AustralieFrV1, Istex, Corpus, bibRecord, 000741

Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials

Identifieur interne : 000741 ( Istex/Corpus ); précédent : 000740; suivant : 000742

Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials

Auteurs : Roy T. Steigbigel ; David A. Cooper ; Hedy Teppler ; Joseph J. Eron ; Jose M. Gatell ; Princy N. Kumar ; Jurgen K. Rockstroh ; Mauro Schechter ; Christine Katlama ; Martin Markowitz ; Patrick Yeni ; Mona R. Loutfy ; Adriano Lazzarin ; Jeffrey L. Lennox ; Bonaventura Clotet ; Jing Zhao ; Hong Wan ; Rand R. Rhodes ; Kim M. Strohmaier ; Richard J. Barnard ; Robin D. Isaacs ; Bach-Yen T. Nguyen

Source :

Clinical Infectious Diseases [ 1058-4838 ] ; 2010-02-15.

RBID : ISTEX:259B06AB26655CD5E97B00AC4EBA9A09FEE8215B

Abstract

BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.

Url:

https://api.istex.fr/document/259B06AB26655CD5E97B00AC4EBA9A09FEE8215B/fulltext/pdf

DOI: 10.1086/650002

Links to Exploration step

ISTEX:259B06AB26655CD5E97B00AC4EBA9A09FEE8215B

Le document en format XML

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<sourceDesc><biblStruct><analytic><title level="a">Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials</title>
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</affiliation>
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<affiliation><mods:affiliation>>Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil</mods:affiliation>
</affiliation>
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<author><name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name>
<affiliation><mods:affiliation>>Hospital Pitié Salpêtrière, Université Pierre et Marie Curie, Paris, France</mods:affiliation>
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<author><name sortKey="Markowitz, Martin" sort="Markowitz, Martin" uniqKey="Markowitz M" first="Martin" last="Markowitz">Martin Markowitz</name>
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</affiliation>
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<author><name sortKey="Lazzarin, Adriano" sort="Lazzarin, Adriano" uniqKey="Lazzarin A" first="Adriano" last="Lazzarin">Adriano Lazzarin</name>
<affiliation><mods:affiliation>>San Raffaele Scientific Institute, Milan, Italy</mods:affiliation>
</affiliation>
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<author><name sortKey="Lennox, Jeffrey L" sort="Lennox, Jeffrey L" uniqKey="Lennox J" first="Jeffrey L." last="Lennox">Jeffrey L. Lennox</name>
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</affiliation>
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<author><name sortKey="Clotet, Bonaventura" sort="Clotet, Bonaventura" uniqKey="Clotet B" first="Bonaventura" last="Clotet">Bonaventura Clotet</name>
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<front><div type="abstract">BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.</div>
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<abstract><p>BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.</p>
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<subject>Brief Report</subject>

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<article-title>Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials</article-title>

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<name>

<surname>Steigbigel</surname>

<given-names>Roy T.</given-names>

</name>

<xref rid="aff1" ref-type="aff">1</xref>

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<name>

<surname>Cooper</surname>

<given-names>David A.</given-names>

</name>

<xref rid="aff7" ref-type="aff">7</xref>

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<name>

<surname>Teppler</surname>

<given-names>Hedy</given-names>

</name>

<xref rid="aff3" ref-type="aff">3</xref>

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<name>

<surname>Eron</surname>

<given-names>Joseph J.</given-names>

</name>

<xref rid="aff4" ref-type="aff">4</xref>

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<name>

<surname>Gatell</surname>

<given-names>Jose M.</given-names>

</name>

<xref rid="aff8" ref-type="aff">8</xref>

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<name>

<surname>Kumar</surname>

<given-names>Princy N.</given-names>

</name>

<xref rid="aff5" ref-type="aff">5</xref>

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<surname>Rockstroh</surname>

<given-names>Jurgen K.</given-names>

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<xref rid="aff10" ref-type="aff">10</xref>

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<surname>Schechter</surname>

<given-names>Mauro</given-names>

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<xref rid="aff11" ref-type="aff">11</xref>

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<surname>Katlama</surname>

<given-names>Christine</given-names>

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<xref rid="aff12" ref-type="aff">12</xref>

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<given-names>Martin</given-names>

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<surname>Yeni</surname>

<given-names>Patrick</given-names>

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<xref rid="aff13" ref-type="aff">13</xref>

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<surname>Loutfy</surname>

<given-names>Mona R.</given-names>

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<xref rid="aff14" ref-type="aff">14</xref>

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<surname>Lazzarin</surname>

<given-names>Adriano</given-names>

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<xref rid="aff15" ref-type="aff">15</xref>

