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TPT CME Slides FOR HEALTH CARE WORKERS IN
- 2. Latent tuberculosis infection(LTBI): A state of persistent immune response to stimulation by M. tuberculosis antigens with no evidence of clinically manifest active TB TB preventive treatment (TPT): Treatment offered to individuals who are considered at risk of TB disease in order to reduce that risk TB disease - this occurs when a person exposed to TB bacteria develops signs and symptoms of TB Household contact (HHC): A person who shared the same enclosed living space as the index case for one or more nights or for frequent or extended daytime periods during the 3 months before the start of current treatment Definition of key terms
- 3. One-quarter of theworld population is estimated to have LTBI 5–15% of those infected will develop active TB disease over the course of their lives, usually within the first 5 years after initial infection (WHO LTBI Guideline 2019) People with LTBI form reservoirs for a significant proportion of emerging active TB • People with LTBI are “seedbeds” of tuberculosis in the community The positivity of LTBI among health care workers in Kiambu County was 78%( preliminary report) The proportion of the Kenyan population that is infected with Mycobacterium tuberculosis is unknown Burden and implications of LTBI
- 4. • TB livesbut does not grow in body • Does not cause symptoms • Can not be transmitted • Can advance to active TB disease • TB is active and grows in body • Causes symptoms • Can be transmitted • Can cause long term complications and death if not treated Latent TB Active TB • Latent TB Infection (LTBI) is defined as a positive test of TB infection without evidence of clinically active TB • 2 billion people are infected with LTBI globally Difference between active and latent TB
- 5. Since 5–15% ofthose with Latent TB will progress to active TB in their lives, it is therefore important to offer TB preventive therapy Kenya’s targets for treatment of persons with LTBI is 900,000 (NSP 2019-2023) Prevention of active TB disease by TPT is a: - Critical component of the End TB Strategy - Key strategy in achieving the global agenda of ending TB by 2035 The TB/ HIV confection rate has reduced with the introduction of TB preventive therapy and ART Why should Latent TB Infection be treated?
- 6. To reduce therisk of progression from latent TB to active disease by killing the dormant mycobacteria TPT • Reduces morbidity • Reduces progression from LTBI to active Tb disease, hence reducing transmission of TB Cost saving: treatment of active TB involves four antibiotics, LTBI treatment uses one or two antibiotics Mycobacteria bacilli are not actively replicating, there is a reduced likelihood of developing acquired drug resistance Rationale for TB preventive therapy
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- 8. Clinical risk groups •Patients receiving immunosuppressants • Patients receiving dialysis • Patients preparing for an organ or haematological transplant • Patients with silicosis Eligible populations for TPT Prisoners and staff working in prison settings Health care workers and other staff in healthcare settings People living with HIV (PLHIV): Children aged ≥ 12 months, adolescents and adults All household contacts of a bacteriologically confirmed PTB patients
- 9. HIV is thestrongest risk factor associated with the development of active TB with up to 40% of patients progressing to TB disease after exposure PLHIV also have approximately 21 times higher risk of TB disease compared to the HIV negative persons. About 2% of PLHIVs get TB annually Mortality among TB/HIV co-infected patients during TB treatment is three times more than TB uninfected PLHIV The early detection and treatment of LTBI in PLHIV reduces the overall risk of TB disease progression by 33% People Living with HIV
- 10. Meta-analyses have shownthat adults and children on ART have reduced TB incidence regardless of CD4 count. Test all people with active TB for HIV and start ART Screen all PLHIV for TB symptoms/signs STARTING TB TREATMENT RAPIDLY REDUCES INFECTIOUSNESS AND TRANSMISSION, AND MAKES PATIENTS FEEL BETTER IN ADULTS, OVERALL IN CHILDREN 70% ART reduces risk of TB in HIV patients 65% Source: Suthar et al., 2012; Dodd et al., 2017; Gupta, A. Choices and Dilemmas: Preventing Tuberculosis in People with HIV Infection. Presented at: CROI 2019. EARLY SCREENIN G EARLY DIAGNOSI S & TREATMEN T
- 11. Source: TEMPRANO ANRS12136 Study Group, 2015 2056 participants randomized DEFERRED ART DEFERRED ART + IPT EARLY ART EARLY ART + IPT After 2.5 years (30 months) of follow-up… 1 2 3 4 Early ART and IPT each independently reduced the risk of morbidity. The combination of early ART and IPT had the greatest protective effect. The TEMPRANO study investigated the benefit of ART, six months of isoniazid (IPT), or both in HIV-positive adults with high CD4 counts in Cote d’Ivoire. The study looked at the effect of ART and IPT on morbidity. ART is good, but ART + TPT is better
