Track B: Clinical Research, Treatment and Care

1
Track B Clinical Research, Treatment and
Care Chief Rapporteur James McIntyre Assistant
Rapporteurs Polly Clayden, Glenda Gray,
Christopher Hoffmann, Michael Mugavero, Schlomo
Staszewski, Claire Thorne
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AIDS 2006 24,000 participants, 13,000 abstract
submissions
Track B 29 sessions, 145 papers, 875 posters 1
rapporteur team
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Time to deliver evidence that treatment success
is blind to race and continent

• ART works well for both adults and children in
  the developed and developing world
• In adults, low CD4 counts before ART predict
  mortality
• ART reduces the incidence of TB in HIV-infected
  adults
• Nutritional support may augment antiretroviral
  treatment outcomes, but further well-designed
  studies are needed to inform future policy
  decisions

4
Time to Deliver Scaling Up ART

• By end of June 2006, 1,65 million people
  receiving ART worldwide
• There has been a ten fold increase in Africans on
  treatment since December 2003, but there remains
  70 unmet need for antiretroviral treatment
• Clinical data on response and adherence support
  the wide scale up of antiretroviral therapy
• Studies confirm that the abolition of fees at the
  point of care increases access, improves
  adherence and facilitates treatment success

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Number of people on antiretroviral therapy in
low- and middle-income countries, 2002?2005
1400
1200
1000
People receiving therapy (thousands)
800
600
400
200
0
End 2002
Mid- 2003
End 2003
Mid- 2004
End 2004
Mid- 2005
End 2005
Piot WESS0102
2006 Report on the global AIDS epidemic (UNAIDS,
2006)
6
Scale up of treatment in the Elizabeth Glaser
Pediatric AIDS Foundation Project HEART
Initiating Care and ARV Treatment for over 68,000
people in 28 months at 95 sites in four African
countries
Côte dIvoire 57 sites South Africa 3 sites
Marlink THAB0201
7
Cumulative Enrollment in Lusaka May 2004 - 2004

20,148 Adults on ART
1,726 Children on ART
872 Children not on ART
9,635 Adults not on ART
Mubiana-Mbewe MOAB0201
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Women's access to HIV treatment, June 2006
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The long-tail of ART access
In addition to the large scale, high impact
access programmes, thousands of smaller
programmes are treating hundreds of thousands of
people, successfully and at a community level.
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Refuting the Afro-pessimists

• Adherence to ART is better in African programmes
  than in North America
• A meta-analysis of 27 studies in sub-Saharan
  African countries and 31 North American studies
  showed that adequate adherence was observed in
  77 of patients in Africa and 55 of patients in
  North America.
• It is important to ensure that these reassuring
  initial rates of adherence will be sustained over
  time.
• Data from Senegal suggest that the involvement of
  communities may be the key to maintaining
  adherence in the long term.

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Treatment Simplification - 1996 - 2006
Selected regimens
Montaner WEPL0101
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Simplification of treatment an idea whose time
has come?
A decade ago, in Vancouver, we learned that three
drugs could control HIV In Toronto, weve seen
promising results for monotherapy in patients who
have successfully controlled their virus using
HAART.
AIDS therapy is not about the number of drugs
but about potency the number of drugs is
negotiable Julio Montaner
13
Late breaking data on Kaletra monotherapy
Three independently conducted randomized trials
using different study designs came to similar
conclusions For the majority of patients who
have never failed on a Protease Inhibitor
containing regimen, including naïve patients,
Kaletra (LPV/r) monotherapy may be an effective,
virologically suppressive and well tolerated
regimen characterized by a high genetic barrier
and by very low incidences of viral resistance.
14
Time from LPV/r monotherapy to 1st of 2 VL gt 50
c/mLLPV/r maintenance versus corresponding EFV
subjects
Cameron THLB0201
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Time from LPV/r monotherapy to 1st of 2 VL gt 500
c/mL LPV/r maintenance versus corresponding EFV
subjects
Cameron THLB0201
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MK-0518 Mercks integrase inhibitor great promise

• MK-0518 is a promising new strand transfer
  inhibitor of HIV integrase with potent and
  durable antiretroviral effect.
• In treatment naïve patients with HIV RNA 5000
  copies/ml and CD4 100/mm3, MK-0518 studied at
  four dose levels for 24 weeks
• had potent antiretroviral activity
• 85-95 with HIV RNA lt 50 copies/mL
• achieved viral suppression faster than EFV
• was generally well tolerated

Markowitz THLB0214
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Markowitz THLB0214
18
Markowitz THLB0214
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The overlapping challenges of two epidemics HIV
and TB

• TB is a leading cause of death in Africa and, in
  some settings, the leading cause of death among
  people with HIV
• First 3-6 months after starting HAART may even
  have increase in TB followed by decline
• Early diagnosis is required to further decrease
  this risk

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High prevalence and mortality from
extensively-drug resistant (XDR) TB in TB/HIV
co-infected patients in rural South Africa
Survival from time of Sputum Collection
Gandhi THLB0210
21
Hepatitis C/HIV co-infection in IDUs is a major
issue in Europe
IDU as of all HIV/AIDS cases with known
transmission routeNOTE of AIDS cases in
countries not reporting HIV
Sources EuroHIV national reports
Kruk WEAX0101
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(No Transcript)
23
(No Transcript)
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Children need to be on the global agenda

• Children make up
• 14 of new global infections,
• 18 of HIV related deaths
• 5.6 of persons living with HIV

KLINE WESY0104
UNICEF estimates that 660,000 children urgently
require antiretroviral treatment, most of them in
sub-Saharan Africa Care of the infected and
uninfected child must include treatment of their
mothers and families Ruth Nduati
25
Accumulating data from resource-limited settings
on the success of paediatric treatment

• Children benefit from antiretroviral treatment,
  with improved survival and low rates of
  treatment failure and drug toxicities
• Barriers to universal access include
• limited access to infant diagnosis,
• lack of age-appropriate paediatric antiretroviral
  formulations
• the reluctance of healthcare workers to treat
  this age group.

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Successful clinical outcomes in children
Puthanakit, WESY0102
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Open your purses, we need more nurses,

• The issue of nursing staff needs was a common
  theme through many presentations in Track B.
• In sub Saharan Africa alone, more than 600,000
  nurses are needed to deliver HIV care and other
  services
• Nurses staff need to be supported and
  appropriately utilised

If Id wanted to be an undertaker, I wouldnt
have trained as a nurse South African nurse,
quoted by Alta Van Dyke
28
We cant treat our way out of this epidemic..

• Conclusive evidence was presented to show that
  antiretroviral treatment is successful around the
  world
• Treatment is available too late for many adults
  and children early diagnosis and earlier
  initiation of treatment is a priority
• Treatment enhances prevention efforts