PMID- 32412901 OWN - NLM STAT- MEDLINE DCOM- 20211008 LR - 20211008 IS - 2148-5607 (Electronic) IS - 1300-4948 (Print) IS - 1300-4948 (Linking) VI - 31 IP - 4 DP - 2020 Apr TI - Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience. PG - 305-317 LID - 10.5152/tjg.2020.19197 [doi] AB - BACKGROUND/AIMS: mbitasvir/paritaprevir/ritonavir (OMV/PTV/r) +/- dasabuvir (DSV) +/- ribavirin (RBV) combination has demonstrated excellent rates of sustained virologic response (SVR) and a very good safety profile in patients with the chronic hepatitis C virus (HCV) genotype 1 or 4 infections. We aimed to investigate the effectiveness and safety of OMV/PTV/r +/- DSV +/- RBV combination regimen in a real-world clinical practice. MATERIALS AND METHODS: Data from HCV genotype 1 and 4 patients treated with OMV/PTV/r +/- DSV +/- RBV (n=862) in 34 centers across Turkey between April 1, 2017 and August 31, 2018 were recorded in a large national database. Demographic, clinical, and virologic data were analyzed. RESULTS: The mean age of the patients was 55.63, and 430 patients (49.9%) were male. The majority had HCV genotype 1b infection (77.3%), and 66.2% were treatment-naive. Non-cirrhosis was present at baseline in 789 patients (91.5%). SVR12 rate was 99.1% in all patients. Seven patients had virologic failure. No significant differences were observed in SVR12 according to HCV genotypes. HCV RNA was undetectable at treatment week 4 in 90.9%, at treatment week 8 in 98.5%, and at the end of treatment (EOT) in 98.9%. SVR12 ratio was significantly higher in the non-cirrhotic patients compared to that in the compensated cirrhotic patients. Rates of adverse events (AEs) in the patients was 59.7%. CONCLUSION: The present real-life data of Turkey for the OBV/PTV/r +/- DSV +/- RBV treatment of patients with HCV genotype 1b, 1a, or 4 infection from 862 patients demonstrated high efficacy and a safety profile. FAU - Aygen, Bilgehan AU - Aygen B AD - Department of Infectious Diseases and Clinical Microbiology, Erciyes University School of Medicine, Kayseri, Turkey. FAU - Demirturk, Nese AU - Demirturk N AD - Department of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University School of Medicine, Afyonkarahisar, Turkey. FAU - Yildiz, Orhan AU - Yildiz O AD - Department of Infectious Diseases and Clinical Microbiology, Erciyes University School of Medicine, Kayseri, Turkey. FAU - Celen, Mustafa Kemal AU - Celen MK AD - Department of Infectious Diseases and Clinical Microbiology, Dicle University School of Medicine, Diyarbakir, Turkey. FAU - Celik, Ilhami AU - Celik I AD - Department of Infectious Diseases and Clinical Microbiology, Saglik Bilimleri University Kayseri Training and Research Hospital, Kayseri, Turkey. FAU - Barut, Sener AU - Barut S AD - Department of Infectious Diseases and Clinical Microbiology, Gaziosmanpasa University School of Medicine, Tokat, Turkey. FAU - Ural, Onur AU - Ural O AD - Department of Infectious Diseases and Clinical Microbiology, Selcuk University School of Medicine, Konya, Turkey. FAU - Batirel, Ayse AU - Batirel A AD - Department of Infectious Diseases and Clinical Microbiology, Saglik Bilimleri University Kartal Dr. Lutfu Kirdar Training and Research Hospital, Istanbul, Turkey. FAU - Mistik, Resit AU - Mistik R AD - Department of Infectious Diseases and Clinical Microbiology, Uludag University School of Medicine, Bursa, Turkey. FAU - Simsek, Funda AU - Simsek F AD - Department of Infectious Diseases and Clinical Microbiology, Okmeydani Training and Research Hospital, Istanbul, Turkey. FAU - Asan, Ali AU - Asan A AD - Department of Infectious Diseases and Clinical Microbiology, Saglik Bilimleri University Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey. FAU - Ersoz, Gulden AU - Ersoz G AD - Department of Infectious Diseases and Clinical Microbiology, Mersin University School of Medicine, Mersin, Turkey. FAU - Turker, Nesrin AU - Turker N AD - Department of Infectious Diseases and Clinical Microbiology, Katip Celebi University Ataturk Training and Research Hospital, Izmir, Turkey. FAU - Bilgin, Huseyin AU - Bilgin H AD - Department of Infectious Diseases and Clinical Microbiology, Marmara University School of Medicine, Istanbul, Turkey. FAU - Kinikli, Sami AU - Kinikli S AD - Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey. FAU - Karakecili, Faruk AU - Karakecili F AD - Department of Infectious Diseases and Clinical Microbiology, Erzincan University School of Medicine, Erzincan, Turkey. FAU - Zararsiz, Gokmen AU - Zararsiz G AD - Department of Biostatistics, Erciyes University School of Medicine, Kayseri, Turkey. FAU - Turkish Society Of Clinical Microbiology And Infectious Diseases, The Study Group For Viral Hepatitis Of The AU - Turkish Society Of Clinical Microbiology And Infectious Diseases TSGFVHOT LA - eng PT - Evaluation Study PT - Journal Article PL - Turkey TA - Turk J Gastroenterol JT - The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology JID - 9515841 RN - 0 (Anilides) RN - 0 (Antiviral Agents) RN - 0 (Cyclopropanes) RN - 0 (Lactams, Macrocyclic) RN - 0 (Sulfonamides) RN - 2302768XJ8 (ombitasvir) RN - 49717AWG6K (Ribavirin) RN - 56HH86ZVCT (Uracil) RN - 9DLQ4CIU6V (Proline) RN - CKR7XL41N4 (2-Naphthylamine) RN - DE54EQW8T1 (dasabuvir) RN - HG18B9YRS7 (Valine) RN - O3J8G9O825 (Ritonavir) RN - OU2YM37K86 (paritaprevir) SB - IM MH - 2-Naphthylamine/*administration & dosage MH - Adult MH - Aged MH - Aged, 80 and over MH - Anilides/administration & dosage MH - Antiviral Agents/*administration & dosage MH - Cyclopropanes/administration & dosage MH - Databases, Factual MH - Drug Therapy, Combination MH - Female MH - Genotype MH - Hepacivirus/*genetics MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Lactams, Macrocyclic/administration & dosage MH - Male MH - Middle Aged MH - Proline/administration & dosage/analogs & derivatives MH - Ribavirin/*administration & dosage MH - Ritonavir/administration & dosage MH - Sulfonamides/*administration & dosage MH - Sustained Virologic Response MH - Turkey MH - Uracil/administration & dosage/*analogs & derivatives MH - Valine/administration & dosage MH - Young Adult PMC - PMC7236650 COIS- Conflict of Interest: The authors have no conflict of interest to declare. EDAT- 2020/05/16 06:00 MHDA- 2021/10/09 06:00 PMCR- 2020/04/01 CRDT- 2020/05/16 06:00 PHST- 2020/05/16 06:00 [entrez] PHST- 2020/05/16 06:00 [pubmed] PHST- 2021/10/09 06:00 [medline] PHST- 2020/04/01 00:00 [pmc-release] AID - tjg-31-3-305 [pii] AID - 10.5152/tjg.2020.19197 [doi] PST - ppublish SO - Turk J Gastroenterol. 2020 Apr;31(4):305-317. doi: 10.5152/tjg.2020.19197.