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<surname>Lennox</surname>

<given-names>Jeffrey L.</given-names>

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<xref rid="aff6" ref-type="aff">6</xref>

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<surname>Clotet</surname>

<given-names>Bonaventura</given-names>

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<xref rid="aff9" ref-type="aff">9</xref>

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<surname>Zhao</surname>

<given-names>Jing</given-names>

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<surname>Wan</surname>

<given-names>Hong</given-names>

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<xref rid="aff3" ref-type="aff">3</xref>

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<name>

<surname>Rhodes</surname>

<given-names>Rand R.</given-names>

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<xref rid="aff3" ref-type="aff">3</xref>

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<name>

<surname>Strohmaier</surname>

<given-names>Kim M.</given-names>

</name>

<xref rid="aff3" ref-type="aff">3</xref>

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<name>

<surname>Barnard</surname>

<given-names>Richard J.</given-names>

</name>

<xref rid="aff3" ref-type="aff">3</xref>

</contrib>

<contrib contrib-type="author">

<name>

<surname>Isaacs</surname>

<given-names>Robin D.</given-names>

</name>

<xref rid="aff3" ref-type="aff">3</xref>

</contrib>

<contrib contrib-type="author" corresp="yes">

<name>

<surname>Nguyen</surname>

<given-names>Bach-Yen T.</given-names>

</name>

<xref rid="cor1" ref-type="corresp"></xref>

<xref rid="aff3" ref-type="aff">3</xref>

</contrib>

<contrib contrib-type="author">

<collab>BENCHMRK Study Teams</collab>

<xref ref-type="author-notes" rid="FN1">a</xref>

</contrib>

<aff id="aff1"><label>1</label>
<institution>State University of New York at Stony Brook</institution>
, <addr-line>New York, New York</addr-line>
</aff>

<aff id="aff2"><label>2</label>
<institution>Aaron Diamond Research Center, The Rockefeller University</institution>
, <addr-line>New York, New York</addr-line>
</aff>

<aff id="aff3"><label>3</label>
<institution>Merck Research Laboratories</institution>
, <addr-line>North Wales, Pennsylvania</addr-line>
</aff>

<aff id="aff4"><label>4</label>
<institution>University of North Carolina</institution>
, <addr-line>Chapel Hill</addr-line>
</aff>

<aff id="aff5"><label>5</label>
<institution>Georgetown University Medical Center</institution>
, <addr-line>Washington, DC</addr-line>
</aff>

<aff id="aff6"><label>6</label>
<institution>Emory University School of Medicine</institution>
, <addr-line>Atlanta, Georgia</addr-line>
</aff>

<aff id="aff7"><label>7</label>
<institution>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</institution>
, <addr-line>Sydney, Australia</addr-line>
</aff>

<aff id="aff8"><label>8</label>
<institution>Hospital Clinic-IDIBAPS, University of Barcelona</institution>
, <addr-line>Barcelona, Spain</addr-line>
</aff>

<aff id="aff9"><label>9</label>
<institution>Hospital Germans Trias i Pujol, Fundación Irsicaixa, UAB</institution>
, <addr-line>Barcelona, Spain</addr-line>
</aff>

<aff id="aff10"><label>10</label>
><institution>Department of Medicine I, University of Bonn</institution>
, <addr-line>Bonn, Germany</addr-line>
</aff>

<aff id="aff11"><label>11</label>
><institution>Universidade Federal do Rio de Janeiro</institution>
, <addr-line>Rio de Janeiro, Brazil</addr-line>
</aff>

<aff id="aff12"><label>12</label>
><institution>Hospital Pitié Salpêtrière, Université Pierre et Marie Curie</institution>
, <addr-line>Paris, France</addr-line>
</aff>

<aff id="aff13"><label>13</label>
><institution>Hospital Bichat-Claude Bernard</institution>
, <addr-line>Paris, France</addr-line>
</aff>

<aff id="aff14"><label>14</label>
><institution>University of Toronto</institution>
, <addr-line>Ontario, Canada</addr-line>
</aff>

<aff id="aff15"><label>15</label>
><institution>San Raffaele Scientific Institute</institution>
, <addr-line>Milan, Italy</addr-line>
</aff>

</contrib-group>

<author-notes>

<corresp id="cor1">Reprints or correspondence: Dr. Bach-Yen Nguyen, Merck Research Laboratories, PO Box 1000, UG3D-56, North Wales, PA 19454-1099 (<email>bachyen_nguyen@merck.com</email>
).</corresp>

