Dosing and frequency

Clinical description

• Table 17 shows the number of tablets to be taken by children and adults once or twice per day.

• 10 weight-bands are used to determine the number of paediatric tablets to be given.
• Most paediatric formulations are tablets that can be crushed if necessary. The only exceptions are:

o LPV/r and ATV/r tablets must be given whole (not split or crushed or chewed).

Table 16: Standard ART Regimens (all strengths in mg)

Regi- Formulation Used for ART Prescri- Relative If confirmed, use men Paed. + Paed. Paed. + Adult Adult initiation Line ber level Contraindications Possible adverse reaction Alt 1 Alt

• Anaemia, vomiting, appetite loss 5, 17 13,

AZT 60 / AZT 300 / AZT 300 / 3TC 150 • Lipodystrophy, lactic acidosis 5, 17 13, 15 4 3TC 30 + + 3TC 150 + No 1st

• Anaemia <8g/dl
• History of psychosis • Hepatitis, rash 1, psychosis, gynaecomastia 2 14 13, 15,

EFV 200 EFV 200 EFV

• Treatment failure 13 15, 9,
• Renal failure 17 3 4, 153,

Alternative if TDF 300 / • Hepatitis, rash1, psychosis, gynaecomastia2 7 13, 15, 14 5 3TC 300 / EFV 400 (relative) DTG contra- 1st

• History of psychosis
• Renal failure • Persistent dizziness, visual disturbances 13 7, 15,

indications

• Treatment failure 14 8,

TDF 300 / • Renal failure

• Renal failure 153 11, NS
• Rifampicin or

7 3TC 300 + No 2nd 2 rifapentine

• Pre-existing jaundice
• Jaundice 6 13 10, NS

ATV/r 300/100 or hepatitis 5 • Treatment failure 7 (12)

• Anaemia <8g/dl • Anaemia, vomiting, appetite loss 15 9, 13, NS

AZT 300 /

• Patient on rifampicin • Lipodystrophy, Lactic acidosis 15 9, 13, NS

8 3TC 150 + No 2nd 2 or rifapentine4

• Pre-existing jaundice • Jaundice6 11 14,

ATV/r 300/100 or hepatitis5 • Treatment failure7 (12)

ABC 120 / ABC 600 / ABC 600 / • Fever, body pains, vomiting, cough 8 10, 11 14, 13, 8 3TC 300 1st 9 3TC 60 + + 3TC 300 + or 2nd 1 • ABC hypersensitivity • Diarrhoea, vomiting, dizziness, headache 15 7 LPV/r 100/25 LPV/r 100/25 LPV/r 200/50 • Treatment failure7 (12)

TDF 300 / • Renal failure 93 14, 153, 8 10 3TC 300 + No 2nd 2 • Renal failure • Diarrhoea, vomiting, dizziness, headache 7 13, 14, 15 LPV/r 200/50 • Treatment failure7 (12)

AZT 300 / • Anaemia, vomiting, appetite loss 9 13, 15 AZT 60 / 3TC 150 AZT 300 / 1st • Lipodystrophy, lactic acidosis 9 13, 15 11 3TC 30 + + LPV/r 100/25 3TC 150 + No or 2nd 2 • Anaemia <8g/dl

• Diarrhoea, vomiting, dizziness, headache 8

LPV/r 100/25 LPV/ 200/50

• Treatment failure7 (12)

DRV 150 + • Diarrhoea, vomiting, headache, dizziness, insomnia 10, obesity, DRV 150 + DRV 600 + • Epilepsy 9 diabetes 11, hepatitis 12 NS r 50 + r 50 12 DTG 10 + r 100 + DTG 50 No 3rd 2 • (Hepatitis B or C)12

• Patient on rifampicin
• Neuropathy NS

(± NRTIs) DTG 50 (± NRTIs) or rifapentine4 • Rash, jaundice NS Regi- Formulation Used for ART Prescri- Relative If confirmed, use men Paed. + Paed. Paed. + Adult Adult initiation Line ber level Contraindications Possible adverse reaction Alt 1 Alt

• Renal failure 15 3
• Renal failure

TDF 300 / Standard for 1st • Diarrhoea, vomiting, headache, dizziness, insomnia10, obesity, 5 7 13 3TC 300 / DTG 50 all patients 30 kg+ or 2nd

• Uncontrolled diabetes
• Epilepsy9

diabetes11, hepatitis12

• Hepatitis 10 5, NS
• (Hepatitis B or C)12
• Treatment failure7 (8) (11)
• Anaemia, vomiting, appetite loss, lipodystrophy, lactic acidosis 13
• Renal failure 153

AZT 60 / AZT 60 / AZT 300 / 1st • Anaemia <8g/dl 14 3TC 30 + 3TC 30 + 3TC 150 + No or 2nd 1 • Epilepsy9

• (Hepatitis B or C)12
• Diarrhoea, vomiting, headache, dizziness, insomnia10, obesity,

diabetes11, hepatitis12 4 8, 11 DTG 10 DTG 50 DTG 50 • Hepatitis 4

• Treatment failure7 (7) (9, 10)
• Fever, body pains, vomiting, cough8 13

ABC 120 / ABC 600 / ABC 120 / Standard for 1st • ABC hypersensitivity • Diarrhoea, vomiting, headache, dizziness, insomnia10, obesity, 15 3TC 60 + 3TC 60 3TC 300 + all patients below 30 kg or 2nd 1 • Epilepsy9

• (Hepatitis B or C)12

diabetes11, hepatitis12 17 4, 9, NS DTG 10 + DTG 50 • Treatment failure7 (8) (11, 7)

DTG 50 ABC 120 / ABC 600 / ABC 600 / • Fever, body pains, vomiting, cough8 5 13, 4, 14 3TC 300 17 3TC 60 + + 3TC 300 + No 1st

• ABC hypersensitivity
• History of psychosis
• Hepatitis, rash1, psychosis, gynaecomastia2 15 16, 9, 7,

EFV 200 EFV 200 EFV 400 • Treatment failure 14 8, 11 1 Mild skin rash and/or dizziness and nightmares are common after starting EFV. This usually resolves by itself and is not usually a reason to interrupt or change regimen.

