This is an\nopen label phase II\/III, multicenter, trial to assess the efficacy, safety,\ntolerance, and pharmacokinetics of sofosbuvir plus ravidasvir in HCV (+\/-HIV)\nchronically infected adults with no or compensated cirrhosis in Thailand and\nMalaysia<\/p>\n\n\n\n
Brief\nSummary: <\/strong>The study will\nassess the efficacy and safety of SOF-RDV across all genotypes, among\nnon-cirrhotic and cirrhotic with CTP class A, interferon\/ribavirin na\u00efve or\nexperienced, HCV mono-infected and HCV\/HIV co-infected subjects.<\/p>\n\n\n\n It\nwill also study the pharmacokinetics of RDV and, in HCV\/HIV co-infected\nsubjects, possible drug-drug interactions with antiretrovirals.<\/p>\n\n\n\n The\ntreatment duration will be 12 weeks for subjects with no cirrhosis (Metavir F0\nto F3) and 24 weeks for subjects with compensated cirrhosis (Metavir F4, CTP\nclass A). After enrollment of the first 300 evaluable patients is complete,\nenrollment will pause while data is being accumulated and analyzed.<\/p>\n\n\n\n After\nreview of interim results by the independent Data and Safety Monitoring Board\n(DSMB), and by the study Steering Committee, enrollment will resume.<\/p>\n\n\n\n Should\nmodification of the study design be required upon interim analysis, decision\nwill be taken by the study steering committee and the amended protocol or\nexpanded protocol will be submitted to the Ethics Committee for approval.<\/p>\n\n\n\n Results: <\/strong>Of the 25 subjects with intensive PK data: 21 were male (84%) and 21 non-cirrhotic (4 cirrhotic). Median age (range) was 49.2 (21.2-64.0) years, weight was 65.5 (46.2-88.3) kg and body mass index 23.3 (18.3-30.9) kg\/ m2<\/sup>. Median RDV AUC0-24h, Cmax and C24 were 17.3 (3.2-69.9) \u03bcg.hr\/mL, 2.3 (0.4-6.4) \u03bcg\/mL and 0.11 (0.03-1.63) \u03bcg\/mL, respectively. Sixty-five HIV\/HCV co-infected subjects were included: median age (range) was 42.9 (23.4-61.5) years and weight 62.0 (45.0-100) kg. Tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), efavirenz (EFV) and nevirapine (NVP) were the most commonly prescribed ARVs in HIV\/HCV co-infected patients. A total of 47 subjects had tenofovir (TFV) ARVs concentrations before and after SOF\/RDV treatment, 34 had FTC, 51 had EFV and 7 had NVP. Mid-dose tenofovir (TFV) concentrations were significantly higher with concomitant SOF\/RDV treatment, while mid-dose FTC, EFV and trough NVP concentrations were not significantly different. <\/p>\n\n\n\n (Source: Cressey TR, et al. Ravidasvir\npharmacokinetics and ARV drugs interactions in HCV+\/-HIV infected adults.\nAbstract #471. Presented at CROI 2018)<\/p>\n","protected":false},"excerpt":{"rendered":" \t\t\t\tThis is an open label phase II\/III, multicenter, trial to assess the efficacy, safety, tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir in HCV (+\/-HIV) chronically infected adults with no or compensated cirrhosis in Thailand and Malaysia\t\t<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-1843","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1843","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/comments?post=1843"}],"version-history":[{"count":2,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1843\/revisions"}],"predecessor-version":[{"id":3469,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1843\/revisions\/3469"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1843"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1843"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1843"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}