Tuberculosis Supplemental Notes PDF

AHMED, CANLAS, ESGUERRA | EBPT2 14 SUPPLEMENTAL NOTES DIAGNOSTIC DEFINITION PULMONARY TB BASED ON DIAGNOSTICS...

AHMED, CANLAS, ESGUERRA | EBPT2 14 SUPPLEMENTAL NOTES DIAGNOSTIC DEFINITION PULMONARY TB BASED ON DIAGNOSTICS BACTERIOLOGIC CONFIRMATION OF PTB BASED ON PRESUMPTIVE TB MICROBIOLOGIC TESTS  A patient who presents with symptoms or signs suggestive Bacteriologically Smear A patient with at least one of PTB Confirmed positive (1) sputum specimen  Previous definition (2006): TB suspect or symptomatic TB positive for AFB, with or without radiologic BACTERIOLOGICALLY CONFIRMED abnormalities consistent  A patient from whom a biological specimen is POSITIVE by with active TB smear microscopy, culture or MTB/RIF or Gene Xpert Culture A patient with positive CLINICALLY DIAGNOSED positive sputum culture for MTB  A patient who does not fulfill the criteria for complex, with or without radiographic abnormalities bacteriologically confined TB but was diagnosed with active TB but a clinician or other medical practitioner who has consistent with active TB decided to give the patient a full course of TB treatment Rapid A patient with sputum diagnostic positive for MTB complex BASED ON LOCATION test using rapid diagnostic PULMONARY TB positive modalities such as Xpert  Any bacteriologically confirmed or clinically diagnosed MTB/ Rif, with or without case of TB involving the lung parenchyma, or the radiographic abnormalities tracheobronchial tree consistent with active TB Clinically A patient with 2 sputum specimens EXTRAPULMONARY TB Diagnosed negative for AFB or MTB, smear not done  Any bacteriologically confirmed or clinically diagnosed due to specified conditions but with case of TB involving organs other than the lungs radiographic abnormalities consistent with active TB, and there has been no CLASSIFICATION BASED ON TIME OF DIAGNOSIS response to empiric antibiotics and/or NEW CASE symptomatic medications, and who has  A patient who has NEVER had treatment for TB our has been decided to have TB disease taken anti TB medications for less than 1 month requiring full course of anti-TB chemotherapy RETREATMENT  Relapse - A patient previously treated for TB who has been DIRECT SPUTUM SMEAR MICROSCOPY declared cured or treatment completed in their most recent INTERPRETATION OF DSSM treatment episodes and is presently diagnosed Bacteriologically confirmed (BC) or Clinically diagnosed (CD)  Treatment after Failure (TAF) - Patient who has been treated previously for TB whose treatment failed at the end of their most recent course  Treatment after lost to ff up (TALF) - Patient who was previously treated for TB but was lost to ff up for 2 months or more in their most recent course of treatment  Previous treatment outcome unknown (PTOU) - Patient who have been previously treated for TB but whose outcome after their most recent course of treatment is unknown CLINICAL MANIFESTATION  Cough of at least 2 weeks duration (strong recommendation, low quality evidence) How many sputum specimen should be collected?  Unexplained cough of any duration in a close contact of a  2 sputum specimens should be obtained for DSSM known active TB case (strong recommendation, low quality  Same day (spot-spot) strategy using 2 consecutive evidence) specimens collected 1-hour apart is recommended for direct  Chest x-ray findings suggestive of PTB WITH OR WITHOUT Ziehl-Neelsen microscopy symptoms (strong recommendation, low quality evidence) WHEN SHOULD TB CULTURE BE REQUESTED?  Any of the ff symptoms: cough of any duration, significant  TB culture remains the GOLD STANDARD for TB diagnosis and unintentional weight loss, fever, bloody sputum or  Sputum TB culture with Drug susceptibility testing should be hemoptysis, chest pains not referable to any muscular performed for the following: disorders, easy fatigability or malaise, night sweats, o Retreatment cases shortness of breath or difficulty of breathing (weak o Treatment failure recommendation, low quality evidence) o Contacts of known drug-resistant TB cases  AHMED, CANLAS, ESGUERRA | EBPT2 15 XPERT MTB/RIF least 1 of 3 second line injectable drugs in addition WHEN TO REQUEST FOR XPERT MTB/RIF to multi drug resistance Rifampicin resistant TB (RR- Resistance to Rifampicin with TB) OR without resistance to other anti TB drugs (whether mono, poly, MDR or XDR) TYPES OF DRUG RESISTANCE TYPES DEFINITION Primary Drug Resistance Results when a person has