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Unit 7: Treatment of TB. Botswana National Tuberculosis Programme Manual Training for Medical Officers. Objectives. At the end of this unit, participants will be able to: Explain the principles of TB treatment Use the category regimens appropriately

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unit 7 treatment of tb

Unit 7: Treatment of TB

Botswana National Tuberculosis Programme Manual Training for Medical Officers

objectives
Objectives

At the end of this unit, participants will be able to:

Explain the principles of TB treatment

Use the category regimens appropriately

Properly monitor treatment, follow-up, and end of treatment

Discuss side effects of drugs and their management

admission policy
Admission Policy

Admit patients who present with the following:

TB meningitis and miliary TB, until ambulatory

Danger signs (e.g., respiratory distress, temperature of 39º C or more, inability to walk unaided)

Spinal TB

Severe adverse events (e.g. hepatitis)

Observe strict infection control and isolation procedures

aims of tb treatment
Aims of TB Treatment

Cure the patient of TB

Prevent death from active TB or its latent effects

Prevent relapse of TB

Prevent the development of acquired resistance

Prevent transmission of TB to others

importance of follow up
Importance of Follow-up

Retrospective analysis in 1997 in Gaborone with 127 patients:

11.8% had treatment delay

10.2% had incomplete workup (one smear performed) & were not registered

4.5% had 2 or more positive smears and were not registered for treatment

Source: Creek T, et al., Int J Tuberc Lung Dis, 2000.

treatment regimens
Treatment Regimens

Category I regimen for new patients

Category II regimen for re-treatment patients

Category III regimen for children with less severe cases of TB

Category IV for chronic and MDR-TB cases

mode of action special population hypothesis
Mode of Action: Special Population Hypothesis

High

Continuous

Growth

INH (RMP, SM)

PZA

RMP

Speed of bacterial growth

In Acid

environment

Spurts

Of

Metabolism

Dormant

Low

Source: Mitchison DA, Tubercle, 1985.

modern tb chemotherapy 1
Modern TB Chemotherapy (1)

INH – kills rapidly growing organisms (early bactericidal activity)

INH and RMP protect each other from development of resistance

Rifampicin and pyrazinamide kill slowly growing organisms

Sterilising activity

Source: Combs D et al., Ann Intern Med., 1990.

history of tb treatment
History of TB Treatment

TB Drug Development Milestones

1944 | Streptomycin

1949 | P-Aminosalicylic Acid

1952 | Isoniazid

1954 | Pyrazinamide

1955 | Cycloserine

1962 | Ethambutol

1963 | Rifampicin

Courtesy of: Global Alliance for TB Drug Development, 2007.

slide13

History of TB Treatment in Botswana

  • S= streptomycin
  • T= thiacetazone
  • H= isoniazid
  • R= rifampicin
  • Z= pyrazinamide
  • E=ethambutol
  • 1975-1986: 2STH/16TH
  • 1986-1993: 2SHRZ/4HR
  • 1993-present: 2HRZE/4HR
modern tb chemotherapy 2
Modern TB Chemotherapy (2)

British Thoracic Society

No. 2; 1982

Initial 2 months

HRZE

Continuation 4 months

HR

97% cure rate

US Public Health Service

No. 21; 1990

Initial 2 months

HRZ+/-E

Continuation 4 months

HR

97% cure rate

Source: Iseman, MD. A Clinician’s Guide to Tuberculosis. 2000.

British Thoracic Society, 1982.

category i regimen
Category I Regimen

Initial Phase

Normally two months

4 drugs: 2HRZE

Isoniazid (H)

Rifampicin (R)

Pyrazinamide (Z)

Ethambutol (E)

Daily and observed

Continuation Phase

Normally four months

2 drugs: 4HR

Isoniazid (H)

Rifampicin (R)

Daily and observed

category i regimen eligibility
Category I Regimen Eligibility

New Patients

Sputum smear + PTB

Sputum smear – PTB

Extra-pulmonary TB

TB Meningitis: streptomycin substitutes for ethambutol

Streptomycin should not be used if pregnant

fdc fixed dose combination tabs 1
FDC: Fixed DoseCombination Tabs (1)

