Transcript PRACTICE GUIDELINEs FOR TB TREATMENT - Home

PRACTICE GUIDELINEs
FOR TB TREATMENT
DR. AWADH AL-ANAZI
Asst. Professor
Consultant internist , Infectious Diseases
Director of Residency Training Program
Department of Medicine
King Kalid University Hospital
College Of Medicine,King Saud University
Riyadh.
• TB leading infection killer of youth and adult
• TB leading killer of women
• TB leading infection killer of HIV/AIDS patients
• TB creates more orphans than any other ID
• One third of world population infected with TB
• 30 million people could die from TB in next 10 yrs
• 3.8 million new cases reported to W.H.O. (1995)
• 8 million became sick with TB (1999)
• 80 million cases ? Occurred worldwide
• Someone infected with TB every second
• Every Country vulnerable to consequences
of poor TB management practices in other
countries
IDSA – TB Committee / CDC- TB Elimination Division
Indentified
10 Essential recommendations and performance
indicators
FOR TB CARE
• They include recommendation for;
treatment of active TB Disease and
treatment of latent TB infection
• All recommendation graded “A” (strongly
recommended) by IDSA – USPHS ranking system
• Associated performance indicators:
Easily measurable
Allow straightforward assessment of
adequacy of TB treatment by care providers
and organizations.
• IDSA – USPHS grading system for ranking
recommendations in clinical guidelines (TABLE 2)
• Specific Recommendations
Rankings:
indicating strength of each
recommendation and qualify
evidence supporting it, and
performance indicators: would be
summarized at end of presentation.
Rationale for and explanation of Recommendation
• TB ancient, worldwide spread, deadly disease
• Care of TB patients shared by variable levels of
provider, speciality health clinics to primary care
providers/PCC
• More patients with TB: S/B physicians and H.C.
providers unfamiliar with TB diagnosis and
management.
• Care of infected patients entails public health
obligations not relevant to care of other ID… this
because of mode of TB spread
• Care providers and health care systems unfamiliar
with TB recommendations
• Practice guidelines are principles to:
treat active TB disease
treat latent TB infection
ensure best outcome for :
a) treatment patients with TB
b) control of TB in community
• Recommend. that are intended for practitioners:
focus on management strategies for treating clinicians
Do not address actions usually taken by public health
authorities to limit TB spread in community:
a) Contact tracing
b) Maintaining surveillance system
• Strength of Recommendation Ranked (A-E)
• Quality of Evidence Ranked (I-III)
• Performance indicators – target for frequency of
following recommended practices:
* Clearly defined, measurable objectives, relevant
to the recommended practice
* Useful in evaluating performance of both care
providers and managed care plans so that
minimum performance standard guaranteed
• Performance indicator: Calculated as % of instances
recommend. actually achieved. Divided by instances in
which recommendation was applicable.
Infectious Disease Society of America-US Public Health Service grading
system for recommendations in clinical guidelines
CATEGORY,
GRADE
DEFINITION
Strength of
Recommendation
A
Good evidence to support a recommendation for use
B
Moderate evidence to support a recommendation for use
C
Poor evidence to support a recommendation
D
Moderate evidence to support a recommendation against use
E
Good evidence to support a recommendation against use
Quality of Evidence
I
Evidence from at least 1 properly randomized, controlled trial
II
Evidence from at least 1 well designed clinical trial without randomization, from cohort
or case-control analytic studies (preferably from >1 center), from multiple time-series
studies, or from dramatic results in uncontrolled experiments
III
Evidence from opinions of respected authorities, based on clinical experience,
descriptive studies, or reports of expert committees
• To accomplish action described in the
recommendations:
• A Benchmark set for frequency with which
recommended practice followed
Example
• Culture diagnosis in children not expected as often
compared to adults because sputum expectoration
difficult to obtain in children
• HIV serologic status cannot always be obtained
because patient refusal thus 80% rather 100%
proposed Benchmark.
