Generic Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohort

Hdl Handle:
http://hdl.handle.net/10144/18315
Title:
Generic Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohort
Authors:
Calmy, A; Pinoges, L; Szumilin, E; Zachariah, R; Ford, N; Ferradini, L
Journal:
AIDS (London, England)
Abstract:
BACKGROUND: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and nevirapine (3TC/d4T/NVP) are scarce. OBJECTIVE: To analyse 6861 patients in a large observational cohort from 21 Médecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. METHODS: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio. RESULTS: Median baseline CD4 cell count at initiating of FDC was 89 cells/microl [interquartile range (IQR), 33-158]. The median follow-up time was 4.1 months (IQR, 1.9-7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8-14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95% CI, 92-94) at 6 months (n = 2,231) and 0.90 (95% CI, 89-91) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m and CD4 cell count 15-50 cells/microl or < 15 cells/microl. Subcohort analysis of 655 patients after 1 year of follow-up (M12 FDC cohort) revealed that 77% remained on HAART, 91% of these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. CONCLUSIONS: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.
Affiliation:
MSF, Campaign for Access to Essential Medicines, 78 rue de Lausanne, 1205 Geneva, Switzerland. acalmy@stvincents.com.au
Issue Date:
12-May-2006
URI:
http://hdl.handle.net/10144/18315
DOI:
10.1097/01.aids.0000226957.79847.d6
PubMed ID:
16691068
Language:
en
ISSN:
0269-9370
Appears in Collections:
HIV/AIDS

Full metadata record

DC FieldValue Language
dc.contributor.authorCalmy, A-
dc.contributor.authorPinoges, L-
dc.contributor.authorSzumilin, E-
dc.contributor.authorZachariah, R-
dc.contributor.authorFord, N-
dc.contributor.authorFerradini, L-
dc.date.accessioned2008-02-14T14:37:06Z-
dc.date.available2008-02-14T14:37:06Z-
dc.date.issued2006-05-12-
dc.identifier.citationGeneric Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohort. 2006, 20 (8):1163-9 AIDSen
dc.identifier.issn0269-9370-
dc.identifier.pmid16691068-
dc.identifier.doi10.1097/01.aids.0000226957.79847.d6-
dc.identifier.urihttp://hdl.handle.net/10144/18315-
dc.description.abstractBACKGROUND: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and nevirapine (3TC/d4T/NVP) are scarce. OBJECTIVE: To analyse 6861 patients in a large observational cohort from 21 Médecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. METHODS: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio. RESULTS: Median baseline CD4 cell count at initiating of FDC was 89 cells/microl [interquartile range (IQR), 33-158]. The median follow-up time was 4.1 months (IQR, 1.9-7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8-14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95% CI, 92-94) at 6 months (n = 2,231) and 0.90 (95% CI, 89-91) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m and CD4 cell count 15-50 cells/microl or < 15 cells/microl. Subcohort analysis of 655 patients after 1 year of follow-up (M12 FDC cohort) revealed that 77% remained on HAART, 91% of these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. CONCLUSIONS: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.en
dc.language.isoenen
dc.rightsPublished by Wolters Kluwer Lippincott Williams & Wilkins - Archived on this site by kind permission Wolters Kluweren
dc.subject.meshAdulten
dc.subject.meshAnti-HIV Agentsen
dc.subject.meshAntiretroviral Therapy, Highly Activeen
dc.subject.meshCD4 Lymphocyte Counten
dc.subject.meshDeveloping Countriesen
dc.subject.meshDrug Administration Scheduleen
dc.subject.meshDrugs, Genericen
dc.subject.meshEpidemiologic Methodsen
dc.subject.meshFemaleen
dc.subject.meshHIV Infectionsen
dc.subject.meshHumansen
dc.subject.meshLamivudineen
dc.subject.meshMaleen
dc.subject.meshMedically Underserved Areaen
dc.subject.meshNevirapineen
dc.subject.meshReverse Transcriptase Inhibitorsen
dc.subject.meshStavudineen
dc.subject.meshTreatment Outcomeen
dc.titleGeneric Fixed-Dose Combination Antiretroviral Treatment in Resource-Poor Settings: Multicentric Observational Cohorten
dc.contributor.departmentMSF, Campaign for Access to Essential Medicines, 78 rue de Lausanne, 1205 Geneva, Switzerland. acalmy@stvincents.com.auen
dc.identifier.journalAIDS (London, England)en

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