been infected with a drug- PRESUMPTIVE DR TB resistant TB strain  RETREATMENT: relapse, TAF, TALF, PTOU, non-converter Acquired (Secondary) Drug Results from inadequate,  NEW: with close contact with DR TB, non-converter, PLHIV Resistance incomplete or poor with CXR suggestive of TB or if with TB symptoms treatment quality that allows the selection of mutant SELECTED VULNERABLE GROUPS resistant strains  Inmates, elderly, children, DM patients with signs and symptoms of TB PRE-TREATMENT EVALUATION  The need for at least 6-8 months (DSTB), 20-24 months  Presumptive EPTB (CTR) of supervised well documented TB treatment and NEW CASE (DSSM NEGATIVE) importance of compliance  CXR suggestive of TB with or without symptoms  Free anti-TB drugs in a DOTS program RESULTS AND INTERPRETATION  Public health facilities that offer FREE bacteriologic services  Schedule of follow up DSSM for monitoring RESULT INTERPRETATION  Tracing mechanism if lost to ff up TP MTB detected  How to address possible adverse reactions Rifampicin resistance not detected  Relevance of contact investigation RR MTB detected  Cough etiquette and other pertinent infection control Rifampicin resistance detected measures TI MTB detected  Do pre-treatment evaluation and address all pertinent Rifampicin resistance indeterminate health issues appropriately N MTB not detected  Refer patients to appropriate specialists or health CT SCAN VS CXR FOR SCREENING institutions for any needed interventions (ART, DM control,  The routine use of chest CT scan in the diagnosis of active smoking cessation program, visual or hearing acuity test, PTB is not recommended, unless other co-existing disease monitoring of liver enzymes etc) conditions are highly considered  Prior to start of treatment, clinical and laboratory  Clinical correlation and bacteriologic confirmation should examinations need to be undertaken still be done  Pre-treatment assessment should be systematically  A chest CT scan has 91% sensitivity and 76% specificity (as conducted on all patients to identify those at a greatest risk compared to 49% sensitivity for a plain chest radiograph) of adverse effects and poor outcomes  Emphasis on good history taking and physical examination! CLASSIFICATION OF TB TREATMENT  Drug sensitive TB (DSTB) - For new cases, sensitive to ALL BASELINE LABORATORY EXAMINATION first line TB drugs based on Gene Xpert or Culture and  Baseline testing for ALT and serum creatinine are Sensitivity recommended before starting anti TB treatment  Drug resistant TB (DRTB) - Proven to be resistantto one or  In resource limited settings, baseline ALT and serum more first line TB drugs creatinine should be requested for patients older than 60 years old and those with risk factors for liver or kidney CLASSIFICATION BASED ON DRUG SUSCEPTIBILITY disease before starting TB treatment CLASSIFICATION DEFINITION  All patients with TB with history of high-risk behavior for HIV Mono resistant TB Resistance to ONE 1st line and coming from areas with high prevalence of HIV should anti TB drug only (except be offered counseling and testing for HIV rifampicin)  Screening for DM using FBS, RBS or 75g OGTT is Polydrug resistant TB Resistance to more than one recommended for ALL patients with TB first line anti TB drug (other  At present, HBA1c is NOT routinely recommended in the than both Isoniazid and Philippines to screen for DM due to problems with Rifampicin) standardization, if available, it should be confirmed by FBS, Multidrug resistant TB Resistance to BOTH Isoniazid RBS or 75g OGTT (MDRTB) and Rifampicin  Serum uric acid testing is NOT recommended. The finding of Extensive drug resistant TB Resistance to any asymptomatic hyperuricemia is not an indication to avoid (XDRTB) fluoroquinolone AND to at pyrazinamide  AHMED, CANLAS, ESGUERRA | EBPT2 16 MANAGEMENT OF TB DOSE REQUIREMENT OF 1ST LINE TB MEDICATIONS RECALL DRUG ADULTS Isoniazid (H) 4-6 mg/kg (5) max: 400mg/day Rifampicin (R) 8-12 mg/kg (10) max: 600mg/day Pyrazinamide (Z) 20-30mg/kg (25) max: 2g/day Ethambutol (E) 15-20 mg/kg (15) max: 1.2g day Streptomycin (S) 12-18 mg/kg (15) max: 1g/day DRUG CHILDREN Isoniazid (H) 10-15 mg/kg (10) max: 300mg/day Rifampicin (R) 10-20 mg/kg (15) max: 600mg/day Pyrazinamide (Z) 20-40 mg/kg (30) TREATMENT max: 2g/day Ethambutol (E) 15-25 mg/kg (20) max: 1.2g/day Streptomycin (S) 20-40 mg/kg (30) max: 1g/day FIXED DOSE COMBINATIONS Body wt (kg) Intensive Phase Continuation Phase HR Number of tablets