TB Nurse Case Management San Antonio, Texas April 9-11, 2013 TB / Dose Counting Rachel Munoz, RN. TB Nurse Case Manager/Nurse Consultant Austin/Travis County Health Department April 10, 2013 Rachel Munoz, RN., has the following disclosures to make: No conflict of interests No relevant financial relationships with any commercial companies pertaining to this educational activity 1
Cure the individual patient Minimize risk of death and disability; and Reduce transmission of M. Tuberculosis to other persons Directly Observed Therapy 4-drug Regimen Treat 6 months or longer Single drug=resistance Adding single drug to failing regimen can lead to additional resistance!!!!! 2
Treatment failure Relapse Ongoing transmission; and Development of drug resistance 4 basic treatment regimens recommended for adults with TB disease Known drug susceptible to 4 initial drugs Each regimen consists of initial 2- months phase followed by a continuation phase of 4-7 months 3
Crucial for preventing the emergence of drug resistance and determining the ultimate outcome of the regimen! All 4 drugs should be included in initial phase INH and RIF- allow for short-course regiments with high cure rates PZA- potent sterilizing activity allowing for further shortening of the regimen from 9 to 6 months EMB- helps to prevent emergence of RIF resistance when primary INH resistance is present (if drug-susceptibilities are known, EMB need not be included if EMB sensitive) Regimen 1 INH, RIF, PZA and EMB 7days/week for 56 doses (8weeks) Or 5 days/week for 40 doses (8weeks) 4
Regimen 2 7days/week for 14 doses (2weeks) Then, 2 days/week for 12 doses (6 weeks) Or 5 days/week for 10 doses (2 weeks) Then, 2 days/week for 12 doses (6weeks) (doses less than 7 days a week should be DOT) Regimen 3 3 times weekly for 24 doses (8weeks) 5
Regimen 4 o 7day/week for 56 doses (8weeks) Or o 5 days/week for 40 doses (8weeks) (via DOT) Treatment for 4-7 months 4 months only for uncomplicated, non-cavitary, drugsusceptible TB and only if there is documented sputum culture conversion within the first 2 months 7 months for patients with the following: Cavitary or extensive pulmonary TB caused by drugsusceptible organisms and sputum culture obtained at time of completion of 2 months of treatment is positive Initial phase did not include PZA Treated with once-weekly INH and RPT, whose sputum culture at time of completion of initial phase(i.e., after 2 months) is positive 6
Regimen 1 1a INH and RIF 7 days/week for 126 doses (18 weeks) or 5 days/week for 90 doses (18 weeks) 1b INH and RIF 2days/week for 36 doses (18 weeks) 1c INH/RPT 1 day/week for 18 doses (18 weeks) (HIV neg, neg smears at 2 months of therapy, no cavitation on initial CXR, extend treatment 3 months if culture + after 2 months) Regimen 2 2a INH and RIF 2days/week for 36 doses (18 weeks) 2b INH /RPT 1day/week for 18 doses (18 weeks) (HIV neg, neg smears at 2 months of therapy, no cavitation on initial CXR, extend treatment 3 months if culture + after 2 months) 7
Regimen 3 3a INH/RIF 3 times weekly for 54 doses (18weeks) Regimen 4 4a INH/RFT 7 days/week for 217 doses (31 weeks) or 5 days/week for 155 doses (31 weeks) 4b INH/RIF Twice weekly for 62 doses (31 weeks) 8
Patients on regimens given less than 7 days a week should receive DOT Regimens given less than 3 times a week are NOT recommended for HIV-infected patients with CD4+ counts less than 100 Although basic TB regimens are broadly applicable, there are modifications that should be made under special circumstances (e.g., HIV infection, drug resistance, pregnancy, or treatment of children). Total number of doses prescribed within the specified time frame Duration of therapy depends on the drugs used, the drug susceptibility test results of the isolate, and the patient s response to therapy Goal is to complete all doses within 1 year. 9
32 y/o female HIV Positive CD 4 count- 89 CXR- RUL cavitary lesion Smear and culture positive for MTB. Initial Phase 4 drugs Daily for 56 doses (8 weeks) Drug susceptible DC EMB DC PZA after 56 doses 10
INH and Rifampin Daily 7x week for 217 doses (31 weeks) Consider changing to 3x week once CD 4 count above 100+ to complete 39 weeks 24 y/o female HIV negative CXR- bilateral infiltrates Smear and culture positive 11
Initial Phase 4 drugs Regimen #1= daily for 8 weeks (7 or 5 day) 14 doses for 2 weeks (DOT), or 10 doses 5 days/week then 2x week for 6 weeks (12 doses) After 2 weeks patient develops rash and itching. Drug challenge Found to be PZA PZA is Discontinued 12
Finish out Initial phase with 3 drugs Find she is drug Susceptible DC EMB Sputum converted within 2 months. What drugs would you use? INH/RIF How Long would you treat? 9 months Why? Unable to use PZA in initial phase. 13
32 Y/O Male HIV negative Uncontrolled Diabetic CXR- right pleural effusion Smear positive and culture positive on pleural biopsy Initial Phase 4 drugs- Daily for 8 weeks most physicians will chose to do dailies during the initial phase on an uncontrolled diabetic. Drug Susceptibilities-sensitive to all 4 EMB Discontinued Pulmonary sputa returning smear and culture negative 14
PZA discontinued after 8 weeks INH/RIF Which Regimen? 3 times weekly for 54 doses (18 weeks), or 2 times weekly for 36 doses (18 weeks) How Long? Total of 26 weeks may need to extend depending on patients improvement, and DM, WHY? Diabetics have a lowered immune system in general and take longer to convert sputa in pulmonary MTB, have increased risk for relapse During Initial Phase > 14 days- restart treatment from beginning < 14 days- continue treatment to complete planned total number of doses ( complete within 3 months) 15
During Continuation Phase > 80% of doses, and sputum was AFB smear negative on initial testing- further therapy may not be necessary > 80% of doses, sputum was AFB smear positive on initial testing- continue therapy until all doses completed < 80 % of doses, and lapse is less than 3 months in duration- continue until all doses are completed (full course); or < 80% of doses, and lapse is greater than 3 months in duration- restart therapy form the beginning of initial phase. Get a consult Get extended panel Molecular testing Daily DOT Failure to convert sputum cultures to negative after 4 months= treatment failure Augment regimen with 2 or 3 new drugs Drug levels 16
1) Initial phase should consist of 4 drugs? True 2) The continuation phase consists of 6 months? False 3) If there is not documented sputum conversion within the first 2 months of therapy the 4 month continuation phase is enough? False 4) If a patient received PZA in the initial phase the 4 month continuation phase is plenty? True 5) DOT is not necessary on patients who receive medication less than 7 days a week? False 6) It is okay to give 2x a week medication to an HIV infected individual with a CD 4 count less than 100? False 7) PZA is discontinued once drug susceptibilities are known? False 1) The goal to complete all doses of TB treatment is within 1 year? True 17