6th IAS Conference On HIV Pathogenesis, Treatment and Prevention

New Drugs and Strategies TUAB01

Type:
Oral Abstract Session Back
Venue: SR 1
Time: 11:00 - 12:30, 19.07.2011
Code: TUAB01
Chairs: David Back, United Kingdom
Zhang Fugie, China



Presentations in this session:

11:00
TUAB0101
Abstract
Powerpoint
Slides with audio
Efficacy and safety of lersivirine (UK-453,061) vs. efavirenz in antiretroviral treatment-naïve HIV-1-infected patients: week 48 primary analysis results from an ongoing, multicentre, randomised, double-blind, phase IIb trial (study A5271015)
Presented by Anton Pozniak, United Kingdom
P. Vernazza1, C. Wang2, A. Pozniak3, E. Weil2, P. Pulik4, D. Cooper5, R. Kaplan6, A. Lazzarin7, H. Valdez8, J. Goodrich9, C. Craig10, J. Mori10, M. Tawadrous2
1Cantonal Hospital, St Gallen, Switzerland, 2Pfizer, Inc., New London, United States, 3Chelsea & Westminster Hospital, London, United States, 4Provincial Infectious Hospital of Warsaw, Warsaw, Poland, 5National Centre in HIV Epidemiology & Clinical Research, Darlinghurst, Australia, 6Desmond Tutu HIV Foundation, Cape Town, South Africa, 7Universita Vita-Salute San Raffaele, Milan, Italy, 8Pfizer, Inc., New York, United States, 9ViiV HealthCare, Research Triangle Park, United States, 10Pfizer Global Research & Development, Sandwich Laboratories, Kent, United Kingdom

11:15
TUAB0102
Abstract
Powerpoint
Slides with audio
Rapid, robust and sustained antiviral response with once-daily (QD) dolutegravir (DTG, S/GSK1349572), a next generation integrase inhibitor (INI) in combination therapy in antiretroviral-naïve adults: 48 week results from SPRING-1 (ING112276)
Presented by Jan van Lunzen, Germany
J. Van Lunzen1, F. Maggiolo2, B. Phung3, O. Tsybakova4, B. Young5,6, J. Gatell7, S. Almond8, M. St. Clair9, C. Brothers9, S. Min9
1University Medical Center, Hamburg-Eppendorf, Germany, 2Ospedali Riuniti de Bergamo, Bergamo, Italy, 3Hôpital Bichat-Claude Bernard, Paris, France, 4AIDS Center, Smolensk, Russian Federation, 5Rocky Mountain CARES/DIDC, Denver, United States, 6Health Connections International, Amsterdam, Netherlands, 7University of Barcelona, Barcelona, Spain, 8GlaxoSmithKline, Mississauga, Canada, 9GlaxoSmithKline, Research Triangle Park, United States

11:30
TUAB0103
Abstract
Powerpoint
Slides with audio
48-week results of a dual-therapy regimen of once-daily maraviroc (MVC) 150 mg in combination with ritonavir-boosted atazanavir (ATV/r) compared to emtricitabine/tenofovir (FTC/TDF) + ATV/r in treatment-naïve (TN) patients infected with CCR5-tropic H
Presented by Anthony Mills, United States
S. Portsmouth1, C. Craig2, A. Mills3, D. Mildvan4, D. Podzamczer5, G. Fätkenheuer6, M. Leal7, H. Valdez1, S.R. Valluri1, J. Heera1
1Pfizer, Inc., New York, United States, 2Pfizer, Sandwich, Kent, United Kingdom, 3UCLA, Los Angeles, United States, 4Beth Israel Medical Center, Division of Infectious Diseases, New York, United States, 5Hospital Universitari de Bellvitge, HIV Unit, Infectious Disease Service, Barcelona, Spain, 6Universitaet Koeln, Koeln, Germany, 7Virgen del Rocio University Hospital, Laboratory of Immunovirology, Biomedicine Institute of Seville (IBIS), Infectious Disease Service, Seville, Spain

11:45
TUAB0104
Abstract
Powerpoint
Slides with audio
Impact of HSV-2 suppressive therapy with daily acyclovir on HIV-1 disease progression: a randomized placebo-controlled trial in Rakai, Uganda
Presented by Steven Reynolds, United States
S. Reynolds1,2, F. Makumbi3, N. Kiwanuka3, K. Newell4, P. Ssebbowa5, V. Ssempijja5, F. Bbosa5, R. Gray6, M. Wawer6, T. Quinn1,2, D. Serwadda3
1National Institute of Allergy and Infectious Diseases, National Institutes of Health, Division of Intramural Research, Bethesda, United States, 2Johns Hopkins University School of Medicine, Division of Infecious Diseases, Baltimore, United States, 3Makerere University College of Health Sciences, Kampala, Uganda, 4SAIC-Frederick Inc., Clinical Monitoring Research Group, Frederick, United States, 5Rakai Health Sciences Program, Kalisizo, Uganda, 6Johns Hopkins Bloomberg School of Public Health, Baltimore, United States

12:00
TUAB0105
Abstract
Abstract withdrawn: HIV-1 viremia persists despite autologous bone marrow transplantation for AIDS-related lymphoma
Presented by Anthony Cillo, United States
A. Cillo1, A. Krishnan2, D. McMahon1, S. Li2, J. Rossi2, J. Zaia2, J. Mellors1
1University of Pittsburgh, Pittsburgh, United States, 2City of Hope National Medical Center, Duarte, United States