per day 30 - 37 2 2 38 - 54 3 3 55 - 70 4 4 TB AND STEROIDS > 70 5 5  The use of corticosteroids as adjunctive therapy is recommended ONLY for patients with TB meningitis and/or WHEN IS TB TREATMENT CONSIDERED NON INFECTIOUS? TB pericarditis  Bacteriologically confirmed - 14 days of treatment with  In TB meningitis: The recommended regimen is sputum conversion and clinical improvement dexamethasone 0.4 mg/kg/24 hours with a reducing  Clinically diagnosed - at least 5 daily doses of treatment course over 6-8 weeks with clinical improvement  In TB pericarditis, the recommended regimen is Prednisolone MANAGEMENT OF CASES WITH INTERRUPTED TREATMENT o 60mg - week 1 to 4 o 30mg - week 5 to 8 o 15mg - week 9 to 10 o 5mg - week 11 HOW SHOULD ANTI TB MEDICATIONS BE ADMINISTERED?  Patient centered, directly observed therapy (DOT) should be offered to all patients who will undergo treatment  Outcomes are better with patient-centered DOT in terms of completion of treatment, smear conversion and default rates compared to daily health facility based treatment and is less expensive in a programmatic setting (Strong recommendation, high quality evidence) TRACKING PATIENTS AND MONITORING ADHERENCE TO OUTCOME DEFINITION TREATMENT Cured A patient with bacteriologically-confirme d  Remind patients of their appointments, by pre-appointment TB at the beginning of treatment and who is phone calls and SMS smear- or culture-negative in the last month  Default reminder letter or home visits for those who miss of treatment and on at least one previous appointments occasion in the continuation phase.  Use of SMS as reminders Treatment A patient who completes treatment without  Give incentives and enablers such as nutritious, culturally Completed evidence of failure but with no record to appropriate daily meals and food packages show that sputum smear or culture results in  Coordinate with DOTS centers and support groups the last month of treatment and on at least one previous occasion are negative, either  AHMED, CANLAS, ESGUERRA | EBPT2 17 because tests are not done or because o Monitoring of patients with baseline risk factors results are unavailable. o Abnormal baseline LFTs This group includes:  ALT greater than 3x the upper limit of normal in the  A bacteriologically-confirmed patient presence of symptoms who has completed treatment but  More than 5x the upper limit of normal in the presence of without DSSM follow-up in the last symptoms month of treatment and on at least one  ALL medications should be stopped immediately (Strong previous occasion. recommendation, moderate quality evidence)  A clinically diagnosed patient who has completed treatment. WHEN SHOULD WE RESUME MEDICATIONS? AND HOW? Treatment A patient whose sputum smear or culture is  After normalization to ALT to less than twice the ULN and Failed positive at five (5) months or later during resolution of clinical symptoms treatment.  Stepwise reintroduction of potentially hepatotoxic anti-TB OR drugs may be restarted with Rifampicin followed by INH A clinically-diagnosed patient for whom after 3-7 days, with subsequent checking of ALT sputum examination cannot be done and  PYRAZINAMIDE should be permanently discontinued. who does not show clinical improvement (Strong recommendation, low quality evidence) anytime during treatment. Died A patient who dies for any reason during the HOW TO DEAL WITH GASTROINTESTINAL UPSET course of treatment.  Mild GI symptoms are frequent in the initial weeks of Lost to A patient whose treatment is interrupted for treatment. Patients must be reassured of this, and anti TB Follow-up two (2) consecutive months or more. medications should be continued Not A patient for whom no treatment outcome is  Antacids may be given patients who develop persistent GI evaluated assigned. This includes cases transferred to adverse drug reactions (Strong recommendation, moderate another DOTS facility and whose treatment quality evidence) outcome is unknown.  