RECOMMENDATIONS
• 8 recommend. – care and treatment
Active TB Disease
• 2 recommend. – care and treatment Latent TB
infection
• Each recommendation includes:
• ranking for its strength
• quality of evidence supporting it
• performance indicators
• I obtain specimens for bacteriologic confirmation
and susceptibility testing for patients with TB or
suspected of having TB (A-II)
•
ADULT – obtain culture spp. for MTB from Adult with PTB or
other accessible EPTB sites
• CHILD – perform culture on all available spp.
• Early morning gastric aspirate/washing (Diff sputum spect.
esp <10 yr. Old)
• can be done o.p.
• Important to obtain culture spp. from child when no cult.
Positive index case or MDR TB suspected
• Sputum cult & stain best obtained early morning x 3 separate
days
• During Last 10-15 years – new technology developed
• rapid id of Bacilli in Cl. Spp. & culture
• rapid reporting of drug sens.
• Direct amplification test that id MTB in AF smear positive
resp. spp. but cult. Needed for sens. testing
• Mycolic acid analysis by* HpLC: rapid id method for
mycbac. Isolates.*(high performance liquid chroatography)
• If your micro. Lab fascility limited,send spp.to lab. Using
rapid id method(liquid media)
Good TB lab: standard care = more than 90% of adult
patients with cl. Diagnosis TB, should have confirmed diag.
by culture
* bacteriologic confirm. & suscept. testing
achieved by almost all adult case
• Performance indicator (P.I.) set at 90%
• unable to cult. bec. Tech diff. (EPTB)
• pts refused invasive procedures
• In child < 12 yrs. P.I. set at 50% because diff. obtaining
sputum samples
II – Place persons with suspected or confirmed smear
positive pulmonary or laryngeal TB in resp. isolation until
non-infection (A-II)
• MTB transmitted by coughing, sneezing, speaking,
singing, by inhalation of airborne aerosol droplet
• Nosocomial Tx
• close contact with infected patients with TB
• certain procedure B. Scope, ETI, suctioning, open
abscess irrigation, autopsy
• aerosol treatment by inducing cough
• Keep patient in resp. isolation until
• determined not having TB
• Disch. from hospital or
• Confirmed non-infectious
• Receiving effective therapy
• improving clinically
• negative sputum AFB smear x 3
• Clinically responding pts., yet have positive smear:
• Dischar. Home IF
• Household contact already exposed
• Contacts not at increased risk of TB (infants, immunosupp.)
• Pt. agree not to have contact with other susceptible persons
• 100% lack of infectiousness in pul. Or laryn. TB:
impractical (cutl 6-8 wks)
• Conversion to negative smear used as indicator for noninfectiousness
• P.I: Pt. Non-infectious (Clinical response to anti TB
meds, 3 negative sputum smear).
• All pts. Isolated.( exemption pt. returning to residence
where contacts positive TST).
• such pts. can be disch. from isolation before smear
conversion
•P.I. thus set at 90%
III. Begin treatment of patients who have confirmed or
suspected TB dis. with one of following drugs, combinations
depending on local resistance pattern:
INH-RIF-PZA or
INH-RIF-PZA-ETHAM or
INH-RIF-PZA-STREPT (A-III)
• Based on risk of treating unsuspected D.R. TB when suscept.
Pattern ukn.
• If INH resis. more than 4%, use fourth drug until INH sens.
obtained
• Exemption from 4 drugs regimen
• Dis. Acquired from contact with MTB Kn. Sens. INH, RIF, PZA
• Suscept result kn at treatment start and MTB sens: thus IRP safely
used for first 8 weeks
• P.I (Bec. such cases unk) set at 90% of pts to received 4 drugs if
INH res > 4% and 3 drugs if INH res. < 4%
IV. Report each case of TB promptly to local public
health department (A-III)
•
Function of reporting syst:
•
Perform contact and find other untreated infectious TB
pt. Present in community
•
Monitor compliance with meds.
•
id infected contacts
•
Record keeping & surveillance to check if public health
goals achieved
•
Reporting suspected cases (clinical or AFB in spp)
should not await cult. Confirmation
•
Prompt reporting save pts. of loosing F.U.
