Pediatric Antiretroviral Resistance Challenges
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1 Pediatric Antiretroviral Resistance Challenges Thanyawee Puthanakit, MD The HIVNAT, Thai Red Cross AIDS research Center The Research Institute for Health Science, Chiang Mai University
2 Outline The burden of drug resistance in children The drug resistance mutations pattern in children failed NNRTI-based regimen Options for the second line therapy in children
3 HIV-infected children in Thai National AIDS program Gender Male Female Female 4,243; 54% Male 3,665; 46% Data as of Sep 2008, Slide collection: Dr. Sorakij
4 Thai National AIDS program HIV-infected children Age distribution Age distribution คน On ARV Total ป Data as of Sep 2008, Slide collection: Dr. Sorakij
5 ARV regimen C 1% D 9% B 2% E 3% A,B,C: first-line D, E: second-line A 85% A B C D E Data as of Sep 2008, Slide collection: Dr. Sorakij
6 Result of viral load testing (5,925 tests) VL<2,000 VL=>2,000 VL=>2,000; 1,503; 25% VL<2,000; 4,422; 75% Data as of Sep 2008, Slide collection: Dr. Sorakij
7 The prevalence of virologic failure after first-line therapy Uganda Kamya MR. JAIDS 2007;46: /222 children (26%) had VL > 400 copies/ml at M12 Cambodia Janssens B. Pediatrics 2008;120:e % had VL > 1,000 copies/ml at M12 3.7% had VL copies/ml at M12 Thailand Puthanakit T, Pediar Infect Dis 2007; 26: /107 (17%) had VL > 1,000 copies at M48 (include 10 had changed to PI-based regimen)
8 Risk factors of VL > 400 copies/ml at 12 Months in Cambodia Janssens B. Pediatrics 2008;120:e
9 Predictors of Long-Term Viral Failure Among Ugandan Children Predictors of Virologic Failure at 12 Months 454 Adults Started on First-Line Therapy 222 Children and Adolescents Started on First-Line Therapy Multivariate Analysis Multivariate Analysis OR (95% CI) P OR (95% CI) P Male gender 1.48 (0.77to 2.83) (1.20 to 4.93) 0.01 WHO stage -Stage III vs. stage I-II 0.93 (0.35 to 2.45) (0.71 to 10.2) Stage IV vs. stage I-II 1.19 (0.041 to 3.43) (0.16 to 6.72) 0.96 d4t-3tc-nvp vs. ZDV- 3TC-EFV Baseline CD4 <5% or <100 cell/mm3 (adults) 2.59 (1.20 to 5.59) (1.23 to 4.90) (0.74 to 2.40) (1.28 to 5.63) Kamya MR. JAIDS 2007;46:
10 NVP Resistance among Infants Failing Prophylaxis % with Resistance 100% 80% 60% 40% 20% SD NVP SD NVP, no maternal SD NVP AZT + SD NVP AZT + SD NVP, no maternal SD NVP 8% 13% 17% 20% 27% 33% 36% 53% 46% 42% 87% 0% Thai S Africa (NO mom NVP) Cote d'ivorie Thai Malawi (NVAZ NO mom NVP) Thai S Africa (with mom NVP) S Africa HIVNET 012 SAINT Malaw i (NVAZ with mom NVP) Clade: E,B C A E,B C E,B C C A,D C C CRF01, 06
11 Infants who exposed to NVP prophylaxis more likely to have Viral Failure with NVP-Based HAART Median age at start HAART 8.5 months Analysis after 6 months of HAART: 1/12 placebo group and 10/13 in SD NVP group had HIV RNA >400 copies/ml Lockman S, et al. NEJM 2007;356:135-47
12 Challenges: Optimal regimen A. Perform genotypic test and choose ARV depend on resistance pattern B. Use 2NRTI + boosted PI in all case who expose to NVP C. Use 2NRTI + NVP and perform viral load monitoring within 6 months D. Depend on severity of a child; - severe- use 2 NRTI + boosted PI, - mild/moderate- use 2NRTI + NVP
13 The drug resistance mutations pattern in children failed NNRTIbased regimen
14 Resistance Development While on 2NRTI+NNRTI Regimens Very early failure 3TC-R: M184V Early failure 3TC-R: M184V NNRTI-R: e.g.k103n, Y181C/I, Y188L, G190A/S Other NRTI-R: minimal or none Late failure 3TC-R: M184V NNRTI-R: e.g.k103n, Y181C/I, Y188L, G190A/S TAMs: M41L, D67N, K70R, L210W, T215Y, K219Q/E
