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Why an HIV vaccine?. Catherine Hankins MD MSc FRCPC Chief Scientific Adviser to UNAIDS Office of the Deputy Executive Director. Journalist training, HIV vaccine research National Press Foundation and Global HIV Vaccine Enterprise Atlanta, Georgia, September 27 th , 2010.

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Why an hiv vaccine l.jpg

Why an HIV vaccine?

Catherine Hankins MD MSc FRCPC

Chief Scientific Adviser to UNAIDS

Office of the Deputy Executive Director

Journalist training, HIV vaccine research

National Press Foundation and Global HIV Vaccine Enterprise

Atlanta, Georgia, September 27th, 2010


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Why an HIV Vaccine?

  • Global epidemic (facts and figures)

    • Know Your Epidemic/Know your Response

  • Economic burden

    • Funding trends and resource needs

  • New prevention technologies

    • Male circumcision, microbicides, pre-exposure prophylaxis


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Global estimates for adults and children, 2008

  • People living with HIV33.4 million[31.1 – 35.8]

  • New HIV infections in 20082.7 million [ 2.4 – 3.0]

  • Deaths due to AIDS in 20082.0 million[1.7 – 2.4]

  • Almost half of people living with HIV are women

  • Of the 7400 new infections per day in 2008, about 1200 were in children under 15 years of age


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HIV: a stabilized epidemic (incidence/deaths)

  • spread of HIV peaked in 1996 at 3.5 new infections (2008: 2.7 million)

  • new infections have dropped by 17% since 2001

  • deaths peaked in 2004 at 2.2 million

    (2008: 2 million)

Number of patients newly

infected with HIV

UNAIDS epidemic update 2009 * National household surveys

4


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HIV: a stabilized epidemic (prevalence)

Adult HIV prevalence

  • Almost 60 million people have been infected by HIV and 25 million have died of HIV-related causes

  • 2008: stabilized HIV prevalence is the result of reduced new infections and the effect of antiretroviral therapy

UNAIDS epidemic update 2009

5


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Know your epidemic and response synthesis process

ANALYSIS OF EPIDEMIC

Incidence data

(modelled or otherwise)

Epidemiological

Review:

Drivers/

country specificity

SYNTHESIS

Prevention policies, response and strategic info review

Review of resources for prevention

ANALYSIS OF RESPONSE


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Incidence by mode of HIV transmission in East and Southern Africa

Source: MOT country reports available at http://www.unaidsrstesa.org/hiv-prevention-modes-of-transmission


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Collectively we’ve made remarkable progress in many aspects of the response to HIV… … incidence of new infections, antiretroviral treatment, human rights


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Treatment benefits are clear…. aspects of the response to HIV…

The number of AIDS-related deaths has declined by over 10% over the past five years…

Since 1996 the availability of effective treatment, has saved some 2.9 million lives…



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Why we need a prevention revolution medicines

  • # people accessing antiretroviral treatment has increased 12-fold in just 6 years

  • 2010 WHO guidelines for treatment initiation (CD4 count of 350 cells) increased # in need by 50%

  • Globally, 2 of every 3 people who need treatment are not accessing it - 10 million people are waiting now

  • Globally, new infections are outstripping expansion of treatment availability - for every 2 people who start taking antiretroviral drugs, another 5 are newly infected

  • Great progress but not only are we not keeping up, we are increasingly behind

  • Need a prevention revolution to break the trajectory of the epidemic


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Young people are leading the prevention revolution by taking definitive action toprotect themselves from HIV

  • HIV prevalence in young people aged 15-24 has declined in 22 high burden countries in sub-Saharan Africa:

  • delaying onset of sex

  • fewer partners

  • correct & consistent condom use


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Human rights issues definitive action toand the AIDS movement

  • Recent advances include the decision of the Delhi high court to strike down an anti-sodomy law dating back to the early days of the British Raj

  • China’s launching of needle exchange and methadone programmes for people who inject drugs need to be multiplied

  • Lifting of travel restrictions: USA, China

“Gay couple freed by Malawi presidential

pardon return to home villages”

