TB Preventive Therapy (TPT)

Clinical description

• A single course of TPT can prevent active TB in people who are at high risk:

o HIV infected children, adolescents and adults o Children under 5 years – regardless of HIV status – who are household contacts of clients with pulmonary TB (bacteriologically confirmed or clinical): give IPT – 6H.

• HIV patients who have completed a course of TPT or TB treatment in the past do not need

another course of TPT.

• Do not give TPT to a patient who has any signs suggestive of active TB: such patients need full

investigation for TB and may require full TB treatment to avoid TB drug resistance.

o New patients: Start TPT together with ART and CPT.

• Two alternative TPT options are similarly effective:

o 3HP: 3-month course of weekly doses of isoniazid + rifapentine

• Preferred regimen for patients newly initiating ART

o 6H: 6-month course of daily dose of Isoniazid:

• Use as an alternative regimen for those with contraindications to 3HP
• Suitable for children and can be combined with all ART regimens
• Both 3HP and 6H should not be routinely given in pregnancy and 3 months postpartum due to

increased risk of hepatotoxicity and potential adverse birth outcomes (low birth weight and preterm delivery).

• TPT is well tolerated by most patients. Most side effects are mild and disappear with time.

Serious side effects are rare: hypersensitivity, neuropathy and severe hepatitis.

• Document all serious side effects on the yellow pharmacovigilance forms and submit to PMRA

or report using the MEDSAFE-360 USSD platform.

• Stop TPT if any of the following are seen:

o Nausea, vomiting, loss of appetite: early warning signs for hepatitis o Pellagra-type skin rash in sun-exposed areas and other severe skin rash o Yellow eyes o Dizziness / confusion / convulsions o Moderate numbness/burning pain and muscular weakness of legs and/or arms o Flu-like symptoms, syncope

• DO NOT RESTART TPT if any significant side effect is experienced.

Preventive services for HIV patients 51 Dispensing TPT

• Patients who have already completed a full course of TPT or TB treatment in the past are exempt.
• Emphasize adherence during treatment.
• Ensure proper documentation on patient card.
• Always give pyridoxine to prevent neuropathy. Don’t prescribe TPT if pyridoxine is not available.
• Stop immediately if clients develop severe peripheral neuropathy, hypersensitivity reactions,

gastrointestinal intolerance and hepatotoxicity.

• Report to the health facility immediately with nausea or loss of appetite. These are early warning

signs of hepatotoxicity.

3HP

• Easier to complete due to short duration and fewer side effects.
• All clients newly initiated on ART (<3 months) in all districts are eligible for 3HP.
• Start 3HP at the same time as ART. If this was missed, start 3HP up to 3 months after ART initiation.

Ensure rifapentine tablets are swallowed whole without crushing.

• Not suitable for patients on PI- and NNRTI-based ART regimens.
• Do not give 3HP to children on paediatric ART formulations (blue patient card).
• Women on hormonal contraception need to use condoms while on 3HP. Rifapentine reduces

contraceptive effectiveness.

• 3HP reduces the effectiveness of malaria treatment, do not combine with LA.
• Check drug interaction job aid before starting any new drugs for someone on 3HP
• Give a single course of 12 weekly doses of rifapentine/isoniazid based on weight (see Table 17 on

page 70).

• Give 1 daily tablet of Pyridoxine 24-hourly for 12 weeks. Adults: 25 or 50mg.
• Review patients at month 1, 2 and 3 after starting 3HP for side effects and adherence. Align ART

appointments with 3HP dispensing and clinical review visits.

6H

• Offer 6H as an alternative TPT regimen to all ART clients with contraindications to 3HP.
• Give 1 daily dose of INH and pyridoxine for 6 months (cumulative total of at least 168 daily doses).

Use weight-based dosing chart for children.

• Give 1 daily tablet of pyridoxine 24-hourly. Adults: 25 or 50mg. Children <20kg: about 1mg/kg
• Review patients at month 1, 2 and 3 after starting 6H for side effects and adherence. Align ART

appointments with 6H dispensing and clinical review visits.

TPT completion and management of interruption

• Provide adherence support for clients to complete TPT course.
• Table 9 shows the expected number of doses and the expected period to completion. It also shows

the minimum doses and the maximum permissible period for a complete course of 3HP and 6H.

• 3HP requires completing 12 weekly doses, preferably without gap. A patient who interrupts:

o Less than 1 month: continues the course. The course can be extended up to 120 days (4 months) in total. Ensure that at least 11 doses are taken.

o More than 1 month: restarts the whole course, ignoring any doses that were taken before the interruption.

• 6H requires completing 182 daily doses, preferably without gap. A patient who interrupts:

o Less than 2 months: continues the course. The course can be extended up to 239 days (8 months) in total. Ensure that at least 146 doses are taken.

o More than 2 months: restarts the whole course, ignoring any doses that were taken before the interruption.

Table 9: Expected doses and duration for 3HP and 6H. Min. requirements for completion of course TPT Regimen Expected doses Minimum doses Expected duration Max. duration 3HP 12 doses 11 doses 84 days 120 days 6H 182 doses 146 doses 182 days 239 days TPT in Prisons

• Perform a thorough systematic symptom screen for TB among prisoners upon entry and every six

months.

• Give 3HP to HIV-infected prisoners using the same eligibility criteria as for all other patients (see

above).

• Provide enhanced adherence counselling for TPT regimen completion.

TPT Contraindications Table 10: Contraindications for IPT and 3HP IPT and 3HP 3HP

• Suspected or confirmed active TB • Prior adverse events or hypersensitivity to

rifapentine, rifampicin or INH

• Prior adverse events or hypersensitivity to INH
• PI- and NNRTI-based regimens must not be
• Active hepatitis, hepatitis surface antigen combined with 3HP

positive, liver damage, heavy alcohol use

• Active hepatitis, hepatitis surface antigen
• Severe or moderate peripheral neuropathy positive, liver damage, heavy alcohol use
• Pregnant women or women planning to

become pregnant during treatment Management of non-communicable diseases