hiv / aids Treatment in Children

Table of Contents

Treatment Modalities of HIV/AIDS

Treatment Modality	Description
Antiretroviral Therapy (ART)	Suppresses viral load to undetectable levels, reducing morbidity, mortality, and transmission of HIV.
Treatment of Acute Bacterial Infections	Addresses immediate bacterial infections.
Prophylaxis and Treatment of Opportunistic Infections	Prevents and manages opportunistic infections.
Maintenance of Good Nutrition	Ensures adequate nutrition to support overall health.
Immunization	Administers vaccines to prevent opportunistic infections.
Management of AIDS-Defining Illnesses	Addresses specific illnesses associated with advanced HIV infection.
Psychological Support for the Family	Provides emotional support and guidance for affected families.
Palliative Care for the Terminally Ill	Offers comfort and support for patients nearing the end of life.

ANTIRETROVIRAL DRUG TREATMENT

The goal of ART

Goal of ART: Suppress viral load to undetectable levels, reducing morbidity, mortality, and transmission of HIV.

When to Initiate ARV:

All HIV-infected children below 12 months.
Clinical AIDS
Mild to moderate symptoms and immunosuppression.

Process of Starting ART:

Assess all clients for opportunistic infections especially TB and cryptococcal meningitis. If the patient has TB or cryptococcal meningitis, ART should be deferred and initiated after starting treatment for these OIs. Treatment for other OIs and ART can be initiated concurrently.
For patients without TB or cryptococcal meningitis, offer ART on the same day through an opt-out approach. In this approach, the patients should be prepared for ART on the same day and assessed for readiness to start ART using the readiness checklist
If a client is ready, ART should be initiated on the same day. If a client is not ready or opts out of same-day initiation, a timely ART preparation plan should be agreed upon with the aim of initiating ART within seven days for children and pregnant women, and within one month for adults.

Principles for selecting the ARV regimens

The first-line ART regimens for treating HIV infection in Uganda were selected based on the following principles:

∙ Regimen with lower toxicity
∙ Better palatability and lower pill burden
∙ Increased durability and efficacy
∙ Sequencing: spares other available formulations for use in the 2nd line regimen ∙ Harmonization of regimen across age and population
∙ Lower cost
∙ Help the country to achieve a recommended regimen for the vast majority of PLHIV(People Living With HIV)

Available ARVs in Uganda

Drug Class	Examples
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): Incorporate into the DNA of the virus, thereby stopping the building process.	Tenofovir (TDF), Zidovudine (AZT), Lamivudine (3TC), Abacavir (ABC)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): stop HIV production by binding directly onto the reverse transcriptase enzyme, and prevent the conversion of RNA to DNA.	Efavirenz (EFV), Nevirapine (NVP), Etravirine (ETV)
Integrase Inhibitors: interfere with the HIV DNA’s ability to insert itself into the host DNA and copy itself.	Dolutegravir (DTG), Raltegravir (RAL)
Protease Inhibitors (PIs): prevent HIV from being successfully assembled and released from the infected CD4 cell.	Atazanavir (ATV), Lopinavir (LPV), Darunavir (DRV)
Entry Inhibitors: prevent the HIV virus particle from infecting the CD4 cell.	Enfuvirtide (T-20), Maraviroc

Uses of ART (Antiretroviral Therapy)