Human rights campaigner says men have not been reunited amid fears for their safety




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Spending per capita for HIV income countries, 1996-2009

> $10 per capita

$1 - $10 per capita

$0.10 - $1 per capita

< $0.10 per capita

Source: UNAIDS global report 2008, Annex 2


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International AIDS Assistance: Trends in G8/EC & Other Donor Government Assistance, 2002-2009

USD billions

Disbursements

Commitments(Enacted Amounts)

Sources: KFF and UNAIDS, Financing the response to AIDS in low- and middle- income countries: International assistance from the G8, European Commission and other donor Governments in 2009, July 2010


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Assessing Fair Share 2: Donor Rank by Disbursements for AIDS per US$1 Million GDP*, 2009

Sources: KFF and UNAIDS, Financing the response to AIDS in low- and middle- income countries: International assistance from the G8, European Commission and other donor Governments in 2009, July 2010


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International Assistance for HIV, domestic spending, and financing gaps

Eastern Europe and Central Asia

DONOR 2 BILLION

DONOR 3.5 BILLION

South East Asia and the Pacific

DONOR 21 MILLION

Latin America and the Caribbean

DONOR 8 MILLION

Sub-Saharan Africa


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Resources needed to provide ART under two CD4 eligibility criteria (New WHO ART guidelines)

12,000

10,000

8,000

6,000

4,000

CD4 <350

CD4 <200

2,000

Millions

US$

0

2010

2011

2012

2013

2014

2015

23


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  • Investing in AIDS: criteria (New WHO ART guidelines)

    • linked to individual and societal benefits

    • essential for attainment of MDG 3, 4, 5, 6

    • saves money in the long term

  • Millennium development goals (AIDS+MDGs)

    • Eradicate extreme poverty and hunger

    • Achieve universal primary education

    • Promote gender equality and empower women

    • Reduce child mortality

    • Improve maternal health

    • Combat HIV/AIDS, malaria and other diseases

    • Ensure environmental sustainability

    • Develop a global partnership for development

24


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Worst case scenarios if funding decreases: criteria (New WHO ART guidelines)

  • Increased mortality and morbidity

  • Greater transmission risks

  • Treatment interruption

  • Increased burden on health systems

  • Reversal of economic and social gains


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Bilateral Aid for AIDS in criteria (New WHO ART guidelines)

2008

Bonus paid to London

Financial staff at Christmas

2006

Amounts spent on

Valentine's day

Cost of war in Iraq in 2008

-

25

50

75

100

125

150

175

200

US$ billion

How much is too much?

2010 estimated need: 26.8 billion US$. Available: 15.9 billion US$

Is the 11 billion USD gap that we are trying to close too much?


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Resource mobilization action! Financing options criteria (New WHO ART guidelines)

Increase domestic funding

Fair share from bilaterals

Corporate Partnerships

Framework Agreement on Debt2Health

Airline ticket tax

BRICS governments becoming donors

Huge accumulation of wealth (Sovereign Wealth Funds, HNI)

Robin Hood Tax (take a look at the videos on http://robinhoodtax.org.uk/)

27


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Why an HIV Vaccine? criteria (New WHO ART guidelines)

  • Global epidemic (facts and figures)

    • Know Your Epidemic/Know your Response

  • Economic burden

    • Funding trends and resource needs

  • New prevention technologies

    • Male circumcision, microbicides, pre-exposure prophylaxis


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HIV Prevention at the Crossroads criteria (New WHO ART guidelines)

Behaviour change can be effective

need tailored, sustainable strategies

Structural interventions

need better understanding of underlying determinants

Biomedical interventions with partial efficacy

male circumcision in HIV- heterosexual men (clinical trial)

antiretroviral therapy (observational & ecologic data)

pre-exposure prophylaxis trials underway

modest protective efficacy in the Thai RV144 vaccine trial

proof of concept for antiretroviral-containing topical microbicides in CAPRISA 004

No single strategy will work alone:

multi-component, integrated, biomedical, behavioural, and structural approaches: rights-based, evidence-informed combination HIV prevention approaches


