Late Breaker B WELBB1
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Type:
Oral Abstract Session Back
Venue: Session Room 1
Time: 13:00 - 14:00, 22.07.2009
Code: WELBB1
Chairs: Jean Nachega, United States
Paul Volberding, United States
Webcast provided by International AIDS Society



Presentations in this session:

13:00
WELBB101
Abstract
Powerpoint		A randomized trial comparing highly active antiretroviral therapy regimens for virologic efficacy and the prevention of mother-to-child HIV transmission among breastfeeding women in Botswana (The Mma Bana Study)
Presented by Roger Shapiro, United States
R. Shapiro1,2, M. Hughes3, A. Ogwu4, D. Kitch3, S. Lockman2,5, C. Moffat4, J. Makhema4, S. Moyo4, I. Thior4, K. McIntosh6, E. van Widenfelt4, J. Leidner2, K. Powis7, A. Asmelash4, E. Tumbare4, S. Zwerski8, U. Sharma8, E. Handelsman8, O. Jayeoba4, E. Moko4, S. Souda4, E. Lubega4, M. Akhtar4, C. Wester4, W. Snowden9, M. Martinez-Tristani10, L. Mazhani11, M. Essex2, The Mma Bana Study Team
1Beth Israel Deaconess Medical Center, Harvard University, Boston, United States, 2Harvard School of Public Health, Department of Immunology and Infectious Diseases, Boston, United States, 3Harvard School of Public Health, Department of Biostatistics, Boston, United States, 4Botswana-Harvard AIDS Institute, Gaborone, Botswana, 5Brigham and Women's Hospital, Infectious Disease Unit, Boston, United States, 6Harvard Medical School, Division of Infectious Diseases, Boston, United States, 7Massachusetts General Hospital, Departments of Medicine and Pediatrics, Boston, United States, 8National Institutes of Health, National Institute of Allergy and Infectious Diseases, Bethesda, United States, 9GlaxoSmithKline, Greenford, United Kingdom, 10Abbott Virology, Miami, United States, 11Botswana Ministry of Health, Gaborone, Botswana

13:10
WELBB102
Abstract
Powerpoint		Efficacy of darunavir/ritonavir as single-drug maintenance therapy in patients with HIV-1 viral suppression: a randomized open-label non-inferiority trial, MONOI-ANRS 136
Presented by Christine Katlama, France
C. Katlama1, M.A. Valentin1, M. Algarte-Genin2, C. Duvivier3, S. Lambert-Niclot4, P.-M. Girard5, J.-M. Molina6, B. Hosten7, S. Pakianather2, G. Peytavin8, A.G. Marcelin4, P. Flandre2
1Pitié-Salpétrière University Hospital and INSERM U 943, Infectious Disease, Paris, France, 2INSERM U 943, Paris, France, 3Necker Hospital, Infectious Disease, Paris, France, 4Pitié-Salpétrière University Hospital and INSERM U 943, Virology Department, Paris, France, 5Saint Antoine Hospital, Infectious Disease, Paris, France, 6Saint Louis Hospital AP HP, Infectious Disease, Paris, France, 7Bicetre Hospital, Kremlin-Bicetre, France, 8Bichat Claude Bernard Hospital, Paris, France

13:20
WELBB103
Abstract
Powerpoint		Similar efficacy and tolerability of atazanavir (ATV) compared to ATV/ritonavir (RTV, r), each in combination with abacavir/lamivudine (ABC/3TC), after initial supression with ABC/3TC + ATV/r in HIV-1 infected patients: 84 week results of the ARIES trial
Presented by Kathleen Squires, United States
K. Squires1, B. Young2, E. DeJesus3, N. Bellos4, D. Murphy5, D. Sutherland-Phillips6, H. Zhao6, L. Patel6, L. Ross6, P. Wannamaker6, M. Shaefer6
1Thomas Jefferson University, Philadelphia, United States, 2University of Colorado, Denver, United States, 3Orlando Immunology Center, Orlando, United States, 4SW Infectious Diseases Association, Dallas, United States, 5Clinique Medicale L'Actuel, Montreal, Canada, 6GlaxoSmithKline, Research Triangle Park, United States

