SA TB Guidelines The interface with Advanced Clinical Care

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1 SA TB Guidelines The interface with Advanced Clinical Care Dr Kogie Naidoo (MBCHB, PHD) Head: CAPRISA Treatment Research Programme Honorary Lecturer - UKZN Department of Public Heath Medicine Annual Workshop on Advanced Clinical Care ICC Durban 6 October 2016

2 Presentation Outline Diagnostic algorithm for DR and DS TB Retreatment TB: Revised definitions and treatment regimen ART initiation in TB patients Special considerations: Aluvia with TB treatment Atazanavir in TB Ethambutol in Renal failure Moxifloxacin and streptomycin indications TB prevention in HIV infected patients

3 Currently available TB Diagnostic tests

4 Which initial TB diagnostic test does WHO recommend for HIV + people with suspected TB? 1. Smear Microscopy 2. Xpert MTB/RIF 3. Culture

5 Which initial TB diagnostic test does WHO recommend for HIV + people with suspected TB? 1. Smear Microscopy 2. Xpert MTB/RIF 3. Culture

6 Where GeneXpert (GXP) is available, culture may still be required for: 1. HIV positive TB suspects, who have a negative GXP test 2. TB cases diagnosed as Rifampicin(Rif) resistant on GXP for susceptibility testing of other drugs 3. Despite a Rif susceptible result, the patient is failing treatment and treatment adherence is good and thus resistance to drugs other than Rif is suspected 4. All of the above

7 TB SUSPECTS TB and DR-TB contacts, non-contact symptomatic individuals, re-treatment after relapse, failure and default Collect one sputum specimen at the health facility under supervision GXP positive Rifampicin susceptible GXP positive Rifampicin resistant GXP positive Rifampicin unsuccessful GXP negative GXP unsuccessful Treat as TB Start on Regimen 1 Send one specimen for microscopy Treat as MDR-TB Refer to MDR-TB facility Treat as TB Start on Regimen 1 Collect one specimen for microscopy Culture & DST / LPA HIV positive HIV negative Collect one sputum specimen for a repeat GXP Collect one specimen for culture and LPA or culture and DST (for R and H) Treat with antibiotics and review after 5 days Do chest x-ray Treat with antibiotics Follow up with microscopy Collect one specimen for microscopy, culture and DST for Rifampicin, Isoniazid, fluoroquinolone and Aminoglycoside Poor response to antibiotics Clinically TB TB on chest x-ray LPA/ DST results Resistant to R and H/ R only Good response No further follow up Advise to return when symptoms recur Poor response Consider other diagnosis Refer for further investigation Follow up with microscopy and culture Treat as TB Start on Regimen 1 Review culture results Treat as MDR-TB Refer to MDR-TB Unit

8 Where GeneXpert (GXP) is available, culture may still be required for: 1. HIV positive TB suspects, who have a negative GXP test 2. TB cases diagnosed as Rifampicin(Rif) resistant on GXP for susceptibility testing of other drugs 3. Despite a Rif susceptible result, the patient is failing treatment and treatment adherence is good and thus resistance to drugs other than Rif is suspected 4. All of the above

9 Streptomycin is indicated for: 1. All categories of DS TB 2. All categories of retreatment TB 3. For patients that cannot tolerate first line TB medication 4. All of the above 5. None of the above

10 TB SUSPECTS TB and DR-TB contacts, non-contact symptomatic individuals, re-treatment after relapse, failure and default Collect one sputum specimen at the health facility under supervision GXP positive Rifampicin susceptible GXP positive Rifampicin resistant GXP positive Rifampicin unsuccessful GXP negative GXP unsuccessful Treat as TB Start on Regimen 1 Send one specimen for microscopy Treat as MDR-TB Refer to MDR-TB Unit Treat as TB Start on Regimen 1 Collect one specimen for microscopy Culture & DST / LPA HIV positive HIV negative Collect one sputum specimen for a repeat GXP Collect one specimen for culture and LPA or culture and DST (for R and H) Treat with antibiotics and review after 5 days Do chest x-ray Treat with antibiotics Follow up with microscopy Collect one specimen for microscopy, culture and DST for Rifampicin, Isoniazid, fluoroquinolone and Aminoglycoside Poor response to antibiotics Clinically TB TB on chest x-ray LPA/ DST results Resistant to R and H/ R only Good response No further follow up Advise to return when symptoms recur Poor response Consider other diagnosis Refer for further investigation Follow up with microscopy and culture Treat as TB Start on Regimen 1 Review culture results Treat as MDR-TB Refer to MDR-TB Unit