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What works for HIV prevention: criteria (New WHO ART guidelines)Results from randomised controlled trials with HIV incidence endpoints

Review of 37 HIV prevention RCTs on 39 interventions:

PrEP : 1 Behavioural: 7 Microfinance:1 Diaphragm: 1

STI treatment: 9 Vaccines: 4 Microbic: 12 Male Circ: 4

Study

Effect size (CI)

HIV Vaccine

(Thai RV144)

31% (1; 51)

STD treatment

(Mwanza)

42% (21; 58)

57% (42; 68) : M-A

Circumcision

(Orange Farm, Rakai, Kisumu)

CAPRISA 004

39% (6;60)

Efficacy

0% 10 20 30 40 50 60 70 80 90 100%

Padian NS, et al. Weighing the gold in the gold standard: challenges in HIV prevention research. AIDS 2010, 24:621–635


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Develop, implement & criteria (New WHO ART guidelines)

evaluate setting-appropriate

combination prevention

Scale-up of proven

effective prevention

strategies

Research for new biomedical,

behavioural & structural

prevention strategies

Magic Bullet

Technology

HIV

prevention

Crossroads

Courtesy Q. Abdool Karim


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Impact on HIV incidence: criteria (New WHO ART guidelines)Evidence from observational studies and RCTs Weiss & Hayes

Effect size

Study

(95% CI)

Overall

0.42 ( 0.34, 0.52)

High-risk groups

0.29 ( 0.20, 0.42)

General Population

0.56 ( 0.44, 0.71)

South Africa

0.40 ( 0.24, 0.67)

Kenya

0.41 ( 0.24, 0.70)

Uganda

0.49 ( 0.28, 0.86)

.15

.2

.3

.4

.5

1

1.5

Effect size


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Weiss et al. AIDS 2008 criteria (New WHO ART guidelines)


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Snapshot of Country Progress, Jan 2010 criteria (New WHO ART guidelines)

Situation

Analysis Policy

Quality Service

Assurance Delivery

Training

National

Coordinator Task Force

M&E


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Population-level Impacts by Coverage criteria (New WHO ART guidelines)

Hankins et al.Male circumcision for HIV prevention in high HIV prevalence settings: What can mathematical modelling contribute to informed decision making?

PLoS Medicine 2009;6, September 8


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Communicating about partial protection criteria (New WHO ART guidelines)


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Develop, implement & criteria (New WHO ART guidelines)

evaluate setting-appropriate

combination prevention

Scale-up of proven

effective prevention

strategies

Research for new biomedical,

behavioural & structural

prevention strategies

Magic Bullet

Technology

HIV

prevention

Crossroads

Courtesy Q. Abdool Karim


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Pre-exposure prophylaxis (PrEP) criteria (New WHO ART guidelines)

PrEP is a strategy for HIV-negative individuals to reduce or prevent their risk of infection by:

taking oral antiretroviral drugs used for HIV treatment or

applying microbicides containing the active antiretroviral agent in the vagina or rectum

Dosing can be:

daily

intermittently (e.g. Fridays & Mondays)

episodically (i.e. before & after sex)

PMTCT, PEP, animal studies promising


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Completed/ongoing PrEP studies - safety criteria (New WHO ART guidelines)


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Characteristics of ongoing PrEP efficacy trials criteria (New WHO ART guidelines)

  • HIV seroconversion is 1° endpoint = event-driven trials

    • Studies continue until a pre-defined number of endpoints achieved (=timeline uncertain)

  • Safety is co-1° endpoint

    • Given sample sizes, will provide large amount of safety data

  • Distinct trials

    • Population/route of exposure: IDUs, heterosexual women & men, MSM

    • Agent: TDF, FTC/TDF, vaginal tenofovir gel

    • Location: Africa, Americas, Asia

    • Follow-up: 1-3 years per person

  • Trials designed to detect ~50-70% efficacy

    • Larger trials are designed so that lower limit of 95% confidence bound will exclude low efficacy (25-30%)

