Guía de terapia antirretroviral en niños

Objectives

Bolivia’s paediatric HIV guidance seeks to reduce HIV-related morbidity and mortality, improve quality of life, and prevent mother-to-child transmission through an integrated, universal, rights-based and multidisciplinary response across all levels of the health system.[1]It updates paediatric antiretroviral guidance in line with World Health Organization recommendations, supporting systematic HIV care, earlier diagnosis and lifelong treatment for children, adolescents, pregnant women and other people living with HIV regardless of CD4 lymphocyte count.[2]

• Expand access to universal ‘test and treat’ antiretroviral therapy for children and adolescents, including immediate treatment after diagnosis irrespective of age, clinical condition, CD4 count, viral load or World Health Organization stage.[3][4]
• Advance the 90-90-90 treatment cascade: diagnose 90% of people living with HIV, treat 90% of those diagnosed, and achieve viral suppression in 90% of those receiving treatment.[2]
• Prevent vertical transmission through HIV testing in pregnancy, prompt maternal treatment, delivery and newborn prophylaxis measures, infant diagnostic testing, and avoidance of breastfeeding where replacement feeding is available.[5][6]
• Strengthen paediatric HIV detection because vertical transmission accounted for 97% of reported HIV cases among Bolivian children under 15 years.[7]
• Preserve the effectiveness of available antiretroviral medicines by improving adherence, standardising prophylaxis and treatment protocols, and minimising HIV drug resistance.[8]
• Integrate nutritional assessment, growth and development support, tuberculosis prevention and treatment, and management of coexisting conditions into paediatric HIV care.[9][10][11]

Implementation

Implementation is framed within Bolivia’s Family, Community and Intercultural Health policy, linking services with individuals, families and communities across health promotion, prevention, recovery and rehabilitation.[1]Delivery is led through the National Programme for Sexually Transmitted Infections, HIV and AIDS, with the Ministry of Health, General Directorate of Health Services and National Epidemiology Unit forming part of the institutional framework.[12][1]The guidance combines decentralised testing and care, age-specific clinical protocols, laboratory follow-up, caregiver support and coordination with maternal, tuberculosis, hepatitis, pharmacy and community services.[2][13]

• Provide age-appropriate diagnosis through virological testing for children under 18 months and simplified two-rapid-test algorithms for older children, adolescents and adults at trained levels of care.[14][13]
• Offer routine HIV testing to infants and children of unknown status who are hospitalised, attend malnutrition clinics, outpatient services or vaccination centres, and initiate presumptive treatment for severely ill exposed infants where confirmation is delayed.[15][16]
• Deliver daily combination antiretroviral therapy using first-, second- and, in exceptional cases, third-line regimens selected by age, weight, prior treatment exposure, toxicity, adherence and resistance.[3][17][18]
• Support caregivers and young people to sustain lifelong adherence, recognise adverse effects, attend follow-up, and address feeding difficulties, inadequate care and psychosocial vulnerability.[19][20][11]
• Monitor viral load every six months, with annual testing considered for adherent patients with undetectable viral load; use CD4 assessment, clinical review and paediatric registration and follow-up forms to complement virological monitoring.[21][22]
• Use dried blood spot samples to facilitate viral-load collection and transport from remote settings to reference laboratories where local laboratory infrastructure is limited.[21]
• Manage tuberculosis and HIV jointly through prompt assessment for latent, active and multidrug-resistant tuberculosis, isoniazid preventive therapy after active disease is excluded, timely tuberculosis treatment and antiretroviral regimens adjusted for rifampicin interactions.[9][23][24]
• Strengthen infection prevention in health facilities through triage, separation of suspected cases, respiratory hygiene, reduced waiting times, staff investigation and protection, ventilation, N95 respirators and germicidal ultraviolet irradiation where available.[24][10]
• Provide post-exposure prophylaxis after sexual violence as soon as possible and within 72 hours, with referral to local specialised centres to complete 28 days of prophylaxis.[8][5]
• Engage national and departmental clinical specialists, health institutions, departmental programmes and committees, specialised centres, hospitals, the National Health Fund, the Pan American Health Organization, UNICEF Bolivia, Fundación Hivos and REDBOL in validation and participation processes.[25][26][27]

Monitoring & Evaluation

Monitoring centres on diagnosis, clinical assessment, laboratory follow-up and treatment-response review for children and adolescents living with HIV. Viral load is the preferred measure of therapeutic response and virological failure, supplemented by CD4 T-lymphocyte counts, clinical staging, growth assessment, toxicity monitoring and diagnostic follow-up for HIV-exposed infants.[28][3][21][22]