<fn fn-type="study-group-members" id="FN1"><label>a</label>
<p>Members of the study group are listed at the end of the text.</p>
</fn>

</author-notes>

<pub-date pub-type="ppub">

<day>15</day>

<month>2</month>

<year>2010</year>

</pub-date>

<volume>50</volume>

<issue>4</issue>

<fpage>605</fpage>

<lpage>612</lpage>

<history>

<date date-type="received">

<day>12</day>

<month>6</month>

<year>2009</year>

</date>

<date date-type="accepted">

<day>2</day>

<month>10</month>

<year>2009</year>

</date>

</history>

<copyright-statement>© 2010 by the Infectious Diseases Society of America</copyright-statement>

<copyright-year>2010</copyright-year>

<abstract>

<p>BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.</p>

</abstract>

</article-meta>

</front>

<body>

<p>Raltegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand-transfer inhibitor that is active against multidrug-resistant HIV-1 in vitro [<xref ref-type="bibr" rid="ref1">1</xref>
, <xref ref-type="bibr" rid="ref2">2</xref>
]. In phase II clinical trials, raltegravir demonstrated potent and durable antiretroviral activity for up to 96 weeks when given with optimized background therapy (OBT) in treatment-experienced patients [<xref ref-type="bibr" rid="ref3">3</xref>
] or with tenofovir and lamivudine in treatment-naive patients [<xref ref-type="bibr" rid="ref4">4</xref>
]. Week 48 results of the BENCHMRK phase III studies confirmed the efficacy of raltegravir in treatment-experienced patients infected with multidrug-resistant HIV-1 [<xref ref-type="bibr" rid="ref5">5</xref>
, <xref ref-type="bibr" rid="ref6">6</xref>
]. This report presents follow-up results through week 96 of the ongoing BENCHMRK studies.</p>

<p>Methods. BENCHMRK-1 (protocol 018; NCT 00293267) and BENCHMRK-2 (protocol 019; NCT 00293254) are double-blind, randomized, phase III studies with identical study designs, as described elsewhere [<xref ref-type="bibr" rid="ref5">5</xref>
]. This report presents efficacy results through study week 96 and all available safety data from the double-blind phase through 29 August 2008 (week 96 database lock). From study weeks 16–48, virologic failure was defined as <1 log<sub>10</sub>
 decrease in HIV RNA levels from baseline, confirmed >1 log<sub>10</sub>
 increase in HIV RNA level from the nadir, or 2 consecutive HIV RNA level measurements ⩾400 copies/mL after a prior result of <400 copies/mL. To be consistent with the recently updated recommended target for viral suppression [<xref ref-type="bibr" rid="ref7">7</xref>
], virologic failure after week 48 was defined as confirmed HIV RNA level ⩾50 copies/mL (2 consecutive measurements at least 1 week apart). Patients with virologic failure at any time after week 16 could (1) exit the double-blind study and enter an open-label phase to receive raltegravir as part of a new regimen, (2) remain in the blinded study, or (3) withdraw from the study. The potential emergence of resistance to raltegravir was investigated in patients with virologic failure by genotyping the integrase coding sequence according to standard methods [<xref ref-type="bibr" rid="ref6">6</xref>
] and by comparison with pretreatment genotypes.</p>

<p>The following predefined end points were examined at week 96: proportion of patients with HIV RNA levels <50 copies/mL, proportion of patients with HIV RNA levels <400 copies/mL, change from baseline in log<sub>10</sub>
 HIV RNA level (copies/mL), and change from baseline in CD4 cell count (cells/mm<sup>3</sup>
). For the proportions over time analysis, a worst-case approach as used that counted all patients who did not complete the study as treatment failures; missing HIV RNA level measurements were imputed as failures unless the values flanking the missing value were both successes, in which case the absent value was left as missing. For the change from baseline analyses, an observed failure approach was used: patients who discontinued treatment for lack of efficacy were assumed to have returned to their baseline value at subsequent times, but no other missing values were imputed. Data from patients who discontinued treatment for other reasons were censored at discontinuation. The observed failure approach was also used for exploratory subgroup analyses by potential prognostic factors and for the assessment of treatment effect homogeneity across subpopulations. Suspected AIDS-defining events were reviewed by an independent adjudicator, and blinded safety and efficacy results were periodically reviewed by an independent Data and Safety Monitoring Board. Additional details of the statistical analyses and the adjudication of AIDS-defining events are described elsewhere [<xref ref-type="bibr" rid="ref5">5</xref>
].</p>