Treatment of HIV/AIDS: ART is the primary treatment for managing HIV/AIDS, helping to control the viral load and maintain the health of the immune system.
Prevention of Mother-to-Child Transmission (PMTCT): ART is crucial in preventing the transmission of HIV from an infected mother to her baby during pregnancy, childbirth, and breastfeeding.
Post-Exposure Prophylaxis (PEP): ART is used as an emergency intervention for individuals who have been potentially exposed to HIV. It must be started within 72 hours of exposure to be effective.
Pre-Exposure Prophylaxis (PrEP): ART can be taken by HIV-negative individuals at high risk of infection to prevent acquiring HIV. This is particularly useful for people with HIV-positive partners, among others.
Treatment and Support for Children: Ensuring children with HIV receive ART is essential for their growth, development, and long-term health. Adherence to the treatment regimen is crucial for its effectiveness.
Reducing Viral Load to Undetectable Levels: ART helps reduce the viral load in the body to undetectable levels, significantly lowering the risk of HIV transmission and improving overall health.
Improving Quality of Life: Effective ART can improve the quality of life for people living with HIV by reducing the incidence of opportunistic infections and other HIV-related complications.
Increasing Life Expectancy: ART has been shown to increase the life expectancy of people living with HIV, allowing them to live longer, healthier lives.
Preventing Sexual Transmission of HIV: By reducing the viral load to undetectable levels, ART can prevent the sexual transmission of HIV, a strategy known as “treatment as prevention” (TasP).
Reducing HIV-Related Stigma and Discrimination: Successful ART can help reduce stigma and discrimination associated with HIV by enabling individuals to lead healthy, productive lives, thereby changing perceptions about the disease.
Managing Co-Infections: ART can help in managing co-infections such as hepatitis B and C, tuberculosis, and other conditions that are common in people living with HIV.

Recommended First Line Regimens in Adults, Adolescents, Pregnant Women and Children

HIV management guidelines are constantly being updated according to evidence and public policy decisions. Always refer to the latest official guidelines.

The 2022 guidelines recommend DOLUTEGRAVIR (DTG) an integrase inhibitor as the anchor ARV in the preferred first and second-line treatment regimens for all HIV infected clients; children, adolescents, men, women (including pregnant women, breastfeeding women, adolescent girls and women of child bearing potential).

Patient Category	Preferred Regimens	Alternative Regimens
Adults and Adolescents
Adults (including pregnant women, breastfeeding mothers, and adolescents ≥30Kg)	TDF + 3TC + DTG	– If DTG is contraindicated: TDF + 3TC + EFV400 – If TDF is contraindicated: TAF + FTC + DTG – If TDF or TAF is contraindicated: ABC + 3TC + DTG – If TDF or TAF and DTG are contraindicated: ABC + 3TC + EFV400 – If EFV and DTG are contraindicated: TDF + 3TC + ATV/r or ABC + 3TC + ATV/r
Children
Children ≥20Kg – <30Kg	ABC + 3TC + DTG	– If DTG is contraindicated: ABC + 3TC + LPV/r (tablets) – If ABC is contraindicated: TAF + FTC + DTG (for children >6 years and >25Kg) – If ABC and TAF are contraindicated: AZT + 3TC + DTG
Children <20Kg	ABC + 3TC + DTG	– If intolerant or appropriate DTG formulations are not available: ABC + 3TC + LPV/r granules – If intolerant to LPV/r: ABC + 3TC + EFV (in children >3 years and >10Kg) – If ABC is contraindicated: AZT + 3TC + DTG or LPV/r

Notes:

Contraindications for DTG include known diabetics, patients on anticonvulsants (carbamazepine, phenytoin, phenobarbital) – use the DTG screening tool prior to DTG initiation.
Contraindications for TDF and TAF include renal disease and/or GFR <60ml/min, weight <30Kg.
TAF can be used in subpopulations with bone density anomalies.
Children will be assessed individually for their ability to correctly take the different formulations of LPV.

Notes from Ministry of Health

For clients on an ABC-3TC-DTG based regimen weighing >25 kg, use the fixed-dose combination of Abacavir/Lamivudine/Dolutegravir 600/300/50 mg instead of the separate pills of Abacavir/Lamivudine 600/300 mg plus Dolutegravir 50 mg.
Use Abacavir/Lamivudine 600/300 mg for patients on the following regimens: ABC-3TC-ATV/r, ABC-3TC-LPV/r, and ABC-3TC-DRV/r.
Use the single pill of Dolutegravir 50 mg for patients on AZT-3TC-DTG based regimens.
For eligible patients on ATV/r and LPV/r, optimize to Dolutegravir.
For PrEP, while the guidelines provide options for the use of either TDF/3TC 300/300 mg or TDF/FTC 300/200 mg, use TDF/FTC 300/200 mg for PrEP in terms of programmatic implementation.

