Paediatric ART_2023_v4_Oct23.pdf

SOUTH AFRICAN ART CLINICAL GUIDELINES 2023...

SOUTH AFRICAN ART CLINICAL GUIDELINES 2023 NEED HELP? Contact the TOLL-FREE National HIV & TB Health Care Worker Hotline (Infants and children < 10 years and/or < 30kg) 0800 212 506 / 021 - 406 6782 Alternatively “WhatsApp” or send an SMS or “Please Call Me” to 0 7 1 8 4 0 1 5 7 2 October 2023, Version 4 www.mic.uct.ac.za ART ELIGIBILITY AND DETERMINING THE TIMEFRAME FOR ART INITIATION ART REGIMENS IN NEW CLIENTS MONITORING WHILE ON ART ## WHO IS ELIGIBLE? ≥ 3 kg to < 30 kg, and ≥ 4 weeks to < 10 years ABC + 3TC + DTG (dosing as per paed dosing chart) VIRAL LOAD CLINICAL ASSESSMENT # Neonates - birth to < 4 weeks of age (with birth weight ≥ 2.0 kg and ≥ 35 weeks gestational age at birth) AZT + 3TC + NVP (see dosing below) WHEN: DC€/month 3, 10 and every 12 DCs WHEN: every visit For < 5 year olds done at week 14 (DC 4), month Height, weight, head circumference (< 2 years) and 12 (DC 13) and then at 12 DC intervals neurodevelopment (remember to adjust ART dosage Zidovudine (AZT) Lamivudine (3TC) Nevirapine (NVP) according to weight) Available formulation 10 mg/mL 10 mg/mL 10 mg/mL Remember a VL ≥ 50 is a medical Ask about side-effects REASONS TO DEFER STARTING ART WHEN TO INITIATE ART* Weight (kg) at birth Dose in mL Dose in mg Dose in mL Dose in mg Dose in mL Dose in mg emergency! TB & other opportunistic infection screen TB symptoms (cough, fever, night sweats, No TB: Same day or within 7 days ≥2- 80 mL/min. No additional VL needed before switch. RESPONSE TO REPEAT VL ON DTG REGIMEN, IF VL > 50 Disclosure to another adult living in the same house able to supervise the child’s ART when primary caregiver is unavailable AZT + 3TC + (EFV or NVP) Refer to Adult ART 2023 poster *Clients already on ART should NOT have their treatment interrupted upon diagnosis of the above conditions AZT + 3TC + DTG DTG regimen < 2 years DTG regimen ≥ 2 years VL-DEPENDENT REGIMEN SWITCHES Intensify efforts to Adherence still suboptimal Adherence > 80 %, AND with 2 or more VLs ≥ 1000 BASELINE CLINICAL EVALUATION Clients on PI-based regimens > two years, who have never used a DTG-containing regimen in the past: resolve adherence taken ≥ 2 years after starting DTG regimen OR at least (adherence < 80 %) or switch to DTG is based on their VL within the last 12 months issues persistent low-level viraemia one VL ≥ 1000 and either CD4 < 200 or an TEST AND PURPOSE INTERPRETATION/ACTION VL (c/mL) Repeat VL at next opportunistic infection (2 or more consecutive VLs Recognise the client with respiratory, Identify danger signs as classified in the IMCI Chart CURRENT between 50 and 999) (within the last CRITERIA FOR SWITCH REGIMEN IF CHANGE IS INDICATED scheduled routine VL Intensify adherence neurological or abdominal danger signs booklet. Refer urgently 12 months) REGIMEN Clients who Clients who have never failed a have failed a previous ART regimen: (ABCDE) Nutritional assessment Use the growth chart to plot the weight, height and Switch to DTG-containing regimen previous ART Intensify adherence (ABCDE) LPV/r or Repeat VL at next To monitor growth, developmental stage and deter- head circumference (if < 2 years). Measure MUAC to If VL in last 12 months ≥ 50 but < ABC* + 3TC + DTG regimen: Repeat VL at next scheduled ATV/r based scheduled routine mine correct dosing of ART identify moderate and severe malnutrition VL < 1000 1000: switch, but do ABCDE routine VL regimen > 2 Discuss with an assessment and provide EAC if Repeat VL after 3 months Screen for symptoms of meningitis Identify symptoms of headache, confusion or visual years HIV expert to Resistance to a first-line needed If child is ≥ 30 kg and ≥ 10 years: switch client to TLD To diagnose and treat clients with cryptococcal and disturbances. Other symptoms may include fever, neck authorise and DTG-containing regimen is stiffness or coma. Do/refer the client for a lumbar If already on LPV/r tablets: switch if eGFR > 80 mL/min. Refer to Adult ART 2023 poster interpret RT. extremely rare. Suboptimal other forms of meningitis and reduce associated puncture. Defer ART if meningitis is confirmed to DTG regimen