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.

BACKGROUND: A substantial number of patients start their first-line antiretroviral therapy at an advanced stage of an HIV-1 infection. Potential differences between specific drug regimens in antiviral efficacy and safety in these patients are of major importance. METHODS: A post-hoc analysis within the randomized controlled 2NN trial comparing efficacy between regimes containing nevirapine (NVP), efavirenz (EFV), or both, in addition to stavudine and lamivudine. PRIMARY OUTCOME: risk of virologic failure in different strata of baseline CD4 T-lymphocyte counts and plasma HIV-1 RNA concentrations (pVL). Virologic failure: 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 10(6) cells/l) compared to CD4 counts > 200 x 10(6) cells/l [hazard ratio (HR), 1.28; 95% confidence interval (CI), 0.93-1.77]. The same was seen for a pVL > or = 100,000 copies/ml compared to a lower pVL (HR, 1.20; CI, 0.96-1.50). 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: 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.

Estimation of the Direct Cost of HIV-Infected Patients in Greece on an Annual Basis.

OBJECTIVE: HIV infection is currently regarded as a global chronic disease. The purpose of this study was to assess the direct cost of illness per patient per year in Greece. METHODS: A retrospective study for the estimation of the direct cost of HIV infection was performed from the third-party payer perspective. Data from 447 patients monitored in a general hospital of Athens were collected from their medical records. The survey involved all services and treatments that patients (stratified into three health states according to the number of CD4 cells/ml as defined by the Centers for Disease Control and Prevention classification system for HIV infection) received in 1 year, as well as demographic data. RESULTS: The annual direct cost per patient was calculated at €6859 ± €4699. Antiretroviral therapy cost was estimated at €5741, while the annual cost of providing health care services regardless of health state was computed at €1118, with laboratory investigation and imaging studies representing €924 (13.5%), outpatient visits €34 (0.5%), and hospitalization €160 (2.3%) of total cost, respectively. Overall, direct cost per patient was found to increase as the CD4 T lymphocytes decreased, leading to prolonged hospitalization and an increase in the number of laboratory tests. Direct cost for patients with more than 500 CD4 cells/µl was estimated at €6067, whereas for those with 200 to 499 cells/µl and less than 200 cells/µl, it was assessed at €6857 and €7654, respectively. CONCLUSIONS: The direct cost of HIV infection per patient increased as CD4 T lymphocytes decreased. The largest part of expenses was attributed to antiretroviral therapy, followed by laboratory tests/imaging studies, hospitalization, and finally outpatient visits.