13:30
WELBB104
Abstract
Powerpoint		Raltegravir (RAL) intensification does not reduce low-level residual viremia in HIV-1-infected patients on antiretroviral therapy (ART): results from ACTG A5244
Presented by Rajesh Gandhi, United States
R. Gandhi1, S. Zheng2, R. Bosch2, E. Chan2, D. Margolis3, S. Read4, B. Kallungal5, H. Sprenger6, J. Janik6, J. Jacobson7, A. Wiegand8, M. Kearney8, S. Palmer9, J. Coffin10, J. Mellors11, J. Eron3, AIDS Clinical Trials Group A5244 Team
1Massachusetts General Hospital / Harvard Medical School, Boston, United States, 2Harvard School of Public Health, Boston, United States, 3University of North Carolina, Chapel Hill, United States, 4National Instititues of Health, Bethesda, United States, 5Social & Scientific Systems, Inc., Silver Spring, United States, 6Frontier Science Technology and Research Foundation, Amherst, United States, 7Drexel University College of Medicine, Philadelphia, United States, 8National Cancer Institute-Frederick, Frederick, United States, 9Karolinska Institute, Stockholm, Sweden, 10Tufts University, Boston, United States, 11University of Pittsburgh Medical Center, Pittsburgh, United States

13:40
WELBB105
Abstract
Powerpoint		Widespread ART is associated with decline in TB prevalence
Presented by Keren Middelkoop, South Africa
K. Middelkoop1, R. Wood1, L. Myer2,3, A. Whitelaw4,5, G. Kaplan6, J. McIntyre7, L.-G. Bekker1
1University of Cape Town, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Department of Medicine, Cape Town, South Africa, 2University of Cape Town, Infectious Diseases Epidemiology Unit, School of Public Health & Family Medicine, Cape Town, South Africa, 3Columbia University, Department of Epidemiology, Mailman School of Public Health, New York, United States, 4University of Cape Town, Division of Medical Microbiology, Department of Clinical Laboratory Sciences, Cape Town, South Africa, 5National Health Laboratory Service, Cape Town, South Africa, 6University of Medicine and Dentistry of New Jersey, Laboratory of Mycobacterial Immunity and Pathogenesis, The Public Health Research Institute, New Jersey, United States, 7University of the Witwatersrand, Perinatal HIV Research Unit, Johannesburg, South Africa

Powerpoints presentations
A randomized trial comparing highly active antiretroviral therapy regimens for virologic efficacy and the prevention of mother-to-child HIV transmission among breastfeeding women in Botswana (The Mma Bana Study) - Shapiro

Efficacy of darunavir/ritonavir as single-drug maintenance therapy in patients with HIV-1 viral suppression: a randomized open-label non-inferiority trial, MONOI-ANRS 136 - Katlama

Similar efficacy and tolerability of atazanavir (ATV) compared to ATV/ritonavir (RTV, r), each in combination with abacavir/lamivudine (ABC/3TC), after initial supression with ABC/3TC + ATV/r in HIV-1 infected patients: 84 week results of the ARIES trial - Squires

Raltegravir (RAL) intensification does not reduce low-level residual viremia in HIV-1-infected patients on antiretroviral therapy (ART): results from ACTG A5244 - Gandhi

Widespread ART is associated with decline in TB prevalence - Middelkoop



Rapporteur report

Track B report by Ian Frank, Pablo Tebas, Renslow Sherer and Roger Bedimo


Shapiro presented the Mma Bana Study comparing trizivir to LPV/r and CBV in 570 pregnant women with CD4 cell counts >350 cells/ml, and in comparison to an observed cohort of 170 with CD4 <200 cells/ml. The end points were VL<400 at delivery and throughout breastfeeding for 25 weeks, and the MTCT rate. Exceptional follow up was achieved in this study, with 95-97% follow up in both arms and in the comparison arm. 71% of women breastfed the infants for at least 5 months. The viral endpoint was achieved in 92-96% of groups, with no differences between study arms and the observational arm. A total of 5 MTCTs occurred in the TZV arm and 1 in the LPV/r arm, for an overall MTCT rate of 1%, which is the lowest ever achieved in an MTCT trial. No differences were seen in congenital abnormalities or still births between arms, nor in adverse effects. The authors concluded that HAART for HIV pregnant women was highly protective of vertical transmission, including its use in women with CD4 cell counts >350 cells/ml.