•
Optimal health depts. Monitoring & F.U. mandates
100% P.I. So as to report confirmed cases within one
week of establishing diagnosis
V. Perform HIV testing for all pts. with TB within 2
months of TB diagnosis (A-III)
•
Knowing HIV status of TB pts. Imp:
•
Pts. Infected with HIV and TB can receive standard
anti-TB with good results
•
Pts. TB + HIV: TB may resolve rapidly if concurrently
given anti HIV treatment
•
Testing for either infections require counselling
•
Anti TB maybe altered according to anti HIV meds. Used
•
In U.S. 14% patient with TB, have AIDS (93-1994) HIV
inf. Seen 58% of patients with TB
•
Clinicians are poor predictors as which patient likely HIV
infected, thus HIV testing recommended for all newly
diagnosed TB patients
•
P.I. 80% as some patient refuse HIV testing
VI. Treat patient with TB for 6 months total duration,
using ATS/ CDC – approved regimen (A-I)
•
If MTB sens. To all agents, 6 months course effective, well tolerated,
•
IRP x first 2 months
•
I.R. through entire therapy course
•
Patients with miliary, meningeal, bone/joint require longer course (12
months) ATS/CDC recommended, any of 3 schedules (Daily, twice, or
thrice weekly)
•
ATS/CDC: INH resist. 6 month; R.E.P
RIF resist. Longer regimen
I.R. resist. 18-24 months
•
Treat failure: non-compliance main cause
•
D.O.T. (W.H.O.)
•
D.O.T: pts at high risk for treat failure: MDR, IVDU, Alcoholics,
homeless.
•
P.I. 90% of pt. with drugs sen. isolate to complete course within 12
months
VII. Re-evaluate patietns with TB who are smear
positive at 3 months for possible non-adherence or
infection with drug-resistance bacilli (A-III)
• Response to Anti TB: Clinical sx, sputum smear and cult.
• Treatment failure:
• no cl. Improv.
• smear and cult. continue positive
• convert from negative to positive(PPD) after therapy initiation
• Usu. By 3 mon. smear and cult. Negative
• Continued positive smears and cult. at or after 3 months: reevaluate patient and regimen
• Treat. Failure most commonly due to:
• non-compliance
• Drug resist. (MDR)
• D.O.T.,the only way to eliminate non-compliance
• Detection for non-compliance
• Drug resistance:
• Hx TB treatment
• Area Kn. with high prevalent Drug R. MTB
• Non -compliance
• If treatment failure suspected due drug R
• Repeat cult and suscept.
• Did resist. occur since evaluating initial isolate
• Evaluate patients with negative smear, but positive
culture at 3 months
• P.I. set at 90% within one month (at one month cult. ?
Pending)
VIII. Add two or more new anti-TB agents when TB
treatment failure is suspected (A-III)
• Suspect. + treatment failure
• Lack of clinic response
• Smear & culture persist positive
• 6 weeks to long to wait
• Never add single drug to failing reg.
• Add at least 2 drug
• If treating with second-line anti TB, add at least 3 or
more drugs
• P.I. 100% as it is for regimen prescribed by clinician
and independent of patient action.
IX. Re-evaluate patietns with TB who are smear
positive at 3 months for possible non-adherence or
infection with drug-resistance bacilli (A-III)
• T.S.T. with PPD (Manoux): id active/latent TB
• Positive test criteria (Am Rev Resp Dis 1990)
- 5 mm + recent contact with active TB
+ HIV inf. and other immunosup
+ CXR evid. Old TB
- 10 mm + recent arrival from high prevalance area
+ IVDU, child < 4 yrs
+ person with med or social status putting them at increased
risk for TB exposure or progression to TB
- 15 mm + with no kn risk of, nor progression to TB dis
•PPD: in all gps at high risk for latent TB infec. HX – IVDU
homeless, etc.
- HIV strongest Kn. Risk factor for progression of Latent
inf. To active TB dis.