• Monitor progress towards the 90-90-90 cascade through awareness of HIV diagnosis, antiretroviral therapy coverage among diagnosed people, and viral suppression among people receiving treatment.[2]
• Use national surveillance data to track the HIV burden, including reported cases by age group and department. By June 2017, 19,259 HIV cases had been reported in Bolivia, compared with an estimated approximately 21,000 cases from the Joint United Nations Programme on HIV/AIDS; 64 cases among children under 15 were reported in 2016, and 278 were notified during 2012-2016.[29][7]
• Apply clinical and immunological classification systems based on World Health Organization clinical stage, Centers for Disease Control and Prevention categories, CD4 count or percentage, and viral load, supporting case definition, prognosis and extended AIDS surveillance.[30][31][32][33]
• Conduct virological testing for definitive diagnosis in children under 18 months, because maternal antibodies may make antibody-based tests unreliable; test schedules vary according to the adequacy of prevention of mother-to-child transmission and breastfeeding exposure.[28][14][13]
• Use rapid antibody tests for children aged 18 months or over and simplified two-rapid-test algorithms at trained levels of care to accelerate diagnosis and treatment initiation.[14][13]
• Undertake baseline assessment after diagnosis, including clinical staging, full blood count, blood chemistry, lipid profile, blood glucose, plasma HIV RNA viral load and CD4 count, with additional testing for co-infections and opportunistic disease according to clinical risk.[19][3]
• Monitor viral load and CD4 count initially every six months, with annual viral-load testing considered for patients with good adherence and sustained undetectable viral load.[4][11][21]
• Define virological failure as persistent viral load above 1,000 copies per millilitre after at least 24 weeks of adherent treatment; use viral-load trends and adherence review to inform decisions on switching regimens.[20][34][35][36]
• Assess immunological failure after at least 24 weeks of treatment using age-specific CD4 thresholds, preferably with at least two measurements where feasible.[34][35][36]
• Assess clinical failure through new or recurrent World Health Organization stage 3 or 4 events after 24 weeks of therapy, while distinguishing disease progression from immune reconstitution inflammatory syndrome and excluding poor adherence, intercurrent illness and inadequate nutrition.[20][34][35]
• Monitor treatment safety through clinical review, caregiver reports and regimen-specific laboratory tests, including haemoglobin monitoring for zidovudine and liver-enzyme monitoring during early nevirapine treatment or where liver risk is present.[37][38][21][22]
• Monitor growth through weight, height or length and head circumference, using these measures as indicators of nutritional status, HIV progression and response to antiretroviral therapy; check weight and height at every consultation.[10][11][39]
• Complete a paediatric HIV patient registration and follow-up form at every consultation to support continuity of clinical monitoring.[21][22]
• Use dried blood spot samples to facilitate viral-load sample collection and transport from remote areas to reference laboratories where infrastructure is limited; the guidance anticipates future use of this approach in Bolivia.[21]
• Monitor prevention of mother-to-child transmission through HIV testing when pregnancy is confirmed or in the first trimester, repeat testing in the third trimester, newborn virological testing and follow-up of HIV-exposed infants.[5][6][40]
• Assess children living with HIV for tuberculosis exposure, latent infection, active disease and possible multidrug-resistant tuberculosis, using GeneXpert MTB/RIF as the preferred initial test in specified high-suspicion situations.[9][23]
• Review antiretroviral doses regularly as new evidence and formulations become available, and use genotyping for second-line treatment failure only after verifying good adherence.[18][41][42]

The material provides extensive clinical monitoring schedules and thresholds, but does not specify a comprehensive programme-level indicator set, routine reporting timetable, audit process, evaluation schedule, public accountability mechanism or institutional performance targets.[43][20][21][27]

Costing & Financing

Financing information is limited. The publication’s printing received financial support from the Global Fund, while the supplied material does not provide a programme budget, detailed costed plan, allocation, funding gap, resource-mobilisation target or economic assumption.[12]

• Reduce treatment costs through lower efavirenz dosage, although no monetary estimate or budget impact is provided.[2]
• Recognise that paediatric syrups and oral solutions have higher costs, limited availability, storage difficulties and shorter permitted storage periods than solid formulations.[37]
• Use generic antiretroviral formulations where available, noting that they generally do not require a cold chain.[44]
• Plan for resource needs including trained personnel, antiretroviral medicines, testing capacity, replacement feeding, laboratory services, paediatric formulations, tuberculosis diagnostics, N95 respirators, ventilation and germicidal ultraviolet irradiation, without stated financial values.[45][46][10]
• Note that integrase inhibitors were undergoing acquisition, but no procurement cost, financing source or timeline is specified.[47]
• Use more economical rapid-test algorithms where appropriate, although the source provides no price or savings estimate.[13]

No explicit expenditure estimates, medicine prices, donor commitments beyond printing support, funding-gap analysis, fiscal period, allocation formula or economic evaluation is specified in the supplied material.[12][21][27]