11 Streptomycin is indicated for: 1. All categories of DS TB 2. All categories of retreatment TB 3. For patients that cannot tolerate first line TB medication 4. All of the above 5. None of the above

12 TB Treatment if unable to treat with standard first line Rx Missing drug Possible regimen Duration of treatment INH Rifampicin Rifampicin/INH Moxifloxacin/ rifampicin/ ethambutol Moxifloxacin/ INH/ ethambutol Moxifloxacin/ ethambutol/ streptomycin 12 months ±PZA in intensive phase 18 months(pza or streptomycin in intensive phase) 18 months PZA Rifampicin/INH/ ethambutol Nine months

13 Mechanism of TB treatment associated DILI Drug Mechanism Clinical picture RIF PZA INH Dose-dependent interference with bilirubin uptake ±hypersensitivity reaction Dose-dependent and idiosyncratic hepatotoxicity Free radical generation: toxic to hepatocytes Onset: Transient, early in treatment Subclinical, Jaundice without hepatocellular damage, Unconj Bil. May potentiate hepatotoxic effects of other drugs. Hypersensitivity reactions with eosinophilia and liver injury or granulomatous hepatitis. More damage in liver with pre-existing disease. Onset: Within weeks to months. Rechallenge does not always elicit a rapid recurrence of hepatotoxicity **Alcohol consumption doubles rate of probable INH hepatitis

14 Definition of DILI SA HIV Clinician s Society DILI guidelines: ALT level > 120 IU/L and symptomatic (Nausea, vomiting, abdominal pain, jaundice) or ALT level >200 IU/L and asymptomatic or Total serum bilirubin concentration > 40 umol/l

15 Risk factors for DILI Modifiable HIV infection Hepatitis B Surface antigen positivity Hepatitis C coinfection Malnutrition Hypo-albuminaemia Abnormal baseline ALT Alcohol use Non-modifiable Underlying liver disease Age >35 years Childhood Slow acetylator status Female sex

16 Management of TB DILI Limited data Most guidelines are based on expert opinion

17 Principles of TB DILI management Moderate to severe liver damage STOP drugs Investigate for other causes of hepatitis Confirm the diagnosis of TB Green card Intensive phase/ continuation phase Search for pending TB culture results Re-investigate for TB

18 TB Drug Rechallenge in DILI If patient presented in liver failure: TB drug re-challenge is not recommended Otherwise, re-challenge Rates of DILI recurrence in re-challenge is 12 % Rechallenge method: Regimen Rechallenge vs Sequential Drug Rechallenge - latter in full doses vs incremental doses RCT data on Rates of DILI recurrence by type of Rechallenge method: Regimen Rechallenge (14%) vs Sequential Drug Rechallenge in full (10%) vs incremental (9%) doses

19 Case 1 Miss HS is a HIV positive 34 year old female. She is clinically stable on an FDC. She is diagnosed with TB Lymphadenopathy based on AFB demonstrated in LN aspirate following a 2 month duration of fever and LOA. She tolerates TB Rx well and has resolution of constitutional symptoms. On routine LFT is as follows: ALT= 79 IU/L Normal Total bilirubin AST= 60 IU/L Normal ALP and GGT

20 What is the most appropriate management? 1. Refer for admission, Stop TB treatment, Stop ART 2. Continue TB treatment and ART, discharge from follow up 3. Continue TB treatment and ART, repeat ALT and Bili in 1 week 4. Continue TB treatment and ART, repeat ALT and Bili daily

21 What is the most appropriate management? 1. Refer for admission, Stop TB treatment, Stop ART 2. Continue TB treatment and ART, discharge from follow up 3. Continue TB treatment and ART, repeat ALT and Bili in 1 week 4. Continue TB treatment and ART, repeat ALT and Bili daily

22 Mild DILI Clinically well ALT <200 and Total Bili <40 Continue TB drugs Continue ART if already initiated Repeat ALT and Bili in 1 week If ALT and bili improving or normal then stop Lab monitoring If ALT and Bili continue to rise, treat as moderate or severe DILI

