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Global Control of Neglected Tropical Diseases

Neeraj Mistry, MD, MPH Johns Hopkins University

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Neglected Tropical Diseases: Policy and Program Overview

Section A

! Seventeen major chronic parasitic and related infectious diseases are identified as neglected tropical diseases (NTDs) and are divided into two broad categories: ! Preventive chemotherapy and transmission control (PCT) diseases ! Intensified disease management (IDM) diseases

! NTDs … ! Are the most common infections in developing countries ! Are ancient conditions that have affected humankind for thousands of years ! Disproportionately affect the world’s poorest people

• The “Bottom Billion” • Subsistence farmers and families • Urban slum dwellers

! Often cause high morbidity and disability but low mortality ! Promote poverty and interfere with economic development

What Are Neglected Tropical Diseases?

Seven of the 17 Total NTDs Account for 90% of the Global Burden

Ascariasis (Roundworm)

Trichuriasis (Whipworm) Hookworm

Lymphatic Filariasis

(Elephantiasis)

Schistosomiasis (Snail Fever/

Bilharzia) Trachoma

Onchocerciasis (River

Blindness)

Soil-transmitted helminthes (STH; intestinal worms)

1.2 billion 795 million 740 million 240 million 120 million 41 million 26 million

Global Distribution of the Seven Most Common NTDs

Source: WHO. (2008). 5

Chronic, Long-Term Diseases That Disable, Disfigure, and Stigmatize

L. F.: “It’s quite a problem for me when I have to stand at work for long periods.”

Trachoma: 4th leading cause of preventable blindness

Hookworm: 40% reduction in future wage earnings

! Poor educational outcomes: ! Reduced physical and cognitive

development ! Children cannot attend school or

absorb lessons

! Low productivity: ! Infected adults cannot work ! Adults may stay home to care for

infected family members

NTDs Promote Poverty

2. Béoline is infected with

NTDs

3. Béoline cannot attend school or earn

a living through work

1. Béoline lives in poverty

conditions

! When the MDGs expire at the end of 2015, they will make way for the SDGs ! Currently contain 17 goals and 229 proposed indicators

! Goal 3. Ensure healthy lives and promote well-being for all at all ages ! 3.3 by 2030 end the epidemics of AIDS, tuberculosis, malaria, and neglected

tropical diseases and combat hepatitis, water-borne diseases, and other communicable diseases

Sustainable Development Goals (SDGs)

! Preventive chemotherapy (PCT) ! Mass drug administration (MDA) in schools and communities ! Leveraging teachers and community health workers

! Vector control ! Mosquito nets (lymphatic filariasis) and spraying of pesticides

! Environmental improvements ! Access to clean water and hygienic sanitation ! Hygiene education ! Housing and other infrastructure improvements

Major Approaches to NTD Control

! Historically, NTDs have been addressed in silos

! We advocate for integrated control because NTDs … ! Frequently overlap ! Are concentrated in underserved communities ! Share many features that make integrated technical guidance both feasible and

advantageous

! Integration is an opportunity for more efficient use of financial resources, staff, delivery systems, and contacts with populations

Integrated NTD Control

The Time Has Come for NTD Control

2008 2009 2010

February 2008:

U.S. President George W. Bush announces a five-year, $350 million commitment to fight NTDs in Latin America, Africa, and Asia

July 2008:

For the first time ever, NTDs are featured on the agenda at the G8 Summit in Hokkaido, Japan

September 2008: British Department for International Development (DFID) announces a £50 million commitment to control and eliminate guinea worm and a number of other common NTDs over five years.

September 2008: Former U.S. president Bill Clinton calls Sabin President Dr. Peter Hotez on stage with him and Gordon Brown at the closing session of the Clinton Global Initiative Annual Meeting. Clinton highlights the work of the Global Network and recommends that those listening donate to NTD control.

May 2009: U.S. President Barack Obama unveils new Global Health Initiative, which calls for the control and elimination of NTDs as one of eight critical global health pillars.

