HIV/AIDS Response: defining the Nigerian Experience Simon Agwale, - - PowerPoint PPT Presentation

HIV/AIDS Response: defining the Nigerian Experience

Simon Agwale, Ph. D

Innovative Biotech USA, Nigeria Innovative Vaccines Nig. LTD.

1st Biomedical HIV Prevention Forum

Transcorp Hilton Hotel, Abuja 18th and 19th November, 2013

Introduction

Nigeria is currently experiencing an HIV/AIDS epidemic that is

currently estimated to be 4.1 % , this is however a decline from 2001 and 2008 data.

In order to combat the rising morbidity and mortality due to

HIV/AIDS, the Nigerian government has decided to implement a national antiretroviral program, which is providing life-saving medications including antiretroviral drugs.

Unfortunately, there are many problems associated with the use of

antiretroviral drugs: complicated to administer, require close medical monitoring, significant side effects , emergence of resistant and transmission of resistant viruses.

HIV/AIDS prevention technologies will be by far the most powerful

weapon for reversing these truly horrific trends.

National median HIV prevalence trend 1991-2010

NACA

National Prevalence

NACA

ACCESS, COVERAGE AND QUALITY OF SERVICE

• Number of health facilities offering ART services- 516;457 public,59 private*

(FMoH 2012)

• Number of HIV positive adults and children who are eligible and currently

receiving ARV in accordance with WHO guidelines- 491,021 (FMOH 2012)

• Percent of adults eligible receiving ART: 38%
• Percent of children eligible receiving ART: 12%
• Number of HIV positive pregnant women who receive ARVs to reduce the risk
• f mother to child transmission- 40,465
• Percentage of HIV positive pregnant women who receive ARVs to reduce the

risk of mother to child transmission-21% (EPP/Spectrum 2012)

• Percentage of adults and children with HIV known to be on treatment 12

months after initiation of antiretroviral treatment- 77.5% (PEPFAR 2011)

• Free 1st and 2nd line drug regimen for all eligible patients.

NACA

Comprehensive HIV Prevention

Anzala

Imagine a full spectrum of interventions

• Rights-focused behaviour

change

• Voluntary counselling &

testing

• Sexually transmitted

infection screening and treatment

• Male medical circumcision
• Preventative vaccines
• Pre-exposure prophylaxis

(PrEP)

Prior to exposure Point of transmission After infection

• Male & Female condoms

and lubricant

• Treatment to prevent

vertical transmission (PMTCT)

• Clean injecting equipment
• Post-exposure prophylaxis

(PEP)

• Vaginal & rectal

microbicides

• Cervical barriers
• Antiretroviral treatment
• Treatment for opportunistic

infections

• Basic care/nutrition
• Prevention for positives
• Education and rights-focused

behaviour change

• Therapeutic vaccines

AVAC

PMTCT

*Global elimination target 90% by 2015 NACA

Pre-exposure prophylaxis (PrEP)

Daily oral tenofovir or Truvada for HIV negative

individuals

Reduces risk of becoming infected with HIV Effectiveness dependent upon adherence Protective effect in trials:

• iPrex (MSM): 44% reduction in risk of acquiring HIV
• TDF2 (heterosexuals in Botswana): 63% reduction
• Partners PrEP (heterosexual discordant couples Kenya & Uganda):

62%/73% reduction (tenofovir/Truvada)

• FEM-PrEP (women in Kenya, Tanzania, South Africa): no protection
• VOICE (women in Africa): no protection

Ukpong

National PrEP Research Plan (1)

The National PrEP research plan is going

• n as planned with concluded modeling

study and plans for formative study

Model shows major impact on discordant

couples expected to come from putting HIV positives with CD4<350 onto ART with only slight additional impact from PrEP or from TasP. PrEP could still be important to prevent external transmission and is cost-effective.

National PrEP Research Plan (2)

Recruitment of sero-discordant couples

may be challenging with current scenario. Would be important to take cognisance

• f multiple parameters, many of which

data remain unavailable.

PrEP project outcome will hopefully

increase range of tools available for use for HIV prevention in Nigeria.

Vaccines

Vaccines are presently the most

powerful and cost effective health interventions

Successful in the global

eradication of some transmissible diseases

• Small pox
• Polio
• Measles

Benefits of Disease Eradication

Populations have much better biological

production.

Absence of disease aids production and

development.

Increases general welfare.

Vaccines and Disease Eradication

Definition: Eradication can be defined as

"permanent reduction to zero of the worldwide incidence of infection caused by a specific agent, as a result of deliberate efforts, such that intervention measures are no longer needed“.

1977-after a decade-long campaign,

smallpox was the first disease to be eradicated from such a worldwide effort.

Portugal: A Case Study

In the 19th and early 20th centuries,

Portugal, like most of southern Europe, suffered major malaria epidemics, with

• ver 100 000 cases a year. Eradication

was finally and successfully achieved in

• 1958. After that date, the country saw a

surge of economic growth associated with increased foreign investment and tourism.

Eradication/elimination programmes (EP)

have therefore been considered to be dominated by nonsustainable activities that may bypass or, at worst, even compromise the development of the health sector, especially in the poorer developing countries.

Possible solution

Conduct clinical trials where the vaccine

would eventually be used.

Establish “Biotechnology” which will

encourage local production, distribution and therefore availability of medical products to the population.

Lessons from Vaccine Trials

1.

Vaxgen (no efficacy).

• induced weak neutralizing antibodies.

2.

STEP Merck Ad5 gag-pol-nef (no efficacy).

• Cellular response but not broad and sustained.
• Evidence of protection against vaccine matched viral strains in

vaccine recipients in vivo and in vitro.

• 3. RV144 Canarypox + gp120 (31% reduction of HIV-1

acquisition with no viral load effect).

