Hospital-based Surveillance of Rotavirus Gastroenteritis ...

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Hospital-based Surveillance of Rotavirus Gastroenteritis

in Latin America

The Latin America Rotavirus Vaccine Study Group Presented by Miguel O’Ryan

ProfessorInstitute of Biomedical Sciences

University of Chile

• Background– RV-associated disease burden data are limited

•Opportunity– Set up of phase III RV vaccine trial

•Objective– Describe disease burden of RV GE in Latin America

•Methods– Prospective, multi-center, hospital-based study in 11

countries– Inclusion Criteria

• Children <3 years • Treated at hospital site for Gastroenteritis

Study Sites in Latin America

Ciudad de México(MX)

Durango (MX)

Belem (BZ)

Santo Domingo (DR)

Léon (NI)

Tegucigalpa (HO)

Panamá (PA)

Viña del Mar (CH)Concepción-Talcahuano

Chiriqui (PA)

Mendoza (AG)

Valencia (VE)

Cali (CO)

Estado de México (MX)

Morelos (MX)

Study Duration by Country- limitation of study -

Country Nov-02 Dec-02 Jan-03 Feb-03 Mar-03 Apr-03 May-03 Jun-03 Jul-03 Aug-03 Sep-03

VenezuelaBrazilCosta RicaMexico PanamaChileDominican RepublicHondurasArgentinaNicaraguaColombia

Range: 50-220 days; Median: 158 days

Results

Baseline DataDiarrhea episodes 8,031

Completed questionnaires and stool samples

81% (6,521)

Hospitalized patients (inpatients) 78%

Median age 1 year

Male : Female ratio 1.4 : 1

Rotavirus positive/tested (%) 3,122/6,361 (49%)

Hospitalized patients (inpatients) 2,421 (78%)

Male : Female ratio 1.4 : 1

0%

20%

40%

60%

80%

Dec Jan Feb Mar Apr May Jun

% o

f po

sitiv

e RV

sam

ples

Mexico (n=1154) / Range 10% - 79%

0%

20%

40%

60%

80%

Dec Jan Feb Mar Apr May Jun

% of

pos

itive

RV

sam

ples

Venezuela (n=301) / Range 8% - 7 8%

0%

20%

40%

60%

80%

Dec Jan Feb Mar Apr May Jun

% o

f po

sitiv

e RV

sam

ples

Costa Rica (n=635) / Range 11% - 63%

0%

20%

40%

60%

80%

Dec Jan Feb Mar Apr May Jun

% o

f po

sitiv

e R

V sa

mpl

es

Dom Rep (n=395) / Range 35% - 80%

Proportion of RV Positive by Month

0

20

40

60

80

100

0 6 12 18 24 30

Age in months

Perc

ent

Overall Cumulative Age Distribution of RV+ Children (%)

12 months 54% 24 months 90%6 months 18%

0

20

40

60

80

100C

hile

Cos

ta R

ica

Pan

ama

Bra

zil

Nic

arag

ua

Arg

entin

a

Mex

ico

Hon

dura

s

Dom

inic

an

Vene

zuel

a

Ove

rall

Cumulative age distribution of rotavirus positive children at 12 months of age, by country

54%

Median delay between RV GE onset andhospital adm ission 2 days

Received oral hydration (single or combinationtherapy) 52%

Received antibiotic therapy 27%

Results

Treatment RV+ GE• Before coming to hospital site

Received oral-intravenous hydration (single or combination therapy) 69-77%

Received antibiotic therapy 24%

• At hospital site

0

1

2

3

4

Overa

llCol

ombi

aCos

ta R

icaMex

icoHon

dura

sPan

ama

Argen

tina

Chile

Nicara

gua

Venez

uela

Brazil

Median Duration of Hospitalization Due to RV Gastroenteritis

(2 days)

