/tjg.2020.20696
dc.identifier.urihttps://hdl.handle.net/11443/2845
dc.identifier.urihttp://dx.doi.org/10.5152/tjg.2020.20696
dc.identifier.wosWOS:000621603800007
dc.publisherAVES
dc.relation.ispartofTURKISH JOURNAL OF GASTROENTEROLOGY
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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