July 2009: Leaders at the G8 Summit in L’Acquilla, Italy state: “We will implement further efforts towards universal access to HIV/AIDS prevention, treatment, care and support by 2010 … We will combine this with actions to: combat TB and Malaria; address the spread of Neglected Tropical Diseases and work towards polio eradication.”

July 2009: President Obama discusses NTDs in his keynote speech in Ghana during his first trip to Africa.

February 2010: The Obama Administration unveils the FY2011 federal budget and details of its Global Health Initiative, including a budget request of $155 million for NTDs, a 138% increase over the previous year.

November 2009: U.K.’s All-Party Parliamentary Group on Malaria expands to include NTDs in their name and mandates the release of their report: NTDs: A Challenge We

Could Rise To – Will We?

The Time Has Come for NTD Control

2020 goal: elimination of

lymphatic filariasis, onchocerciasis, trachoma, and schistosomiasis; control of STHs

August 2010:

WHO Director General, Margaret Chan, holds significant NTD stakeholder event.

October 2010:

The WHO releases its first ever comprehensive report on NTDs. Pharma companies increase their commitments to NTD drug donation programs. The German government pledges EUR €20 million over four years for NTD research and development.

2011 (ongoing): The WHO helps more than 40 countries draft five-year national plans for addressing their most common NTDs.

July 2011:

Despite budget cuts, the U.S. Government increases the budget for USAID’s NTD Program from $65 million in FY 2010 to $77 million in FY 2011.

September 2011:

The UK’s All-Party Parliamentary Group on Malaria and NTDs launches the report: The Neglected Tropical Diseases: Great

progress has been made

since 2009 – however, the

challenge remains to

overcome these diseases.

2010 2011

January 2012:

Bill & Melinda Gates Foundation, Pharma companies, DFID, and WHO make joint commitment to collaborate toward elimination by 2020; DFID announces a major increase in funding for NTDs (£195M over 4 years).

2012

December 2011:

The U.S. Government increases the budget for USAID’s NTD Program again, this time from $77 million in FY 2011 to $89 million in FY 2012.

WHO and the London Declaration

Sources: Left: Sixty-Sixth World Health Assembly. (2013). Agenda item 16.2: neglected tropical diseases. Available at: http://www.who.int/neglected_ diseases/mediacentre/W HA_66.1 2_Eng. pdf. Accessed February 16, 2015. Middle: WHO. (2012). Accelerating work to overcome the global impact of neglected tropical diseases: a roadmap for implementation. Geneva: WHO. Available at: http://www.emro.who.int/neglected-tropica l-disea ses /nt d-infoc us/ ntd- roadmap.html. Accessed February 16, 2015. Right: Uniting to Combat NTDs. (2014). Delivering on Promises and Driving Progress. Available at: http://unitingtocombatnt ds.org/ resource/deliver ing- promises-and-dr iving- progr ess-s econd-pr ogres s-report. Accessed February 16, 2015. 13

Company Commitment Target(s) Eisai Co., Ltd. 2.2 billion tablets of diethylcarbamazine (DEC)

for 2014-2020 Lymphatic filariasis

Sanofi/Eisai/BMGF 120 million DEC tablets 2012-2013 Lymphatic filariasis GlaxoSmithKline More than 2 billion tablets of Albendazole since

1998; 1 billion tablets annually Lymphatic filariasis and soil-transmitted helminthes

Johnson and Johnson

50 million tablets of Mebendazole yearly since 2007; now increased to 200 million annually

Soil-transmitted helminthes

Merck and Co., Inc. Unlimited supply of Mectizan; more than 2.9 billion tablets donated since 1987

Onchocerciasis and lymphatic filariasis

Merck KGaA 200 million tablets of praziquantel for 2008- 2020

Schistosomiasis

Pfizer, Inc. Unlimited supply of azithromycin; more than 145 million tablets of azithromycin since 1998

Trachoma

NTD Drug Donations

Mass Drug Administration

DONATED DRUGS

+ Delivery

+ Training

+ Community mobilization

+ Monitoring and evaluation

USD $0.50 / GBP £0.31 per person per year

! Pharmaceutical companies have pledged drugs valued at US$17.8 billion for the 10 LD diseases through to 2020