Food intake affects bioavailability of several anti TB medications ADVERSE DRUG REACTIONS TB MEDICATIONS AND PERIPHERAL NEUROPATHY COMMON ADVERSE REACTIONS TO ANTI TB DRUGS  All individuals receiving INH should be monitored for signs and symptoms of peripheral neuropathy  Gastrointestinal intolerance o Burning sensation  Mild or localized skin reactions o Numbness or tingling sensation of hands and feet  Orange/Red-colored urine  No laboratory tests are recommended for monitoring  Pain at the injection site peripheral neuropathy  Burning sensation in the feet due to peripheral neuropathy  Other risk factors: alcoholism, DM, HIV co infection,  Arthralgia due to hyperuricemia pregnancy, breast feeding and renal failure (strong  Flu-like symptoms recommendation, moderate quality evidence) MAJOR ADVERSE REACTIONS TREATMENT FOR PERIPHERAL NEUROPATHY  Severe skin rash due to hypersensitivity  Pyridoxine (Vitamin B6) at 50-100mg/day  Jaundice due to hepatitis  Co-administering Vitamin B6 at 10mg/day with INH is  Impairment of visual acuity and color vision due to optic recommended to prevent INH induced neuropathy (Strong neuritis recommendation, low quality evidence)  Hearing impairment, ringing of the ears, dizziness due to TB MEDICATIONS AND VISUAL IMPAIRMENT damage of the 8th cranial nerve  Oliguria or albuminuria due to renal disorder  Manifestations of ocular toxicity include bilateral progressive painless blurring of vision, decreased color  Psychosis or convulsion perception, loss of central vision and optic atrophy  Thrombocytopenia, anemia, shock  Testing for visual acuity and color perception should be HOW TO MANAGE ADVERSE REACTIONS done for individuals who develop signs and symptoms of  Minor adverse reactions can be managed symptomatically ocular toxicity o First line drugs should not be stopped  ETHAMBUTOL should be discontinued  For major adverse reactions, all drugs must be discontinued  Patients should be referred to ophthalmologist o Switching to single drug formulation is needed TB MEDICATIONS AND OTOTOXICITY o Referral to specialist is warranted  Patients on STREPTOMYCIN who develop symptoms of TB DRUGS AND HEPATOTOXICITY ototoxicity (decrease hearing, vertigo, nausea, vomiting,  Routine liver function monitoring is NOT needed among nystagmus or ataxia) should be referred to ENT for asymptomatic patients evaluation (Strong recommendation, low quality evidence)  ALT should be requested for TB MEDICATIONS AND HYPERURICEMIA o Individuals who exhibit symptoms of hepatotoxicity  Patients on PYRAZINAMIDE should be monitored for such as jaundice, anorexia, nausea, vomiting or symptoms of gouty arthritis abdominal pain  AHMED, CANLAS, ESGUERRA | EBPT2 18  Serum uric acid should ONLY be requested for patients who develop gouty arthritis  Pyrazinamide should be discontinued if patient develops hyperuricemia/gout and continued once symptoms resolve. Referral to rheumatologist for management may be necessary TB MEDICATIONS AND CUTANEOUS REACTIONS  Always examine patients for pruritus, maculopapular rashes, wheal formations, angioedema, vesicles, erythema, areas of exfoliation, xerosis and mucous membrane lesions  For minor rashes, anti-histamines may be given for symptomatic relief  If with generalized erythematous rash, especially if fever or mucous membrane involvement develops: STOP ALL DRUGS IMMEDIATELY  Petechial rashes may suggest thrombocytopenia in patients taking RIFAMPICIN. Check platelet count. TB MEDICATIONS AND NEPHROTOXICITY  Routine monitoring of renal function is not needed among symptomatic patients without risk factors for nephrotoxicity  Serum BUN and creatinine and urinalysis should be requested for patients who have signs and symptoms of nephrotoxicity such as oliguria and edema  Among individuals who develop nephrotoxicity from anti-TB drugs, RIFAMPICIN and STREPTOMYCIN should be discontinued. DRUG SENSITIZATION  Rechallenge with the drug least likely to be responsible for the reaction (INH followed by RIF and then PZA or EMB), with gradually increasing doses over 3 days. If there is no reaction after the 3rd day, add the second drug at a small challenge dose. This procedure is repeated adding in one drug at a time  If the rash recurs, the last drug added should be stopped. If no rash appears after the last three drugs have been restarted, the fourth drug should not be restarted unless the rash was relatively mild and the fourth drug is considered essential for therapy.  For HIV infected individuals, RIF may be re-introduced last. SUMMARY  TB remains highly endemic in the Philippines  It should be suspected in individuals who present with a chronic cough  TB culture is still the gold standard, but rapid POC tests such as TB Gene Xpert should be utilized  Enrollment in DOTS should be encouraged  Treatment is usually 6-12 months, depending on the type of TB  A multi-drug regimen is used (never a single drug)  Adverse drug effects are common and should be monitored END