Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome.
OBJECTIVE: To assess the feasibility and impact of highly active antiretroviral therapy (HAART) started in vertically HIV-1-infected infants less than 3 months of age. DESIGN: A multicentre, phase I/II, non-randomized, open-label study (PENTA 7). METHODS: Adverse events, plasma HIV-1 RNA, CD4 cell...
| Main Authors: | , , , , , , , , , , , |
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| פורמט: | Journal article |
| שפה: | English |
| יצא לאור: |
2004
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| _version_ | 1826283940802985984 |
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| author | Aboulker, J Babiker, A Chaix, M Compagnucci, A Darbyshire, J Debré, M Faye, A Giaquinto, C Gibb, D Harper, L Saïdi, Y Walker, A |
| author_facet | Aboulker, J Babiker, A Chaix, M Compagnucci, A Darbyshire, J Debré, M Faye, A Giaquinto, C Gibb, D Harper, L Saïdi, Y Walker, A |
| author_sort | Aboulker, J |
| collection | OXFORD |
| description | OBJECTIVE: To assess the feasibility and impact of highly active antiretroviral therapy (HAART) started in vertically HIV-1-infected infants less than 3 months of age. DESIGN: A multicentre, phase I/II, non-randomized, open-label study (PENTA 7). METHODS: Adverse events, plasma HIV-1 RNA, CD4 cell counts, CD4 cell percentage (CD4%) and clinical progression were recorded at baseline and prospectively to 72 weeks in order to assess the toxicity, tolerability and efficacy of a combination of stavudine, didanosine and nelfinavir. Selection of genotypic resistance was also investigated. RESULTS: Twenty infants, of whom only three had Centers for Disease Control and Prevention stage B, initiated HAART at median age 2.5 months (range, 0.9-4.7) with median HIV-1 RNA concentration 5.5 log10 copies/ml (range, 3.2-6.8) and CD4% 33% (range, 11-66). Median follow-up was 96 weeks (range, 60-144). At week 72, 11 infants were still taking the original treatment. Few adverse events were reported related to treatment, all minor and causing treatment interruption in only three infants. No AIDS-defining events occurred; one child died of non-HIV-related causes (prematurity). All but two had CD4% > 25% at 72 weeks; however, 14 infants had virological failure and six acquired resistance mutations. CONCLUSIONS: Early treatment with stavudine, didanosine and nelfinavir was well tolerated and associated with good clinical and immunological outcomes at week 72. However, a high rate of virological failure with emergence of genotypic resistance is of great concern. More palatable drug combinations for infants and closer drug monitoring are required. |
| first_indexed | 2024-03-07T01:06:23Z |
| format | Journal article |
| id | oxford-uuid:8b7b6477-8bdb-48f8-a8bc-5df0c1fdf8aa |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T01:06:23Z |
| publishDate | 2004 |
| record_format | dspace |
| spelling | oxford-uuid:8b7b6477-8bdb-48f8-a8bc-5df0c1fdf8aa2022-03-26T22:38:20ZHighly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8b7b6477-8bdb-48f8-a8bc-5df0c1fdf8aaEnglishSymplectic Elements at Oxford2004Aboulker, JBabiker, AChaix, MCompagnucci, ADarbyshire, JDebré, MFaye, AGiaquinto, CGibb, DHarper, LSaïdi, YWalker, A OBJECTIVE: To assess the feasibility and impact of highly active antiretroviral therapy (HAART) started in vertically HIV-1-infected infants less than 3 months of age. DESIGN: A multicentre, phase I/II, non-randomized, open-label study (PENTA 7). METHODS: Adverse events, plasma HIV-1 RNA, CD4 cell counts, CD4 cell percentage (CD4%) and clinical progression were recorded at baseline and prospectively to 72 weeks in order to assess the toxicity, tolerability and efficacy of a combination of stavudine, didanosine and nelfinavir. Selection of genotypic resistance was also investigated. RESULTS: Twenty infants, of whom only three had Centers for Disease Control and Prevention stage B, initiated HAART at median age 2.5 months (range, 0.9-4.7) with median HIV-1 RNA concentration 5.5 log10 copies/ml (range, 3.2-6.8) and CD4% 33% (range, 11-66). Median follow-up was 96 weeks (range, 60-144). At week 72, 11 infants were still taking the original treatment. Few adverse events were reported related to treatment, all minor and causing treatment interruption in only three infants. No AIDS-defining events occurred; one child died of non-HIV-related causes (prematurity). All but two had CD4% > 25% at 72 weeks; however, 14 infants had virological failure and six acquired resistance mutations. CONCLUSIONS: Early treatment with stavudine, didanosine and nelfinavir was well tolerated and associated with good clinical and immunological outcomes at week 72. However, a high rate of virological failure with emergence of genotypic resistance is of great concern. More palatable drug combinations for infants and closer drug monitoring are required. |
| spellingShingle | Aboulker, J Babiker, A Chaix, M Compagnucci, A Darbyshire, J Debré, M Faye, A Giaquinto, C Gibb, D Harper, L Saïdi, Y Walker, A Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title | Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title_full | Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title_fullStr | Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title_full_unstemmed | Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title_short | Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. |
| title_sort | highly active antiretroviral therapy started in infants under 3 months of age 72 week follow up for cd4 cell count viral load and drug resistance outcome |
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