||Late Breaker Track B
Oral Abstract Session : Track B Clinical Sciences
||Session Room 2
||03.07.2013, 16:30 - 17:30
David Cooper, Australia
Teresa Branco, Portugal
|A daily dose of 400mg efavirenz (EFV) is non-inferior to the standard 600mg dose: week 48 data from the ENCORE1 study, a randomised, double-blind, placebo controlled, non-inferiority trial|
R. Puls, Encore1 Study Group
University of New South Wales, The Kirby Institute, Sydney, Australia
|A pragmatic randomised controlled strategy trial of three second-line treatment options for use in public health rollout programme settings: the Europe-Africa Research Network for Evaluation of Second-line Therapy (EARNEST) Trial|
N. Paton1,2, C. Kityo3, A. Hoppe1, J. Hakim4, J. van Oosterhout5, A. Siika6, P. Mwaba7, A. Kambugu8, P. Easterbrook8, J. Boles1, S. Walker1, P. Mugyenyi3, EARNEST Trial Group
1MRC Clinical Trials Unit, London, United Kingdom, 2National University of Singapore, Singapore, Singapore, 3Joint Clinical Research Centre, Kampala, Uganda, 4University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe, 5College of Medicine, University of Malawi, Blantyre, Malawi, 6Moi University School of Medicine, Eldoret, Kenya, 7University Teaching Hospital, Lusaka, Zambia, 8Infectious Diseases Institute, Kampala, Uganda
|Dolutegravir (DTG) is superior to raltegravir (RAL) in ART-experienced, integrase naive subjects: week 48 results from SAILING (ING111762)|
P. Cahn1, A.L. Pozniak2, H. Mingrone3, C. Brites4, J.F. Andrade-Villanueva5, J. Fourie6, M. Ramgopal7, D. Hagins8, J. Valdez Madruga9, T. Newman10, J. Lombaard11, D. Dorey12, M. Underwood13, S. Griffith13, S. Min13
1Fundacion Huesped, Buenos Aires, Argentina, 2Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom, 3Fundacion IDEAA, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 4Complexo Hospitalar Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Brazil, 5Hospital Civil de Guadalajara “Fray Antonio Alcalde”, CUCS, Universidad de Guadalajara, Guadalajara, Mexico, 6Fourie Medical Centre, Dundee, South Africa, 7Midway Immunology and Research Center, Fort Pierce, United States, 8Chatham CARE Center, Savannah, United States, 9Centro de Referencia e Treinamento DST/AIDS, São Paulo, Brazil, 10Instituto de Infectologia Emilio Ribas, São Paulo, Brazil, 11Josha Research, Bloemfontein, South Africa, 12GlaxoSmithKline, Mississauga, Canada, 13GlaxoSmithKline, Research Triangle Park, United States
|HLA-B*35:05 and CCHCR1 screening reduces nevirapine-associated cutaneous adverse reactions in Thailand: a prospective multicenter randomized controlled trial|
S. Kiertiburanakul1, S. Mahasirimongkol2, N. Rajatanavin1, A. Charoenyingwattana3, A. Rojanawiwat2, W. Wangsomboonsiri4, W. Manosuthi5, P. Kantipong6, A. Apisarnthanarak7, W. Sangsirinakakul8, P. Wongprasit9, R. Chaiwarith10, W. Tantisiriwat11, Y. Nakamura12, T. Mushiroda12, W. Chantratita13, S. Sungkanuparph1
1Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand, Department of Medicine, Bangkok, Thailand, 2Ministry of Public Health, Department of Medical Sciences, Nonthaburi, Thailand, 3Mahidol University, Thailand Center of Excellence for Life Sciences, Bangkok, Thailand, 4Sawanpracharak Hospital, Department of Internal Medicine, Nakornsawan, Thailand, 5Bamrasnaradura Infectious Disease Institute, Department of Internal Medicine, Nonthaburi, Thailand, 6Chiang Rai Prachanukroh Hospital, Department of Internal Medicine, Chiang Rai, Thailand, 7Faculty of Medicine, Thammasat University, Department of Medicine, Pratumthani, Thailand, 8Maharaj Nakornratchasima Hospital, Department of Internal Medicine, Nakornratchasima, Thailand, 9Buriram Hospital, Department of Medicine, Buriram, Thailand, 10Faculty of Medicine, Chiang Mai University, Department of Medicine, Chiang Mai, Thailand, 11Faculty of Medicine, Srinakharinwirot University, Department of Preventive Medicine and Social Medicine, Nakhon Nayok, Thailand, 12RIKEN Center for Integrative Medicine Sciences, Laboratory for Pharmacogenomic, Yokohama, Japan, 13Faculty of Medicine Ramathibodi Hospital, Department of Pathology, Bangkok, Thailand
|Changes in bone mineral density over 48 weeks among participants randomised to either lopinavir/ritonavir (LPV/r) + 2-3N(t)RTI or LPV/r + raltegravir as second-line therapy: a sub-study of the SECONDLINE trial|
J. Hoy1, A. Martin2, C. Moore2, P. Mallon3, S. Emery2, W. Belloso4, P. Phanuphak5, S. Ferret6, D. Cooper2, M. Boyd2, SECOND-LINE study team
1Monash University, Melbourne, Australia, 2University of New South Wales, Kirby Institute, Sydney, Australia, 3UCD School of Medicine and Medical Science, Dublin, Ireland, 4CICAL, Buenos Aires, Argentina, 5Thai Red Cross AIDS Research Center, Bangkok, Thailand, 6Hopital Saint-Louis, Paris, France
|A daily dose of 400mg efavirenz (EFV) is non-inferior to the standard 600mg dose: week 48 data from the ENCORE1 study, a randomised, double-blind, placebo controlled, non-inferiority trial - Rebekah Puls|
|A pragmatic randomised controlled strategy trial of three second-line treatment options for use in public health rollout programme settings: the Europe-Africa Research Network for Evaluation of Second-line Therapy (EARNEST) Trial - Nicholas Paton|
|Dolutegravir (DTG) is superior to raltegravir (RAL) in ART-experienced, integrase naive subjects: week 48 results from SAILING (ING111762) - Pedro Cahn|
|HLA-B*35:05 and CCHCR1 screening reduces nevirapine-associated cutaneous adverse reactions in Thailand: a prospective multicenter randomized controlled trial - Sasisopin Kiertiburanakul|
|Changes in bone mineral density over 48 weeks among participants randomised to either lopinavir/ritonavir (LPV/r) + 2-3N(t)RTI or LPV/r + raltegravir as second-line therapy: a sub-study of the SECONDLINE trial - Jennifer Hoy|
Track B report by Mark Bloch
IAS Late Breakers Track B
were 2 studies on initiating therapy and 3 in experienced patients.
