Antimicrobial Resistance (AMR) Research & Innovation:

Addressing Africa’s Regional Priorities

Dr Francis J Ndowa• Specialist: Venereology/Dermatology• Chairperson, Harare Central Hospital Management Board• Member of the WHO Strategic and Technical Advisory

Group on Antimicrobial Resistance (WHO AMR-STAG)• Member of the Antimicrobial Resistance (AMR) Program Advisory

Committee of Zimbabwe• Executive Member of International Union against STI (IUSTI)• International consultant on STIs and gonococcal

antimicrobial resistance (GC AMR)

Cape Town 1 September 2016

Introduction to Break-Out Sessions

Group 1

Public Health AMR Priorities in Africa

• Surveillance

• Treatments

• Diagnostics

Group 2

Key elements of ensuring stewardship and sustainable access to new treatments

• To impede the rapid development of antimicrobial resistance

• To limit cross-resistance within the class(es) of antibiotics

• Practical policy issues and regulatory processes

Group 3

Clinical Research for Antibiotic Treatments in and for Africa: potential for regional collaboration and clinical trial networks

• What are the gaps

• Where are the gaps (in what areas of intervention?)

Introduction to Break-Out Sessions

Group 1 Surveillance

• Consider what to survey as priority and why

• Populations

• Location and Periodicity

Group 1 Treatments

• Standardisation

• Use of antimicrobial agents

• Availability

• Procurement

Group 1 Diagnostics

• Priority for which infections and why

• Interpretation and use of diagnostic tests – what are the issues?

Introduction to Break-Out Sessions

Group 2 Stewardship

• What does stewardship mean:o At the national level

o At the local (central or peripheral level of health care

• How to foster and sustain stewardship

• How to ensure access but promoting responsible use of:o Existing treatments

o New treatments

Group 3 Clinical Research for Antibiotic Treatments (Use)

• Morbidity and mortality data

• Knowledge and attitudes of health-care providers and clients towards use and importance of antimicrobial agents

• Collaboration between clinicians and laboratorianso What are the gaps?

• What lessons learned from regional collaborative clinical research networks for accelerating introduction of new treatments – how can collaboration help accelerate regulatory pathways where capacity differs among countries?

Countries reporting increased MIC of Cefixime and

Ceftriaxone in N. gonorrhoeae (2010)

Status of gonococcal antimicrobial resistance surveillance in 12

countries in the WHO African Region, July 2013

Country Centres with skills for

AMR susceptibility

testing?

Centres with -

70° or -20°

freezers

Culture media for

GC

Antimicrobial

susceptibility

testing used

Was β-lactamase

test done?

Cameroon Yes Yes Choc agar Agar diffusion

E-test

Yes

Côte

d'IvoireYes Yes TM medium Agar diffusion

E-test

Yes

Dem Rep of

CongoYes Yes Choc agar N/A No

Ethiopia Yes Yes Mod TM Disc diffusion YesGambia Yes Yes Choc agar,

TM, Blood agar

Disc diffusion No

Kenya Yes Yes TM medium N/A N/AMadagascar Blank Yes Blank E-test Yes

Rwanda Yes Yes N/A N/A N/ASeychelles Yes Yes Blood agar Antibiotic disc on

agar plates

No

Tanzania Yes Yes TM medium Agar diffusion

E-test

Yes

Zimbabwe Yes Yes Amies E-test Yes

Number of gonococcal isolates per country by year of

survey in selected African countries, 2004-2012

Country Year of survey Total N. gonorrhoeaeisolates tested by country

2004 2005 2006 2007 2008 2009 2010 2011 2012

Cameroon 79 22 26 18 17 24 186

Central Africa Republic

30 30

Côte d'Ivoire 10 12 9 31

Kenya 166 17 183

Madagascar 126 21 19 22 52 240

Malawi 106 106

Mozambique 55 55

Namibia 123 123

South Africa 259 389 219 682 522 121 175 146 2,513

Zimbabwe 69 69

Total number ofisolates per

year259 444 454 911 565 342 313 224 24 3,536

Use of laboratory results vs clinical status of patientThe case of Mr X Age 19 years

Mr X, age 19 years

Medical History:

• Sexual intercourse with girlfriend known for 1 month (April 2016)

• Genital discharge 1 week later (April 2016)

• Seen by GP: 1 July for “recurrent mucus-like urethral discharge and itchiness of glans penis and ?anal region

• Treated with an exhaustive list of antibiotics!

Laboratory tests1 July: RPR -ve, TPHA -ve, HIV test -ve, Urine microscopy: wbc (occasional), C & S no growth18 August: Persistent penile itchingLaboratory testsUrethral swab: wbc <1Gram stain: Gram +ve cocciCulture: E. coli (see antibiogram)

Use of laboratory results vs clinical status of patientThe case of Mr X Age 19 years

Use of laboratory results vs clinical status of patient: The case of Mr X Age 19 years

Use of laboratory results vs clinical status of patient: The case of Mr X Age 19 years

REQUEST FOR EXPERT OPINION ON RESTRICTION OF FLOROQUINOLONE USE TO TBby

The Medicines Control Authority of Zimbabwe, 3 August 2016

“Before the WHO recommendation for use of floroquinolones for TB treatment MCAZ had registered some products containing levofloxacin, moxifloxacin and ofloxacin for treatment of respiratory tract infections [other] than TB, urinary tract and soft tissue infections. After the WHO indication of levofloxacin, moxifloxacin and ofloxacinfor TB treatment MCAZ has restricted the indications of the new registered products to TB treatment only, with the intention [to] reclassify all previously registered products to be used for TB treatment only. Some applicants with existing open marketing authorisation and other applicants with new marketing authorisations have submitted representations against the proposed restriction of use [of] levofloxacin, moxifloxacin and ofloxacin to TB treatment only. They cite viability issues if the products would be restricted to TB treatment only. The Authority’s concern is possibility of development resistance by TB pathogens to floroquinolone medicines thereby limiting their efficacy in TB treatment”

AN EXAMPLE OF POLICY DECISION AT THE NATIONAL LEVEL TO PREVENT DEVELOPMENT OF ANTIMICROBIAL RESISTANCE IN A SPECIFIC INFECTION

The proposal for policy/guideline change by MCAZ

• i) MCAZ should restrict the use of all medicines containing levofloxacin, ofloxacin and moxifloxacin to the treatment of TB only

• ii) MCAZ should review the indications of already registered levofloxacin, ofloxacin and moxifloxacin products to exclude treatment of other bacterial infections than TB.

• iii) MCAZ should extend the restriction to other earlier generation floroquinolones such as ciprofloxacin in a bid to limit resistance to the fluoroquinolone class.

Enjoy the discussions and Report Back