RECOMMENDED FIRST-LINE REGIMEN FOR INITIATION OF ART IN CHILDREN UNDER 3 YEARS OF AGE

Recommended first-line regimen: ABC+3TC+LPV/r

All HIV-infected children under 3 years should be initiated on abacavir + lamivudine + ritonavir-boosted lopinavir (ABC+3TC+LPV/r).

NB: Children younger than 36 months have a reduced risk of discontinuing treatment, viral failure or death if they start on an LPV/r based regimen instead of the NVP-based regimen. Also, surveillance of drug resistance among vertically infected children younger than 18 months in

Uganda has revealed high levels of resistance to NNRTIs and LPV/r is known to have a high barrier to resistance.

When to use alternative first-line regimens AZT+3TC+LPV/r

AZT+3TC+ LPV/r should only be used in children who experience a hypersensitivity reaction to abacavir (ABC), however, this is rare in African populations.

WHAT REGIMEN TO SWITCH TO (SECOND-LINE AND THIRD-LINE ART)

Second-line ARVS in adolescents/children above 10 years

Recommended 2nd line regimen: 2 NRTIs +ATV/r

HIV-infected adolescents/children above 10 years, initiating 2nd line ART should be initiated on 2 NRTIs and ritonavir-boosted atazanavir (ATV/r). The choice of NRTI should be determined based on the regimen the patient was on.

The recommended sequence is:

After failing on TDF + 3TC or ABC+3TC based regimen, use AZT+3TC
After failing on AZT+3TC based regimen, use TDF + 3TC

When to use alternative 2nd line regimen: 2 NRTIs +LPV/r

LPV/r is should only be used to initiate adolescents/children who weigh less than 40kg.

Second-line ARVS in children aged 3 years to less than 10 years

RECOMMENDED 2nd line REGIMEN: 2 NRTIs +LPV/r

HIV-infected children aged 3 to less than 10 years initiating 2nd line ART should be initiated on 2 NRTIs and ritonavir-boosted lopinavir (LPV/r). The recommended formulation is the LPV/r 100/25mg tablet. The choice of NRTI should be determined based on the regimen the patient was on The recommended sequence of the NRTIs is below:

∙ After failing on ABC+3TC based regimen, use AZT+3TC.

∙ After failing on AZT+3TC based regimen, used ABC+3TC.

Second-line ARVS in children under 3 years

Recommended 2nd line regimen: 2 NRTIs +RAL

HIV-infected children less than 3 years of age initiating 2nd line ART should be initiated on 2 NRTIs and RAL. The choice of NRTI should be determined based on the regimen the patient was on (Table 55). The recommended sequence of the NRTIs is:

∙ After failing on ABC+3TC based regimen, use AZT+3TC.

∙ After failing on AZT+3TC based regimen, used ABC+3TC.

The rationale for using raltegravir

Raltegravir is the recommended drug of choice for the second line ARVs in children with prior exposure to protease inhibitors because there is no data on safety and efficacy of dolutegravir in children under six years, while darunavir is contraindicated in this age group.

When to use alternative 2nd line regimen: 2 NRTIs + LPV/r

LPV/r is recommended in children who have used NNRTI (NVP) in their first line regimen.

Monitoring of ARV Treatment

The monitoring of patients on antiretroviral therapy (ART) serves several purposes:

Assess Response to ART and Diagnose Treatment Failure
Ensure Safety of Medicines: Identify Side Effects and Toxicity
Evaluate Adherence to ART

Methods of Monitoring ARV Treatment

1. Clinical Monitoring: Involves medical history and physical examination.

2. Laboratory Monitoring: Includes various laboratory tests.

Viral Load Monitoring: Preferred for assessing response to ART and diagnosing treatment failure.
CD4 Monitoring: Recommended in specific scenarios.
Other Minor Laboratory Tests: Includes tests for specific indications.

