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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Mboup</name></author><author><name sortKey="Fall, M B Koita" sort="Fall, M B Koita" uniqKey="Fall M" first="M B Koita" last="Fall">M B Koita Fall</name></author><author><name sortKey="Ndiaye, B" sort="Ndiaye, B" uniqKey="Ndiaye B" first="B" last="Ndiaye">B. Ndiaye</name></author><author><name sortKey="Peytavin, G" sort="Peytavin, G" uniqKey="Peytavin G" first="G" last="Peytavin">G. Peytavin</name></author><author><name sortKey="Bennai, Y" sort="Bennai, Y" uniqKey="Bennai Y" first="Y" last="Bennai">Y. Bennai</name></author><author><name sortKey="Benalycherif, A" sort="Benalycherif, A" uniqKey="Benalycherif A" first="A" last="Benalycherif">A. Benalycherif</name></author><author><name sortKey="Girard, P M" sort="Girard, P M" uniqKey="Girard P" first="P M" last="Girard">P M Girard</name></author><author><name sortKey="Sow, P S" sort="Sow, P S" uniqKey="Sow P" first="P S" last="Sow">P S Sow</name></author></analytic><series><title level="j">AIDS research and human retroviruses</title><idno type="eISSN">1931-8405</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Anti-HIV Agents (administration & dosage)</term><term>Anti-HIV Agents (adverse effects)</term><term>Anti-HIV Agents (therapeutic use)</term><term>Atazanavir Sulfate</term><term>Didanosine (administration & dosage)</term><term>Didanosine (adverse effects)</term><term>Didanosine (therapeutic use)</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Female</term><term>HIV Infections (drug therapy)</term><term>HIV Infections (immunology)</term><term>HIV Infections (virology)</term><term>HIV-1 (drug effects)</term><term>HIV-1 (physiology)</term><term>Humans</term><term>Lamivudine (administration & dosage)</term><term>Lamivudine (adverse effects)</term><term>Lamivudine (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Oligopeptides (administration & dosage)</term><term>Oligopeptides (adverse effects)</term><term>Oligopeptides (therapeutic use)</term><term>Pilot Projects</term><term>Pyridines (administration & dosage)</term><term>Pyridines (adverse effects)</term><term>Pyridines (therapeutic use)</term><term>RNA, Viral (blood)</term><term>Reverse Transcriptase Inhibitors (administration & dosage)</term><term>Reverse Transcriptase Inhibitors (adverse effects)</term><term>Reverse Transcriptase Inhibitors (therapeutic use)</term><term>Senegal</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Anti-HIV Agents</term><term>Didanosine</term><term>Lamivudine</term><term>Oligopeptides</term><term>Pyridines</term><term>Reverse Transcriptase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-HIV Agents</term><term>Didanosine</term><term>Lamivudine</term><term>Oligopeptides</term><term>Pyridines</term><term>Reverse Transcriptase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-HIV Agents</term><term>Didanosine</term><term>Lamivudine</term><term>Oligopeptides</term><term>Pyridines</term><term>Reverse Transcriptase Inhibitors</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Senegal</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>HIV-1</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>HIV-1</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Atazanavir Sulfate</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pilot Projects</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">20455760</PMID><DateCreated><Year>2010</Year><Month>05</Month><Day>18</Day></DateCreated><DateCompleted><Year>2010</Year><Month>08</Month><Day>24</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1931-8405</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>5</Issue><PubDate><Year>2010</Year><Month>May</Month></PubDate></JournalIssue><Title>AIDS research and human retroviruses</Title><ISOAbbreviation>AIDS Res. Hum. Retroviruses</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.</ArticleTitle><Pagination><MedlinePgn>519-25</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1089/aid.2009.0123</ELocationID><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></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Landman</LastName><ForeName>Roland</ForeName><Initials>R</Initials><AffiliationInfo><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</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Diallo</LastName><ForeName>M B</ForeName><Initials>MB</Initials></Author><Author ValidYN="Y"><LastName>Gueye</LastName><ForeName>N F Ngom</ForeName><Initials>NF</Initials></Author><Author ValidYN="Y"><LastName>Kane</LastName><ForeName>C Toure</ForeName><Initials>CT</Initials></Author><Author ValidYN="Y"><LastName>Mboup</LastName><ForeName>S</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Fall</LastName><ForeName>M B Koita</ForeName><Initials>MB</Initials></Author><Author ValidYN="Y"><LastName>Ndiaye</LastName><ForeName>B</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Peytavin</LastName><ForeName>G</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Bennai</LastName><ForeName>Y</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Benalycherif</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Girard</LastName><ForeName>P M</ForeName><Initials>PM</Initials></Author><Author ValidYN="Y"><LastName>Sow</LastName><ForeName>P S</ForeName><Initials>PS</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>AIDS Res Hum Retroviruses</MedlineTA><NlmUniqueID>8709376</NlmUniqueID><ISSNLinking>0889-2229</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019380">Anti-HIV Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009842">Oligopeptides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011725">Pyridines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012367">RNA, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018894">Reverse Transcriptase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>2T8Q726O95</RegistryNumber><NameOfSubstance UI="D019259">Lamivudine</NameOfSubstance></Chemical><Chemical><RegistryNumber>4MT4VIE29P</RegistryNumber><NameOfSubstance UI="D000069446">Atazanavir Sulfate</NameOfSubstance></Chemical><Chemical><RegistryNumber>K3GDH6OH08</RegistryNumber><NameOfSubstance UI="D016049">Didanosine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CitationSubset>X</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019380" MajorTopicYN="Y">Anti-HIV Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069446" MajorTopicYN="N">Atazanavir Sulfate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016049" MajorTopicYN="Y">Didanosine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015658" MajorTopicYN="N">HIV Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015497" MajorTopicYN="N">HIV-1</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName><QualifierName UI="Q000502" MajorTopicYN="N">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019259" MajorTopicYN="Y">Lamivudine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009842" MajorTopicYN="Y">Oligopeptides</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010865" MajorTopicYN="N">Pilot Projects</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011725" MajorTopicYN="Y">Pyridines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012367" MajorTopicYN="N">RNA, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018894" MajorTopicYN="N">Reverse Transcriptase Inhibitors</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012675" MajorTopicYN="N" Type="Geographic">Senegal</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>5</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2010</Year><Month>5</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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