Courtesy of: STOP TB Partnership

fdc fixed dose combination tabs 2
FDC: Fixed Dose Combination Tabs (2)
  • Fixed Dose Combination pills include two, three or even four drugs in one pill
  • Advantages of FDCs
    • Reduces the number of pills patients must take
    • Minimises errors in dosing
    • Simplifies distribution of pills to patients
    • Simplifies monitoring adherence
treatment follow up
Treatment Follow-up
  • Patients should be assessed monthly during treatment (more frequently, if needed)
    • Symptoms: cough, weight loss, fever, adverse effects
    • Adherence: review the treatment card
    • Adverse events: enquire about any side effects
    • Weight measurement: adjust dosages to account for any weight change
    • Sputum smear: obtain at 2 and at 5-6 months
the role of cxr in follow up
The Role of CXR in Follow-Up
  • There is no need for routine CXR in follow-up of PTB patients
    • CXR can be useful for the follow-up of some EPTB patients (e.g., pleural effusion)
  • Treatment decisions in PTB (switching to continuation phase, ending treatment) should generally be based upon sputum smear exams at stated intervals and clinical monitoring
monitoring treatment response
Monitoring Treatment Response

Important to tuberculosis control

Allows assessment of

Infectivity of a patient

Response to treatment

Outcome of treatment

Assessed through clinical, laboratory and radiological methods

Relies primarily on sputum conversion

X-rays are not part of routine follow-up of TB cases in Botswana

introduction to category ii regimen
Introduction to Category II Regimen

Adds a fifth drug, streptomycin, to the other first-line medications

Prolongs treatment to 8 months in total

Initiated and managed by the same clinicians and nurses as category I

Requires two months of injections (given daily)

category ii regimen
Category II Regimen

Children

  • Intensive phase
    • 2 months SHRZ
    • 1 month HRZ
  • Continuation phase
    • 5 months HR

Adults

  • Intensive phase
    • 2 months SHRZE
    • 1 month HRZE
  • Continuation phase
    • 5 months HRE

Courtesy of: WHO, 2008.

category ii regimen eligibility
Category II Regimen Eligibility

For smear-positive or culture-positive retreatment cases after

Relapse

Default

Treatment failure

category ii regimen pregnancy
Category II Regimen: Pregnancy

Streptomycin should be avoided in pregnancy if possible

Due to possible foetal ear damage and nephrotoxicity

Women of childbearing age should have a pregnancy test prior to starting category II

If not pregnant, advise contraception

category ii end of 3 months of retreatment
Category II: End of 3 Months of Retreatment

AFB positive

AFB negative

Repeat sputum for culture

and drug sensitivity testing

Continue with remaining four drugs for one month

Repeat smear at the end of four months

Proceed with continuation

phase as planned

Positive result at the end of four months

Start patient on continuation phase

Repeat smear at five months

Positive results indicate failure of treatment

Conduct sputum smear microscopy

at the end of three months of retreatment

category iii regimen
Category III Regimen

This is the recommended regimen for most children with TB in Botswana

Intensive phase

2 months HRZ

Continuation phase

4 months HR

category iv regimen and eligibility
Category IV Regimen and Eligibility

Specially-designed standardised or individualised regimens are recommended

For all patients who remain or become smear positive after completing a fully supervised retreatment regimen

For chronic and MDR-TB cases

Second line TB drugs include amikacin, ethionamide, ciprofloxacin and first line drugs with continued activity against M. tuberculosis

treatment of severe forms of tb
Treatment of Severe Forms of TB

Prolong the continuation phase to 6 months for the following sites of disease:

Tuberculous meningitis*

TB percardiditis

Disseminated TB

Spinal disease with neurologic complications

*For tuberculous meningitis: substitute streptomycin for ethambutol during the initial phase of treatment

Source: Basquoz N, 2007.

treatment of severe tb adjuvant corticosteroid
Treatment of Severe TB: Adjuvant Corticosteroid

Indications:

