Jurgen Rockstroh comments HCV/HIV coinfection in the era of Direct Acting Antivirals...

Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany, gives us a synopsis of what the new DAAs for Hepatitis C will mean for patients with HIV/HCV coinfection. I highly recommend a full read through, Dr. Rockstroh walks through the latest efficacy, resistance and drug -drug interaction data on Boceprevir and Telaprevir as well as current epidemiological patterns in the disease state . We'll need SVR data from both drugs to make a full assessment, but from the interim 12 week data, it appears Telaprevir is very effective at reducing HCV viral load in the coinfected patient, although there are some serious drug-drug interactions to look out for as well as a higher incidence of adverse events. Read the entire article here

NATAP posts CROI coverage....

Always great coverage from the NATAP folks is just a click away... http://www.natap.org/2011/CROI/CROI.htm

Vertex shows Telaprevir RVR data in HIV/HCV co-infected subjects...

Press release from Vertex regarding RVR rate in treatment naive co-infected subjects. Good RVR rates in subjects on both Atripla and boosted Atazanavir (and ? backbone. 'N' is small and of course you'd never treat HCV in someone that wasn't already stable on HIV therapy, but looks promising in those that haven't any resistance to Atripla components and Atazanavir plus whatever backbone regimen was used.

UPDATE 1-Vertex drug promising in hep C patients with HIV
1:06pm EST
* RVR rate 70 pct with telaprevir combination therapy
* RVR rate 5 pct on standard hepatitis C drugs alone
* Vertex expects final cure rate data in 2012

By Bill Berkrot

NEW YORK, March 2 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O: Quote, Profile, Research, Stock Buzz) hepatitis C drug telaprevir helped eliminate the virus in 70 percent of patients who were also infected with HIV, according to interim analysis from a small midstage clinical trial, the company said.

Telaprevir is awaiting a U.S. approval decision after demonstrating an ability to greatly improve hepatitis cure rates when combined with current standard of care medicines compared with those drugs alone.

Patients in the co-infection study, which was presented at a medical meeting on Wednesday, had not yet received other treatment for hepatitis. Telaprevir was tested in one group of patients who were not receiving antiretroviral therapy for HIV and another group who were.

The interim analysis looked for a rapid viral response (RVR), meaning the hepatitis C virus was undetectable in the blood after four weeks of treatment.

At four weeks, 70 percent of those in the 60-patient study who received combination therapy with telaprevir had achieved RVR compared with 5 percent who received only the standard drugs of pegylated interferon and ribavirin, according to data presented at the Conference on Retroviruses and Opportunistic Infections in Boston.

Undetectable virus must be maintained for a far longer period of time in order to achieve sustained viral response (SVR), which is tantamount to a cure. But RVR can be an early indicator of eventual success rates.

SVR rates from the study are expected to be available next year, Vertex said.

In patients who were not also receiving HIV antiretroviral therapy, 71 percent of those treated with telaprevir achieved RVR compared with none on the standard drugs.

For co-infected patients taking Gilead Sciences Inc's Atripla for HIV, 75 percent on telaprevir combination therapy hit RVR versus one patient, or 13 percent, in the control arm.

For HIV patients being treated by Bristol-Myers Squibb's Reyataz, 64 percent on telaprevir hit RVR versus no one in the eight-patient control arm.

Vertex shares were up $1.12, or 2.4 percent, at $47.17 in afternoon trade on Nasdaq. (Reporting by Bill Berkrot, editing by Dave Zimmerman)

From CROI: Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions

(Jules Levin of NATAP.org reports on a session at CROI looking at Boceprevir drug interactions. Fortunately, with the notable exception of Efavirenz, it looks like BOC is a pretty clean drug in terms of DDI's)

Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - see attached full slide report

Reported by Jules Levin

CROI – March 1, 2011
Boston, MA

C Kasserra, E Hughes, M Treitel,
S Gupta, and E O'Mara


AUTHOR CONCLUSIONS
•Radiolabeled data support a primarily hepatic-mediated clearance of BOC
•CYP3A4 probes
–Marked ↑ in midazolam exposure in the presence of BOC indicates that BOC is a strong, reversible inhibitor of CYP3A4
–↑ exposure to BOC with ketoconazole suggests involvement of another non–CYP3A4-mediated pathway
•Metabolic inhibitors (even in combination) did not alter BOC PK profile substantially to change BOC’s dose or schedule
–Diflunisal (AKR inhibitor) did not alter BOC exposure
–Ritonavir (CYP 3A4 inhibitor) did not substantively affect exposure to BOC
–Clarithromycin (CYP3A4, P-gp inhibitor) did not affect exposure to BOC
•No dosage adjustment is needed for the coadministration of BOC with tenofovir or peginterferon
•Clinical implications of a ↓ mean BOC trough concentration when coadministered with efavirenz will be clearer as data from coinfected populations are obtained
•Boceprevir did not affect the exposure to drospirenone/ ethinylestradiol in a manner that would be anticipated to reduce contraceptive efficacy