Dr. Katlama presented the results of the MONOI study, conducted by the ANRS in France. Patients receiving antiretroviral therapy with an undetectable viral load (< 400 copies/mL) after a short induction phase with 2 nucleosides and DRV/r were randomized to continue triple therapy or to drop the nucleoside combination. The design was similar to the MONET study presented yesterday. The definition of failure was somewhat unusual nowadays (2 consecutive HIV RNA levels above 400 copies/mL), or modification/discontinuation of study treatment by week 48. In the per protocol analysis dropping the nucleosides was equivalent to continue triple therapy (although the confidence intervals were calculated at 90% instead of the more typical 95%. The intention to treat results could not demonstrate non-non inferiority, what may raise some concerns for this strategy. Individuals that failed virologically in the monotherapy arm could be resuppressed by adding two nucleosides to their regimen. 

Dr. Squires presented the 84 weeks results of a simplification trial to test the effectiveness of an unboosted PI regimen in patients with virologic suppression.  Subjects (n=515) who entered the trial started on ABC/3TC + boosted ATV, were treated for 36 weeks, and were randomized to continue therapy (n=209) or drop the RTV and continue on ABC/3TC + ATV (n=210) if their viral load was <50 c/mL prior to week 36.  The primary endpoint was the proportion of subjects with VL<50 c/mL at week 84 by TLOVR analysis.  Subjects were predominantly White (63%) and men (84%), with a median viral load of 5.05 log and CD4+ count of 200.  At week 84, 86% of subjects on ATV and 81% on ATV/r had viral loads <50 c/mL (-5%; 95% CI -1.75, 12.48, p=0.140).  Similar results were seen in subjects with baseline viral loads < or >100.000 c/mL.  CD4+ count changes were similar in both groups.  There were a total of 8 virologic failures, 1 in the ATV group and 7 in ATV/r group, and treatment emergent mutations was seen in the one failure in the ATV group (M184) and no mutations in the ATV/r group.  Treatment related adverse events included grade 2-4 hyperbilirubinemia (14% in the induction phase and 4% in the maintenance phase in the ATV arm versus 12% in the induction phase and10% in the maintenance phase in the ATV/r arm.  Decreases in total and LDL cholesterol and triglycerides were observed following discontinuation of RTV in the unboosted ATV arm.  In conclusion, unboosted ATV had comparable activity with less hyperbilirubinemia and a more favorable lipid profile than continued boosted ATV. 

Dr. Gandhi's  study examined the potential of treatment intensification to reduce low level, detectable viremia in patients with quantifiable viral loads <50 c/mL to determine if this low level viremia represents replicating virus or virus release from latent reservoirs. Subjects received raltegravir or placebo for 12 weeks, and then crossed over to the alternative experimental arm and followed until week 24.  The study included subjects with baseline VL >100,000 c/mL and had a screening VL>1 c/mL.  125 subjects screened 60% with detectable VL, 53 were enrolled, and 49 contributed data. The median viral load of subjects was 1.7 c/mL.  There were no differences between the absolute or change in viral load between the two groups or following the switch to the alternative treatment.  There was a trend towards a higher CD4+ count following the addition of raltegravir that reversed after its withdrawal.  These data argue against the hypothesis that ongoing cycles of replication are the main source of residual plasma viremia.   

Middlekoop compared TB prevalence in a random community sample of 10% of 762 adults in 2005 and 1,251 adults in 2008 in Cape Town, South Africa. She found a significant reduction in population TB prevalence from 3% to 1.8% (p=0.03) that was predominantly due to a significant decrease in undiagnosed TB in HIV positive patients from 9.2% in 2005 to 3.6% in 2008 (p=0.02). She noted that new TB cases in Cape Town fell from 8,000 in 2004 to 2,400 in 2008 during the HAART era that began in 2008. Other plausible reasons for these dramatic decreases, such as changes in TB case finding, increasing mortality, or increased emigration of infected individuals had no evidence to support them, and the clear temporal association with the onset of rapid ART scale up added weight to the likely impact of ART on TB incidence.




   

   

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