12:00
TUAB0106
Abstract
Powerpoint
Efficacy of maraviroc (MVC) administered once daily (QD) or twice daily (BID) with boosted protease inhibitors (bPIs) to treatment-experienced patients
Presented by David Hardy, United States
S. Taylor1, J. Arribas2, C.-F. Perno3, R. Burnside4, L. McFadyen5, D. Hardy6, H.-J. Stellbrink7, D.A. Cooper8, J.-M. Molina9, E. van der Ryst5, J. Heera4, H. Valdez10
1Birmingham Heartlands Hospital, Birmingham, United Kingdom, 2Hospital La Paz, Madrid, Spain, 3University of Rome, Tor Vergata, Italy, 4Pfizer, Inc., New London, CT, United States, 5Pfizer, Sandwich, Kent, United Kingdom, 6Cedars-Sinai Medical Center/Geffen School of Medicine-UCLA, Los Angeles, CA, United States, 7ICH Study Center, Hamburg, Germany, 8University of New South Wales and St Vincent's Hospital, Sydney, Australia, 9Assistance Publique-Hopitaux de Paris, Paris, France, 10Pfizer, Inc., New York, NY, United States

12:15
Moderated discussion





Powerpoints presentations
Efficacy and safety of lersivirine (UK-453,061) vs. efavirenz in antiretroviral treatment-naïve HIV-1-infected patients: week 48 primary analysis results from an ongoing, multicentre, randomised, double-blind, phase IIb trial (study A5271015) - Anton Pozniak

Rapid, robust and sustained antiviral response with once-daily (QD) dolutegravir (DTG, S/GSK1349572), a next generation integrase inhibitor (INI) in combination therapy in antiretroviral-naïve adults: 48 week results from SPRING-1 (ING112276) - Jan van Lunzen

48-week results of a dual-therapy regimen of once-daily maraviroc (MVC) 150 mg in combination with ritonavir-boosted atazanavir (ATV/r) compared to emtricitabine/tenofovir (FTC/TDF) + ATV/r in treatment-naïve (TN) patients infected with CCR5-tropic HIV-1 - Anthony Mills

Impact of HSV-2 suppressive therapy with daily acyclovir on HIV-1 disease progression: a randomized placebo-controlled trial in Rakai, Uganda - Steven Reynolds

Efficacy of maraviroc (MVC) administered once daily (QD) or twice daily (BID) with boosted protease inhibitors (bPIs) to treatment-experienced patients - David Hardy



Rapporteur report

Track B report by Roy M. Gulick,


A5271015 (TUAB0101) is a phase IIb study of lersivirine, in which 193 treatment-naïve patients received tenofovir/lamivudine in combination with either lersivirine at 500 or 750 mg daily or efavirenz. At week 48, HIV RNA <50 copies/ml was seen in 79% (both lersivirine arms) and 86% (efavirenz). There were more CNS symptoms and greater lipid rises with efavirenz, and more nausea and headaches with lersivirine.
SPRING-1 (TUAB0102) is a phase IIb study of the integrase inhibitor dolutegravir (10, 25, or 50 mg) in 205 treatment-naïve patients versus efavirenz. At 48 weeks, HIV RNA was <50 copies/ml in 88-91% (dolutegravir groups) vs. 82% (efavirenz). Discontinuations due to adverse events occurred less often with dolutegravir and there were minimal change in lipid levels. Dolutegravir did produce a slight increase is serum creatinine, but no change in GFR.
A4001078 is a phase IIb study of 121 treatment-naïve patients with R5 virus and CD4 at least 100/uL who all received atazanavir/ritonavir (300/100 mg) and randomized maraviroc 150 mg daily or tenofovir/emtricitabine (TUAB0103). At 48 weeks, HIV RNA was <50 copies/ml in 75% (maraviroc) and 84% (tenofovir/emtricitabine). Hyperbilirubinemia occurred more frequently with atazanavir (i.e. without tenofovir).
A placebo-controlled study of suppressive acyclovir on HIV progression was reported from Uganda (TUAB0104). A total of 440 patients seropositive for HSV-2 with CD4 300-400/uL were randomized to acyclovir 400 mg bid or placebo. The primary outcome (CD4 <250 or starting ART for WHO Stage IV disease) was seen in 95 (acyclovir) vs. 110 (placebo) patients, a 27% decrease in disease progression. A late-breaker poster to be presented Wednesday (WEPDB0106) shows that valacyclovir reduces HIV RNA by 0.62 log c/mL compared to acyclovir, suggesting that this drug should also be tested in a clinical endpoint trial.
In a retrospective analysis from the MOTIVATE study of treatment-experienced patients, a total of 448 patients took certain boosted PIs in combination with maraviroc either once-daily, twice-daily, or placebo. At week 48, HIV RNA was <50 copies/ml in 46% (maraviroc once-daily), 48% (maraviroc twice-daily), and 16% (placebo).
Related late-breaker posters included:
The SENSE trial (TULBPE025) a phase 2 placebo controlled trial comparing 2NRTI + once daily etravirine (400mg qd) or efavirenz (600mg qd). Those with HIV RNA<50 at Week 48 was similar in the etravirine arm (75.9%) and the efavirenz arm (74.4%).
 
Vacc-4x (TULBPE028) is a peptide-based therapeutic vaccine that aims to improve immune responses to the HIV-1 p24. In a phase IIB study there was no difference between theVacc-4x and placebo groups regarding time to return to ART (p=0.89) during a 24 week treatment interruption. However, post-hoc analyses for patients who remained off ART until week 52 showed a statistically significant reduction in VL from the pre ART level (0.55 log,p=0.0003) in the Vacc-4x group.
 

 




   

    The organizers reserve the right to amend the programme.


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