• induced antibody responses.
• correlate analysis (V2 specific region antibody binding).
• 4. HVTN 505 Ad5 gag-pol-nef and DNA (no efficacy).
• no evidence of protection (similar results as the STEP Phambili trial in

2007).

Current State of HIV Vaccines

AIDS vaccine shows first efficacy in

clinical trials.

Replicating viral vector effective in

controlling SIV in animal models.

Multiple new antibodies and targets on

HIV discovered (retro or reverse vaccinology, i.e. from antibodies to antigen).

• Fig. Map of Nigeria Showing the Distribution of HIV-1 Subtypes

Agwale et al. (2002).Vaccine; 20: 2131-2139

SOKOTO ZAMFARA KANO KATSINA NIGER KOGI KWARA OYO CROSS RIVER NASARAWA KADUNA JIGAWA BAUCHI GOMBE PLATEAU TARABA ADAMAWA YOBE OGUN OSUN EKITI A(6) G(4) A(6) G(11) A(3) G(3) A(8) G(2) FCT ABUJA A(4) G(4) EDO DELTA BAYELSA RIVERS IMO ENUGU EBONYI ABIA A(2) A(1) A(1) NR NR G(2) G(2) G(3) G(10) G(5) G(5) G(2) A(6) G(8) A(8) G(6) A(8) G(4) A(5) G(7) A(2) G(2) A(2) G(3) A(2) A(2) A(5) G(5) A(7) G(3) A(3) G(2) A(4) G(2) A(4) G(4) A(7) G(1) AKWA IBOM ONDO LAGOS

36 STATES OF NIGERIA

KEBBI A(4) G(5) BORNO A(2) G(5) BENUE A(1) G(5)

C(1)

J(1)

A(3)

Antibody neutralization titer against heterologous viruses

Agwale et al. 2011. Plos One; 6:

Synthetic gp140 Nigerian gene construction strategy(Subtypes CRFO2_AG and G-Bivalent)

22

RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE

Double stranded synthetic DNA Full-length gp140 Insert into DNA vaccine vector

Network of Excellence for Clinical Trials

EDCTP East West Central South

Malaria TB Nigeria, Ibadan Guinea-Bissau Ghana, Accra The Gambia MRC- the Gambia Le Dantec University- Senegal Burkina Faso Nigeria, Keffi Nigeria, Lagos African Sister Institutions Established African Institutions Project Coordinator Project Partners Le Dantec

• Senegal

HIV

Bioethics, GCP, GCLP, Quality control, Writing grant applications, Trial monitoring

CNRFP- Burkina Faso & MRTC- Mali Senegal-Pasteur Ghana, Noguchi

GAPs

Lack of comprehensive treatment programme (weak monitory, and

surveillance capacity e.g viral load and drug resistance).

Weak research infrastructure.

• lack of local R & D innovation.

Weak clinical trials capacity.

• lack of established GLP

, GCP , GMP standards and training.

Lack of reliable health and supply systems. Lack of clear sustainability plan.

• current programme dominated by donor agencies.

Lack of enforcement of Intellectual Property Protection & Other

Laws.

Underdeveloped Manufacturing Capabilities - Lack of

suppliers/raw materials to support R&D/clinical trials/manufacturing.

• makes access to health products difficult and challenging.

I

• Government Strategic Commitment to

Knowledge Based Economy

• Government Investment in R&D
• Infusion of funds to academic and industrial R&D –

IT, Biotechnology

• Development of Innovation Clusters
• State of the Art Core Labs
• Incentives to attract local and international

investment

• Free / subsidized land / rentals
• Tax breaks and incentives
• Salary supplementation for foreign workers
• Salary subsidies for local talent hired and trained

NAPPSA NAPPSA NAPPSA NAPPSA

I

• A highly developed HealthCare / Pharmaceutical

A highly developed HealthCare / Pharmaceutical A highly developed HealthCare / Pharmaceutical A highly developed HealthCare / Pharmaceutical Sector offers the following: Sector offers the following: Sector offers the following: Sector offers the following:

• A healthy citizenry

A healthy citizenry A healthy citizenry A healthy citizenry

• with longer life expectancy who can contribute to the

with longer life expectancy who can contribute to the with longer life expectancy who can contribute to the with longer life expectancy who can contribute to the economic , social and geopolitical growth of Nigeria economic , social and geopolitical growth of Nigeria economic , social and geopolitical growth of Nigeria economic , social and geopolitical growth of Nigeria

• Access to high quality pharmaceutical products

Access to high quality pharmaceutical products Access to high quality pharmaceutical products Access to high quality pharmaceutical products

• Faster access to new innovative therapies

Faster access to new innovative therapies Faster access to new innovative therapies Faster access to new innovative therapies

• Highly skilled, highly paid R&D & Managerial jobs

Highly skilled, highly paid R&D & Managerial jobs Highly skilled, highly paid R&D & Managerial jobs Highly skilled, highly paid R&D & Managerial jobs

• Hope, inspiration and life meaning for next

Hope, inspiration and life meaning for next Hope, inspiration and life meaning for next Hope, inspiration and life meaning for next generation generation generation generation

• Increased direct foreign investment

Increased direct foreign investment Increased direct foreign investment Increased direct foreign investment

NAPPSA NAPPSA NAPPSA NAPPSA Economic , Social and Geopolitical growth of Nigeria Economic , Social and Geopolitical growth of Nigeria Economic , Social and Geopolitical growth of Nigeria Economic , Social and Geopolitical growth of Nigeria

28

Successful intervention

1.Strategies to treat

• 2. Strategies to

prevent

• 3. Methods
• f monitoring
• 4. Reliable

health and supply systems Need to accept that solutions to health issues are multi-factorial !

THANK YOU