MATERNAL ANTIRETROVIRAL THERAPY AND INFANT OUTCOMES THROUGHOUT THE FIRST YEAR OF LIFE: results from the DREAM study in Dschang, Cameroon Taafo F, Doro Altan AM, Fopa F, Buonomo E, Marazzi MC, Scarcella P, Ciccacci F, Orlando S, Mancinelli S, Palombi L 18° ICASA International Conference Harare, 29 Nov – 4 Dec 2015

HIV EPIDEMIC AND E-MTCT STRATEGY IN CAMEROON: WHERE ARE WE? Number of people living with HIV Number of HIV+ people on ART Adult prevalence rate4,8% Prevalence rate in pregnant women (2012)7,8% Number of HIV+ women delivering every year Number of new child infections % of pregnant women receiving ARV drugs for PMTCT (2013)57% % of infants born to HIV+ mothers receiving ARV prophylaxis during breastfeeding (2012) 38% % infants born to HIV+ mothers receiving a virological test24% % infants with PCR+ at 6 weeks15,6% Source: GARP Report 2014 UNAIDS Progress Report on the Global Plan 2014

DREAM PROGRAMME  DREAM is a programme of care for people living with HIV conceived and managed by the Community of Sant'Egidio in collaboration with a large network of public and private partners, governments, religious orders  Key elements of the programme are: high quality care accompanied by laboratory monitoring, use of Informatized Technology, free of charge approach, active involvement of people in care  DREAM has been implementing PMTCT with triple ART since 2004 in several African countries, and is operating in Cameroon since 2008 in partnership with the Daughters of Charity

THE LOCATION: DSCHANG, WEST REGION Dschang WEST REGION  Population:  HIV prevalence: 2,8%  HIV prevalence in pregnant women: 4,9%  Adults and children on ART:  14 ART facilities covering 50% of districts  52% women attending ANC clinics

DSCHANG DREAM CENTRE: DATA AND ACTIVITIES Population/Activities Clinical cards (cumulative) 3698 Pregnant women followed (cumulative) 591 HIV+ children (less than 15 years) 142 Babies born in the PMTCT program 519 Patients in care (current, nov. 2015) 1474 Laboratory (cumulative): CD4 cell counts performed Viral load performed 8000

OPERATIONAL RESEARCH «DREAM»  Operational research «DREAM»,  Approved by the Ministry of Health and the National Ethic Committee  Aim: to evaluate feasibility and outcomes of Option B implementation in the district of Dschang  Objectives:  To evaluate HIV transmission rates  To evaluate infant mortality and HIV-free survival  To evaluate retention in care of HIV+ pregnant and lactating women  To evaluate nutritional status of infants in the first year of life  The present study reports on infant outcomes

METHODS: POPULATION AND PROTOCOLS  Enrolment: September September 2011  Inclusion criteria:  1) Pregnant women who tested positive at ANC during pregnancy and were referred/self referred to DREAM Centre  2) HIV+ women already in ART and having a pregnancy  Women received ART until the end of breastfeeding or indefinitely if their CD4 count was <350mm 3.  Main ARV regimens: d4T+3TC+NVP; AZT+3TC+NVP. Women already on ART continued their previous regimen.  Laboratory monitoring: AST and ALT at baseline, after 15 days and at month 1, 2, 3, 6, 12; full blood count at baseline, after 15 days and at month 1,3,6,12; CD4 count at baseline, after 3 months and every 6 months; VL at baseline, after 6 and 12 months  Women were counselled to exclusively breastfeed until 5 months and to wean by the 6 th month.

METHODS: INFANT PROTOCOL  Newborn received NVP at birth  Monthly health checks  Growth evaluation: weight, height, arm circumference measurement according to standard procedures. Calculation of WAZ, WLZ, LAZ using the WHO 2006 standard population reference  Assessment of HIV infection: VL measurement at 1 and 6 months (infants with > copies considered infected); HIV rapid test at 12 and 18 months

RESULTS: WOMEN’S COHORT Number Age (years) Mean±SD CD4 (cells/mm3) Mean±SD Days on ART before delivery, median (IQR) N. women delivering livebirths N. stillbirths Group 1: Initiated on ART in pregnancy, CD4>350/mm ,4±6,3578± (69-104) 713 Group 2: Initiated on ART in pregnancy, CD4<350/ mm ,0±5,3236± (64-154) 573 Group 3: Established on ART before pregnancy 15230,8±5460± ( ) 1324 All 29830,2±5,4443± (94-802)26010

INFANT COHORT PROFILE Lost to follow up rate: 5 per 100 person/year AgeHIV infectedCumulative transm. rate 1 month1/2650.3% 6 months2/2570.7% 12 months3/2421.2%

HIV INFECTION  3 children acquired HIV infection  HIV transmission rate at 12 months: 3/242 (1,2%)  HIV transmission rate was 0,8% among infants born to women on established ART Children HIV+ Mother’s group Mother’s CD4 during pregnancy Mother’s VL during pregnancy Days of ART before delivery Age at infection Case month Case months Case months

RISK FACTORS FOR LOW BIRTHWEIGHT N. infantsMean birthweight T test, p value Days on ART before delivery Lowest quartile (<94 days) 672.8±0,5 p = 0.02 Highest quartile (>795 days) ±0,5 Maternal CD4 count in pregnancy >350 CD p = 0.02 <350 CD

INFANT GROWTH 0 months3 months6 months12 months Number Weight (kg) Mean±SD 2.9±0.66.4±0.97.9±0.99.3±1.1 WAZ Mean±SD -0.82± ± ± ±1 Lenght (cm) Mean ±SD 48.5± ± ± ±2.8 LAZ Mean±SD -0.99± ± ± ± % of infants have been breastfed Breastfeeding cessation: 6 months of age

INFANT GROWTH: RATES OF UNDERWEIGHT AND STUNTING

INFANT MORTALITY Hazard risk for mortality in children (Cox proportional hazards model, stepwise) Hazard RiskCL 95%P value Maternal Cd4 <350/ mm Underweight Breastfeeding deaths, infant mortality 80 per neonatal deaths, neonatal mortality 29 per 1000 HIV free survival: 91% at 12 months

INFANT SURVIVAL AND MATERNAL CD4

CONCLUSIONS AND RECOMMEDATIONS  The study confirms the concrete possibility of eliminating mother to child transmission of HIV through maternal ART until the end of breastfeeding, or lifelong.  High levels of retention and adherence observed are the key of a successful implementation.  HIV transmission rates in this cohort were low, and very low among infants born to mothers on established ART.  The relationship between infant mortality and maternal CD4 supports the earlier initiation of ART and its prolongation: Option B+ strategy  The current indications on extending breastfeeding until at least 12 months of life, will positively affect nutritional status and survival in HIV exposed infants.

THANK YOU FOR YOUR ATTENTION! ELIMINATING MOTHER TO CHILD TRANSMISSION IS POSSIBLE!