2 EFV can cause breast enlargement in children and men (one side or both sides). This may resolve spontaneously while continuing EFV, but substitution is usually needed (and effective).

3 Patients with CrCl <50 ml/min need lower dose 3TC but full dose ABC. Combine ABC/3TC paed tabs and ABC (single) tabs for the correct dose. Call HIV Dept. logistics hotline for ABC single tabs.

4 Do not combine ATV/r with rifampicin (TB treatment) or rifapentine (TB preventive therapy using 3HP).

5 Do not start patients with pre-existing jaundice or suspected hepatitis on ATV/r and LPV/r.

6 ATV/r can cause jaundice. Mostly, this is only of cosmetic concern. Refer jaundice to a specialist for LFT. If only indirect bilirubin is raised, continue ATV. Stop ATV/r if LFT cannot be done.

7 Treatment failure on ATV/r, LPV/r, DRV and DTG-based regimens need confirmation of resistance mutations by genotyping before switch can be considered.

8 Fever, body pains, vomiting, cough / sore throat and breathing problems can be due to life-threatening ABC hypersensitivity (rare). Stop all ARVs immediately. Never re-start ABC.

9 DTG should not be combined with standard antiepileptic drugs: carbamazepine, phenobarbital, phenytoin and sodium-valproate. Use alternative anti-epileptic if available. Otherwise consider non- DTG based regimen or combine phenobarbital or carbamazepine with double dose of DTG. Check VL 6-monthly to confirm VL suppression.

10 DTG is very well tolerated. Mild headache, insomnia, nausea and diarrhoea usually subside without regimen change.

11 DTG may rarely cause hyperglycaemia and obesity. Use alternative regimens if lifestyle changes are unsuccessful. Check if hyperglycaemia improves on alternative regimen.

12 DTG and RAL may worsen liver damage (alcohol, viral Hepatitis B or C, etc.) and rarely cause hepatotoxicity. Check transaminases before and after starting DTG in patients with known Hep B/C.

Table 17: Standard pack sizes and dosing of Paediatric and Adult formulations of ARVs, TPT and CPT Drug Tablets per 3 – 3.9 kg 4 – 5.9 kg 6 – 9.9 kg 10 – 13.9 kg 14 – 19.9kg 20 – 24.9kg 25 – 29.9kg 30 – 34.9 kg 35 – 39.9 kg 40 – 49.9 kg 50 kg + tin Paed. Adult AM PM AM PM AM PM AM PM AM PM AM PM AM PM AM PM AM PM AM PM AM PM AZT / 3TC 60 60 1 1 1 1 11⁄2 11⁄2 2 2 21⁄2 21⁄2 3 3 1 1 1 1 1 1 1 1 1 1 ABC / 3TC 30 30 1 0 1 0 11⁄2 0 2 0 21⁄2 0 3 0 1 0 1 0 1 0 1 0 1 0 LPV / r liquid / tabs 60 120 1ml 1ml 1.5ml 1.5ml 2 1 2 1 2 2 2 2 3 3 3 3 2 2 2 2 2 2 LPV/r granules (sachets) 120 2 2 2 2 3 3 4 4 5 5 6 6 EFV 90 30 0 1 0 11⁄2 0 11⁄2 0 2 0 2 0 1 0 1 0 1 ATV / r 30 0 1 0 1 0 1 0 1 TDF / 3TC 30 0 1 0 1 0 1 0 1 TDF / 3TC / EFV 30 0 1 0 1 0 1 TDF / 3TC / DTG 30/90 1 0 1 0 1 0 1 0 DTG 90 30 1⁄2 0 1⁄2 0 11⁄2 0 2 0 21⁄2 0 1 0 1 0 1 0 1 0 1 0 1 0 DRV 2 240 60 21⁄2 21⁄2 21⁄2 21⁄2 21⁄2 21⁄2 3 3 1 1 1 1 1 1 r 60 60 1 1 1 1 1 1 1 1 1 1 1 1 1 1 CTX 120 1000 0 1 0 1 1 1 1 1 2 2 2 2 INH 100 100 0 1⁄2 0 1⁄2 0 1 0 11⁄2 0 2 0 21⁄2 CTX 480 1000 0 1⁄2 0 1⁄2 0 1 0 1 0 2 0 2 0 2 0 2 0 2 CTX 960 1000 0 1⁄2 0 1⁄2 0 1 0 1 0 1 0 1 0 1 INH 300 (daily for IPT) 672 0 1⁄2 0 1⁄2 0 1 0 1 0 1 0 1 0 1 INH 300 (weekly for 3HP)* 672 0 1 0 11⁄2 0 11⁄2 0 2 0 2 0 3 RFP 150 (weekly for 3HP)* 24 0 3 0 4 0 5 0 5 0 5 0 6 INH 300 / RFP 300 (3HP)* 36 0 3 0 3 0 3 0 3 2 DRV and r can be given as once daily dosing for patients without any HIV drug resistance against DRV. Follow the advice from the national 3rd line committee for each specific patient.

Understanding ART regimens and formulations