Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected with genotype 1 hepatitis C virus: A multicenter study
Autor: | Sang Hoon Ahn, Nagir Choijamts, Kwang Hyub Han, Damba Enkhtuya, Jamiyandorj Otgonbold, Jazag Amarsanaa, Baljinnyam Gegeebadrakh, Do Young Kim, Jae Seung Lee, Chuluunbaatar Gantuul, Nyamsuren Naranzul, Galsan Ulzmaa, Oidov Baatarkhuu, Radnaa Otgonbayar, Narangerel Tuvshinbayar, Bat Ulzii Saruul, Purev Batbayar, Dorjgotov Badamsuren |
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Rok vydání: | 2020 |
Předmět: |
Ledipasvir
Male real-world medicine.medical_specialty ledipasvir Cirrhosis Sofosbuvir Genotype Hepatitis C virus Hepacivirus medicine.disease_cause Gastroenterology Antiviral Agents 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine medicine Humans 030212 general & internal medicine lcsh:RC799-869 Rapid Virologic Response Molecular Biology Fluorenes Hepatology business.industry Ribavirin Hepatitis C Mongolia Middle Aged Hepatitis C Chronic medicine.disease Rash Lediapsvir Treatment Outcome Editorial chemistry lcsh:Diseases of the digestive system. Gastroenterology 030211 gastroenterology & hepatology Benzimidazoles Drug Therapy Combination Female medicine.symptom business medicine.drug |
Zdroj: | Clinical and Molecular Hepatology Clinical and Molecular Hepatology, Vol 27, Iss 1, Pp 125-135 (2021) |
ISSN: | 2287-285X |
Popis: | Background/Aims: Ledipasvir/sofosbuvir (LDV/SOF) shows high efficacy and safety in patients with genotype 1-hepatitis C virus (HCV). We aimed to investigate the efficacy and safety of LDV/SOF in real-world Mongolian patients.Methods: Between 2015 to 2019, 23 (0.5%) and 5,005 patients (99.5%) with genotype 1a and 1b HCV, respectively, were treated with a fixed-dose tablet containing 90 mg ledipasvir and 400 mg sofosbuvir for 12 weeks, and 81 patients (1.6%) with previous experience of interferon (IFN)-based treatment received additional 1,000 mg ribavirin. HCV RNA was measured at 4, 12, and 24 weeks after the first dose to determine rapid virologic response, end of treatment response (ETR), and sustained virologic response at 12 weeks after end of treatment (SVR12).Results: Most patients (n=5,008; 99.6%) achieved ETR and SVR12 without virologic relapse. Patients with genotype 1a showed low rates of ETR and SVR12 in only 16 patients (69.6%). There was no significant difference in SVR12 rate between patients regardless of IFN experience (n=81; 1.6%), cirrhosis (n=1,151; 22.9%), HCV RNA >6×106 IU/mL (n=866; 17.2%), or liver stiffness >9.6 kPa (n=1,721; 34.2%) (100.0%, 99.3%, 99.4%, and 99.4%, respectively). No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE. The most common AEs were headache (n=472; 9.4%), fatigue (n=306; 6.2%), abdominal discomfort (n=295; 5.9%), and skin rash (n=141; 2.8%).Conclusions: LDV/SOF showed high efficacy and safety for patients with genotype 1, especially 1b HCV, in Mongolia. The real-world data might be applicable to patients in other Asian-Pacific countries. |
Databáze: | OpenAIRE |
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