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.
Paul E. Sax, MD
Associate Editor
NEJM Clinician
Biography | Disclosures & Summaries
Learn more about HIV and ID Observations.
FROM NEJM — Recent Infectious Disease Articles- Shock Not Advised April 30, 2026A physician offers to help in a medical emergency on a transatlantic flight. Though she faces limits of bureaucracy, equipment, and ultimately biology, she discovers her physicianhood is inescapable.
- Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples April 30, 2026Rapid, affordable, and easy-to-use diagnostic testing for tuberculosis is needed. In a multinational study, the accuracy of a tuberculosis diagnostic deployable to peripheral health care centers was assessed.
- Legislating Medicine — Directed Donation and the Politics of Patient Choice April 30, 2026A Tennessee bill focused on directed blood donation exemplifies a pattern of efforts to legislate medical practice in ways that override scientific consensus while invoking the language of autonomy.
- Tackling Maternal Sepsis — Doing the Basics, and Doing Them Well April 30, 2026In the mid-19th century, the Hungarian physician Ignaz Semmelweis’s observations and theories about the transfer of “cadaverous particles” on the hands of doctors led to the development of hygiene protocols, such as hand washing with chlorine, which resulted in a reduction in maternal mortality associated with puerperal fever.1,2 ...
- Case 13-2026: A 76-Year-Old Woman with Fatigue, Rash, and Kidney Failure April 30, 2026A 76-year-old woman, who had a history of treated hepatitis C virus infection, presented with rapidly progressive kidney failure and a stroke. Palpable purpura on the legs was noted. A diagnosis was made.
- Shock Not Advised April 30, 2026