{"id":4012,"date":"2013-04-23T14:32:51","date_gmt":"2013-04-23T18:32:51","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=4012"},"modified":"2015-06-04T14:33:41","modified_gmt":"2015-06-04T18:33:41","slug":"two-papers-four-sofosbuvir-studies-and-soon-an-end-to-interferonologists","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/two-papers-four-sofosbuvir-studies-and-soon-an-end-to-interferonologists\/2013\/04\/23\/","title":{"rendered":"Two Papers, Four Sofosbuvir Studies, and Soon the End of “Interferonologists”"},"content":{"rendered":"

\"\"<\/a>Today, as the The International Liver Congress<\/a> is about to start,\u00a0two papers are published in the New England Journal of Medicine<\/a><\/em> on sofosbuvir, the investigational anti-HCV nucleotide submitted to the FDA for approval earlier this month.<\/a><\/p>\n

Each paper actually includes within them two studies. (For some reason, all the studies sound like 1950s science fiction magazines.) Typical of the frenetic pace of drug development for HCV, the trial designs are a byzantine mish-mash of study populations, strategies, and endpoints, which can make interpretation complex. As a result, here’s an attempt to summarize some key outcomes, with a focus on the bottom line — cure — making the not-so-bold leap that “sustained virologic response at 12 weeks” = “cure”.<\/p>\n

One paper<\/a> looked at treatment-naive patients with any HCV genotype, and included the NEUTRINO and FISSION studies. NEUTRINO was a single-arm treatment with peg IF, RBV and sofosbuvir for genotypes 1, 4, 5, and 6, and FISSION a randomized comparison between sofosbuvir and interferon (both with RBV) for genotypes 2 and 3:<\/p>\n