23 Moderate DILI Clinically well ALT> 200 irrespective of Total Bili Stop TB regimen Discontinue Bactrim prophylaxis and other hepatotoxic drugs Start ETH/ MOX/ STR if treatment necessary Stop ART unless on a stable ART regimen for > 6 months Repeat ALT and Bili in 3 (Inpt) or 7 (Outpt) days When ALT < 100 and Bili is normal, attempt rechallenge

24 TB Drugs in Renal failure INH, rifampicin, PZA : biliary excretion normal doses Streptomycin and ethambutol : can maintain at reduced dose monitor for uveitis Safest regimen: INH, Rifampicin, pyrazinamide X 4 months followed by INH and Rifampicin x 2 months

25 Managing TB treatment Interruption Less than 1 month: extend treatment for the number of days that patient did not take treatment 1-2 months missed: do genexpert Sensitive: add number of days that patient did not take treatment. Resistant: stop treatment: refer to MDR-TB unit More than 2 months missed (loss to follow up) do genexpert Sensitive : restart treatment Resistant : refer MDR-TB

26 Integration of TB HIV Services Screening for TB and HIV at same visit Early initiation of ARVs Co-management of Drug toxicities common to both Consideration of Drug interactions Early detection and management of TB IRIS Initiation of INH prophylaxis

27 In TB co-infection, start with TB treatment first, followed by ART as soon as possible and within 8 weeks If CD4 <50 cells/μl initiate ART within 2 weeks of starting TB treatment, when the patient s symptoms are improving and TB treatment is tolerated If CD4 >50 cells/μl initiate ART within 2-8 weeks of starting TB treatment In cryptococcal or TB meningitis: Defer ART initiation for 4-6 weeks

28 Integrated service delivery TB service One-stop service HIV service TB screening NO To Referral HIV testing ART CPT Condoms HIV and TB Services provided together ART TB diagnosis and treatment IPT TB diagnosis TB treatment TB contact tracing NO To Referral Partially integrated Co-located Adjacent Partially integrated Models for integrated TB and HIV services delivery Source: WHO

29 Concerns of co-treating TB and HIV Overlapping Toxicity Drug Interactions IRIS

30 What are the overlapping drug toxicities with TB treatment and ARVs? 1. Liver Injury 2. Rash 3. Psychosis 4. All of the above

31 Overlapping Toxicities with co-rx of HIV and TB Side-effect Antiretroviral drug TB Therapy Nausea & vomiting Hepatitis Peripheral neuropathy Didanosine, Zidovudine, Ritonavir Nevirapine Efavirenz Stavudine Didanosine Pyrazinamide Rifampicin Isoniazid Pyrazinamide Isoniazid Rash Nevaripine Efavirenz Rifampicin Isoniazid Pyrazinamide Ethambutol Psychosis EFV INH/Ethambutol

32 What are the overlapping drug toxicities with TB treatment and ARVs? 1. Liver Injury 2. Rash 3. Psychosis 4. All of the above

33 Case 2 Mrs AA is HIV + since She was initially started on TDF / 3TC and EFV. In 2014, she was changed to ABC / 3TC and Alluvia due to treatment failure. She now presents with night sweats, loss of appetite and abdominal pain. The Gene Xpert test on ascitic fluid is positive for Rif sensitive MTB

34 How to do you manage further? 1. Start TB Rx, double the dose of Aluvia immediately 2. Start TB Rx, double the dose of Aluvia over 2 weeks 3. Double the dose of Aluvia over 2 weeks then start TB Rx

35 How to do you manage further? 1. Start TB Rx, double the dose of Aluvia immediately 2. Start TB Rx, double the dose of Aluvia over 2 weeks 3. Double the dose of Aluvia over 2 weeks then start TB Rx

36 Mrs AA improves on TB Rx and completes the course. Her symptoms and signs have resolved, and her exit sputum is negative for AFB. How do you manage further? 1. Reduce Aluvia dose to 2T bd immediately 2. Continue TB Rx for two weeks longer 3. Continue the double dose (4T bd) of Aluvia until 2 weeks after TB Rx is completed

37 Mrs AA improves on TB Rx and completes the course. Her symptoms and signs have resolved, and her exit sputum is negative for AFB. How do you manage further? 1. Reduce Aluvia dose to 2T bd immediately 2. Continue TB Rx for two weeks longer 3. Continue the double dose (4T bd) of Aluvia until 2 weeks after TB Rx is completed

38 Case 3 Mr E has been on a second line regimen for a year. His regimen includes AZT/3TC/ATZ/rit because he had severe diarrhoea whilst on Aluvia. He now presents with fever and productive cough. His sputum Gene Xpert is positive for Rif sensitive MTB.