15 Resistance drug mutation patterns in children with early virologic failure after NNRTI-based HAART 202 HIV-infected children, Aug Oct 2006 Monitor CD4, viral load q 6 month Genotypic resistance testing if plasma viral load > 1,000 copies/ml The average age of 7.1 yr, CD4 baseline 6.7% 61% NVP-based, 39% EFV-based Median follow-up time 209 weeks 40/202 (20%) had VL failure > 1,000 copies
16 The probability of non-virological failure in HIV-infected children received NNRTI-based first-line therapy
17 The pattern of NRTI mutation % 84% Percentage of children % 11% 5% 3% 0 Any NRTI M184V/I Any TAM K65R Q151M complex NRTI mutaions 3 TAMs
18 The pattern of NNRTI mutation % % 34% 18% 13% 5% 5% 5% 0% 0% 0% Any NNRTI L100I K103N V106A/M K108I Y181C/I Y188C/L/H G190S/A P225H M230L P236L Percentage of chilren NNRTI mutations
19 Options for the second line therapy in children
20 NRTI NNRTI PI Others Stavudine Nevirapine Lopinavir/r CCR5 inhibitor (Maraviroc) Didanosine Efavirenz Indinavir Integrase inhibitor (Raltegravir) Zidovudine TMC125 Saquinavir Antigp41 (Enfurvirtide) Lamivudine TMC278 Ritonavir Emtricitabine Abacavir Tenofovir Atazanavir (> 6 yr) Nelfinavir Fosamprenavir Darunavir Tipranavir DHHS guidelines, February 28,
21 WHO Recommended Second Line Regimen
22 New LPV/r pediatric tablet The mean (SD) C trough of LPV 8.2(5.7) and 8.2(5.4) mg/l Film-coated tablet of LPV/r 100/25 mg, 200/50 mg No need for refrigeration Take with or without food Need to swallow whole tablet Recommended dose kg 2 tab kg 3 tab > 35 kg 4 tab From the slide collection of Dr. Thanyawee Puthanakit
23 Early Failure: Efficacy of 2NRTI + lopinavir/ritonavir in 21 PI-naïve children (Failed 2NRTI+NNRTI) 15 of 21 were pre-treated with NRTI/NNRTI (median 3 TAMs) months 12 months Viral load < 400 Viral load < 50 Delaugerre, et al. J Acquir Immune Defic Syndr 2004;37: Larru B, et al. J Antimicrobial Chemotherapy 2008: 61(1): years data on 69 PI-exp children
24 Tenofovir Most used NRTI in second line regimen in adults Retains some antiviral activity even when there is NRTI mutations Not approved for age < 18 years Potential toxicities in children Renal tubular diseases (Papaleo A, PIDJ 2007:26(10):949-51) Bone problems Investigational dose in children 2-8 years: 8 mg/kg once daily >8 years: 210 mg/m 2 once daily Maximum 300mg once daily Currently should be restricted to Older children (preferably tanner stage 4 and up) Children with multi-nrti/multiclass resistance and no other good options Need to monitor for growth, kidney and bone toxicity
25 Second-line regimen in children Retrospective cohort: 8 centers from Thailand 241 children failed NNRTI-based regimen Single-boosted (n=104) Double boosted PI (n=137) Age 8.9 ( ) 9.4 ( ) CD4% 17 (7-24) 6 (2-12) Plasma HIV RNA 4.5 ( ) 4.9 ( ) Multi NRTI resistance 11/89 (12.4) 69/114 (60.5) HIV RNA < 400 copies/ml 49/59 (83.1) 42/50 (84.0) CD4% gain (n=147) 7 (2-12) 10 (6-15) (Puthanakit and Ananworanich, et al. in preparation)
26 Pediatric Antiretroviral Resistance Challenges Strategies to maintain the success of firstline regimen Early detection of treatment failure to preserve second-line option ( VL monitoring) The availability of drug that is safe and easy to use in children for second-line drug
27 Acknowledgement Assoc. Prof. Kulkanya Chokephaibulkit Prof. Virat Sirisanthana RIHES, Chiang Mai University HIVNAT, Thai Red Cross Research Center Pediatric centers in Thailand for 086 study
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