An ongoing dialogue on HIV/AIDS, infectious diseases,
January 27th, 2010
No Vicriviroc — Yet
Apparently, Merck — taking over for Schering-Plough — will not seek approval for vicriviroc in treatment-experienced patients:
In two Phase III studies in this patient population, vicriviroc did not meet the primary efficacy endpoint. These studies enrolled a high percentage of patients who had three or more active drugs in their optimized background therapy regimen.
The report goes on to say that the results of these studies will be presented at CROI next month, and that other studies of vicriviroc in treatment-naive patients will continue.
Even though we don’t know the details yet, it’s understandable how this trial didn’t show any benefit for vicriviroc. With the “optimized background therapy” having 3 or more active drugs, how could it? We’re a long way from the TORO/T-20 days, when such “OBT” led to virologic suppression in < 10% of patients.
The control arms in these studies now just do too well. Progress!
Still, given the checkered history of this particular CCR5 antagonist — including a failed phase II study in treatment-naive patients and a possible signal of increased malignancies in another trial — the FDA approval for any indication might be a long hill to climb.
Categories: HIV
Tags: antiretroviral, CCR5 antagonists, HIV, vicriviroc
You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.
Comments are closed.
Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases
Biography | Disclosures | Summaries
Learn more about HIV and ID Observations.
Follow HIV and ID Observations Posts via Email
- Why We Have Antibiotic Shortages and Price Hikes — And What One Very Enterprising Doctor Did in Response
- Brave New Name — How PCP Became PJP and Why It Matters
- The Riveting Conclusion of How PCP Became PJP
- How Electronic Health Records Tyrannize Doctors — ID Doctors in Particular
- Learning the Names of HIV Drugs Is Horribly Difficult — Here’s Why
- ID Cartoon Caption Contest (125)
- ID Cartoon Caption Contest #2 Winner — and a New Contest for the Holidays (92)
- Dear Nation — A Series of Apologies on COVID-19 (80)
- How to Induce Rage in a Doctor (77)
- IDSA’s COVID-19 Treatment Guidelines Highlight Difficulty of “Don’t Just Do Something, Stand There” (74)
-
NEJM Journal Watch — Recent Infectious Disease Articles
- Observations from ID and Beyond: The Riveting Conclusion of How PCP Became PJP
- Rising Rates of Perinatal HIV: Maryland, 2022
- Do Children Need a Booster of Typhoid Conjugate Vaccine?
- Infection with Tecovirimat-Resistant Mpox Virus Is on the Rise in the U.S.
- Kidney Transplantation: Offering HOPE for Those with HIV
-
Tag Cloud
- Abacavir AIDS antibiotics antiretroviral therapy ART atazanavir baseball Brush with Greatness CDC C diff COVID-19 CROI darunavir dolutegravir elvitegravir etravirine FDA HCV hepatitis C HIV HIV cure HIV testing ID fellowship ID Learning Unit Infectious Diseases influenza Link-o-Rama lyme disease MRSA PEP Policy PrEP prevention primary care raltegravir Really Rapid Review resistance Retrovirus Conference rilpivirine sofosbuvir TDF/FTC tenofovir Thanksgiving vaccines zoster