{"id":3998,"date":"2000-12-17T10:30:22","date_gmt":"2000-12-17T10:30:22","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=3998"},"modified":"2014-07-01T11:05:00","modified_gmt":"2014-07-01T11:05:00","slug":"treatment-of-hiv-subjects-co-infected-with-hepatitis-b-or-c-safety-and-efficacy-comparison-of-abt-378r-versus-nelfinavir-from-a-phase-iii-blinded-randomised-clinical-trial","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/3998","title":{"rendered":"Treatment of HIV+ subjects co-infected with hepatitis B or C: safety and efficacy comparison of ABT 378\/r versus nelfinavir from a phase III blinded randomised clinical trial"},"content":{"rendered":"<p><strong>Andrew Moss, HIV i-Base<\/strong><\/p>\n<p><strong>This was a multicentre, international, double-blinded randomised study of 653 ARV &#8211; na\u00a5ve subjects treated with either ABT- 378\/r 400\/100 (n = 326) mg bid or NFV 750 mg tid (n = 327), each arm receiving d4T and 3TC in addition. Those with AST\/ALT &gt; 3 ULN at screening were excluded from the study. Fifty-seven (17%) ABT 378\/r and 68 (21%) NFV subjects were positive for Hep B surface antigen and\/or hepatitis C antibodies.<\/strong><\/p>\n<p>At week 40 94% of ABT378\/r and 82 % of NFV had HIV RNA levels &lt; 400 copies\/ml. Of those who were Hep B\/C positive 91% in the ABT-378\/r group and 76% in the NFV had HIV RNA &lt; 400 copies\/ml. Overall 4% of subjects across both groups developed Grade 3 \/ 4 elevations of AST\/ALT. Incidence of grade 3\/ 4 elevations in the Hep B\/C positive subjects were 6\/57 (12%) for ABT-378\/r and 13\/68 (20%) for the NFV group.<\/p>\n<p>Those who were Hep B\/C positive had a higher incidence of Grade 3 \/ 4 elevations of AST\/ALT than those who were B\/C negative, however there was no discontinuation due to elevated liver enzymes or clinical hepatitis. Efficacy and other safety results were generally similar in both B\/C positive and B\/C negative groups.<\/p>\n<h3>Comment<\/h3>\n<p><strong>No TDM data was shown for these individuals. It may of proven useful for those with Grade 3 \/ 4 elevations to see if they were outside the therapeutic range and whether dose adjustment would of helped.<\/strong><\/p>\n<p><strong>TDM has been useful in individual dosing of other PI&#8217;s for co-infected individuals and should be considered. However as ABT 378\/r is co formulated individualized dosing may prove more difficult. <\/strong><\/p>\n<p>Reference:<\/p>\n<p>J. Arribas, C. Barros, J. Gonzalez-Lahoz, W. Cameron, R. Rubio, F. Altice, B. Clotet, M. King, P. Cernohous, J. Moseley, M. Sattler, B. Bernstein and E. Sun for the M98- 863 study team.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Andrew Moss, HIV i-Base This was a multicentre, international, double-blinded randomised study of 653 ARV &#8211; na\u00a5ve subjects treated with either ABT- 378\/r 400\/100 (n = 326) mg bid or NFV 750 mg tid (n = 327), each arm receiving &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,24],"tags":[81],"class_list":["post-3998","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-hepatitis-coinfection","tag-hiv-5-glasgow-2000"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=3998"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3998\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=3998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=3998"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=3998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}