HIV/AIDS Response: defining the Nigerian Experience Simon Agwale, Ph. D Innovative Biotech USA, Nigeria Innovative Vaccines Nig. LTD. 1 st Biomedical HIV Prevention Forum Transcorp Hilton Hotel, Abuja 18 th and 19 th 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 � of 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 1 st and 2 nd line drug regimen for all eligible patients. � NACA
Comprehensive HIV Prevention Anzala
Imagine a full spectrum of interventions Point of Prior to exposure After infection transmission Male & Female condoms Rights-focused behaviour � Antiretroviral treatment � � and lubricant change Treatment for opportunistic � Treatment to prevent Voluntary counselling & � infections � vertical transmission testing Basic care/nutrition � (PMTCT) Sexually transmitted � Prevention for positives � Clean injecting equipment infection screening � Education and rights-focused and treatment � Post-exposure prophylaxis � behaviour change (PEP) Male medical circumcision � Therapeutic vaccines � Vaginal & rectal Preventative vaccines � � microbicides Pre-exposure prophylaxis � Cervical barriers (PrEP) � 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 on as planned with concluded modeling study and plans for formative study � Model shows m ajor 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 of 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 over 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 Vaxgen (no efficacy). 1. - induced weak neutralizing antibodies. STEP Merck Ad5 gag-pol-nef (no efficacy). 2. - 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).
SOKOTO KATSINA A(2) JIGAWA A(7) G(3) YOBE BORNO G(1) G(3) A(2) ZAMFARA KANO KEBBI G(5) A(2) G(10) A(4) G(5) BAUCHI KADUNA A(4) GOMBE A(6) G(2) A(2) G(11) NIGER A(3) G(3) J(1) ADAMAWA PLATEAU G(5) ABUJA A(4) FCT KWARA A(4) G(4) NASARAWA A(3) A(8) G(4) G(2) G(2) OYO A(7) TARABA G(3) G(5) EKITI A(6) KOGI OSUN C(1) BENUE A(5) G(4) A(1) A(1) G(5) G(5) OGUN ONDO G(2) A(2) ENUGU A(6) A(2) G(2) EDO LAGOS EBONYI G(8) A(5) NR G(2) NR G(7) CROSS ABIA 36 STATES OF NIGERIA RIVER IMO DELTA A(8) A(1) G(2) G(4) RIVERS AKWA A(8) BAYELSA IBOM G(6) A(3) Fig. Map of Nigeria Showing the Distribution of HIV-1 Subtypes Agwale et al . (2002).Vaccine; 20: 2131-2139
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) Double stranded synthetic DNA RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE Full-length gp140 RE RE Insert into DNA vaccine vector 22
Network of Excellence for Clinical Trials West East EDCTP Central South
African Sister Institutions Burkina Faso Guinea-Bissau The Gambia Nigeria, Ibadan Ghana, Noguchi Senegal-Pasteur Nigeria, Keffi Ghana, Accra Nigeria, Lagos HIV TB Malaria Established African Institutions Bioethics, GCP, GCLP, Quality control, Writing grant applications, Trial monitoring Project CNRFP- Burkina Faso Le Dantec Partners MRC- the Gambia & - Senegal MRTC- Mali Project Le Dantec University- Senegal Coordinator
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. , GMP standards and training . lack of established GLP , GCP - � 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
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