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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2010-5-18
pubmed:abstractText
The use of ritonavir as a protease inhibitor boost is rare in sub-Saharan Africa because a heat-stable formula is not available. We report the results of an open-label pilot trial with unboosted atazanavir in combination with lamivudine and didanosine as first-line therapy conducted in Senegal. Treatment-naive HIV-1 infected adult patients without active opportunistic disease were included. The primary endpoint was the proportion of patients with plasma HIV-1 RNA <400 copies/ml at week 48. Forty patients (12 men and 28 women; mean age +/- SD: 40 +/- 9 years) were included. Treatment was changed during the study for two patients (pregnancy, tuberculosis); one patient was lost to follow-up and one patient died (gastroenteritis with cachexia). At week 48, 78% [95% confidence interval (CI): 65-90%] and 68% (95% CI: 53-82%) of the patients had HIV-1 RNA <400 and <50 copies/ml, respectively (intent-to-treat analysis; not completer = failure). Among the seven patients with HIV-1 RNA >or=400 copies/ml at week 48, five were not compliant; genotyping analysis (n = 4) did not reveal a major mutation for protease inhibitors. The mean CD4 cell count change from baseline to week 48 was +238 +/- 79 cells/mm(3). The combination of unboosted atazanavir with lamivudine and didanosine was efficient and well tolerated in HIV-1-infected patients with results similar to those observed in Northern countries. These results suggest that unboosted atazanavir with its high genetic barrier could be a valuable alternative to NNRTIs in resource-limited countries in some HIV-1-infected patients in case of compliance issues with NNRTIs, intolerance to NNRTIs, resistance mutations to NNRTIs, in women with childbearing potential, or as a maintenance therapy in patients with virological suppression.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
1931-8405
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
26
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
519-25
pubmed:meshHeading
pubmed-meshheading:20455760-Adult, pubmed-meshheading:20455760-Anti-HIV Agents, pubmed-meshheading:20455760-Didanosine, pubmed-meshheading:20455760-Drug Administration Schedule, pubmed-meshheading:20455760-Drug Therapy, Combination, pubmed-meshheading:20455760-Female, pubmed-meshheading:20455760-HIV Infections, pubmed-meshheading:20455760-HIV-1, pubmed-meshheading:20455760-Humans, pubmed-meshheading:20455760-Lamivudine, pubmed-meshheading:20455760-Male, pubmed-meshheading:20455760-Middle Aged, pubmed-meshheading:20455760-Oligopeptides, pubmed-meshheading:20455760-Pilot Projects, pubmed-meshheading:20455760-Pyridines, pubmed-meshheading:20455760-RNA, Viral, pubmed-meshheading:20455760-Reverse Transcriptase Inhibitors, pubmed-meshheading:20455760-Senegal, pubmed-meshheading:20455760-Treatment Outcome
pubmed:year
2010
pubmed:articleTitle
Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.
pubmed:affiliation
Institut de Médecine et d'Epidémiologie Appliquée, Service des Maladies Infectieuses et Tropicales, Bichat Claude-Bernard Hospital, Paris Cedex 18, France. roland.landman@univ-paris-diderot.fr
pubmed:publicationType
Journal Article, Clinical Trial