{"id":31,"date":"2008-07-25T16:48:46","date_gmt":"2008-07-25T21:48:46","guid":{"rendered":"http:\/\/blogs.nejm.org\/pov\/hiv-id-observations\/index.php\/2008\/07\/25\/word-salad-jalapenos-abacavir-doripenem-and-pave\/"},"modified":"2008-07-25T16:48:46","modified_gmt":"2008-07-25T21:48:46","slug":"word-salad-jalapenos-abacavir-doripenem-and-pave","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/word-salad-jalapenos-abacavir-doripenem-and-pave\/2008\/07\/25\/","title":{"rendered":"Word salad:  Jalapenos, abacavir, doripenem, and PAVE"},"content":{"rendered":"<p>Some miscellaneous recent items from the ID\/HIV world jumbling around this Friday:<\/p>\n<ul>\n<li>Tomatoes are off the hook &#8212; <a href=\"http:\/\/www.fda.gov\/oc\/po\/firmrecalls\/agricola_zaragoza07_08.html\">it&#8217;s the jalapenos that likely caused the recent salmonella outbreak<\/a>.\u00a0 Since this is the only time of year that tomatoes are even edible in this part of the world, I for one am quite relieved.\u00a0\u00a0I am sure many are wondering\u00a0<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/9586227?ordinalpos=1&amp;itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVLinkOut\">how bacteria could survive on those very hot peppers<\/a>.<\/li>\n<li><a href=\"http:\/\/www.nytimes.com\/2008\/07\/24\/business\/24gene.html?_r=1&amp;scp=1&amp;sq=abacavir&amp;st=cse&amp;oref=slogin\">HLA-B*5701 testing is now &#8220;officially&#8221; recommended before abacavir use <\/a>to reduce the risk of hypersensitivity &#8212; it&#8217;s now in the package insert.\u00a0 We started doing this test two years ago (at the strong encouragement of some British and Australian colleagues), and it\u00a0makes all the difference in the world when prescribing this drug &#8212; the counseling to patients about the safety of abacavir drops from a 30-minute terrifying review of possible death to a 5-minute, &#8220;this could happen, but it won&#8217;t.&#8221;\u00a0 Two further thoughts:\u00a0 1) It&#8217;s too bad\u00a0we didn&#8217;t have this tool available sooner (likely lots of debate within the boardrooms of the manufacturer on the pros and cons from a sales perspective); and, 2) Let&#8217;s hope that other companies can learn from this lesson and, if such tests are potentially available to improve patient safety, they move ahead quickly to validate them.<\/li>\n<li>Oh, and <a href=\"http:\/\/us.gsk.com\/products\/assets\/us_ziagen_tablets.pdf\">the other abacavir label change <\/a>is related to the DAD data and the\u00a0possible association between abacavir use\u00a0and cardiac disease.\u00a0 Not much has changed <a href=\"http:\/\/blogs.nejm.org\/pov\/hiv-id-observations\/index.php\/2008\/03\/31\/fda-investigating-safety-of-abacavir-and-didanosine-old-news-or-new\/\">since I last covered this issue<\/a>, but one wonders what we&#8217;ll hear soon, either confirming or refuting this association.\u00a0 (Or likely, <em>both<\/em> confirming and refuting it.)\u00a0<\/li>\n<li>In other FDA news, an advisory panel was split on whether to recommend approval of doripenem for treatment of nosocomial and ventilator-associated pneumonia &#8212; <a href=\"http:\/\/www.jnjpharmarnd.com\/jnjpharmarnd\/assets\/news_release_07162008.pdf\">but overall narrowly favored approval<\/a>.\u00a0 (No action by the FDA yet.)\u00a0 Not going to get into details of this particular drug or indication &#8212; the FDA&#8217;s decision is unlikely to change clinical practice in the short run &#8212; but isn&#8217;t it peculiar that we have a gazillion (stealing a word from one of our ID Fellows who speaks California-ese) cephalosporins, but only 4 carbapenems?\u00a0 And no oral option?\u00a0 Hey, imipenem was approved by the FDA in the mid 1980s!\u00a0 I asked a medicinal chemist about this a few years ago, and apparently it&#8217;s not so easy to synthesize these drugs &#8212; but the rise in ESBL-producing gram negatives certainly could (and should)\u00a0spur further drug development.<\/li>\n<li>Last, <a href=\"http:\/\/www.nih.gov\/news\/health\/jul2008\/niaid-17.htm\">the NIH halted plans to conduct the PAVE 100 HIV vaccine trial<\/a>.\u00a0 The reason, obviously, is that this adenovirus-based vaccine strategy is similar in many ways to the one tested in the STEP trial &#8212; which showed that the vaccine not only didn&#8217;t work in protecting from HIV infection or lowering HIV RNA levels, <a href=\"http:\/\/aids-clinical-care.jwatch.org\/cgi\/content\/full\/2007\/1119\/1\">but led to an <em>increase<\/em> in the risk of HIV acquisition for those persons vaccinated who had pre-existing adenovirus immunity.<\/a>\u00a0 The challenges of developing an effective AIDS vaccine are legion, but here&#8217;s a particular tough one:\u00a0 can you imagine trying to write the informed consent\u00a0for\u00a0the next major efficacy trial?\u00a0 Yikes.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Some miscellaneous recent items from the ID\/HIV world jumbling around this Friday: Tomatoes are off the hook &#8212; it&#8217;s the jalapenos that likely caused the recent salmonella outbreak.\u00a0 Since this is the only time of year that tomatoes are even edible in this part of the world, I for one am quite relieved.\u00a0\u00a0I am sure [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,8,9],"tags":[],"class_list":["post-31","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-infectious-diseases","category-patient-care","category-policy"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=31"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/31\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=31"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=31"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}