Outcome of Hospitalized RV+ Cases

Fully recovered at time of discharge 96%

Sequelae at time of discharge 4%

Died (2 patients among 3,122 RV+ children) <1%

1240 RV Strains Serotyped (~ 110/country)

Country G1 G2 G3 G4 G9 UntypOverall 51% 1% 10% 18% 3% 17%Argentina 96% 0% 0% 0% 0% 4%Brazil 57% 1% 0% 2% 8% 31%Chile 21% 1% 0% 66% 0% 12%Colombia 88% 0% 0% 0% 0% 13%Costa Rica 30% 0% 68% 2% 0% 0%Dominican 46% 2% 21% 0% 0% 31%Honduras 100% 0% 0% 0% 0% 0%Mexico 48% 3% 5% 11% 9% 23%Nicaragua 28% 3% 33% 20% 0% 16%Panama 89% 4% 7% 0% 0% 0%Venezuela 42% 0% 13% 19% 0% 26%

Household Costs of RV Gastroenteritis

Collaboration Emory University

• Obtained information family expenditures

• Caregiver cost questionnaire (subset of cases)

– payments for medical treatment

– out of pocket expenses (travel, additional supplies)

– time lost from work

– qualitative impact on households

0% 10% 20% 30% 40% 50% 60% 70%

Overall

Chile

Venezuela

Honduras

Brazil

Costa Rica

Argentina

Mexico

Panama

Dominican

Nicaragua

Colombia

Proportion of Parents Who Took Paid Time Off (overall 40%)

0 5 10 15 20 25 30

Overall

Colombia

Costa Rica

Honduras

Panama

Dominican

Mexico

Venezuela

Brazil

Argentina

Chile

Nicaragua

Hours Lost From Paid Work (Median 12 hours)

hours

3%

13%

24%

33%

51%

0% 10% 20% 30% 40% 50% 60%

Sold assets

Asked for donation

Used Savings

Cut Expenses

Borrowed

Source of Money to Pay for Illness Associated Expenses

Impacto de Infección por Rotavirus en LatinoaméricaO’Ryan M, Pérez-Schael et al. Ped Infect Dis J 2001; 20:685-93

Santiago:

Sótero del RíoBs. Aires:

Ricardo Gutiérrez

Valencia:

Jorge Lizarraga

Visitas Médicas: Número de deposiciones:

Lugar Totales Diarrea aguda Obtenidas Rota +

Argentina 116,596 4,375 (3.8%) 1,133 (26%) 438 (39%)

Chile 123,320 6,599 (5.4%) 1,739 (26%) 585 (34%)

Venezuela 36,787 3,370 (9.2%) 2,929 (87%) 848 (29%)

Impacto de la diarrea aguda total y por rotavirusen visitas médicas

Niños < 36 meses de edad, período estudio 48 meses

Hospitalizaciones: Número de deposiciones:

Lugar Totales Diarrea aguda Obtenidas Rota +

Argentina 2.550 56 (2.2%) 34(61%) 24 (71%)

Chile 4.773 283(5.9%) 276 (98%) 130 (47%)

Venezuela 8076 1071(13%) 946 (88%) 355 (38%)

Impacto de la diarrea aguda total y por rotavirusen hospitalizaciones

Impacto de Enfermedad Por Rotavirus ExtrapoladaO’Ryan M, Pérez-Schael et al. Ped Infect Dis J 2001; 20:685-93

Visitas Médicas HospitalizacionesPaís Totales Pob < 3 años Totales Pob < 3 años

Argentina 106.000 1/20 20.875 1:100

Chile 57.761 1/22 8.800 1:136

Venezuela 96.000 1/18 31.000 1:55

Conclusion-Summary

• Rotavirus causes a highly significant proportion of diarrhea cases among children < 3 years of age in Latin America:

– 40-50% of cases requiring hospitalization– 30-40% of cases requiring ER visit

• Seasonal variations and age prevalence variations among countries.– Small proportion (<20%) occurring in < 6 months of age.

• Marked overuse of antimicrobials for rotavirus diarrhea, significant need for IV rehydration.

• Low mortality as expected for a prospective surveillance study• Different serotype patterns across countries within the same season

– Low circulation of G2 types during the period – Emerging G9 in certain countries

• Households in Latin America are economically affected by RV GE – additional point to consider outside “health care perspective”