Puls presented 48 week data on the ENCORE 1 study where 630 treatment naïve
adults in 37 sites were randomized to efavirenz
(EFV) 400mg vs. 600mg daily together with truvada in a double-blind
study. Lower dose EFV was non-inferior and
>94% suppressed viral replication. There were (but not significantly)
fewer adverse events in the lower dose EFV.
Paton explained that there were 6M people taking ART in sub-Saharan Africa. The
ERNEST study examined second-line therapy randomizing 1277 African patients failing
first line to 3 second line treatment options : boosted PI (rPI) + NRTIs vs.
rPI + raltegravir vs. rPI monotherapy (after 3 months co-administration of
raltegravir). Almost all rPI was boosted
lopinavir and in physician nominated therapy, 70% on NRTIs were on tenofovir +
3/FTC. Women comprised 60% and median CD4 was 70 with viral load 70,000. There
was <2% drop out. There was a
composite end point of good disease control, being alive or no new progression (WHO
4), CD4>250 and VL<10000. The NRTI and raltegravir arms performed well
with >90% no new WHO 4 diagnoses and >85% virological suppression. rPI
monotherapy performed less well virologically with higher levels of resistance.
Cahn presented 48 week results from the SAILING study enrolling 711 treatment
failure patients (half with 3 class failure),
who were randomized to dolutegravir 50mg daily vs. raltegravir 400mg bd,
with optimized background therapy. Stratification of VL 50000 and DRV use. Snapshot
analysis at 48/52 revealed 71% on dolutegravir with viral load <50 vs. 64%
on raltegravir arm indicating superiority of dolutegravir. Safety was good in
both arms and differences were due to virological failure in the raltegravir
arm. There was no resistance in the dolutegravir arm but integrase resistance
in the raltegravir arm.
DRV resulted in no differences in virological control between the two arms.
Kiertiburanakul presented results from a prospective Thai study where patients
initiating nevirapine (NVP) therapy were randomized to testing for (and excluding) vs. not testing for HLA
B*3505 and SNPs in CHCR1 – these have been associated with cutaneous adverse
reactions (CAR) to NVP. Genetic screening and exclusion of indicated patients
reduced CAR by 32% and by 45% in women.
Hoy presented bone mineral density (BMD) changes over 48/52 – a sub-study of
the Second-Line study where patients failing first line ART were randomized to
Lop/r + NRTIs vs. Lop/r + raltegravir. There were 52% women, 90% non-caucasian,
with median duration of 1st line therapy 4yrs and 17% on tenofovir.
At baseline21% had Low BMD. There was significantly lower BMD loss in the
raltegravir arm vs. NNRTI arm (2.9% vs 5.2 at the hip and 2%vs 4.2% at the spine).
Predictors of lower BMD were tenofovir use and low body mass.
Track B report by Jürgen Rockstroh
Hoy and colleagues reported about a very interesting bone mineral density substudy of the SECONDLINE trial comparing a NRTI sparing regimen (RTG/LPV/r) vs. a standard of care regimen (NRTI + LPV/r) in second line treatment. The study population comprised 52% women and 97% non-Caucasian participants, primarily from middle income countries. A significantly greater loss of BMD was observed in the LPV/r+2-3N(t)RTI group compared to LPV/r+RAL but the incidence of osteopenia and osteoporosis assessed at the proximal femur over the 48 weeks were similar between groups. The use of tenofovir and low baseline BMI were predictive of reduced BMD at proximal femur and spine. This is the first study to examine changes in BMD in patients virologically failing first line ART regimens, with re-suppression of viremia. The loss of BMD was least in participants treated with raltegravir and greater in those exposed to tenofovir throughout the study and the magnitude of BMD reduction was similar to that observed in ART naive patients initiating therapy. The authors conclude that reduction in BMD secondary to ART remains a significant co-morbidity in the long term management of HIV.