<p>Results. Baseline characteristics were generally balanced between treatment groups [<xref ref-type="bibr" rid="ref5">5</xref>
]. Most enrolled patients were highly treatment-experienced white male individuals with AIDS. Duration of double-blind follow-up was longer in the raltegravir group (median, 110.4 weeks; range, 3.0–127.4 weeks) than in the placebo group (median, 37.6 weeks; range, 5.6–126.4 weeks) because of more frequent discontinuations for virologic failure among placebo recipients (<xref rid="tab1" ref-type="fig">table 1</xref>
).</p>

<p>Virologic and immunologic responses were consistent between the 2 BENCHMRK studies at week 96 (homogeneity P>.1). In the combined studies, 57% of raltegravir recipients, compared with 26% of placebo recipients, sustained an HIV RNA level <50 copies/mL at week 96 (P<.001) (<xref rid="fig1" ref-type="fig">Figure 1<italic>A</italic>
</xref>
); 61% and 28%, respectively, had an HIV RNA level <400 copies/mL (P<.001) (<xref rid="fig1" ref-type="fig">Figure 1<italic>B</italic>
</xref>
). Both the mean changes in log<sub>10</sub>
 HIV RNA level and CD4 cell counts from baseline to week 96 were significantly greater in the raltegravir group than in the placebo group (HIV RNA level: −1.5 log<sub>10</sub>
 copies/mL [95% confidence interval, −1.6 to −1.4 log<sub>10</sub>
 copies/mL] vs −0.6 log<sub>10</sub>
 copies/mL [95% confidence interval, −0.7 to −0.5 log<sub>10</sub>
 copies/mL]; P<.001; CD4 cell count: 123 cells/mm<sup>3</sup>
 vs 49 cells/mm<sup>3</sup>
; P<.001) (<xref rid="fig1" ref-type="fig">Figure 1<italic>C</italic>
</xref>
). There was a nonsignificant trend toward lower rates of AIDS-defining condition and mortality among raltegravir recipients (<xref rid="tab2" ref-type="fig">table 2</xref>
).</p>

<p>In subgroup analyses at week 96, efficacy, by prognostic factors, was generally consistent with the overall analysis, showing potent antiretroviral and immunological efficacy of raltegravir, compared with placebo (Figures 2 and 3), even in patients with poor prognostic factors at baseline, including high HIV RNA level, low CD4 cell count, and low genotypic and phenotypic sensitivity scores. For patients receiving multiple active drugs in their OBT, such as those with genotypic and phenotypic sensitivity scores of ⩾2, there was a trend toward modestly higher numerical response rates for raltegravir, compared with placebo. Additional efficacy analyses, by viral subtype, age, sex, and race, demonstrated consistently greater response rates in the raltegravir group than in the placebo group.</p>

<p>Virologic failure occurred by week 96 in 150 (33%) of 462 raltegravir recipients and in 148 (62%) of 237 placebo recipients. Resistance test results were available for 112 of the raltegravir recipients who experienced virologic failure. Virus isolates from 73 (65%) of these patients had integrase mutations at 1 of 3 residues (Y143, Q148 or N155), usually in combination with at least 1 other mutation. Most drug-resistance mutations (77%) were observed by 24 weeks of therapy. Other known raltegravir-resistance mutations (E92E/Q and L74M+E92Q) were found in 2 of the 39 patients who did not have a primary raltegravir-resistance mutation. Available phenotypic data revealed no raltegravir resistance in virus isolates from the remaining 37 patients.</p>

<p>Outcomes were also available for 192 patients who entered the open-label post–virologic failure phase after documented virologic failure during the double-blind phase; these patients were permitted to reoptimize OBT, if possible, at entry to the open-label–post virologic failure phase. The mean duration of double-blind therapy at entry to the open-label post–virologic failure phase was 41 weeks for raltegravir recipients and 28 weeks for placebo recipients. At week 48 after entry to the open-label post–virologic failure phase, an HIV RNA level <50 copies/mL was achieved in 11 (15%) of 73 patients originally randomized to receive raltegravir therapy and in 51 (43%) of 119 patients originally randomized to receive placebo therapy; for this analysis, patients who did not complete the open-label post–virologic failure phase were counted as treatment failures. In both groups, only 18% of patients (13 of 73 and 22 of 119, respectively) had changed OBT to include new active antiretroviral agents.</p>

