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Bristol-Myers Squibb (BMS) is issuing a "Dear Healthcare Provider" letter regarding is important new clinical data regarding coadministration of Viread (tenofovir disoproxil fumarate [TDF]), Videx EC (didanosine delayed-release capsules enteric-coated beadlets [ddI EC]), and either Sustiva (efavirenz [EFV]) or Viramune (nevirapine [NVP]). Data for EFV + TDF + ddI EC are derived

from an open-label randomized study (virologic failure in 6/14 patients) and a retrospective database analysis (virologic failure in 5/10 patients), while data for NVP + TDF + ddI EC are derived from a retrospective database analysis (virologic failure in 2/4 patients).

· Results from two recently conducted, investigator-sponsored trials have demonstrated a potential for early virologic failure associated with this antiretroviral regimen in treatment-naïve HIV patients with high baseline viral loads. The mechanism of early virologic failure in these patients is unclear.

· Early virologic failure appears to be limited to the specific combination of TDF + ddI EC + either EFV or NVP as there are data from registrational trials supporting the efficacy of EFV and TDF-based regimens as well as EFV and ddI EC-based regimens in treatment-naïve HIV patients.  Additionally, a recent post-hoc analysis performed in treatment-experienced HIV patients with high baseline viral loads receiving a boosted protease inhibitor (PI) with two nucleoside reverse transcriptase inhibitors (NRTIs) demonstrated lower virologic failure rates in subjects receiving ddI EC and TDF than those receiving another nucleoside analogue in combination with TDF, though significance testing could not be performed due to a small number of patients (n=55).

The complete letter is attached in pdf format, which requires an Adobe Acrobat viewer.  Acrobat is free and available directly from Adobe's Website with full installation instructions.

 

<<Final DHCP 11Nov04pdf.pdf>>

Richard Klein                                                  

Office of Special Health Issues                         

Food and Drug Administration                          

 

Kimberly Struble

Division of Antiviral Drug Products

Food and Drug Administration

 

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