Do VL 3 adherence remains the most morbidity and mortality Screen for TB Suspect TB in clients with the following symptoms: If repeat VL < 1000: ABC* + 3TC + DTG months after probable cause for non-suppression. coughing, night sweats, fever, failure to thrive. If Two or more If child is ≥ 30 kg and ≥ 10 years: switch client to TLD new regimen Most clients will re-suppress on DTG To identify TB/HIV co-infection and eligibility for consecutive Adherence implemented -containing regimen if adherent tuberculosis preventive therapy (TPT) present, confirm or exclude TB. Ask about TB contacts If on LPV/r solution or pellets: if eGFR > 80 mL/min. Refer to Adult ART 2023 poster VLs ≥ 1000 < 80 % consider switch to 4-in-1 Do RT only: See eligibility for CPT under CD4 cell count/% section in If repeat VL ≥ 1000: Discuss with HIV expert or the WHO clinical staging taken ≥ 2 years ABC/3TC/LPV/r capsules$. hotline (0800 212 506) to authorise and interpret a if client was incorrectly classified To determine immune status, priority of initiating ART baseline laboratory evaluation below after starting Repeat VL in 2-3 months as a client who has never failed a resistance test. Provide individualised regimen as and need for cotrimoxazole preventive therapy (CPT) LPV/r or ATV/r recommended by HIV expert and repeat VL after 3 ART regimen; or Screen for active depression in older children Identify the child with epilepsy and be aware of and regimen months to confirm re-suppression Relevant drug interactions and epilepsy in all ages monitor for potential drug-drug interactions and drug- Discuss with HIV expert or the hotline (0800 212 506) to authorise and interpret a € Adherence DC = dispensing cycle, defined as the number of days for which a client would have treatment if a single standard “monthly” quantity of tablets was To exclude drug-drug and drug-disease interactions disease interactions resistance test. Provide individualised regimen as recommended by HIV expert and dispensed > 80 % repeat VL after 3 months to confirm re-suppression Neurodevelopmental screen Screening tool is available in Road To Health Booklet DO THE FOLLOWING TESTS IF THE CLIENT IS ON THE DRUG THAT MAY CAUSE THE To identify neurocognitive or developmental delays (RTHB) Only 1 VL > 1000 after 2 years on Do ABCDE assessment, EAC if applicable, repeat VL after 3 months. This result will group the client in ADVERSE EVENT a LPV/r or ATV/r one of the above categories DRUG TEST FREQUENCY ACTION/INTERPRETATION BASELINE LABORATORY EVALUATION regimen AZT FBC + At months 1 and 3, Hb ≥ 8 g/dL: Continue AZT *If client has ABC hypersensitivity: AZT + 3TC + DTG; $If a switch to the 4-in-1 ABC/3TC/LPV/r capsules does not improve adherence, or is not differential thereafter if clinically Hb < 8 g/dL or neutrophil count TEST AND PURPOSE INTERPRETATION/ACTION available, continue to switch to ABC + 3TC + DTG as for non-adherent children on LPV/r tablets WCC indicated persistently < 1000 cells/µL: Use alternative – consult with expert Confirm HIV test result Ensure that the national testing algorithm has been followed. Infants < 1 PI-based Cholesterol + At month 3, if above acceptable To monitor PI-related metabolic To confirm HIV status for those month: HIV drug resistance test for infant if mother is failing treatment on HOW TO MEASURE ADHERENCE OBJECTIVELY regimen Triglycerides range, do fasting cholesterol and side-effects. If fasting cholesterol and TG without documented HIV status TLD2 or a PI-based regimen For adherence to be > 80 %, patient must meet one of the following criteria: (LPV/r, ATV/r, (TG) TG are still above the acceptable range, Pharmacy refills > 80 % in the last 6 - 12 months DRV/r) obtain expert advice Haemoglobin (Hb) Can use AZT if Hb ≥ 8 g/dL. Children with anaemia: TB treatment or ALT If signs/symptoms of hepatitis If ALT is abnormal, refer to specialist or Attendance of > 80 % of scheduled clinic visits in the last 6 - 12 months To identify anaemia and < 5 years: Treat with iron supplementation and deworm child NVP or EFV (e.g. nausea, vomiting, jaundice) phone the HIV hotline (0800 212 506) Detection of current antiretroviral drugs in the