<p>Frequencies and exposure-adjusted rates of clinical adverse events (<xref rid="tab3" ref-type="fig">table 3</xref>
) and grade 3 and 4 laboratory abnormalities (<xref rid="tab4" ref-type="fig">table 4</xref>
) were similar in the raltegravir and placebo groups. Creatine kinase elevations were slightly more common in the raltegravir group but were not associated with clinical myopathy, myositis, or rhabdomyolysis and did not lead to treatment interruption or discontinuation. As of the cutoff date for this analysis, 13 patients (3%) in the raltegravir group and 7 patients (3%) in the placebo group had died during the double-blind phase of the study. Fatal adverse events in the double-blind phase since the previous report [<xref ref-type="bibr" rid="ref5">5</xref>
] were hypovolemic shock, cardiac failure, anal cancer, and head injury in the raltegravir group and lymphoma in the placebo group. Exposure-adjusted rates for new, recurrent, or progressive cancer during the double-blind phase were 3.0 cases per 100 person-years in the raltegravir group and 2.6 cases per 100 person-years in the placebo group (relative risk, 1.1; 95% confidence interval, 0.5–3.1).</p>

<p>Discussion. The ongoing BENCHMRK studies represent the longest placebo-controlled experience with raltegravir in treatment-experienced patients to date. More than 90% of patients in both studies had a history of AIDS. All patients had experienced failure of multiple prior antiretroviral regimens and had documented resistance to at least 1 nucleotide reverse-transcriptase inhibitor, 1 nonnucleotide reverse-transcriptase inhibitor, and 1 protease inhibitor. In these heavily pretreated patients with highly drug-resistant virus, raltegravir (400 mg twice daily) with OBT demonstrated a potent and superior antiretroviral effect, compared with OBT alone; 57% of patients in the raltegravir group achieved viral suppression to <50 copies/mL at week 96, compared with 26% of patients in the placebo group. These response rates are comparable to those observed at week 48 [<xref ref-type="bibr" rid="ref5">5</xref>
], showing durability of the superior efficacy of raltegravir.</p>

<p>Although the BENCHMRK studies were not powered to show statistically significant effects within subgroups [<xref ref-type="bibr" rid="ref9">9</xref>
], efficacy analyses by baseline prognostic factors continued to demonstrate a consistent treatment advantage of raltegravir over placebo, even in patients with high baseline HIV RNA levels or low baseline CD4 cell counts. Raltegravir also demonstrated superior efficacy, compared with placebo, in patients who received OBT and had genotypic and/or phenotypic sensitivity scores of 0—generally regarded as the most challenging treatment scenario. Among patients who received new, active antiretroviral therapy in their OBT, up to 79% of raltegravir recipients had undetectable HIV RNA levels at week 96. Overall, these data demonstrate that raltegravir has a potent antiviral effect in most patients with few or no remaining treatment options and has even greater efficacy when used in combination with other active antiretroviral agents.</p>

<p>Raltegravir was well tolerated in these trials despite a study population with advanced HIV infection and frequent comorbidities. After 96 weeks of treatment, adverse event profiles and laboratory abnormalities were generally comparable for raltegravir- and placebo-containing regimens, with few discontinuations of treatment because of adverse events. In addition, the development of cancer was comparable between the raltegravir and placebo groups.</p>

<p>In summary, in highly treatment-experienced HIV-infected patients, raltegravir combined with OBT provided continued superior viral suppression, compared with OBT alone, despite the presence of triple-class drug-resistant virus. The potent suppression of viremia observed in raltegravir recipients at week 16 and week 48 [<xref ref-type="bibr" rid="ref5">5</xref>
] was sustained through week 96. Raltegravir continued to demonstrate a consistently favorable treatment effect regardless of baseline viral load, CD4 cell count, genotypic and phenotypic sensitivity scores, or inclusion of enfuvirtide and/or darunavir in the OBT. The favorable safety profile of raltegravir after at least 96 weeks of treatment is consistent with previous reports [<xref ref-type="bibr" rid="ref3">3</xref>
–<xref ref-type="bibr" rid="ref5">5</xref>
]. These long-term data confirm that raltegravir offers a valuable treatment option for patients infected with multidrug-resistant HIV.</p>

