Paul E. Sax, MD is the Editor-in-Chief, Journal Watch HIV/AIDS Clinical Care, Clinical Director of the Division of Infectious Diseases at Brigham and Women's Hospital, and Professor of Medicine at Harvard Medical School.
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(6 votes, average: 5.00 out of 5)As expected, simeprevir, and now also sofosbuvir, are being given “priority review” by the FDA. With the 6-month rule under the Prescription Drug User Fee Act — usually just said as “pah-DOOF-ah” — that means there’s a good chance we’ll have both of these anti-HCV drugs some time in late 2013. Which also means HCV treaters [...]
(4 votes, average: 5.00 out of 5)Today, as the The International Liver Congress is about to start, two papers are published in the New England Journal of Medicine on sofosbuvir, the investigational anti-HCV nucleotide submitted to the FDA for approval earlier this month. Each paper actually includes within them two studies. (For some reason, all the studies sound like 1950s science fiction [...]
(3 votes, average: 5.00 out of 5)Yesterday, the FDA issued a drug safety alert about severe rashes — “some fatal” — in patients treated for HCV with interferon, ribavirin, and telaprevir. The culprit, of course, is the telaprevir. The label already contained warning information about serious skin rashes with the drug, and this alert serves to heighten our awareness of the [...]
(3 votes, average: 5.00 out of 5)The Liver Meeting, the annual meeting of the American Association for the Study of Liver Disease, does not take place until November 9-13, in Boston. But if you want a preview, a couple of notable studies have already been “announced” in the press. Specifically, there’s this: Abbott today announced initial results from “Aviator,” a phase 2b study of [...]
(3 votes, average: 5.00 out of 5)In the fastest-moving area of ID drug development, answers are eagerly sought to the following questions three: What does the bad news on BMS-986094 — formerly INX-189 — mean for other investigational HCV nucleotides? Severe cardiotoxicity, fatal in one case, has ended the drug’s development. Importantly, nothing similar has thus far been observed with the structurally-similar IDX184, but that [...]
(6 votes, average: 4.83 out of 5)I didn’t attend “The Liver Meeting” (the nickname for the annual meeting of the American Association for the Study of Liver Diseases, AASLD), but the studies presented there this week on HCV treatment were absolutely mind-boggling. “Breathtaking!” said one of my HCV-oriented colleagues. “Hopeful is an understatement,” said another. An example: Dual Oral Combination Therapy [...]
(5 votes, average: 5.00 out of 5)From the prolific folks at NATAP came this surprising announcement: The Cardinals are stepping up to the plate against Hepatitis C. Starting Monday, August 22, fans will be able to get free Hepatitis C screenings at Busch Stadium. It’s part of a nationwide effort by Major League Baseball to bring attention to the causes and treatment of [...]
(2 votes, average: 4.50 out of 5)Today’s ID/HIV items come to you courtesy of a winter game being played during a summer month: So it appears that community-based care of HCV augmented by telemedicine is just as good as traditional clinic visits to specialists. My first thought on reading this important paper is that there are undoubtedly lots of ways to [...]