! Over 5.5 billion tablets have been donated providing 3.5 billion treatments since the launch of the London Declaration in 2012

! In 2014 1.45 billion treatments were made available to endemic countries, representing a 36% increase since 2011

NTD Drug Donations

US Government Contributions

! President’s Global Health Initiative goal: ! Reduce the prevalence of seven NTDs by 50% among 70% of

the affected population, contributing to: • The elimination of onchocerciasis in Latin America by 2016, • The elimination of lymphatic filariasis globally by 2020, and • The elimination of leprosy

! Funding committed for integrated NTD control: ! $25 million for NTDs in FY09 ! $65 million for NTDs in FY10 ! $77 million for NTDs in FY11 ! $89 million for NTDs in FY12

US Government Contributions

! USAID working in: ! Twelve African countries ! Four Asian countries ! One Latin American/Caribbean country

! US contribution to African Programme for Onchocerciasis Control (APOC): ! $9.2 million between 2001 and 2010 ! $2.3 million in 2010

UK Government Contributions

! In 2008, UK Department for International Development (DFID) committed £50 million toward NTD control and elimination efforts over a five-year period ! Thirteen African countries ! Two Asian countries

! UK contribution to African Programme for Onchocerciasis Control (APOC): ! $13.7 million between 2001 and 2010 ! $5 million in 2010 ! $5.5 million 2014-2016 (50% APOC:50% ESPEN)

! New contribution announced in January 2012: ! A further £195 million commitment over four years ! Targeted at:

• Guinea worm disease • Lymphatic filariasis • River blindness • Schistosomiasis • Developing new programs for blinding trachoma, visceral leishmaniasis,

research, and integrated country approaches ! November 2015:

! The Chancellor of the Exchequer announces The Ross Fund, a £1billion portfolio of investments to be made across malaria, TB, AMR, emerging threats and NTDs (£200 million) including R&D for new tools and delivery of new products for control and elimination efforts

UK Government Contributions

Other Governments’ Contributions to NTD Treatment Specifically (Excludes Research and Development Commitments)

To be replaced by the Expanded Special Project to End Neglected Diseases in Africa (ESPEN) in 2016

African Programme for Onchocerciasis Control (APOC) between 2001 and 2010*

Netherlands $15 million

Canada* $13.6 million

France $6.9 million

Luxembourg* $5 million

Belgium* $3.8 million

Saudi Arabia* $3 million

Kuwait* $1.9 million

Germany $1.3 million

Norway $832,000

Poland $140,000

Japan $9,583

*Countries that donated in 2010 21

Global Coverage Status

Annual Scorecard (2013)

Key Challenges Remain

Impact at the national level requires multiple layers of influence

Political will and funding capacity constraints create impediments to country-level ownership.

Distribution of treatments still lags

Approximately 43% of the population requiring PCT is receiving treatment for at least one disease. Coverage is not increasing rapidly enough to achieve global targets. The average 1.6% annual increase since 2008 is too low (UtC Third Progress Report).

Funding is disproportional to the health burden

NTD funding has almost doubled from just three years ago and almost 10-fold since 2000, but it is still only 1% of the funding to HIV/AIDS, tuberculosis, and malaria. Extended donor cultivation period is required to raise awareness of and funds for these diseases.

Advocacy efforts have improved but increased coordination and action is needed

NTDs lack the punch of global diseases and defy branding simplicity. Gaps in coordination remain prevalent between global, regional, and local levels.

Integrated Control

Section B

Integrated NTD Control: Mapping to Surveillance

Data Collection and Disease Mapping

! Sample collection

! Surveys

! Weight and height measurement

! Medical history

Pictures courtesy of SCI. 3

Example: Disease Endemicity in Uganda

4Source: Global Atlas of Helminth Infections (GAHI). Available at: http://www.thiswormyworld.org/.