<p>Principal investigators. BENCHMRK-1: A. Allworth, J. Anderson, M. Bloch, D. A. Cooper, J. Hoy, and C. Workman (Australia); N. Clumeck, R. Colebunders, and M. Moutschen (Belgium); J. Gerstoft, C. Larsen, L. Mathiesen, and C. Pedersen (Denmark); J. F. Delfraissy, P. Dellamonica, C. Katlama, J. M. Molina, F. Raffi, J. Reynes, D. Vittecoq, and P. Yeni (France); K. Arasteh, G. Fatkenheuer, H. Jaeger, J. Rockstroh, and A. Stoehr (Germany); F. Aiuti, G. Carosi, R. Cauda, F. Chiodo, G. Di Perri, G. Filice, M. Galli, A. Lazzarin, and V. Vullo (Italy); M. Castaneda, A. Florez, F. Mendo, A. Paredes, R. Salazar, and E. Ticona (Peru); R. Antunes, A. Diniz, K. Mansinho, J. Saraiva da Cunha, R. Sarmento, E. Teofilo, and J. Vera (Portugal); J. Arrizabalaga, B. Clotet, P. Domingo Pedrol, J. Gatell Artigas, S. Moreno Guillen, and V. Soriano Vazquez (Spain); B. Hirschel and M. Opravil (Switzerland); H.-H. Lin, W.-H. Sheng, and J.-H. Wang (Taiwan); S. Sungkanuparph and S. Suwanagool (Thailand). BENCHMRK-2: B. Grinsztejn, J. V. Madruga, and M. Schecter (Brazil); J.-G. Baril, M. R. Loutfy, J. S. Montaner, C. Tremblay, C. M. Tsoukas, and S. Vezina (Canada); J. A. Cortes, H. Mendoza, and J. Velez (Colombia); N. Quintero Perez, J. Ramos, and E. Rodriguez (Mexico); J. O. Morales-Ramirez and G. E. Sepulveda (Puerto Rico); J. Aberg, G. W. Beatty, P. Benson, R. K. Bolon, U. F. Bredeek, C. Bruno, T. Campbell, R. Campo, G. O. Coodley, R. B. Corales, E. DeJesus, J. J. Eron, W. J. Fessel, R. J. Fetchick, C. J. Gonzalez, C. Hicks, M. A. Horberg, D. B. Klein, M. J. Kozal, P. N. Kumar, A. LaMarca, J. L. Lennox, K. A. Lichtenstein, R. Liporace, S. J. Little, A. Luetkemeyer, F. Mariuz, M. Markowitz, D. K. McMahon, G. Perez, G. Pierone, R. C. Reichman, F. Rhame, P. Shalit, P. Sklar, W. Short, P. R. Skolnik, R. T. Steigbigel, E. M. Tedaldi, D. J. Ward, A. A. Wiznia, and D. P. Wright (United States).</p>

</body>

<back>

<ack>

<title>Acknowledgments</title>

<p>We thank all the patients and their caregivers who participated in this study; the investigators who enrolled their patients in this study, for their important contributions; and Bernard Akyena and Anthony Rodgers, for their expert assistance.</p>

<p>Financial support. Merck.</p>

<p>Potential conflicts of interest. R.T.S. has received research support, speaker fees, and/or consulting fees from Merck. D.A.C. has received research support, speaker fees, and/or consulting fees from Merck. J.J.E. has received research support from Merck, Abbott, and Panacos and speaker fees and/or consulting fees from Merck, BMS, GSK, Gilead, Tibotec, Roche, and Pfizer. J.M.G. has received research support, speaker fees, and consulting fees from Merck. P.N.K. has been an investigator for Merck and GSK; has been a paid consultant to Boehringer-Ingelheim, BMS, GSK, and Tibotec; and has received speaker fees from GSK, Abbott, Tibotec, Pfizer, and Boehringer-Ingelheim. J.K.R. has received honoraria for lectures or advisory boards from Merck, Roche, GSK, BMS, Tibotec, Pfizer, Gilead, Abbott, and Boehringer Ingelheim. C.K. has received honoraria for advisory boards or lectures from Merck, Gilead, Roche, GSK, Tibotec, BMS, and Boehringer Ingelheim. M.M. has received research support, speaker fees, and/or consulting fees from Merck. P.Y. has received consulting fees from Merck. M.R.L. has received research support from Merck. A.L. has received honoraria for lectures or advisory board meetings and/or research support from Merck, GSK, BMS, Gilead, Roche, Tibotec, Pfizer, Boehringer-Ingelheim, Abbott, Monogram, and Schering-Plough. J.L.L. has received research support and speaker's fees from Merck and serves on Merck's antiretroviral scientific advisory board. B.C. has been a consultant on advisory boards, has participated in speakers' bureaus, or has conducted clinical trials with Roche, Boehringer-Ingelheim, Abbott, BMS, GSK, Gilead, Tibotec, Janssen, Merck, Pfizer, Siemens, Monogram Biosciences, and Panacos. H.T., M.S., H.W., R.R.R., K.M.S., R.J.B., R.D.I., and B.-Y.T.N.are employees of Merck Research Laboratories and may own stock and/or stock options in the company.</p>

</ack>

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<collab>version 1.0</collab>

