Early Virologic Failure with Tenofovir/FTC + Nevirapine as Initial Therapy

Investigators stopped a clinical study when three of seven patients receiving tenofovir/FTC + nevirapine experienced early virologic rebound; each had evidence of multiclass viral resistance.

The combination of tenofovir, FTC (or 3TC), and nevirapine is listed in several guidelines as a preferred or alternative regimen for initial HIV treatment. However, this combination has never been studied in a fully powered, prospective clinical trial. Now, results from a small study raise concerns about its antiviral efficacy.

In this open-label clinical trial, treatment-naive patients were randomized to receive once-daily tenofovir/FTC plus either nevirapine (200 mg twice daily) or ritonavir-boosted atazanavir. The primary purpose of the study was to evaluate changes in plasma lipid levels. However, in April 2007, investigators decided to conduct an interim analysis of efficacy, after data from the DAUFIN study showed early virologic failu…

Reviewing Author

Paul E. Sax, MD

Disclosures

Consultant/Advisory BoardGilead Sciences; GlaxoSmithKline/ViiV; Merck; Shionogi

Grant/Research SupportNIH; Gilead Sciences; ViiV

Editorial BoardsUpToDate; Clinical Infectious Diseases

Paul E. Sax, MD

Disclosures

Consultant/Advisory BoardGilead Sciences; GlaxoSmithKline/ViiV; Merck; Shionogi

Grant/Research SupportNIH; Gilead Sciences; ViiV

Editorial BoardsUpToDate; Clinical Infectious Diseases

Early Virologic Failure with Tenofovir/FTC + Nevirapine as Initial Therapy

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Reviewing Author