Support for Pediatric HIV in the 2019 COPs:

Point of Care Early Infant Diagnosis (POC EID)

HIV Infections Among Infants is a Public Health Emergency

The WHO recommends early testing of all HIV-exposed infants, rapid return of results, and prompt antiretroviral treatment (ART) initiation for those who are HIV-positive• All HIV-exposed infants should have a virological test at four to six weeks of age or

at the earliest opportunity thereafter (strong recommendation)1

• The turnaround time (TAT) from specimen collection to results return to caregiver should never be longer than four weeks. (strong recommendation)2

• Positive test results should be fast-tracked to the mother-baby pair as soon as possible to enable prompt initiation of ART, if needed (strong recommendation)1

• Point-of-care early infant HIV diagnosis (POC EID) can be used for early infant HIV testing (conditional recommendation)2

• POC EID testing can be used to confirm positive test results3

• Consideration can now be given to replacing RDT at nine months with NAT (e.g. POC EID)3

Early infant diagnosis of HIV (EID) is vital to ensure HIV-infected infants begin lifesaving treatment as early as possible, thereby ensuring their survival

1 World Health Organization (2016). Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Second edition. Geneva.2 World Health Organization (2010). WHO recommendations on the diagnosis of HIV infection in infants and children. Geneva.3 World Health Organization (2018). Technical report. HIV diagnosis and ARV use in HIV-exposed infants: A programmatic update. Geneva.

With laboratory-based EID testing, the number of steps from sample collection to return of results to caregiver and clinical action lead to persistent delays and a high proportion of lost results.

Step 1

Step 2

Step 3

Step 4

Step 5

Timeframe: 30-90 days

Specimen collection at health facility

Sample transport to laboratory

Batching and analysis at the laboratory

Result return to health facility

Result returnto caregiver

Why POC EID? Challenges with the Conventional EID Cascade

Turnaround time from blood sample collection to return of results to caregiver: 30-90 days

Source: On the Fast-Track to an AIDS-Free Generation, UNAIDS, 2016

Based on a weighted average of nine studies and monitoring and evaluation (M&E) data, 42% of EID test results are not received by the patient • Wasted reagents

• Wasted HR time• Unnecessary repeat

testing• Infants LTFU before

receiving results • Poor linkage between

testing and care and treatment

• High infant mortality

42%

58%

Results notreceivedResultsreceived

With Conventional EID Testing Many Infants Never Get Results

Implementing POC EID in Routine Clinical Care: EGPAF’s Approach

• Bringing the test closer to

the client in nine project

countries

• Pragmatic placement of

POC platforms and

implementation based on

current resources and

human resources

• Phased approach – started

with a 6 month pilot period

• Maximize access to POC

EID testing through hub-

and-spoke models and

multiple entry points

Results from Implementation in Nine Countries: Conventional vs. POC EID(Cameroon, Cote d’Ivoire, Eswatini, Kenya, Lesotho, Mozambique, Rwanda, Zambia, Zimbabwe)

Conventional EID

(N=96 sites,

n=2899 tests)

POC EID

(N=339 sites,

n=19,058 tests)

p value

Median TAT from blood sample collection to result returned to caregiver (IQR)

55 days (31-77) 0 days (0-1 ) p<0.001

Results received by caregiver within 30 days

18.7 %

(542/2,899)98.3%

(18,737/19,058) p<0.001

Percent of HIV-infected infants started on ART within 60 days of sample collection

43.3% (42/97)

92.3%

(639/692)p<0.001

Median TAT from blood sample collection to ART initiation for HIV-infected infants (IQR) 49 days (30-68) 0 days (0-3) p<0.001

Cost Per Test Result Returned• Current conventional reagents are approximately $10, while the price of POC

EID cartridges range from $14.90 to $25.

• BUT what truly matters is cost per test result returned so clinical action can be taken (and time and resources not wasted).

Conventional POC (current throughput)

POC (optimal throughput)

Cost per result returned in 30 days (range)

$131.02 USD ($96.26-$165.76)

$37.89 USD ($32.54-$43.25)

$27.24 USD ($21.39-$33.10)

Cost per result returned in 3 months (range)

$38.89 USD ($28.57-$49.21)

$37.51 USD ($32.21-$42.81)

$26.97 USD ($21.17-$32.76)

*https://www.theglobalfund.org/media/5765/psm_viralloadearlyinfantdiagnosis_content_en.pdf

The incremental cost-effectiveness ratio (ICER) for POC EID is $630

per year of life saved. This is $740 less per year of life save than

Option B+ for PMTCT, which is a widely accepted and used

intervention.

Conclusions: POC EID Is a Game-Changer• Early HIV testing, prompt return of test results, and rapid initiation of

treatment reduce morbidity and mortality among HIV-infected infants.• HIV-exposed infants have a right to a timely and accurate diagnosis • POC testing resulted in significantly improved EID outcomes when compared

with conventional EID:• Dramatically reduced turnaround time for test results (median of 49 days with

conventional testing versus 0 days with POC)• Four times more likely for results to be returned to caregiver within 30 days with

POC• Twice as likely for HIV+ infants to be initiated on treatment in 60 days

• POC EID is cost-effective and saves lives• But donors are basing their investment decisions primarily on the up-front

sticker price of testing cartridges• Clinicians say going back to the conventional system is unethical given the clear

clinical benefits for HIV+ infants

COP 19 Technical Guidance• In COP19, country teams are encouraged to use POC platforms

to support EID scale-up:“New testing strategies to include use of Point of Care (POC) platforms have helped to address some barriers to achieving high testing coverage by age 2 months and early initiation of ART for HIV infected infants. PEPFAR programs should continue to use POC to support EID scale-up.”

• PEPFAR programs should also use POC for Viral Load testing, but among pregnant and breastfeeding women only.

• COPs should include sufficient funding for POC EID testing cartridges and operational support

• Funding is needed to maintain and scale-up existing POC EID platforms in: Cameroon, Cote d’Ivoire, DRC, Ethiopia, Eswatini, Kenya, Lesotho, Malawi, Mozambique, Rwanda, Senegal, Tanzania, Uganda, Zambia, and Zimbabwe.

• Funding is needed to introduce POC EID in other high prevalence countries

COP 19 Asks on POC EID

Acknowledgements

The EGPAF POC EID project was made possible thanks to Unitaid’s support.Unitaid accelerates access to innovation so that critical health products can

reach the people who most need them.

For more information contact:

Rebecca Bailey: rbailey@pedaids.orgCatherine Connor: cconnor@pedaids.orgJen Cohn: jcohn@pedaids.orgJudith Kose: jkose@pedaids.org

Or visit: www.pedaids.org

Thank you!