2nd line failure, provincial evaluation process for 3rd line therapy, 3rd line treatment options James Nuttall

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1 2nd line failure, provincial evaluation process for 3rd line therapy, 3rd line treatment options James Nuttall Paediatric Infectious Diseases Unit, Red Cross War Memorial Children s Hospital & University of Cape Town Paediatric HIV Course, 10 September 2016

2 Outline Based on Western Cape Consolidated Guidelines for HIV Treatment: Prevention of Mother-to-Child Transmission of HIV (PMTCT), Children, Adolescents and Adults, Amended Version 2015

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13 Provincial HAST Pharmaceutical Policy Specialist Contact details Jackie Voget

14 Stanford University HIV Drug Resistance Database A curated public database designed to represent, store, and analyse the divergent forms of data underlying HIV drug resistance Genotypic resistance interpretation algorithm ra?action=mutationsinput

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17 Recommendations on 2 nd & 3 rd line ART regimens for children 1 st line regimen 2 nd line regimen 3 rd line regimen 2 NRTIs + LPV/r Expert opinion (genotype result & expert committee consensus) SA 2015 WHO 2015 SA 2015 WHO 2015 If <3 yrs of age: 2 NRTIs + RAL If >3 yrs: 2 NRTIs + EFV 2 NRTIs + EFV 2 NRTIs + LPV/r 2 NRTIs + LPV/r Based on genotype result & expert committee consensus DTG + 2 NRTIs Or DRV/r + 2 NRTIs Or DRV/r + DTG + 2 NRTIs 2nd line: If RAL is not available, no change is recommended unless in the presence of advanced clinical disease progression or lack of adherence specifically because of poor palatability of LPV/r. In this case, switching to a second-line NVP-based regimen should be considered. DRV/r should not be used in children younger than three years of age. RAL can be used in children failing PI-based second-line treatment when DTG is not available and when RAL has not been used in a previous regimen. DTG is currently only approved for children 12 years and older, however studies are ongoing to determine dosing in younger children and approval to lower age groups is expected in the near future.

18 Provincial Paediatric 3 rd line ART committee Members Prof Mark Cotton Prof Brian Eley Dr Helena Rabie Dr James Nuttall Dr Marvin Hsiao

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24 Dolutegravir (DTG) Newer generation Integrase Strand Transfer Inhibitor (INSTI) Same drug class as Raltegravir Once a day dosing Higher barrier to resistance Good safety profile Registered from 18 years in SA but from 12 and 40 kg in USA

25 Holding regimens Sometimes used as a temporary intervention in patients with serious adherence problems, inability to tolerate certain formulations or unavailability of suitable formulations of certain drugs e.g. certain 3 rd line ARVs based on age or weight of child Use of NRTI only drug regimens to which the patient is already resistant with aim of maintaining presence of mutated virus which is less pathogenic that the wildtype virus that would predominate if all drugs were stopped. Usually based on result of HIV drug resistance testing Avoid risk of developing further resistance mutations to other classes of drugs (NNRTI & PI) Aim is to maintain clinical status & CD4 count better than would be case if treatment was stopped altogether Monitor clinical status, CD4 count 3-4 monthly, not viral load Lamivudine monotherapy (once a day) 3-4 NRTI only regimens e.g. AZT/3TC/ABC

26 Case 1 5 yr old boy, born 17/01/2011 Mother diagnosed HIV+ 5 yrs earlier, not on ART, substance abuser, unbooked pregnancy, received NVP at birth HIV PCR + at 6 weeks of age at local clinic Hospitalised with severe pneumonia at 3 mths Started ABC/3TC/LPV/r at 3 ½ mths Admitted into convalescent care facility & remained there until 2 yrs of age Viral non-suppression

27 Time on ARV regimen Age (mths) ARV regimen Baseline 3 Started ABC/3TC/L PV/r Viral load abs Viral load log CD4 abs CD4% Weight (kg) > mths 8 cont mths 11 cont mths 15 cont Lopinavir trough levels: >1 mg/l (11.8 & 5.5) Genotyping: V82A, L10F (intermediate res to LPV, MS 30, susceptible to DRV), L74V, M184I, T215A/T (high res to ABC & 3TC), Y181C, H221Y (high res to NVP, intermediate res to EFV & ETR)

28 Time on ARV regimen Age (mths) ARV regimen Viral load abs Viral load log CD4 abs CD% Weight Starts 3TCm 3 mths 20 cont mths 22 cont mths 26 cont mths 28 cont No 3TC for 1 month 19 mths 36 cont Mother demises, caregiver is father then grandmother 23 mths 39 cont mths 42 cont mths 46 cont mths 49 cont mths 52 cont mths 56 cont Diagnosed with PTB, RHZE started 44 mths 60 cont

29 3 rd line regimen will be: Darunavir: 375 mg bd (2x150 mg tabs + 1x75 mg tab bd) Ritonavir: 0.6 ml solution bd or 100 mg tablet bd Raltegravir: 100 mg bd (1x100 mg chewable tab bd) Zidovudine: 200 mg am (2x100mg tabs), 100 mg pm (1x100 mg tab) Lamivudine: 150 mg (1 tab) once daily 3 rd line ART pill burden at current weight (18 kg): 6-8 tabs twice a day (14 tabs a day)

30 Case 2 10 yr old boy, born 15/03/2006 Ex-prem, birthweight 900g Started d4t/3tc/lpv/r in 2007 Concurrent Rifampicin-based TB Rx (disseminated BCG & TB meningitis) apparently without Ritonavir superboosting Prolonged virological failure 2013: genotyping done: high level LPV res, susceptible to DRV, M184V, D67N CD4 count at time: 2341 / 31% Started 3TC monotherapy in 2013 (age 7 yrs) at primary clinic Diagnosed with TB and severe anaemia 16 months later (CD4 712 at time) TB Rx started but required recurrent blood transfusions (3TC-associated red cell aplasia suspected) CD4 count remained >900 & >25% throughout Motivation for 3 rd line ART to be started after completing rifampicin-based TB Rx Started Darunavir/ritonavir/Raltegravir/Abacavir May 2015 Virally suppressed with CD4 1616/37% 7 months later

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