HIV and ID Observations

March 29th, 2014

Opening Day ID Link-o-Rama

Several ID/HIV tidbits to keep you entertained until Sunday night’s opening “day” — for baseball that is. (I hear there’s some sort of basketball tournament going on as well.) Away we go! Female-to-female sexual transmission of HIV is extremely uncommon — though one such case was diagnosed at our hospital over 20 years ago — but this most recent report from Texas […]

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June 27th, 2013

Testing Out the New Website with an ID Link-o-Rama

Hey, new website is live! Interested to hear what you think about our new-ish look. In celebration, here are some quick ID/HIV tidbits that have recently crossed my path, or have been sitting in my inbox for a while, dying to get out: Doxycycline shortage. Hardly anything more frightening to a New England ID doc than a shortage […]

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June 11th, 2013

Both Simeprevir and Sofosbuvir Likely Approved by 2014 — Clinical/Ethical/Pharmacoeconomic Dilemmas Loom

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 will soon […]

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April 23rd, 2013

Two Papers, Four Sofosbuvir Studies, and Soon the End of “Interferonologists”

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 magazines.) […]

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April 10th, 2013

Simeprevir and Sofosbuvir Submitted to FDA — Clock Ticking on Boceprevir, Telaprevir, Even Interferon

Two weeks, two companies, two press releases, two future HCV drugs that begin with “S”: March 28, 2013: Janssen Research & Development announced that it has submitted a New Drug Application to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the […]

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December 20th, 2012

Severe Telaprevir Rashes and Waiting (or Not Waiting) to Treat Hepatitis C

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 problem, […]

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August 25th, 2012

On HCV, These Questions Three

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 drug […]

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May 20th, 2012

News on HIV and HCV Testing, and in Praise of Accurate Screening Tests

Two recent news items reminded me how lucky we are to have some very accurate screening tests for certain infectious diseases. The news: An expert FDA panel backed approval of the first true home test for HIV, the OraQuick mouth swab test. Approval of OraQuick for home use may occur later this year. While home testing for […]

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April 17th, 2012

EASL Starts Tomorrow — Get Ready for the HCV Treatment Deluge

I can’t think of a single upcoming scientific meeting in ID that’s likely to be more “game changing”  — sorry for the tired metaphor — than the 47th European Association for the Study of the Liver (EASL) meeting, which starts tomorrow in Barcelona. As a hint of what’s to come, earlier this month Abbott released these […]

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February 23rd, 2012

Hepatitis C and the “Retooling” of HIV/ID Specialists

The news that hepatitis C (HCV) has passed HIV as a cause of death in the United States got quite a bit of attention when it was first presented last year at ICAAC — and no doubt the published paper, in this week’s Annals of Internal Medicine, will also cause a stir. In fact, I boldly predict […]

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