- 12. Repeat TPT isnot recommended among PLHIV except if a PLHIV becomes a household contact of a person with bacteriologically-confirmed pulmonary TB Recommendations for PLHIVs Children aged ≥ 12 months, adolescents and adults with no active TB disease should receive TPT irrespective of immune status, ART status, previous history of TB and pregnancy status Infants <12 months living with HIV who are household contact of a person with bacteriologically-confirmed pulmonary TB, and whom active TB have been ruled out should receive TPT TPT may be given immediately following successful completion of TB treatment among the PLHIV
- 13. ● Prevalence ofLTBI is higher among persons above 5 years of age compared to children below 5 years ● Children below 5 years are at a higher risk of progression to active TB disease ● Household contacts, regardless of their age have a significantly higher risk of progression to TB disease compared to general population ● They should be provided with TPT after ruling out active TB disease regardless of their age and HIV status NB- Currently, contacts of DRTB patients are excluded from TPT Household contacts of Bact. confirmed TB cases
- 14. 1 – WHO consolidatedguidelines on TB: TPT (2020) Pooled estimates for risk of active TB among HH contacts
- 15. ● All householdcontacts (adults, adolescents and children) of bacteriologically confirmed PTB should be given TPT after ruling out active TB disease irrespective of age or HIV status ● Active TB should be ruled out after appropriate clinical evaluation in accordance with the National guidelines ● Where available, LTBI test (TST or IGRA) may be provided to Adults, adolescents and children aged ≥5 contacts as part of screening before initiation of TPT Recommendations for Household contacts
- 16. ● Global riskof TB in prison is estimated to be 23 times higher than in the general population ● Risk factors in TB transmission include late diagnosis, inadequate treatment, overcrowding, poor ventilation and repeated prison transfers ● HIV infection, malnutrition and substance abuse encourage the progression of Latent TB to active disease ● Due to constant interaction with the prisoners, staff working in prison settings are also at an increased risk of TB infection Prisoners and staff working in prison settings
- 17. ● Prisoners shouldbe screened for TB at entry to prison and thereafter bi-annually during imprisonment ● TPT should only be given to those who are to be confined for at least 3 months (to ensure completion ● Staff working in prison settings should also be routinely screened for active TB every 6 months ● Those without active TB disease should be put on a course of TPT (once in their lifetime) Recommendations for Prisoners and staff
- 18. ● Healthcare workersface a two- to three-fold increased risk of developing TB compared with the general population ● This is due to frequent and prolonged exposure to undiagnosed persons with TB or DRTB in the workplace ● The increased risk is also attributed to close contact with TB patients and handling of TB specimens Health workers and staff in healthcare settings
- 19. ● HCWs shouldbe regularly screened for TB (at least bi-annually) and adhere to infection prevention and control measures ● HCWs should be given TB preventive therapy after ruling out active TB disease irrespective of age or HIV status Recommendations for health care workers
- 20. ● Other clinicalat risk groups include; • Patients initiating chemotherapy or those who are taking certain immunosuppressive drugs • Patients receiving dialysis • Patients preparing for an organ or hematological transplant • Patients with silicosis ● Patients with weakened immune systems have an increased risk of activating LTBI and acquiring of TB infection leading to TB disease ● TPT to these patients is essential to prevent progression to disease Other populations at risk
- 21. Due to lackof strong evidence TPT is not recommended for the following unless they belong to other risk groups; 1. Persons with diabetes 2. Those who inject drugs 3. Those with harmful alcohol use 4. Tobacco smokers 5. The homeless 6. Malnourished 7. Immigrants from high TB burden countries Unless they meet the criteria for TPT target populations Populations excluded from TPT
- 22. Symptomatic screening shouldbe conducted to all at-risk populations TPT should be offered to the asymptomatic individuals Those with symptoms should be offered TB diagnostics investigations and managed appropriately TB cardinal symptoms • Children: Persistent cough, Fever , Poor feeding, Weight loss/failure to thrive, Fatigue, Reduced playfulness and decreased activity • Adults: Cough, Night sweats, Fever, Weight loss Note: Testing using TST or IGRA where available could be offered to the asymptomatic before initiating TPT LTBI screening Algorithm
- 23. Screening algorithm beforeinitiating TPT Contraindications: Active TB, Active Hepatitis, Peripheral neuropathy, Chronic alcoholism
- 24. Discussion session What aresome of the strategies we can put in place to ensure that the following populations are identified, screened for TB and offered TPT? 1. PLHIVs 2. HCWs 3. Household contacts of pulmonary Bact. Confirmed TB patients 4. Prisoner and those in prison settings 5. Clinical risk groups
- 25. Treatment of Latent TBInfection
