Efficacy and Safety of Antiretroviral Therapy Initiated One Week after Tuberculosis Therapy in Patients with CD4 Counts < 200 Cells/μL: TB-HAART Study, a Randomized Clinical Trial
Identifieur interne : 003071 ( Ncbi/Curation ); précédent : 003070; suivant : 003072Efficacy and Safety of Antiretroviral Therapy Initiated One Week after Tuberculosis Therapy in Patients with CD4 Counts < 200 Cells/μL: TB-HAART Study, a Randomized Clinical Trial
Auteurs : Wondwossen Amogne [Suède, Éthiopie] ; Getachew Aderaye [Éthiopie] ; Abiy Habtewold [Suède, Éthiopie] ; Getnet Yimer [Suède, Éthiopie] ; Eyasu Makonnen [Éthiopie] ; Alemayhu Worku [Éthiopie] ; Anders Sonnerborg [Suède] ; Eleni Aklillu [Suède] ; Lars Lindquist [Suède]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
Given the high death rate the first two months of tuberculosis (TB) therapy in HIV patients, it is critical defining the optimal time to initiate combination antiretroviral therapy (cART).
A randomized, open-label, clinical trial comparing efficacy and safety of efavirenz-based cART initiated one week, four weeks, and eight weeks after TB therapy in patients with baseline CD4 count < 200 cells/μL was conducted. The primary endpoint was all-cause mortality rate at 48 weeks. The secondary endpoints were hepatotoxicity-requiring interruption of TB therapy, TB-associated immune reconstitution inflammatory syndrome, new AIDS defining illnesses, CD4 counts, HIV RNA levels, and AFB smear conversion rates. All analyses were intention-to-treat.
We studied 478 patients with median CD4 count of 73 cells/μL and 5.2 logs HIV RNA randomized to week one (n = 163), week four (n = 160), and week eight (n = 155). Sixty-four deaths (13.4%) occurred in 339.2 person-years. All-cause mortality rates at 48 weeks were 25 per 100 person-years in week one, 18 per 100 person-years in week four and 15 per 100 person-years in week eight (P = 0.2 by the log-rank test). All-cause mortality incidence rate ratios in subgroups with CD4 count below 50 cells/μL versus above were 2.8 in week one (95% CI 1.2–6.7), 3.1 in week four (95% CI 1.2–8.6) and 5.1 in week eight (95% CI 1.8–16). Serum albumin < 3gms/dL (adjusted HR, aHR = 2.3) and CD4 < 50 cells/μL (aHR = 2.7) were independent predictors of mortality. Compared with similar subgroups from weeks four and eight, first-line TB treatment interruption was high in week one deaths (P = 0.03) and in the CD4 subgroup <50 cells/μL (P = 0.02).
Antiretroviral therapy one week after TB therapy doesn’t improve overall survival. Despite increased mortality with CD4 < 50 cells/μL, we recommend cART later than the first week of TB therapy to avoid serious hepatotoxicity and treatment interruption.
ClinicalTrials.gov
Url:
DOI: 10.1371/journal.pone.0122587
PubMed: 25966339
PubMed Central: 4429073
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PMC:4429073Le document en format XML
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<author><name sortKey="Amogne, Wondwossen" sort="Amogne, Wondwossen" uniqKey="Amogne W" first="Wondwossen" last="Amogne">Wondwossen Amogne</name>
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<author><name sortKey="Makonnen, Eyasu" sort="Makonnen, Eyasu" uniqKey="Makonnen E" first="Eyasu" last="Makonnen">Eyasu Makonnen</name>
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<author><name sortKey="Sonnerborg, Anders" sort="Sonnerborg, Anders" uniqKey="Sonnerborg A" first="Anders" last="Sonnerborg">Anders Sonnerborg</name>
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</nlm:aff>
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<author><name sortKey="Aklillu, Eleni" sort="Aklillu, Eleni" uniqKey="Aklillu E" first="Eleni" last="Aklillu">Eleni Aklillu</name>
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</nlm:aff>
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<author><name sortKey="Lindquist, Lars" sort="Lindquist, Lars" uniqKey="Lindquist L" first="Lars" last="Lindquist">Lars Lindquist</name>
<affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Department of Medicine, Division of Infectious Diseases, Karolinska Institute at Karolinska University Hospital Huddinge, Stockholm, Sweden</addr-line>
</nlm:aff>
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<wicri:regionArea>Department of Medicine, Division of Infectious Diseases, Karolinska Institute at Karolinska University Hospital Huddinge, Stockholm</wicri:regionArea>
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<front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title>
<p>Given the high death rate the first two months of tuberculosis (TB) therapy in HIV patients, it is critical defining the optimal time to initiate combination antiretroviral therapy (cART).</p>
</sec>
<sec id="sec002"><title>Methods</title>
<p>A randomized, open-label, clinical trial comparing efficacy and safety of efavirenz-based cART initiated one week, four weeks, and eight weeks after TB therapy in patients with baseline CD4 count < 200 cells/μL was conducted. The primary endpoint was all-cause mortality rate at 48 weeks. The secondary endpoints were hepatotoxicity-requiring interruption of TB therapy, TB-associated immune reconstitution inflammatory syndrome, new AIDS defining illnesses, CD4 counts, HIV RNA levels, and AFB smear conversion rates. All analyses were intention-to-treat.</p>
</sec>
<sec id="sec003"><title>Results</title>
<p>We studied 478 patients with median CD4 count of 73 cells/μL and 5.2 logs HIV RNA randomized to week one (n = 163), week four (n = 160), and week eight (n = 155). Sixty-four deaths (13.4%) occurred in 339.2 person-years. All-cause mortality rates at 48 weeks were 25 per 100 person-years in week one, 18 per 100 person-years in week four and 15 per 100 person-years in week eight (P = 0.2 by the log-rank test). All-cause mortality incidence rate ratios in subgroups with CD4 count below 50 cells/μL versus above were 2.8 in week one (95% CI 1.2–6.7), 3.1 in week four (95% CI 1.2–8.6) and 5.1 in week eight (95% CI 1.8–16). Serum albumin < 3gms/dL (adjusted HR, aHR = 2.3) and CD4 < 50 cells/μL (aHR = 2.7) were independent predictors of mortality. Compared with similar subgroups from weeks four and eight, first-line TB treatment interruption was high in week one deaths (P = 0.03) and in the CD4 subgroup <50 cells/μL (P = 0.02).</p>
</sec>
<sec id="sec004"><title>Conclusions</title>
<p>Antiretroviral therapy one week after TB therapy doesn’t improve overall survival. Despite increased mortality with CD4 < 50 cells/μL, we recommend cART later than the first week of TB therapy to avoid serious hepatotoxicity and treatment interruption.</p>
</sec>
<sec id="sec005"><title>Trial Registration</title>
<p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01315301">NCT 01315301</ext-link>
</p>
</sec>
</div>
</front>
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