client’s blood or urine eligibility for AZT ≥ 5 years: Do FBC and manage according to Primary Health Care EML NVP ALT If rash develops If ALT is abnormal, refer to specialist or Eligibility for CPT: To calculate adherence percentage in the past 6 - 12 months: Amount of scheduled visits actually attended by client/caregiver X 100 phone the HIV hotline (0800 212 506) CD4 cell count/% Amount of scheduled visits To determine eligibility for All HIV-positive infants < 1 year irrespective of CD4 % or clinical stage Based on the 2023 ART Clinical Guidelines for the Manage- cotrimoxazole preventive HIV-positive child 1 - 5 years with WHO stage 2, 3 or 4, or CD4 % ≤ 25 % * ment of HIV in Adults, Pregnancy and Breastfeediing, therapy (CPT) HIV-positive child under 5 years of age with PJP infection: start CPT after PJP CHILDREN CO-INFECTED WITH TUBERCULOSIS Adolescents, Children, Infants and Neonates, South African National Department of Health, April 2023 treatment is completed Children taking ART and TB treatment together will have to tolerate a large amount of medication. Intensify adherence support. This publication was supported under funding provided by the Global Fund to Fight AIDS, Tuberculosis and Malaria through the National Department of HIV-positive child > 5 years with WHO stage 2, 3 or 4, or CD4 ≤ 200 Remember to add pyridoxine (vitamin B6) to TB treatment Health of South Africa and the NDoH Pharmacovigilance Centre for Public Health Programmes. Its contents are solely the responsibility of the authors DTG-based AND receiving a rifampicin-containing TB regimen: Boosting of DTG required while on rifampicin-containing TB and do not necessarily represent the official views of the Global Fund or the National Department of Health of South Africa GeneXpert (MTB/Rif Ultra) Only for those with a positive TB symptom screen regimen treatment and until two weeks after rifampicin has been stopped. See ART Drug Dosing Chart for Children 2022 3TC = lamivudine; ABC = abacavir; ALT = Alanine transaminase; ART = antiretroviral therapy; AST = Aspartate transaminase; ATV/r = atazanavir and ritonavir; To diagnose TB AZT = zidovudine; CM = cryptococcal meningitis; CPT = cotrimoxazole preventive therapy; CrAg = cryptococcal antigen; DR = drug-resistant; DS = drug-sensitive; EFV-based regimen No dose adjustments or changes in ART regimen needed for DS-TB treatment DTG = dolutegravir; DRV/r = darunavir and ritonavir; EAC = enhanced adherence counselling; EFV = efavirenz; eGFR = estimated glomerular filtration rate; EML = essential medicines list; FBC = full blood count; FTC = emtricitabine; HBV = hepatitis B virus; HBsAg = hepatitis B surface antigen; IMCI = Integrated management of If patient comes from a different facility provide patient with treatment on the day of presentation. Referral AND receiving a rifampicin-containing TB regimen: Additional ritonavir should be added or the LPV/r dose childhood illness; InSTI = Integrase strand transfer inhibitor; LPV/r = lopinavir and ritonavir; LP = lumbar puncture; MUAC = mid-upper arm circumference; LPV/r-based increased according to the ART Drug Dosing Chart for Children 2022. TB treatment should be dosed at standard NCD = non-communicable disease; NRTI = nucleoside reverse transcriptase inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor; NVP = nevirapine; letters are helpful, however a patient shouldn’t be required to leave the facility without treatment to first regimen doses. Stop additional ritonavir or increased LPV/r dose 2 weeks after TB-treatment completed Paed = paediatric; PI = protease inhibitor; OI = opportunistic infection; PJP = Pneumocystis jirovecii pneumonia; RPC = repeat prescription collection; RT = resistance obtain a referral/transfer letter * test; TB = Tuberculosis; TBM = Tuberculosis meningitis; TC = total cholesterol; TDF = tenofovir; TLD = tenofovir + lamivudine + dolutegravir; TEE = tenofovir + emtricitabine + efavirenz; TG = Triglycerides; TPT = TB preventive therapy; VL = viral load; WCC = white cell count This list is not exhaustive. Download the free SA HIV/TB Hotline app for a complete interaction checker – scan QR code in the NEED HELP box