  • Seroconverters followed for ≥1 year

    • CD4, HIV-1 RNA, resistance testing


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Ongoing PrEP studies - efficacy criteria (New WHO ART guidelines)


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Systemic versus topical administration in women criteria (New WHO ART guidelines)


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67 criteria (New WHO ART guidelines)

Past & Current Microbicide Clinical Trials

(courtesy of CAPRISA, Durban)

1st class:

Surfactants

eg. N9, SAVVY

2nd class:

Polymers

eg. PRO2000,

Carraguard,

Cellulose Sulfate (CS)

3rd class:

ARVs

eg. Tenofovir gel,

Dapivirine gel/ring

4th class:

Co-receptor

Blockers

eg. CD4 blocker,

CCR5 Blockers

Kenya

N-9 sponge

trial

CONRAD

CS trial

FHI CS

Trial

CAPRISA

Tenofovir gel trial

FHI

N-9 film trial

PopCouncil

Carraguard trial

Zena Stein publishes seminal article “HIV prevention: the need for methods women can use”

UNAIDS

COL-1492 trial

MTN 003

VOICE trial

HPTN PRO2000 & BufferGel trial

IPM

Dapivirine

gel & ring

trial

FHI SAVVY trial

MDP 0.5%

PRO2000 trial

2% PRO2000

‘90 ‘92 ’98 ’00 ‘03 ‘04 ‘04 ’05 ’05 ’07 ‘10

Safe but not effective

Increased HIV infection

Stopped for futility


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CAPRISA 004 dosing strategy (BAT 24) – based on nevirapine in childbirth

BAT 24

Insert 1 gel up to 12 hours Before sex,

insert 1 gel as soon as possible within 12 hours After sex,

no more than Two doses in 24 hours

HIVNET 012 nevirapine regimen

CAPRISA 004 tenofovir gel regimen

asap

72 hrs

asap

12 hrs

Onset of labour

Delivery

44


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CAPRISA Vulindlela Clinic in childbirth

KwaZulu-Natal Midlands

CAPRISA eThekwini Clinic

Durban City Centre

CAPRISA 004: Urban and Rural sites


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Effectiveness of tenofovir gel in preventing HIV infection in childbirth

Incidence rate ratio: 0.61 (CI: 0.4 to 0.94); p = 0.017

39% lower HIV incidence in tenofovir gel group

46


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Impact of adherence on effectiveness of tenofovir gel in childbirth(overall 39% [6,60])

47


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HIV infection rates in the Tenofovir and placebo gel groups: Kaplan-Meier survival probability

Tenofovir

Placebo

p=0.017

After 12 months of gel use:

HIV endpoints: 65

Effectiveness: 50%

P-value: 0.007

(0.017)


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Tenofovir gel – Next steps Kaplan-Meier survival probability

Moral obligation and public health imperative to confirm whether tenofovir gel is a viable HIV prevention option for women

  • VOICE trial reports in 2013: daily dosing, powered to provide strength of evidence to support licensure of tenofovir gel if it shows at least 58% effectiveness

  • FACTS 001: proposed South African trial 16 to 30 years BAT24

  • MDP 302: proposed trial in other African countries: BAT24 plus single dose arm

  • CAPRISA 008: implementation trial in HIV-negative women

  • CAPRISA 009: seroconverter study

Funding need: US$100 million over 3 years ( US$33 million/year)

Committed: US$58 million Gap: US$42 million

In comparison: US $868 million invested in HIV vaccines in 2009 of US$1.165 billion invested in HIV prevention R& D


Acknowledgements l.jpg

Carlos Avila Kaplan-Meier survival probability

Salim Abdool Karim

Helen Weiss

Richard Hayes

Jared Baeton

Connie Celum

Quarraisha Abdool Karim

Eleanor Gouws

Alexandra Calmy

Tim Hallett

Lynn Paxton

Dawn Smith

Myron Cohen

Toby Kasper

Kim Dickson

John Stover

Tim Farley

Elizabeth McGrory

Acknowledgements


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hivthisweek.unaids.org Kaplan-Meier survival probability

Zero new HIV infections

Zero discrimination

Zero HIV-related deaths


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