Example: Disease Endemicity in Uganda

! Program design for MDA ! Community based versus school based

Development of National Plans of Action

! Program design for MDA ! Community based versus school based

! Budget development ! Gap analysis ! Coordination with donors

Development of National Plans of Action

! Program design for MDA ! Community based versus school based

! Budget development ! Gap analysis ! Coordination with donors

! Training of personnel ! Community health workers/teachers ! Laboratory staff

Development of National Plans of Action

! Program design for MDA ! Community based versus school based

! Budget development ! Gap analysis ! Coordination with donors

! Training of personnel ! Community health workers/teachers ! Laboratory staff

! Distribution of drugs ! National, district, and community levels

Development of National Plans of Action

Using Existing Infrastructures for Delivery

! School-based programs are a key approach for deworming ! Collaboration between Ministry of

Health and Ministry of Education ! Teachers also providing health

education

! Community-based programs can provide multifaceted interventions ! Linked to nutrition and other

healthcare programs ! Can combine training of healthcare

workers in multiple disciplines

Countries Requiring PCT Interventions for NTDs

Source: WHO, 2008. 11

Global Coverage of PCT-Ready Diseases

Implementation of National Plans of Action

Reaching Communities Beyond the End of the Road

14Courtesy of Mectizan® Donation.

Monitoring and Evaluation

0 2 4 6 8

10 12 14 16 18 20

2000 2001 2002 2003

Kizimbazi Kwankani

Results: NTD Elimination Through MDA

Lymphatic filariasis—Zanzibar

20%

40%

60%

80%

1997 1999 2001 2003

Zagora Errach. Tat Ouarz. Figuig

Results: NTD Elimination Through MDA

Trachoma—Morocco

Results: NTD Elimination Through MDA

Lymphatic filariasis—South Pacific

0 1 2 3 4 5 6 7 8 9

10 11 12 13 14 15 16 17 18

1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001

To ta

l N

o .

o f

D o se

Years

Prevalence of S. mansoni

Prevalence of S. haematobium

Results: NTD Elimination Through MDA

Schistosomiasis—Egypt

Health Systems Strengthening and Cross-Cutting Interventions

Section C

! HIV/AIDS ! Women with urogenital schistosomiasis are three times more likely to contract HIV ! Deworming HIV/AIDS patients has been shown to reduce viral load and CD4+ cell

counts and to reduce the risk of vertical transmission of HIV/AIDS (from mother to infant)

NTDs and HIV/AIDS, Malaria, and Tuberculosis

! HIV/AIDS ! Women with urogenital schistosomiasis are three times more likely to contract HIV ! Deworming HIV/AIDS patients has been shown to reduce viral load and CD4+ cell

counts and to reduce the risk of vertical transmission of HIV/AIDS (from mother to infant)

! Malaria ! Hookworm exacerbates anemia caused by malaria:

• 50 million school children and 7.5 million pregnant women with potential for co-infection

NTDs and HIV/AIDS, Malaria, and Tuberculosis

! HIV/AIDS ! Women with urogenital schistosomiasis are three times more likely to contract HIV ! Deworming HIV/AIDS patients has been shown to reduce viral load and CD4+ cell

counts and to reduce the risk of vertical transmission of HIV/AIDS (from mother to infant)

! Malaria ! Hookworm exacerbates anemia caused by malaria:

• 50 million school children and 7.5 million pregnant women with potential for co-infection

! Tuberculosis (TB) ! Intestinal worms have been found to be one of the risk factors for the development

of active pulmonary TB ! Intestinal worms diminish therapeutic response to anti-TB chemotherapy

NTDs and HIV/AIDS, Malaria, and Tuberculosis

Additional Interventions Integrated with Ivermectin Delivery

Source: African Programme for Onchocerciasis Control. (2007). Revitalising health care delivery in sub-Saharan Africa. Available at: http://www.who.int/apoc/publications/ EN_H ealt h Care07_7_3_08.pdf. Accessed February 16, 2015. 5

NTDs and HIV/AIDS Overview

! Infection as young girls with urogenital schistosomiasis, the most common form of schistosomiasis in sub- Saharan Africa, makes women three times more likely to contract HIV

! Schistosomiasis prevalence overlaps geographically with some of the greatest HIV/AIDS risk areas

