First-line Therapy with Efavirenz or Nevirapine is Effective in Patients with Advanced HIV Infection, and the Incidence of Rash in the Nevirapine Group Is Significantly Higher in Women with Higher CD4 Counts 

First-line Therapy with Efavirenz or Nevirapine is Effective in Patients with Advanced HIV Infection, and the Incidence of Rash in the Nevirapine Group Is Significantly Higher in Women with Higher CD4 Counts.

A significant number of individuals start their first-line antiretroviral therapy at an advanced stage of HIV infection. The potential differences in the antiviral efficacy and safety between specific drug regimens used by these patients are of major importance.

A sub-analysis within the randomized, controlled 2NN trial compared the efficacy between regimens containing nevirapine/NVP (Viramune), efavirenz/EFV (Sustiva), or both, in addition to stavudine (Zerit) and lamivudine (Epivir).

The primary outcome of this sub-study was risk of virologic failure in different strata of baseline CD4 T-lymphocyte counts and plasma HIV-1 RNA concentrations (pVL). Virologic failure was defined as never reaching a pVL < 400 copies/ml, or a rebound to two consecutive values > 400 copies/ml.

Results

The risk of virologic failure was increased at very low CD4 counts (< 25 x 106 cells/l) compared to CD4 counts > 200 x 106 cells/l. The same was seen for a pVL >= 100 000 copies/ml compared to a lower pVL.

There were no statistically significant differences between NVP and EFV in risk of virologic failure within any of the CD4 or pVL strata, although EFV performed slightly better in the low CD4 stratum.

The incidence of rash in the NVP group was significantly higher in female patients with higher CD4 cell counts, while adverse events in the EFV group were not associated with CD4 cell count.

Conclusions

The authors conclude, “Initial antiretroviral therapy including NVP or EFV is effective in patients with an advanced HIV-1 infection. A high baseline CD4 cell count is associated with the occurrence of rash in female patients using NVP.”

03/21/05

Reference
F van Leth and others (for the 2NN study group). The effect of baseline CD4 cell count and HIV-1 viral load on the efficacy and safety of nevirapine or efavirenz-based first-line HAART. AIDS 19(5): 463-471. March 25, 2005.