<collab>December 2004; clarification August 2009</collab>

</person-group>

<comment><ext-link ext-link-type="uri" xlink:href="http://rcc.tech-res.com/document/safetyandpharmacovigilance/DAIDS_AE_GradingTable_Clarification_August2009_Final.pdf">http://rcc.tech-res.com/document/safetyandpharmacovigilance/DAIDS_AE_GradingTable_Clarification_August2009_Final.pdf</ext-link>
. Accessed 13 January 2010</comment>

</nlm-citation>

</ref>

<ref id="ref9">

<label>9</label>

<nlm-citation citation-type="journal">

<person-group person-group-type="author">

<name>

<surname>Wang</surname>

<given-names>R</given-names>

</name>

<name>

<surname>Lagakos</surname>

<given-names>SW</given-names>

</name>

<name>

<surname>Ware</surname>

<given-names>JH</given-names>

</name>

<name>

<surname>Hunter</surname>

<given-names>DJ</given-names>

</name>

<name>

<surname>Drazen</surname>

<given-names>JM</given-names>

</name>

</person-group>

<article-title>Statistics in medicine—reporting of subgroup analyses in clinical trials</article-title>

<source>N Engl J Med</source>

<year>2007</year>

<volume>357</volume>

<fpage>2189</fpage>

<lpage>2194</lpage>

</nlm-citation>

</ref>

</ref-list>

<sec sec-type="display-objects">

<title>Figures and Tables</title>

<fig position="float" id="fig1">

<label>Figure 1</label>

<caption>

<p><italic>A</italic>
, Percentage of patients with a plasma HIV RNA level <50 copies/mL, over time, by treatment group. <italic>B</italic>
, Percentage of patients with a plasma HIV RNA level <400 copies/mL, over time, by treatment group. The proportion of patients with an HIV RNA level below the limit of quantification for the ultrasensitive assay and the standard assay, respectively, are shown; patients who did not complete the study were counted as treatment failures. <italic>C</italic>
, Change from baseline in CD4 cell count, over time, by treatment group. The mean change in CD4 cell count per mm<sup>3</sup>
 from baseline are shown using the observed failure approach, carrying baseline values forward (thereby assigning a value of 0 to change from baseline) for all treatment failures. Vertical brackets represent the 95% confidence intervals. OBT, optimized background therapy.</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-fig001.tif"></graphic>

</fig>

<fig position="float" id="fig2">

<label>Figure 2</label>

<caption>

<p>Proportion of patients with an HIV RNA level <50 copies/mL at week 96, by subgroup. Filled circles represent the point estimate of the between-group differences; horizontal bars represent the corresponding 95% confidence intervals (CIs). The vertical line at zero is provided as a reference indicating no treatment difference. Dar, darunavir; Enf, enfuvirtide; GT, genotypic test; OBT, optimized background therapy; PT, phenotypic test; TPV, tipranavir. **Median age, 45 years.</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-fig002.tif"></graphic>

</fig>

<fig position="float" id="fig3">

<label>Figure 3</label>

<caption>

<p>Change in CD4 cell count from baseline to week 96, by subgroup. Filled circles represent the point estimate of the between-group differences; horizontal bars represent the corresponding 95% confidence intervals (CIs). The vertical line at zero is provided as a reference indicating no treatment difference. Dar, darunavir; Enf, enfuvirtide; GT, genotypic test; OBT, optimized background therapy; PT, phenotypic test; TPV, tipranavir. **Median age, 45 years.</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-fig003.tif"></graphic>

</fig>

<fig position="float" id="tab1">

<label>Table 1</label>

<caption>

<p>Patient Disposition</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-tbl001.tif"></graphic>

</fig>

<fig position="float" id="tab2">

<label>Table 2</label>

<caption>

<p>Exposure-Adjusted Rates and Relative Risk of Confirmed AIDS-Defining Condition (ADC) and Death, Week 96 (Double-Blind Phase)</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-tbl002.tif"></graphic>

</fig>

<fig position="float" id="tab3">

<label>Table 3</label>

<caption>

<p>Clinical Adverse Events (AEs).</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-tbl003.tif"></graphic>