39 How do you manage further? 1. Commence TB treatment immediately 2. Double the dose of Atazanavir as you do for Aluvia 3. Atazanavir may not be given to patients on TB treatment. Refer to specialist 4. Stop the ART, treat TB, then restart ART

40 How do you manage further? 1. Commence TB treatment immediately 2. Double the dose of Atazanavir as you do for Aluvia 3. Atazanavir may not be given to patients on TB treatment. Refer to specialist 4. Stop the ART, treat TB, then restart ART

41 Drug Interactions: 1. RIF and EFV Previously reported that Rif caused a 30% decrease in EFV trough concentrations, particularly in patients >50kg. An increase in EFV dose recommended by FDA (USA) Later reports clearance of EFV is reduced in black African patients, due to CYP enzyme polymorphisms (therefore drug levels actually increased by 30-50%) No increase in EFV dose recommended in SA

42 2. RIF and PI PI metabolized by CYP 3A4: induced by Rifampicin and inhibited by Ritonavir Significant reduction of plasma drug levels of most PI s, except Ritonavir LPV/r (Aluvia): Ritonavir boosted Lopinavir (400/100mg) Increase Ritonavir to 400mg daily to overcome the enzyme induction double Aluvia dose Usual 2T BD, increased to 3T BD for 1 wk then 4T BD Maintain escalated dose of PI until 2 wks after TB Rx completion Rif accelerated Atazanavir/r metabolism, cannot be overcome by boosting with Ritonavir Referral to higher centre to change PI or change Rifampicin to Rifabutin

43 TB IRIS TB diagnosed & treatment started before ART initiation No TB diagnosis before ART initiation ART Initiation Clinical deterioration of TB as a result of ART-induced immune recovery = Paradoxical TB IRIS Atypical inflammatory presentation of TB as a result of ART-induced immune recovery = Unmasking IRIS Lawn Expert Rev Anti Infect Ther, 2011.

44 TB IRIS incidence, risk factors and outcomes Unmasking TB IRIS Incidence 4.8% (most common ) Paradoxical TB-IRIS Incidence 18% Onset 14 days after ART initiation in 48% Hospitalisation 25% Mortality 7%, death attributed to TB IRIS 2% Increased mortality in CNS IRIS Risk Factors: Low CD4 count, Short interval between TB treatment and ART, Disseminated TB

45 TB IRIS Management Double-blind, placebo-controlled RCT Intervention: Prednisone 1.5mg/kg/day x 2 wks then 0.75mg/kg/day x 2 wks Primary outcome = hospital days Findings: Steroid arm - fewer days in hospital and fewer procedures. IRIS associated mortality same in both arms, except CNS disease Excl other causes of patient deterioration: MDR TB etc

46 What are the current guidelines for IPT for patients on ART? months IPT for all patients months IPT for all patients 3. 6 months IPT for all patients months IPT for TST positive, 12 months for TST negative, 6 months for TST unknown

47 INH Prophylaxis

48 What are the current guidelines for IPT for patients on ART? months IPT for all patients months IPT for all patients 3. 6 months IPT for all patients months IPT for TST positive, 12 months for TST negative, 6 months for TST unknown

49 Questions Are patients eligible for more IPT post TB therapy completion? 1. Yes: can be started immediately after TB treatment in all patients 2. No: patients no longer at risk for TB, having just completed TB treatment 3. Yes: can be started immediately after TB treatment but only in patients with documented bacteriologic cure

50 Questions Are patients eligible for more IPT post TB therapy completion? 1. Yes: can be started immediately after TB treatment in all patients 2. No: patients no longer at risk for TB, having just completed TB treatment 3. Yes: can be started immediately after TB treatment but only in patients with documented bacteriologic cure

51 Summary Diagnostic algorithm for DR and DS TB Retreatment TB: Revised definitions and treatment regimen ART initiation in TB patients Special considerations: Aluvia with TB treatment Atazanivir in TB Ethambutol in Renal failure Moxifloxacin and streptomycin indications TB prevention in HIV infected patients

52 Acknowledgements This training was supported by the Grant or Cooperative Agreement Number U2G GH001142, funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the presenters and do not necessarily represent the official views of the U.S. Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services

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