TB meningitis, TB pericarditis, Massive lymphadenopathy with airway obstruction

Recommended dose: usually prednisolone

TB meningitis: 2mg/kg/day up to 60mg/day for 4 weeks, then taper over several weeks

TB pericarditis: 2mg/kg/day up to 60mg/day for 4 weeks, then 30mg/day for 4 weeks, then taper over several weeks

In patients that cannot tolerate oral medication, IV dexamethasone is recommended

side effects
Side Effects

Each TB medication has potential side effects and drug interactions

Patients should be educated on particulars of potential side effects

Courtesy of: Virot P, Lung Health Image Library, 2004.

clinical monitoring for toxicity
Clinical Monitoring for Toxicity

Symptoms

Nausea

Vomiting

Right upper quadrant pain

Burning in feet

Change in vision

Joint pain

Dizziness

Signs

Fever

Rash

Jaundice

Pallor

Other signs of anaemia

Confusion, psychosis

Seizures

paradoxical reactions
Paradoxical Reactions

Apparent clinical worsening of TB on appropriate therapy

Caused by an immunologic reaction to TB as patient improves

Common with TB adenitis

Also occurs with brain tuberculomas and other manifestations

Monitor for bacteriologic relapse/failure

Continue TB treatment

Steroid therapy may be helpful for severe paradoxical reaction, after excluding TB treatment failure and other etiologies of apparent clinical worsening

slide45

Shared Side Effects

of TB and ARV Therapy

managing minor side effects
Managing Minor Side Effects

Loss of appetite, nausea, abdominal pain

Provide anti-emetics such as promethazine or metoclopromide

Check liver function tests or ALT, especially if symptoms persist

Joint pains

Aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAID)

Peripheral Neuropathy

Give pyridoxine 100-200 mg daily until symptoms disappear and then decrease to preventive dose

Orange/red urine

Reassurance

Source: WHO, 2004.

managing major side effects
Managing Major Side Effects

Severe rash

Stop all drugs; see Unit 8

Jaundice, vomiting and abdominal pain, confusion

Stop all drugs; see Unit 8

Visual changes

Stop ethambutol and revise treatment

Generalised reaction, shock, purpura

Stop all drugs until stable

serial drug challenge
Serial Drug Challenge

When symptoms of a major side effect have subsided, wait two weeks

Reintroduce TB medicines as described in Table 6.7 in the Botswana National Tuberculosis Programme Manual

drug interactions
Drug Interactions
  • With many patients on ARVs also taking ATT, quite common for drug levels to be altered to some degree
  • Antituberculosis drugs sometimes change concentrations of other drugs
  • Rifampicin can decrease serum concentrations of many drugs (e.g., most of the HIV-1 protease inhibitors) to subtherapeutic levels
  • Isoniazid increases concentrations of some drugs (e.g., phenytoin) to toxic levels
cytochrome p450 cyp3a
Cytochrome P450 CYP3A

Source: Cupp M, et al., American Family Physician, 1998.

treatment of mott
Treatment of MOTT

The most common non-tuberculous mycobacteria that cause disease in the US are

MAC, M.kansasii, M.fortuitum

MAC is treated with clarithromycin, rifampicin, and ethambutol for 18-24 months

M. kansasii is treated for 1 year after culture conversion with rifampicin, ethambutol and INH

Source: American Thoracic Society, 2007.

mott management
MOTT Management

Patients with MOTT are generally not isolated

These bacteria are widespread in the environment and are typically not spread person-to-person

MOTT is not MDR TB

MOTT may be present on culture but not cause disease

key points 1
Key Points (1)

TB treatment rapidly kills growing bacteria, prevents the emergence of drug resistance, and kills persistent organisms to avoid relapse

Treatment renders adherent and drug-sensitive patients non-infectious, usually within several days to several weeks

Modern chemotherapy can cure 97% of persons with drug susceptible TB

key points 2
Key Points (2)

There are 4 treatment categories of anti-TB medicines

First-line anti-TB medicines are isoniazid, rifampicin, pyrazinamide, ethambutol, and streptomycin

TB treatment should be monitored monthly

Side effects should be addressed as they occur