Aethlon Medical Inc (AEMD)

[ANESRI]

http://www.medpagetoday.com/InfectiousDisease/Hepatitis/26160

Some points from the article -

Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.

"To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."


On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.

The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.

Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.

But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.

Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.

The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.


Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.