Viral Load Monitoring

Preferred method for monitoring ART response. A patient who has been on ART for more than 6 months and is responding to ART should have viral suppression (VL <1000 copies/ml) irrespective of the sample type (either DBS or plasma).
Provides an early and more accurate indication of treatment failure and the need to switch from first line to second-line drugs, hence reducing the accumulation of drug resistance mutations and improving clinical outcomes.
Early and accurate indication of treatment failure.
Differentiates between treatment failure and non-adherence.
Recommended frequency: Every six months for children and adolescents under 19 years.

CD4 Monitoring

Baseline CD4 count is essential for assessing opportunistic infection risk.
Recommended for patients with high viral load or advanced clinical disease.

Other Laboratory Tests

Tests	Indication
CrAg	Screen for cryptococcal infection
Complete Blood Count (CBC)	Assess anaemia risk
TB Tests	Suspected tuberculosis
Serum Creatinine	Assess kidney function
ALT, AST	Evaluate liver function
Lipid Profile, Blood Glucose	Assess metabolic health

Problems Associated with ARV Treatment

Immune Reconstitution Inflammatory Syndrome (IRIS)

IRIS is a spectrum of clinical signs and symptoms linked to immune recovery triggered by ART. It occurs in 10–30% of individuals starting ART, usually within the first 4–8 weeks.

Serious Forms: Most severe cases happen in patients co-infected with TB, Cryptococcus, Kaposi’s sarcoma, and herpes zoster.
Risk Factors: Include low CD4+ cell count (<50 cells/mm3) at ART initiation and disseminated opportunistic infections.
Management: Usually self-limiting; treat co-infections to reduce symptoms and reassure patients to maintain ART adherence.

Steps to Reduce IRIS Development

Early HIV Diagnosis: Initiate ART before CD4 declines to below 200 cells/mm3.
Optimal Management of Opportunistic Infections: Screen and treat infections before starting ART, especially TB and cryptococcus.

ARV Drug Toxicity

Range of Toxicities: ARVs can cause mild to life-threatening side effects.
Challenges: Differentiating between ARV toxicity and HIV complications can be complex.
Management: Assess patients for side effects at every clinic visit and take appropriate actions based on severity.

Management of ARV Side Effects/Toxicities

Category	Action
Severe, Life-threatening Reactions (e.g., SJS/TEN, severe hepatitis)	– Discontinue all ARVs immediately. – Manage the medical event and substitute offending drug when stable.
Severe Reactions (e.g., Hepatitis and Anemia)	– Substitute offending drug without stopping ART.
Moderate Reactions (e.g., Gynaecomastia, Lipodystrophy)	– Substitute with a drug in the same class or different class with a different toxicity profile. – Do not discontinue ART; continue if feasible.
Mild Reactions (e.g., Headache, Minor Rash, Nausea)	– Do not discontinue or substitute ART. – Provide reassurance and support to mitigate adverse reactions. – Counseling about the events.

Management of HIV Positive Pregnant Mother

Key Interventions for eMTCT:

Routine HIV Counseling and Testing during ANC (at 1st contact. If negative, repeat HIV test in the third trimester/ labour).
Enrolment in HIV care if the mother is positive and not yet on treatment.
If the mother is already on ART, perform viral load and continue the current regimen.
ART in pregnancy, labour, post-partum, and for life – Option B+.

Recommended ARV for option B+:

One daily Fixed Dose Combination (FDC) pill containing TDF + 3TC + EFV started early in pregnancy irrespective of the CD4 cell count and continued during labor and delivery, and for life.

Alternative regimens for women who may not tolerate the recommended option are:

If TDF contraindicated: ABC+3TC+EFV
If EFV contraindicated: TDF + 3TC + ATV/r
TDF and EFV are safe to use in pregnancy.
Those newly diagnosed during labor will begin HAART for life after delivery.

Prophylaxis for Opportunistic Infections

Cotrimoxazole 960 mg 1 tab daily during pregnancy and postpartum –– Mothers on cotrimoxazole DO NOT NEED IPTp with SP for malaria.

