RESUMEN

BACKGROUND: Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) for hepatitis C virus (HCV) in patients with or without human immunodeficiency virus (HIV) coinfection. AIM: To evaluate the effectiveness and safety of generic VEL/SOF-based therapy for HCV infection in patients with or without HIV coinfection in Taiwan. METHODS: Sixty-nine HIV/HCV-coinfected and 159 HCV-monoinfected patients receiving 12 weeks of generic VEL/SOF with or without ribavirin (RBV) for HCV were prospectively enrolled. The anti-viral responses and the adverse events (AEs) were compared between the two groups. The characteristics potentially related to sustained virological response 12 weeks off therapy (SVR12 ) were analysed. RESULTS: The SVR12 was achieved in 67 HIV/HCV-coinfected patients (97.1%; 95% CI: 90.0%-99.2%) and in 156 HCV-monoinfected patients (98.1%; 95% CI: 94.6%-99.4%) receiving VEL/SOF-based therapy, respectively. The SVR12 rates were comparable between HIV/HCV-coinfected and HCV-monoinfected patients, regardless of pre-specified baseline characteristics. One hundred twenty-two (53.5%) and seven (3.1%) patients had baseline resistance-associated substitutions (RASs) in HCV NS5A and NS5B regions, but the SVR12 rates were not affected by the presence or absence of RASs. One (1.4%) and five (3.1%) patients in the HIV/HCV-coinfected and HCV-monoinfected groups had serious AEs. No patient died or discontinued treatment due to AEs. The eGFR remained stable throughout the course of treatment in HIV/HCV-coinfected patients receiving anti-retroviral therapy containing tenofovir disoproxil fumarate (TDF). CONCLUSIONS: Generic VEL/SOF-based therapy is well-tolerated and provides comparably high SVR12 rates for HCV infection in patients with and without HIV coinfection.

Asunto(s)

Antivirales/administración & dosificación , Carbamatos/administración & dosificación , Hepatitis C/tratamiento farmacológico , Compuestos Heterocíclicos de 4 o más Anillos/administración & dosificación , Sofosbuvir/administración & dosificación , Adulto , Anciano , Antivirales/uso terapéutico , Coinfección , Combinación de Medicamentos , Femenino , Infecciones por VIH/tratamiento farmacológico , Hepacivirus/aislamiento & purificación , Humanos , Masculino , Persona de Mediana Edad , Ribavirina/uso terapéutico , Respuesta Virológica Sostenida , Taiwán , Tenofovir/uso terapéutico , Resultado del Tratamiento

RESUMEN

This work detects protonated molecular ions of highly reactive pyrolytic products--cyclopentadienylideneketene, cyclohexadienylideneketenimine, and acetylketene--using a flow pyrolyzer connected to a multiple-channel electrospray mass spectrometry. The ketene generated in the flow pyrolyzer is directly conducted into the central channel of a seven-channel electrospray ionization source by a stream of nitrogen gas. Concurrently, a methanol solution containing 0.1% trifluoroacetic acid is electrosprayed through the outside six channels. The protonated methanol ions and the charged droplets generated from the outside six electrospray channels facilitate the ionization of the neutral ketenes through ion-molecule reactions or absorption followed by protonation.