Association between First-Year Virologic Response to Raltegravir and Long-Term Outcomes in Treatment-Experienced Patients with HIV-1 Infection
Identifieur interne : 003B91 ( Main/Exploration ); précédent : 003B90; suivant : 003B92Association between First-Year Virologic Response to Raltegravir and Long-Term Outcomes in Treatment-Experienced Patients with HIV-1 Infection
Auteurs : Joseph J. Eron [États-Unis] ; David A. Cooper [Australie] ; Roy T. Steigbigel [États-Unis] ; Bonaventura Clotet [Espagne] ; Patrick Yeni [France] ; Kim M. Strohmaier [États-Unis] ; Anthony Rodgers [États-Unis] ; Richard J. Barnard [États-Unis] ; Bach-Yen T. Nguyen [États-Unis] ; Hedy Teppler [États-Unis]Source :
- Antiviral therapy [ 1359-6535 ] ; 2014.
Abstract
We explored the relationship between virologic response in the first year of treatment and long-term outcomes in the BENCHMRK studies.
Patients failing ART with 3-class resistant HIV-1 received double-blinded raltegravir (or placebo) with optimized background therapy (OBT) until week 156, then open-label raltegravir with OBT up to week 240. In this exploratory analysis of patients randomized to raltegravir, virologic response over weeks 16–48 was categorized as�continuous suppression (CS: vRNA always <50 copies/mL), low-level viremia�(LLV: vRNA always < 400 copies/mL; <50 copies/mL at least once), or not suppressed (NS: vRNA <400 copies/mL at least once). The association between these first-year vRNA response categories and baseline factors was analyzed with univariate and multivariate models. Virologic and immunologic outcomes for years 2–5 were assessed by first-year vRNA response category (observed failure approach).
Baseline vRNA, baseline CD4 count, and rapid viral decay (vRNA <50 copies/mL between weeks 2–12) correlated with first-year vRNA response (p<0.001); only rapid viral decay remained significant by multiple regression. Virologic response rates were similar in the LLV and CS groups and lowest in the NS group. CD4 increased through week 240 in the CS and LLV groups. Time to loss of virologic response (confirmed vRNA ≥400 copies/mL) through Week 240 did not support as strong a difference between the LLV and CS groups (log-rank p=0.11) as previously reported through Week 156 and 192 (p<0.05).
Treatment-experienced patients on a raltegravir-based regimen with early LLV may have long-term virologic and immunologic benefit when their therapy is maintained.
Url:
DOI: 10.3851/IMP2912
PubMed: 25350973
PubMed Central: 4422784
Affiliations:
- Australie, Espagne, France, États-Unis
- Caroline du Nord, New Jersey, Nouvelle-Galles du Sud, État de New York, Île-de-France
- Paris, Sydney
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Le document en format XML
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">We explored the relationship between virologic response in the first year of treatment and long-term outcomes in the BENCHMRK studies.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">Patients failing ART with 3-class resistant HIV-1 received double-blinded raltegravir (or placebo) with optimized background therapy (OBT) until week 156, then open-label raltegravir with OBT up to week 240. In this exploratory analysis of patients randomized to raltegravir, virologic response over weeks 16–48 was categorized as�continuous suppression (CS: vRNA always <50 copies/mL), low-level viremia�(LLV: vRNA always < 400 copies/mL; <50 copies/mL at least once), or not suppressed (NS: vRNA <400 copies/mL at least once). The association between these first-year vRNA response categories and baseline factors was analyzed with univariate and multivariate models. Virologic and immunologic outcomes for years 2–5 were assessed by first-year vRNA response category (observed failure approach).</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Baseline vRNA, baseline CD4 count, and rapid viral decay (vRNA <50 copies/mL between weeks 2–12) correlated with first-year vRNA response (p<0.001); only rapid viral decay remained significant by multiple regression. Virologic response rates were similar in the LLV and CS groups and lowest in the NS group. CD4 increased through week 240 in the CS and LLV groups. Time to loss of virologic response (confirmed vRNA ≥400 copies/mL) through Week 240 did not support as strong a difference between the LLV and CS groups (log-rank p=0.11) as previously reported through Week 156 and 192 (p<0.05).</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">Treatment-experienced patients on a raltegravir-based regimen with early LLV may have long-term virologic and immunologic benefit when their therapy is maintained.</p>
</sec>
</div>
</front>
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<name sortKey="Barnard, Richard J" sort="Barnard, Richard J" uniqKey="Barnard R" first="Richard J." last="Barnard">Richard J. Barnard</name>
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<name sortKey="Steigbigel, Roy T" sort="Steigbigel, Roy T" uniqKey="Steigbigel R" first="Roy T." last="Steigbigel">Roy T. Steigbigel</name>
<name sortKey="Strohmaier, Kim M" sort="Strohmaier, Kim M" uniqKey="Strohmaier K" first="Kim M." last="Strohmaier">Kim M. Strohmaier</name>
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<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name>
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<country name="Espagne"><noRegion><name sortKey="Clotet, Bonaventura" sort="Clotet, Bonaventura" uniqKey="Clotet B" first="Bonaventura" last="Clotet">Bonaventura Clotet</name>
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<country name="France"><region name="Île-de-France"><name sortKey="Yeni, Patrick" sort="Yeni, Patrick" uniqKey="Yeni P" first="Patrick" last="Yeni">Patrick Yeni</name>
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