The treatment outcomes of antiretroviral substitutions in routine clinical settings in Asia; data from the <scp>TREAT</scp> Asia <scp>HIV</scp> Observational Database (<scp>TAHOD</scp>)

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公開日
2017-12-01
DOI
  • 10.1002/jia2.25016
  • 10.60692/0gsam-kxf59
  • 10.60692/wmj5m-nax56
公開者
Wiley

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<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>Although substitutions of antiretroviral regimen are generally safe, most data on substitutions are based on results from clinical trials. The objective of this study was to evaluate the treatment outcomes of substituting antiretroviral regimen in virologically suppressed <jats:styled-content style="fixed-case">HIV</jats:styled-content>‐infected patients in non‐clinical trial settings in Asian countries.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The study population consisted of <jats:styled-content style="fixed-case">HIV</jats:styled-content>‐infected patients enrolled in the <jats:styled-content style="fixed-case">TREAT</jats:styled-content> Asia <jats:styled-content style="fixed-case">HIV</jats:styled-content> Observational Database (<jats:styled-content style="fixed-case">TAHOD</jats:styled-content>). Individuals were included in this analysis if they started combination antiretroviral treatment (<jats:styled-content style="fixed-case">cART</jats:styled-content>) after 2002, were being treated at a centre that documented a median rate of viral load monitoring ≥0.8 tests/patient/year among <jats:styled-content style="fixed-case">TAHOD</jats:styled-content> enrolees, and experienced a minor or major treatment substitution while on virally suppressive <jats:styled-content style="fixed-case">cART</jats:styled-content>. The primary endpoint to evaluate outcomes was clinical or virological failure (VF), followed by an <jats:styled-content style="fixed-case">ART</jats:styled-content> class change. Clinical failure was defined as death or an <jats:styled-content style="fixed-case">AIDS</jats:styled-content> diagnosis. VF was defined as confirmed viral load measurements ≥400 copies/mL followed by an <jats:styled-content style="fixed-case">ART</jats:styled-content> class change within six months. Minor regimen substitutions were defined as within‐class changes and major regimen substitutions were defined as changes to a drug class. The patterns of substitutions and rate of clinical or VF after substitutions were analyzed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 3994 adults who started <jats:styled-content style="fixed-case">ART</jats:styled-content> after 2002, 3119 (78.1%) had at least one period of virological suppression. Among these, 1170 (37.5%) underwent a minor regimen substitution, and 296 (9.5%) underwent a major regimen substitution during suppression. The rates of clinical or VF were 1.48/100 person years (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 1.14 to 1.91) in the minor substitution group, 2.85/100 person years (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 1.88 to 4.33) in the major substitution group and 2.53/100 person years (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 2.20 to 2.92) among patients that did not undergo a treatment substitution.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The rate of clinical or VF was low in both major and minor substitution groups, showing that regimen substitution is generally effective in non‐clinical trial settings in Asian countries.</jats:p></jats:sec>

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