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Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV-1 RNA levels in chronically HIV-1-infected patients.
AIDS 2007; 21(2):169-78AIDS

Abstract

OBJECTIVE

We evaluated the safety of CD4 cell count and plasma HIV-1 RNA (pVL)-guided treatment interruptions (GTI) and determined predictors of duration of treatment interruption.

METHODS

Chronically HIV-1-infected adults with sustained CD4 cell counts > 500 cells/microl and pVL < 50 copies/ml were randomly assigned to either continue with standard antiretroviral therapy (control group, n = 101) or to interrupt therapy aimed at maintaining CD4 cell counts > 350 cells/microl and pVL < 100,000 copies/ml (GTI group, n = 100). Both groups were followed for 2 years.

RESULTS

There were no AIDS-defining illnesses or deaths in either group. Compared to controls, subjects interrupting therapy reduced treatment exposure by 67%, but suffered significantly more adverse events related to the intake of medication or to therapy interruption [relative hazard, 2.71; 95% confidence interval (CI), 1.64-4.49; P < 0.001), mainly due to an excess in mononucleosis-like symptoms. While GTI subjects demonstrated improvements in the psychosocial spheres of quality of life and pain reporting, GTI had no effect on the physical aspects of quality of life. Although both groups had a similar hazard for developing CD4 cell count < 200 cells/microl; at least 10% of subjects on GTI had CD4 cell counts < 350 cells/microl at every time point. Drug resistance mutations were detected in 36% of subjects but were selected de novo only in subjects interrupting non-nucleoside reverse transcriptase inhibitor therapy. Lower CD4 cell count nadir, higher set-point pVL and prior exposure to suboptimal regimens were all independent predictors of the need to reinitiate treatment.

CONCLUSIONS

Overall, GTI were not as safe as continuing therapy. Despite achieving some improvements in quality of life, GTI did not reduce the overall rate of management-related adverse events.

Authors+Show Affiliations

Fundació IrsiCaixa and HIV Clinical Unit, Hospital Universitari Germans Trias i Pujol, Universitat Autonòma de Barcelona, Badalona, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17197807

Citation

Ruiz, Lidia, et al. "Antiretroviral Therapy Interruption Guided By CD4 Cell Counts and Plasma HIV-1 RNA Levels in Chronically HIV-1-infected Patients." AIDS (London, England), vol. 21, no. 2, 2007, pp. 169-78.
Ruiz L, Paredes R, Gómez G, et al. Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV-1 RNA levels in chronically HIV-1-infected patients. AIDS. 2007;21(2):169-78.
Ruiz, L., Paredes, R., Gómez, G., Romeu, J., Domingo, P., Pérez-Alvarez, N., ... Clotet, B. (2007). Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV-1 RNA levels in chronically HIV-1-infected patients. AIDS (London, England), 21(2), pp. 169-78.
Ruiz L, et al. Antiretroviral Therapy Interruption Guided By CD4 Cell Counts and Plasma HIV-1 RNA Levels in Chronically HIV-1-infected Patients. AIDS. 2007 Jan 11;21(2):169-78. PubMed PMID: 17197807.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antiretroviral therapy interruption guided by CD4 cell counts and plasma HIV-1 RNA levels in chronically HIV-1-infected patients. AU - Ruiz,Lidia, AU - Paredes,Roger, AU - Gómez,Guadalupe, AU - Romeu,Joan, AU - Domingo,Pere, AU - Pérez-Alvarez,Nuria, AU - Tambussi,Giuseppe, AU - Llibre,Josep Maria, AU - Martínez-Picado,Javier, AU - Vidal,Francesc, AU - Fumaz,Carmina R, AU - Clotet,Bonaventura, AU - ,, PY - 2007/1/2/pubmed PY - 2007/3/30/medline PY - 2007/1/2/entrez SP - 169 EP - 78 JF - AIDS (London, England) JO - AIDS VL - 21 IS - 2 N2 - OBJECTIVE: We evaluated the safety of CD4 cell count and plasma HIV-1 RNA (pVL)-guided treatment interruptions (GTI) and determined predictors of duration of treatment interruption. METHODS: Chronically HIV-1-infected adults with sustained CD4 cell counts > 500 cells/microl and pVL < 50 copies/ml were randomly assigned to either continue with standard antiretroviral therapy (control group, n = 101) or to interrupt therapy aimed at maintaining CD4 cell counts > 350 cells/microl and pVL < 100,000 copies/ml (GTI group, n = 100). Both groups were followed for 2 years. RESULTS: There were no AIDS-defining illnesses or deaths in either group. Compared to controls, subjects interrupting therapy reduced treatment exposure by 67%, but suffered significantly more adverse events related to the intake of medication or to therapy interruption [relative hazard, 2.71; 95% confidence interval (CI), 1.64-4.49; P < 0.001), mainly due to an excess in mononucleosis-like symptoms. While GTI subjects demonstrated improvements in the psychosocial spheres of quality of life and pain reporting, GTI had no effect on the physical aspects of quality of life. Although both groups had a similar hazard for developing CD4 cell count < 200 cells/microl; at least 10% of subjects on GTI had CD4 cell counts < 350 cells/microl at every time point. Drug resistance mutations were detected in 36% of subjects but were selected de novo only in subjects interrupting non-nucleoside reverse transcriptase inhibitor therapy. Lower CD4 cell count nadir, higher set-point pVL and prior exposure to suboptimal regimens were all independent predictors of the need to reinitiate treatment. CONCLUSIONS: Overall, GTI were not as safe as continuing therapy. Despite achieving some improvements in quality of life, GTI did not reduce the overall rate of management-related adverse events. SN - 0269-9370 UR - https://www.unboundmedicine.com/medline/citation/17197807/Antiretroviral_therapy_interruption_guided_by_CD4_cell_counts_and_plasma_HIV_1_RNA_levels_in_chronically_HIV_1_infected_patients_ L2 - http://Insights.ovid.com/pubmed?pmid=17197807 DB - PRIME DP - Unbound Medicine ER -