- 26. 3HP Treatment of LatentTB Infection Rifapentine and isoniazid once a week for 3 months will be offered to ≥15 years adolescents and adults.(Both HIV Negative and HIV Positive Population Rifampicin and isoniazid daily for 3months will be offered to HIV Negative children and adolescents aged < 15 years. 3RH Isoniazid daily for 6months will be offered to HIV Positive children and adolescents <15 years. • will also be offered to Pregnant women and those who can not tolerate the above regimens 6H
- 27. •Availability of child-friendly formulation(same FDC as for continuation phase treatment – RH 75/50mg) •Suitable for children up to 25kg •Older children can use adult FDCs •Better adherence •Do not give to patients on PI or NVP based ART •Low cost (FDC) •Better adherence (shorter regimen) •FDC now available •child-friendly formulation not available •No evidence for use in children <2 years •Safe to use in PLHIV on EFV and RAL •Do not give to patients on PI or NVP based ART •Studies on use with DTG so far show no interactions •Still regimen of choice for CALHIV on ART •Lowest cost (uncoated tab) •Poor adherence & low completion rates with longer regimen •Higher rates of hepatotoxity compared to other regimens NB- All these regimens should be co administered with pyridoxine as per the dosing chart 6 H - Isoniazid 3 HP – Rifapentine & isoniazid 3 RH- Rifampicin & Isoniazid Comparing options for LTBI treatment
- 28. Drug Affected Rifapentine Management LPV/r andATV/r Decreases significantly the levels of LPV/r and ATV/r ● Avoid co-administration ● Offer 6H as TPT Hormonal contraceptives Decreases the levels of oral and implant contraceptives Use non-hormonal methods or Use barrier methods Quinine, Artemether and Lumefantrine Decreases the level of Antimalarials significantly If a patient is diagnosed with malaria but is not yet on TPT, decisions regarding 3HP initiation should be delayed until the episode of malaria has resolved. RAL, EFV, DTG No interactions expected No dose adjustment required Management of drug-drug interactions
- 29. • Eligible candidatesshould be screened to rule out active TB Those who screen negative for TB, should be initiated on appropriate TPT regimen Signs and symptoms of liver disease including yellowness of eyes, abdominal pain should be ruled out before treatment initiation Asses for: • Comorbidities like diabetes mellitus, neuropathy (persistent numbness and burning sensation in the feet and hand • Active substance or alcohol use/abuse Consideration before initiating treatment
- 30. Health care workersshould educate the clients on the following: Reasons for initiating TPT Importance of adhering to treatment Signs and symptoms for TB and prompt reporting to the health facility Ideal nutritional status Drugs and substance abuse/indigenous medicine Side effects associated with treatment Pre- treatment adherence counseling Non adherence to TPT will end up in progression to active TB or development of drug
- 31. Patients on TPTshould be followed up on monthly basis and other clinic appointments harmonized. During each clinic visit, conduct the following; • Symptom based TB screening and update TB status • Assess and reinforce adherence of the patients to ascertain compliance and completion of doses • Assess for any adverse drug reactions and intervene appropriately Follow Up of Patients on TB preventive therapy (TPT) If a patient screens positive for TB while on TPT, stop TPT and manage according to National
- 32. TPT outcome Description Treatmentcompleted An individual who has taken a full course of TPT in line with the guidelines Lost to follow up An individual whose TPT was interrupted for more than one month Discontinued An individual whose TPT was stopped due to; ❖Adverse drug reactions ❖Development of active TB disease in the course of TPT ❖Persistent non- adherence Died An individual who died in the course of TPT TPT outcomes
- 33. Conduct symptom-based TBscreening • At every clinic visit for PLHIVs • At month 6 and month 12 for the HIV negative clients If a patient screens positive after completing TPT, manage according to national TB guidelines Follow up after completion of TPT
- 34. You are workingin a TB clinic and have recently learned about the importance of child contact management. You know from previous data that on average, you will identify 1 child under 5 years of age for every 3 index cases In the past 6 months, there have been 300 bacteriologically positive index cases and 50 child contacts recorded in the child contact register. Of these, 45 have come in for screening, 2 were diagnosed with active TB disease. 40 were initiated on TPT and 38 had documented completion. Where are most of the losses happening? What are some strategies to help you confirm? Case study 1
- 35. Suspect child contactidentification challenges if number of child contacts identified is lower than average child contacts < 5 years/adult What do you do? • You could consider consider randomly sampling bacteriologically-positive index cases and conducting household visits. Does the number of child contacts during visit match what was reported? • Are healthcare workers having difficulty documenting child contacts? • Are index cases understanding the question? Case study 1 Cont’d..