</fig>

<fig position="float" id="tab4">

<label>Table 4</label>

<caption>

<p>Grade 3 or 4 Laboratory Abnormalities</p>

</caption>

<graphic mimetype="image" xlink:href="50-4-605-tbl004.tif"></graphic>

</fig>

</sec>

</back>

</article>
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<titleInfo type="alternative" contentType="CDATA"><title>Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials</title>
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<name type="corporate"><namePart>BENCHMRK Study Teams</namePart>
<affiliation>Reprints or correspondence: Dr. Bach-Yen Nguyen, Merck Research Laboratories, PO Box 1000, UG3D-56, North Wales, PA 19454-1099 (bachyen_nguyen@merck.com).</affiliation>
</name>
<name type="personal"><namePart type="given">Roy T.</namePart>
<namePart type="family">Steigbigel</namePart>
<affiliation>State University of New York at Stony Brook, New York, New York</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">David A.</namePart>
<namePart type="family">Cooper</namePart>
<affiliation>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Hedy</namePart>
<namePart type="family">Teppler</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Joseph J.</namePart>
<namePart type="family">Eron</namePart>
<affiliation>University of North Carolina, Chapel Hill</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Jose M.</namePart>
<namePart type="family">Gatell</namePart>
<affiliation>Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona, Spain</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Princy N.</namePart>
<namePart type="family">Kumar</namePart>
<affiliation>Georgetown University Medical Center, Washington, DC</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Jurgen K.</namePart>
<namePart type="family">Rockstroh</namePart>
<affiliation>>Department of Medicine I, University of Bonn, Bonn, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Mauro</namePart>
<namePart type="family">Schechter</namePart>
<affiliation>>Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Christine</namePart>
<namePart type="family">Katlama</namePart>
<affiliation>>Hospital Pitié Salpêtrière, Université Pierre et Marie Curie, Paris, France</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Martin</namePart>
<namePart type="family">Markowitz</namePart>
<affiliation>Aaron Diamond Research Center, The Rockefeller University, New York, New York</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Patrick</namePart>
<namePart type="family">Yeni</namePart>
<affiliation>>Hospital Bichat-Claude Bernard, Paris, France</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Mona R.</namePart>
<namePart type="family">Loutfy</namePart>
<affiliation>>University of Toronto, Ontario, Canada</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Adriano</namePart>
<namePart type="family">Lazzarin</namePart>
<affiliation>>San Raffaele Scientific Institute, Milan, Italy</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Jeffrey L.</namePart>
<namePart type="family">Lennox</namePart>
<affiliation>Emory University School of Medicine, Atlanta, Georgia</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Bonaventura</namePart>
<namePart type="family">Clotet</namePart>
<affiliation>Hospital Germans Trias i Pujol, Fundación Irsicaixa, UAB, Barcelona, Spain</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Jing</namePart>
<namePart type="family">Zhao</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Hong</namePart>
<namePart type="family">Wan</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Rand R.</namePart>
<namePart type="family">Rhodes</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Kim M.</namePart>
<namePart type="family">Strohmaier</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Richard J.</namePart>
<namePart type="family">Barnard</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Robin D.</namePart>
<namePart type="family">Isaacs</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">Bach-Yen T.</namePart>
<namePart type="family">Nguyen</namePart>
<affiliation>Merck Research Laboratories, North Wales, Pennsylvania</affiliation>
<affiliation>E-mail: bachyen_nguyen@merck.com</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
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<typeOfResource>text</typeOfResource>
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<originInfo><publisher>The University of Chicago Press</publisher>
<dateIssued encoding="w3cdtf">2010-02-15</dateIssued>
<copyrightDate encoding="w3cdtf">2010</copyrightDate>
</originInfo>
<abstract>BENCHMRK-1 and -2 are ongoing double-blind phase III studies of raltegravir in patients experiencing failure of antiretroviral therapy with triple-class drug-resistant human immunodeficiency virus infection. At week 96 (combined data), raltegravir (400 mg twice daily) plus optimized background therapy was generally well tolerated, with superior and durable antiretroviral and immunological efficacy, compared with optimized background therapy alone.</abstract>
<note type="footnotes">Members of the study group are listed at the end of the text.</note>
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<titleInfo type="abbreviated"><title>Clinical Infectious Diseases</title>
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<identifier type="eISSN">1537-6591</identifier>
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<identifier type="PublisherID-hwp">cid</identifier>
<part><date>2010</date>
<detail type="volume"><caption>vol.</caption>
<number>50</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>4</number>
</detail>
<extent unit="pages"><start>605</start>
<end>612</end>
</extent>
</part>
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<identifier type="istex">259B06AB26655CD5E97B00AC4EBA9A09FEE8215B</identifier>
<identifier type="DOI">10.1086/650002</identifier>
<accessCondition type="use and reproduction" contentType="copyright">© 2010 by the Infectious Diseases Society of America</accessCondition>
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Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials

Long-Term Efficacy and Safety of Raltegravir Combined with Optimized Background Therapy in Treatment-Experienced Patients with Drug-Resistant HIV Infection: Week 96 Results of the BENCHMRK 1 and 2 Phase III Trials

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