! Intestinal worms put a burden on an already weakened immune system

! Deworming HIV/AIDS patients has been shown to reduce viral load, increase CD4 T-cell counts, and reduce the risk of vertical transmission of HIV/AIDS (from mother to infant)

Source: WHO. (2009). Report of an informal working group meeting on urogenital schistosomiasis and hiv transmission. Available at: http://whqlibdoc.who.int/hq/2 010/W HO_HTM_NTD_PCT_20 10.5_ eng. pdf. Accessed February 16, 2015. 6

Geographic Overlap of NTDs and HIV/AIDS

! Geographic overlap of NTDs and HIV/AIDS

! Demographic overlap of NTDs and HIV/AIDS

! Impact of co-infection on at-risk populations

! Almost 85% of those infected with schistosomiasis live in sub-Saharan Africa

! Africa represents 68% of all people living with HIV worldwide and 76% of AIDS deaths globally in 2007

Image sources: Top: World Health Organization. Bottom: UNAIDS. (2008). Report on the Global AIDS Epidemic. 7

NTDs and Malaria Overview

! Hookworm exacerbates anemia caused by malaria, leading to increased morbidity and mortality in mothers and children

! Fifty million school children and 7.5 million pregnant women are at risk of co-infection

! NTDs may reduce immune response and promote increased susceptibility to malaria

! Same mosquito vector carries malaria and lymphatic filariasis

! One in four school children in sub-Saharan Africa is at risk of co-incident infection with malaria and NTDs

Source: The Global Network for Neglected Tropical Diseases; Sabin Vaccine Institute. (2010). A White Paper prepared for DFID on: Opportunities for Linking NTD Control to the Control of Malaria, HIV/AIDS, and Tuberculosis, with an Emphasis on Sub-Saharan Africa. 8

Geographic Overlap of NTDs and Malaria

! Burden and impact of NTDs ! Geographic overlap of NTDs

and malaria ! Demographic overlap of NTDs

and malaria ! Impact of co-infection on at-

risk populations

Source: Brooker, S., Clements, A. C. A., Hotez, P. J., Hay, S. I., Tatem, A. J., Bundy, D. A. P., & Snow, R. W. (2006). The co-distribution of Plasmodium falciparum and hookworm among African schoolchildren. Malaria Journal, 5, 99. doi:10.1186/1475-2875-5- 99 9

! Intestinal worms have been found to be one of the risk factors for the development of active pulmonary TB

! Intestinal worms diminish therapeutic response to anti-TB chemotherapy

! Helminth infections also reduce the effectiveness of BCG, the only available tuberculosis vaccine, in humans

NTDs and Tuberculosis Overview

Theoretical Mechanisms of Reduced Vaccine Response in Infants

11 Source: LaBeaud, A. D., Malhotra, I., King, M. J., King, C. L., & King, C. H. (2009). Do Antenatal Parasite Infections Devalue Childhood Vaccination? PLoS Negl Trop Dis, 3(5), e442. doi:10.1371/journal.pntd. 0000 442

The Global Network for Neglected Tropical Diseases

! An advocacy and resource mobilization initiative working with international organizations, governments, technical agencies, and donors to enhance collaboration and coordination in support of NTD control and elimination goals

! Implement community-driven and country-owned plans

! Strengthen local health systems

! Build on existing programs and successes

Our Guiding Principles

! Implement community-driven and country-owned plans

! Strengthen local health systems

! Build on existing programs and successes

! Optimize partners’ capabilities within region

! Utilize multisector approaches to help ensure sustainability and lasting impact

! Pursue transparency in decision making

! Foster regional and country-level strategic and technical collaboration

Our Guiding Principles

! High–net-worth individuals

! Corporations and foundations ! Pharmaceutical leadership initiative to end the neglect

! Bilateral aid

! Multilaterals ! World Bank International Development Assistance (IDA) fund ! Development banks

Resource Mobilization

Advocacy: END7 Campaign

! Objectives: ! Raise awareness of NTDs in United States and United Kingdom ! Build legitimacy of issue among all donor audiences

! Grassroots audience

! Social media driven

! Launched in December 2011

! Web site and YouTube Channel links available in Online Library and Lecture home page