{"id":4429,"date":"2009-08-23T09:59:35","date_gmt":"2009-08-23T08:59:35","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=4429"},"modified":"2013-08-16T13:17:19","modified_gmt":"2013-08-16T13:17:19","slug":"bioavailability-of-thai-generic-lopinavirritonavir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/4429","title":{"rendered":"Bioavailability of Thai generic lopinavir\/ritonavir"},"content":{"rendered":"<p><strong>Polly Clayden, HIV i-Base<\/strong><\/p>\n<p><strong>A poster authored by J van der Lugt and coworkers from Thailand and the Netherlands described pharmacokinetic (PK) data and short-term safety of a generic lopinavir\/ritonavir (LPV\/r) 200\/50mg formulation tablet.<\/strong> [1]<\/p>\n<p>In this study, patients receiving PI based therapy with viral load &lt;50 copies\/mL were switched to generic LPV\/r 400\/100mg twice daily. Trough concentrations (Cmin) were measured prior to the switch in 16 patients receiving Kaletra and 4 weeks after the switch in all patients.<\/p>\n<p>Plasma levels of LPV and RTV were measured using high performance liquid chromatography with a lower limit of quantification of 0.1mg\/L for LPV and 0.045mg\/L for RTV.<\/p>\n<p>A group of 37 patients were evaluated in this study; their mean (SD) weight was 60.3 (11.8) kg and18 were women. Two patients discontinued the study medications due to intolerance.<\/p>\n<p>The investigators reported the mean (SD) Cmin of LPV was 7.3 (1.8) mg\/mL. None of the patients evaluated had subtherapeutic levels. They found no difference in LPV Cmin in patients receiving Kaletra before switching to the generic formulation of LPV\/r, p=0.21. However, the Cmin of the generic RTV was higher than that reported for Kaletra, p=0.019. They found the coefficient of variation was 25% for the tablet formulation and 54% for the Kaletra. They noted that these values did not appear to be affected by food intake.<\/p>\n<p>They concluded: \u0093These data support the efforts in scaling up access to generic second line treatment in middle and low income countries.\u0094<\/p>\n<h3>Comment<\/h3>\n<p><strong>There are currently limited protease inhibitors available for second line treatment in low and middle-income countries. Although originator LPV\/r (Kaletra\/Aluvia) is the most common protease inhibitor in industrialised countries, generic LPV\/r is not widely used in resource limited settings as there have been concerns about the quality (including studies by the originator company) and limited data. [2]<\/strong><\/p>\n<p><strong>These data are reassuring, as is the FDA tentative approval in March this year of Indian generic versions of LPV\/r manufactured by Aurobindo and Matrix Laboratories. [3]<\/strong><\/p>\n<p><strong>Studies of a paediatric \u0093sprinkle\u0094 formulation from Cipla are underway.<\/strong><\/p>\n<p>References:<\/p>\n<ol>\n<li>van der Lugt J et al. Bioavailability of generic lopinavir\/ritonavir in HIV-1 infected individuals. 10th International Workshop on Clinical Pharmacology of HIV Therapy, 15-17 April 2009, Amsterdam. Abstract P_41.<\/li>\n<li>Garren KW et al. Bioavailability of Generic Ritonavir and Lopinavir\/ritonavir Tablet Products in a Dog Model Abbott Laboratories, Abbott Park, IL. 2nd International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource-Poor Settings, 20-23 May 2008, Dakar, Senegal.<\/li>\n<li><a href=\"http:\/\/www.fda.gov\/InternationalPrograms\/FDABeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm\">http:\/\/www.fda.gov\/InternationalPrograms\/FDA BeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base A poster authored by J van der Lugt and coworkers from Thailand and the Netherlands described pharmacokinetic (PK) data and short-term safety of a generic lopinavir\/ritonavir (LPV\/r) 200\/50mg formulation tablet. [1] In this study, patients receiving &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[133],"class_list":["post-4429","post","type-post","status-publish","format-standard","hentry","category-conference-reports","tag-pk-workshop-10th-2009"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4429","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=4429"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4429\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=4429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=4429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=4429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}