- 36. You have improvedyour identification strategy by providing HCW education. You review your data again six months later and there have been 250 bacteriologically positive index cases and 150 child contacts recorded in the register. 75 have come in for screening, 5 were diagnosed with active TB disease. 68 were initiated on PT and 68 had documented completion. Where are the losses occurring? What else do you want to know? What are some possible solutions? Case study 2
- 37. • Healthcare workersreport that with the increased number of children identified, it has been very difficult to keep up with managing the active cases and conducting child contact management. • Possible Solutions • Assign one day a week (a lighter active TB patient day) to child contact management screening and ask index cases to bring children on that day • Remember, chest x-ray is not necessary – if asymptomatic and machine is down or other issues, START PT Case study 2 cont’d..
- 38. You decided todedicate one day a week to child contact management and you have one staff member who is in charge of doing the screening on that day. This is working well and you are screening >90% of child contacts identified. You learn that index cases have been asking to transfer their child contacts to a TB clinic that is closer so although there is documentation that IPT was recommended, 50% of the asymptomatic child contacts were labeled ‘transferred out’ and no IPT was initiated. How do you handle this? What strategies could you think of to over come this challenge? Case study 3
- 39. • Transfer challenges •Can give child contacts initial dose of IPT and document in register. HCWs can then make follow up call to transfer facility to assess completion. • Stigma challenges • There may be stigma against TPT amongst healthcare workers and the community. Educate, educate, educate! • Ask about disclosure Case study 3 cont’d..
- 40. Zawadi is an8 year old female, lives in Thika, identified through contact tracing. Her father who is a banker recently tested Positive for TB, sputum smear +, MTB detected, Rif sensitive. HIV Testing done and was Negative She is a grade 2 pupil and currently on break because of the COVID 19 Pandemic •What plan will you give Zawadi? •What TPT Regimen will you consider for Zawadi? •How differently will you treat Zawadi if she was HIV Positive? Case study 4
- 41. 46 year oldmale, born in Murang’a, history of homelessness in the last 5 years, excessive drug and alcohol use but stopped one year ago. CXR: Left upper lobe consolidation and left hilar lymphadenopathy, GENE XPERT- MTB detected, Rif Sensitive. Newly diagnosed HIV POSITIVE •What do we do for this patient? •When do we initiate ART? •When do we start TPT? •What TPT regimen do we start this client on? Case study 5
- 42. Salim is a42 year old Male, Currently serving a 6 months jail term at Kiambu Maximum Prison. Presents with no symptom suggestive of Active TB disease. •Does Salim qualify for TPT? •What Regimen will you give Salim? Case study 6
Editor's Notes
- #2 Most infected people have no signs or symptoms of TB but are at risk for active TB disease Also referred to as LTBI treatment or preventive therapy
- #4 the risk for active TB disease after infection depends on several factors, the most important being immunological status TPT can offer protection for up to 5 years after initial infection.
- #10 Source; Stop TB partnership
- #14 TPT after completion of treatment gives additional protective benefit by eliminating any dormant bacilli that were not killed by anti-TB treatment
- #16 The prevalence of LTBI was higher among children and adolescents aged > 15 years and adults than in children < 5 years, who were at greatest risk for progression to active TB disease. All household contacts, regardless of their age or LTBI status, were at a substantially higher risk for progression to active TB than the general population
- #17 Appropriate clinical evaluation should include assessment of the intensity of and risk for exposure, the risk for development of active TB and/or ascertainment of infection by testing for LTBI.
- #20 For the purposes of TB prevention in Kenya, the definition of health care workers extends beyond those frequently engaged in direct clinical and nursing care to include even those in administrative and clerical duties. It also includes students who are in their clinical years or interact with patients frequently. This broad definition thus includes, and not limited to, doctors (including those in administrative roles), clinical officers, nurses, laboratory technologists, community health workers, students (especially those in clinical years), paramedical staff (e.g., public health officers, physiotherapists, community health volunteers, occupational therapists), support staff (including clerical officers, casual workers, drivers, receptionists, telephone operators) among others.
- #30 On hormonal contraceptives need further discusions
- #31 Explain to participants how to assess for DM, nutrition, neuropathy, alcohol use
- #32 Facilitator to discuss with the participants each of the points above
- #33 PLHIVS on TPT do not put under the stable patients category
- #43 Treat for TB (Standard Rx)