WHO 2013 Consultative Meeting Tawanna Hotel October 15, 2013

THE NEW PMTCT GUIDELINES OCTOBER 2013

Couple counselli ng -HAART for all regardles s of CD4 PMTCT National Program in Thailand - AZT from 34 wk GA -VCT -Infant formula up to 12 months of age - Partner HIV testing - CD4 testing postpartum -ART and OI Rx for mothers and family --AZT from 28 wk GA + SD- NVP - antepartum CD4 - HAART if CD4<200 or symtomatic -Tail Rx (AZT+3TC x 7 day) - DNA PCR in infants

อัตราถ่ายทอดเชื้อเอชไอวีจากแม่สู่ลูก , NAP Database Analyzed date Feb 13, data cutoff Dec 2012

PMTCT: Challenges Late ANC 50%, No ANC 10-15% ท้องไม่พร้อม Low couple counseling rate (only 1/3); 1/2 of husband of positive pregnant were unknown serology Diagnosis in infants not early enough for CURE strategy เชื้อดื้อยาเป็นปัญหาที่จะพบมากขึ้น Communication between health centers/ referral system สิทธิการรักษาต่างกองทุน ขาดการเชื่อมโยง

PMTCT Guidelines 2013 Regimen Do not wait for CD4 count Post-partum ART CD4 count (cells/mm 3 ) >500 CD4 count (cells/mm 3 ) <500 AZT+3TC +LPV/r ASAP- Continue HAART if sero- discordant couple or unknown sero-status in couple, co-infection with TB, HBV, HCV Continue HAART Use TDF+3TC+EFV if CD4 <500 cells/mm 3, sero- discordant couple or unknown sero-status in couple, co- infection with TB, HBV, HCV Infants take AZT 4 weeks, infant formula for all

CasesIntrap artum Post-partum MotherInfants High risk CD4> 500 cells/ mm 3 AZT (300) Q 3 hr + SD NVP* AZT+3TC+ LPV/r x 4 wk then stop - AZT+3TC+ NVP 6 wk or >1 negative PCR AZT+3TC+L PV/r x 4 wk then HAART CD4< 500 cells/ mm 3 No SD NVP if not deliver in 2 hr High Risk Cases: ART 1,000 at 36 wk GA/delivery, recent exposure

Early Infant Diagnosis DNA-PCR or RNA-PCR (viral load) – First test at 1 month – If positive at 1 month, re-test right away – If negative at 1 month, re-test at 2 months – High risk case also test at 4 months Always perform anti-HIV at 18 months old – false positive if use 4 th generation test – false negative in early Rx

THE NEW PEDIATRIC GUIDELINES OCTOBER 2013

ART in Children Under UC 2013 (N= 5565) PI+NRTI EFV+NRTI NVP+NRTI

Pediatric HIV Treatment in Thailand Challenges Delayed diagnosis and treament in infants Adherence, Drug resistance, Family/social problems Long-term complications from ART Adolescent issues

When to Start : Thai Guidelines 2013 < 1 yo1- 3 yo 3- <5 yo > 5-15 yo Clinical stage Any -CDC category B, C -Or WHO stage 3, 4 -Consider in category A or VL > 100,000 copies/ml CDC category B, C หรือ WHO stage 3, 4 CDC category B, C หรือ WHO stage 3, 4 Immunologic stage %CD4 / CD4 counts AnyCD4 < 25% or < 1,000 cells/mm 3 CD4 < 25% < 750 cells/mm 3 CD4 < 350 cells/mm 3 -Consider in CD cells/mm 3 May change LPV/r to NVP if Rx >12 months and VL <50 cp/ml

What to Start With; Thai Guidelines 2013 < 1 yo 1- 3 yo3- 12 yo > 12 yo Preferred regimens AZT ( or ABC) + 3TC + LPV/r AZT (or ABC) + 3TC + LPV/r AZT (or ABC) + 3TC + EFV TDF+ 3TC + EFV Alternative regimens AZT (d4T 6 mo if anemia) + 3TC + NVP AZT (or ABC) + 3TC + NVP d4T # + 3TC + LPV/r ( หรือ NVP) AZT +3TC + NVP AZT+ 3TC + EFV (or NVP) ABC+3TC+ EFV (or NVP) TDF+ 3TC + EFV (or NVP) d4T # + 3TC + EFV ( or NVP) ABC use: no need to test HLA B*5701

Monitoring Clinical F/U every few months Plasma HIV RNA at 6 months after ART initiation, then every 6-12 months CD4 every 6 months, and consider every 12 months in > 5 year-old with plasma HIV RNA 500 cell/mm 3 and with good adhrence

Second Line and Salvage Regimens in Children: Thai Guidelines st line regimenSecond-line regimen Salvage regimen with expert consultation AZT+3TC+NVP or EFV TDF+3TC+LPV/r 1 ≥1 NRTI+DRV/r ± others(ETR and/or RAL and/or MVC) TDF or ABC +3TC+NVP or EFV AZT+3TC+LPV/r 2 ≥1 NRTI+DRV/r ± others(ETR and/or RAL and/or MVC) AZT +3TC+LPV/r No NNRTI resistant: TDF + 3TC + EFV 3 ( DRV/r if with in-use NRTI resistant) With NNRTI resistant: TDF +3TC + DRV/r ≥1 NRTI+ boosted PI ± others(ETR and/or RAL and/or MVC) ABC+3TC+LPV/rNo NNRTI resistant: TDF + AZT+ EFV 4 ( DRV/r if with in-use NRTI resistant) With NNRTI resistant: TDF+ AZT + DRV/r ≥1 NRTI+ boosted PI ±others(ETR and/or RAL and/or MVC)

Darunavir/r Use in Children Under UC 1.Protease inhibitor-resistant 2.Need PI, but intolerance to LPV/r, ATV/r 3. With other effective combining drugs available Only DRV 300 mg tab available Weight DRV/r (mg/dose) bid With food DRV/r (mg) od if without DAM 10 - < 15*300/5035/7 mg/kg 15 - < 30*450/50 am 300/50 pc600/ <40450/100600/100 > 40600/100900/100 RTV 100mg may replace 50mg

Thank you