MTB reactivation rate 7-10% per yr.
- TST : Simple with few S.E. As test read 48-72 hr later,
some patients fail to return.
-Thus P.I of 80 % expected.
X.
Administer treatment to all persons with Latent
TB infection unless prior treatment of Latent TB
can be documented A.1
-
Treatment of Latent TB inf. (formerly preventive
therapy)
•
Effective in preventing TB Dis in positive TST
persons at risk for reactivation
•
Its use thus strongly recommended.
-Recom Regimes:
•
9 months INH
•
2 mons Rif + PZA
•
4 mons. Rif (less Recom)
•
children: only INH for 9 mons.
-Randomised prospective trials support using Latent TB
inf. Treatment in
•
HIV infected & HIV uninfected.
-Rif not Recom in pregnant women.
-At > 35 yrs. Of age, INH toxicity may increase thus
individualise treatment regimen.
-Persons with High likelihood to develop Active TB:
•
HIV inf with positive PPD.
•
HIV inf with TB infectious contacts regardless of PPD
status.
•
TST converters within past 2 years.
•
PPD positive contacts of active TB.
•
Immunosupp with positive PPD.
-BCG receiver may be PPD positive without Latent TB inf,
but can benefit from treating Latent TB inf.
-No test can distinguish true PPD + from false positive TST
(BCG related)
-Latent TB inf. treatment completion difficult to ensure
•Reluctance of asym. Patients to take meds.
-68% adherence with 12 mon. INH
-80% adherence with 2 mon. rif + PZA.
-Thus P.I of 75% completion within year after treat started, is
expected
Recommendation
I
Ranking
Obtain bateriologic confirmation and
susceptibility testing for patients with
TB or suspected of having TB
A - II
Performance indicator
90% of adults or suspected of having TB
have 3 cultures for myocabacteria
obtained before initation of
antitubeculosis therapy (50% of children
0-12 years).
II
Place person with suspected or
confirmed smear-positive pulmonary
or laryngeal TB in respiratory
isolation until non infectious.
A-II
90% of persons with sputum smearpositive TB remain in respiratory
isolation until smear converts to
negative.
III
Begin treatment of patients with
confirmed or suspected TB disease
with 1 of the following drug
combinations, depending on local
resitance patterns: INH + RIF + PZA +
EMB, or INH + RIF +PZA + SM
A-III
90 % of all patients with TB are started
in INH + RIF + PZA + EMB or SM in
geographic areas where > 4 % of TB
isolates are resistant to INH.
IV
Report each case of TB promptly to
the local public health department.
A-III
100% of persons with active TB are
reported to the local public health
department within 1 week of diagnosis.
V
Perform HIV testing for all patients
with TB
A-III
80% of all patients with TB have HIV
status determined within 2 months of a
diagnosis of TB.
VI
Treat patients with TB caused by a
susceptible organism for 6 months,
using an ATS/CDC approved regimen
A-I
VII
Re-evaluate patients with TB who are
smear positive at 3 months for
possible non-adherence or infection
with drug resistant bacilli
AIII
VIII
Add> 2 new antuberculosis agents
when TB treatment failure is
suspected
A-II
IX
Perfomr tuberculim skin testing on all
patients with a history of > 1 of the
following: HIV infection, injection
drug use, homelessness, incarceration,
or contact with a person with
pulmonary TB
Administer treatment for latent TB
infection to all persons with latent TB
infection, unless it can be documented
that they received such treatment
previously
A-II
80% of persons in the indicated
population groups receive
tuberculin skin test and return for
reading
A-I
75% of patients with positive
tuberculin skin tests who are
candidates for treatment for latent
TB infection complete a course of
therapy within 12 months of
initiation.
X
90% of all patients with TB
complete 6 months of therapy
within 12 months of beginning
treatment
90% of all patients with TB who
are smear positive at 3 months
have sputum culture/susceptibility
testing performed within 1 month
of the 3 month visit
100% of patients with TB with
suspected treatment failure are
prescribed > 2 new
antituberculosis agents