Food and Drug Administration - November 12, 2004
Richard Klein

Bristol-Myers Squibb (BMS) is issuing a "Dear Healthcare Provider" letter regarding its 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-na ve 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-na ve 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 in pdf format, please see: Final DHCP Letter 11/2004

Richard Klein

HIV/AIDS Program Director

Office of Special Health Issues

Food and Drug Administration
041112
FD041101

SOURCE: Food and Drug Administration (FDA).

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