High sustained virologic response in genotypes 3 and 6 with generic NS5A inhibitor and sofosbuvir regimens in chronic HCV in myanmar
Autor: | Soe Thiha Maung, Aung Hlaing Bwa, Sithu Lin, Sithu Sein Win, Naomi Khaing Than Hlaing, Moe Zaw Maung, Khin Thuzar Myint, K. Rajender Reddy, A. Mi Mi Kyaw, Khin Maung Win, Gayatri Nangia, Kyaw Thet Tun, Bao-Li Loza |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male medicine.medical_specialty Pyrrolidines Cirrhosis Daclatasvir Genotype Sustained Virologic Response Sofosbuvir Hepacivirus Myanmar Antiviral Agents Heterocyclic Compounds 4 or More Rings Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Virology Internal medicine Ribavirin medicine Humans 030212 general & internal medicine Adverse effect Aged Hepatology business.industry Imidazoles Valine Hepatitis C Chronic Middle Aged medicine.disease Clinical trial Regimen Infectious Diseases chemistry Drug Therapy Combination Female 030211 gastroenterology & hepatology Carbamates business medicine.drug |
Zdroj: | Journal of Viral Hepatitis. 26:1186-1199 |
ISSN: | 1365-2893 1352-0504 |
Popis: | Exclusive HCV therapy clinical trials with genotype 6 patients in high prevalence areas have been sparse. We analysed the safety and efficacy of two generic, pangenotypic NS5A/NS5B combination oral DAA regimens, primarily in genotypes 3 and 6, in a real-world setting: (a) daclatasvir/sofosbuvir (DCV/SOF) ± ribavirin (RBV) and (b) Velpatasvir/sofosbuvir (VEL/SOF ± RBV). Between December 2015 and November 2017, data from 522 patients were analysed, 311 of whom were treated with DCV/SOF ± RBV for 12/24 weeks (genotype 3: n = 193, genotype 6: n = 89) and 211 were treated with VEL/SOF ± RBV for 12/24 weeks (genotype 3: n = 83, genotype 6: n = 77). Overall SVR rates were high for both DCV/SOF ± RBV (96.1%, n = 299/311) and VEL/SOF ± RBV (95.3%, n = 201/211), and there was a good adverse event profile. Treatment naïve status and inclusion of RBV (in advanced fibrosis/cirrhosis) were significant independent predictors of achieving SVR12, while type of DAA regimen was not predictive. In this large cohort of genotypes 3 (n = 276) and 6 (n = 166; n = 127 unique subtype of 6c-l), high SVR rates of 94.9% (n = 262/276) and 95.2% (n = 158/166), respectively, were noted. In conclusion, generic and pangenotypic DCV/SOF and VEL/SOF ± RBV regimens were highly effective and safe, in genotypes 3 and 6 chronic HCV in Myanmar. These efficacious pangenotypic regimens suggest that baseline genotype testing can be eliminated moving forward. While RBV may still be needed for those with advanced fibrosis/cirrhosis, in a global elimination strategy it would not be practical even if it does compromise SVR in a minority with difficult to treat characteristics. |
Databáze: | OpenAIRE |
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