Care of HIV Exposed Infant

HIV-exposed infants should receive care at the mother-baby care point together with their mothers until they are 18 months old. A mother-baby care point is a healthcare facility that provides comprehensive services to both HIV-exposed infants and their parents.

The goals of HIV-exposed infant care services are:

To prevent the infant from being HIV infected.
Among those who get infected: to diagnose HIV infection early and treat it.
Offer child survival interventions to prevent early death from preventable childhood illnesses.

The HIV Exposed Infant and the mother should consistently visit the health facility at least nine times during that period i.e (i.e., at 6, 10 and 14 weeks, then at 5, 6, 9, 12, 15 and 18 months).

Nevirapine Prophylaxis

Provide NVP syrup from birth for 6 weeks: Give NVP for 12 weeks for babies at high risk, that is breastfeeding infants who mothers:

Have received ART for 4 weeks or less before delivery; or
Have VL >1000 copies in 4 weeks before delivery; or
Diagnosed with HIV during 3rd trimester or breastfeeding period (Postnatal)

Do PCR at 6 weeks (or at first encounter after this age) and start cotrimoxazole prophylaxis

If PCR positive, start treatment with ARVs and cotrimoxazole and repeat PCR (for confirmation)
If PCR negative and the baby never breastfed, the child is confirmed HIV negative. Stop cotrimoxazole, continue clinical monitoring and do HIV serology test at 18 months.
If PCR is negative but the baby has breastfed/is breast feeding, start/continue cotrimoxazole prophylaxis and repeat PCR 6 weeks after stopping breastfeeding.
Follow up any exposed child and do PCR if they develop any clinical symptom suggestive of HIV at any time and independently of previously negative results.
For negative infants, do serology at 18 months before final discharge.

Dosages of Nevirapine

Age Group	Weight Range	Dosage	Syrup Volume (10 mg/ml)
Child 0-6 weeks	2-2.5 Kg	10 mg once daily	1 ml
Child 0-6 weeks	>2.5 Kg	15 mg once daily	1.5 ml
Child 6 weeks – 12 weeks	Any weight	20 mg once daily	2 ml

Cotrimoxazole Prophylaxis: Provide cotrimoxazole prophylaxis to all HIV exposed infants from 6 weeks of age until they are proven to be uninfected.

Child <5 kg: 120 mg once daily
Child 5-14.9 kg: 240 mg once daily

Isoniazid (INH) Preventive Therapy (IPT):

Give INH for six months to HIV-exposed infants who are exposed to TB.
Isoniazid 10 mg/kg + pyridoxine 25 mg daily
For newborn infants, if the mother has TB disease and has been on anti-TB drugs for at least two weeks before delivery, INH prophylaxis is not required.

Immunization

Immunise HIV exposed children as per national immunisation schedule.

In case of missed BCG at birth, do not give if the child has symptomatic HIV.

Avoid yellow fever vaccine in symptomatic HIV.

Measles vaccine can be given even in symptomatic HIV.

Counselling on Infant Feeding Choice

Explain the risks of HIV transmission by breastfeeding (15%) and other risks of not breastfeeding (malnutrition, diarrhoea).
Mixed feeding may also increase the risk of HIV transmission and diarrhoea.
Tell her about options for feeding, advantages, and risks.
Help her to assess choices, decide on the best option, and then support her choice.

Feeding Options

Recommended option: Exclusive breastfeeding, then complementary feeding after the child is 6 months old.
Exclusive breastfeeding stopping at 3-6 months old if replacement feeding is possible after this.
If replacement feeding is introduced early, the mother must stop breastfeeding.
Replacement feeding with home-prepared formula or commercial formula and then family foods (provided this is acceptable, feasible, safe, and sustainable/affordable).

If Mother Chooses Breastfeeding

The risk may be reduced by keeping the breasts healthy (mastitis and cracked nipples raise HIV infection risk).
Advise exclusive breastfeeding for 3-6 months.

If Mother Chooses Replacement Feeding

Counsel and teach her on safe preparation, hygiene, amounts, times to feed the baby, etc.
Follow up within a week from birth and at any visit to the health facility.

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