Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.
Identifieur interne : 000048 ( PubMed/Corpus ); précédent : 000047; suivant : 000049Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.
Auteurs : Roland Landman ; M B Diallo ; N F Ngom Gueye ; C Toure Kane ; S. Mboup ; M B Koita Fall ; B. Ndiaye ; G. Peytavin ; Y. Bennai ; A. Benalycherif ; P M Girard ; P S SowSource :
- AIDS research and human retroviruses [ 1931-8405 ] ; 2010.
English descriptors
- KwdEn :
- Adult, Anti-HIV Agents (administration & dosage), Anti-HIV Agents (adverse effects), Anti-HIV Agents (therapeutic use), Atazanavir Sulfate, Didanosine (administration & dosage), Didanosine (adverse effects), Didanosine (therapeutic use), Drug Administration Schedule, Drug Therapy, Combination, Female, HIV Infections (drug therapy), HIV Infections (immunology), HIV Infections (virology), HIV-1 (drug effects), HIV-1 (physiology), Humans, Lamivudine (administration & dosage), Lamivudine (adverse effects), Lamivudine (therapeutic use), Male, Middle Aged, Oligopeptides (administration & dosage), Oligopeptides (adverse effects), Oligopeptides (therapeutic use), Pilot Projects, Pyridines (administration & dosage), Pyridines (adverse effects), Pyridines (therapeutic use), RNA, Viral (blood), Reverse Transcriptase Inhibitors (administration & dosage), Reverse Transcriptase Inhibitors (adverse effects), Reverse Transcriptase Inhibitors (therapeutic use), Senegal, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Anti-HIV Agents, Didanosine, Lamivudine, Oligopeptides, Pyridines, Reverse Transcriptase Inhibitors.
- chemical , adverse effects : Anti-HIV Agents, Didanosine, Lamivudine, Oligopeptides, Pyridines, Reverse Transcriptase Inhibitors.
- chemical , blood : RNA, Viral.
- chemical , therapeutic use : Anti-HIV Agents, Didanosine, Lamivudine, Oligopeptides, Pyridines, Reverse Transcriptase Inhibitors.
- geographic : Senegal.
- drug effects : HIV-1.
- drug therapy : HIV Infections.
- immunology : HIV Infections.
- physiology : HIV-1.
- virology : HIV Infections.
- Adult, Atazanavir Sulfate, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Pilot Projects, Treatment Outcome.
Abstract
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.
DOI: 10.1089/aid.2009.0123
PubMed: 20455760
Links to Exploration step
pubmed:20455760Le document en format XML
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<front><div type="abstract" xml:lang="en">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.</div>
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<ArticleTitle>Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.</ArticleTitle>
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<Abstract><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.</AbstractText>
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