Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/31264
Type
ArticleCopyright
Restricted access
Embargo date
2025-01-01
Collections
- INI - Artigos de Periódicos [3488]
Metadata
Show full item record
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
Author
Affilliation
University of Amsterdam. Department of Internal Medicine. Academic Medical Center. International Antiviral Therapy Evaluation Center. Netherlands.
Brooklyn Medical Center. Cape Town, South Africa.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
North Manchester General Hospital. Manchester, UK.
Hellenic Red Cross General Hospital. Athens, Greece.
University of Amsterdam. Department of Internal Medicine. Academic Medical Center. International Antiviral Therapy Evaluation Center. Netherlands.
University of British Columbia. St. Paul’s Hospital. Vancouver, Canada.
Brooklyn Medical Center. Cape Town, South Africa.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
North Manchester General Hospital. Manchester, UK.
Hellenic Red Cross General Hospital. Athens, Greece.
University of Amsterdam. Department of Internal Medicine. Academic Medical Center. International Antiviral Therapy Evaluation Center. Netherlands.
University of British Columbia. St. Paul’s Hospital. Vancouver, Canada.
Abstract
Backgound: A substantial number of patients start their first-line antiretroviral therapyat 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 (< 25 106 cells/l) compared to CD4 counts > 200 106 cells/l [hazard ratio (HR), 1.28; 95% confidence interval (CI), 0.93–1.77]. The same was seen for a pVL 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.
Share