TB and HIV Co-infection Research Update. Tennessee 2016 Clinical TB Symposium April Pettit, MD, MPH March 30, 2016
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1 TB and HIV Co-infection Research Update Tennessee 2016 Clinical TB Symposium April Pettit, MD, MPH March 30, 2016
2 Objectives 1. Describe the epidemiology of TB-HIV co-infection nationally, statewide, and locally in order to achieve early diagnosis and timely treatment for this population. 2. Identify risk factors for poor outcomes among TB-HIV co-infected persons to prevent transmission and to improve diagnosis and treatment outcomes. 3. Discuss challenges in the diagnosis and management of TB in persons with HIV co-infection to improve completion of treatment and treatment outcomes.
3 Case 25yo African American man with diarrhea, subjective fevers/chills, and 30 pound weight loss he denies respiratory symptoms. PMH: HIV (CD4+ 32, VL 298K) ART naïve PE unremarkable aside from being underweight TST no induration Patient had no cough and was unable to produce an induced sputum specimen ART was initiated Manabe et. al. JID 2009; 199(3):
4 20 days later. Patient presented with fever to 104 and cough TST was repeated-24mm induration Induced sputum AFB smear negative BAL AFB smear negative All cultures several weeks later subsequently grew drugsusceptible MTB Manabe et. al. JID 2009; 199(3):
5 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons Clinical Manifestations Diagnosis Treatment Timing of HAART initiation
6 TB Case Rates,* United States, 2014 D.C. < 3.0 (2014 national average) >3.0 *Cases per 100,000.
7 Question What is the estimated proportion of TB cases in the US and Tennessee are co-infected with HIV? A. 2% B. 5% C. 10% D. 20%
8 Estimated HIV Coinfection in Persons Reported with TB, United States, * 60 All Ages % Coinfection All Ages *Updated as of June 5, Note: Minimum estimates based on reported HIV-positive status among all TB cases in the age group.
9 HIV Coinfection in Persons Reported with TB, Tennessee, All ages % Coinfection Year All ages
10 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons CD4, ART, LTBI Clinical Manifestations Diagnosis Treatment Timing of HAART initiation
11 ? HIV Exposure Infection (LTBI) 10-30% HIV No Infection 70-90% Latent Infection 70-90% Primary Active Disease 10-30% HIV Reactivation Schaaf eds. Tuberculosis: A Comprehensive Clinical Reference 1 st Edition. Elsevier; 2009.
12 CD4 and TB Risk 1130 HIV+ persons not on ART (U.S.: Pulmonary Complications of HIV Study Group) TB risk greater with lower CD4 count CD4 < 200: 1.2 TB cases per 100 p-y CD4 > 200: 0.5 TB cases per 100 p-y RR: 2.4 (95% CI: 1.1, 5.2) Markowitz et. al. Ann Intern Med 1997;126: HIV+ persons receiving ART (South Africa) TB risk associated only with current CD4 count (within 4 months) 25% decrease in TB risk per 100 cell in CD4 count Lawn et. al. AIDS 2006;20:
13 ART and TB Risk TB rate per 100,000 person-years: No ART ART HAART U.S (40% ) 190 (80% ) S. Africa (81% ) Jones et. al. Int J Tuberc Lung Dis 2000;4: Badri et. al. Lancet 2002;359:
14 ART and TB risk Intention to Treat (ITT) Time Interval TB Follow-up TB incidence (per 100K p-y) cases (p-y) Off HAART 31 33, , 132 HAART initiation-<3 months 8 5, , 302 >3 months -<6 months 13 5, , 434 >6 months , , 55 Overall , , 78 Pettit et. al. JAIDS (in press).
15 Hypothesis 1: Immune Reconstitution Inflammatory Syndrome (IRIS) Meintjes et. al. Lancet Infect Dis August ; 8(8):
16 Hypothesis 2: ART Started at low CD4 Marginal Structural Model Adjusting for time-updated CD4 and ART exposure Characteristic HAART status Not on HAART <6 months of HAART >6 months of HAART ITT Analysis aor* (95% CI) Reference 0.65 (0.28, 1.51) 0.29 (0.16, 0.53) Pettit A. JAIDS 2011;57(4): Pettit et. al. JAIDS (in press).
17 LTBI Prevalence Characteristic Est popln N x (1,000) TST LTBI Prev (95% CI) Est. popln w/ LTBI x (1,000) QFT-GIT LTBI Prev (95% CI) Est. popln w/ LTBI x (1,000) All participants 282, ( ) 12,398 (8,869-17,230) 4.8 ( ) 13,628 (11,411-16,241) Characteristic # of NHANES subjects TST LTBI Prev (95% CI) Est. popln w/ LTBI x (1,000) QFT-GIT LTBI Prev (95% CI) All participants ( ) Est. popln w/ LTBI x (1,000) 49 (13-164) Mancuso et. al. AJRCCM 2016 [Epub ahead of print].
18 HIV and LTBI reactivation risk Est # Cases Est % of US Popln w/ LTBI Est US popln Est p-y at risk for TB Est Rate TB per 100 p-y HIV+ 2, , , ( ) HIV- 16, ,243,000 22,850, ( ) >20x Shea et. al. AJE 2014; 179(2):
19
20 Question CDC Guidelines for the prevention of TB disease state that testing for latent TB infection should occur for ALL HIV-infected persons: A. At the time of HIV diagnosis AND yearly after the first test regardless of risk B. At the time of HIV diagnosis regardless of risk AND yearly after the first test only if other risk factors are identified C. At the time of HIV diagnosis only if other risk factors are identified AND subsequent testing is not indicated
21 LTBI Testing Guidelines All persons should be tested for LTBI at the time of HIV diagnosis regardless of risk Persons with negative diagnostic tests for LTBI and CD4+ <200 should be retested once they start ART and CD4+>200 Annual testing with high risk persons: incarceration, congregate settings, active drug users, etc
22 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons Clinical Manifestations Diagnosis Treatment Timing of HAART initiation
23 Clinical Manifestations Symptom Sensitivity 95% CI Specificity 95% CI Likelihood Ratio Negative Cough 38.5 ( ) 81.8 ( ) ( ) Fever 42.8 ( ) 79.8 ( ) ( ) Night sweats 31.4 ( ) 82.2 ( ) ( ) Weight loss 49.3 ( ) 71.1 ( ) ( ) Any 78.9 ( ) 49.6 ( ) ( ) Getahun et. al. PLoS Medicine 2011; 8 (1): e
24 Extrapulmonary TB Jones et. al. AJRCCM 1993; 148:
25 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons Clinical Manifestations Diagnosis Treatment Timing of HAART initiation
26 Diagnosis-Chest Radiography CXR N=124 HIV+ N=72 HIV- N=52 P-value Focal infiltrate 38 (53%) 46 (89%) <0.01 Upper lobe 19 (26%) 32 (62%) <0.01 infiltrate Cavitary Disease 5 (7%) 23 (44%) <0.01 LAD 28 (39%) 6 (12%) <0.01 Normal 8 (11%) 3 (6%) NS Alpert et. al. CID 1997; 24:
27 Diagnosis-Sputum Smear Smear status N=107 HIV+ N=64 HIV- N=43 AFB+, Number (%) % AFB-, Number (%) % % % Alpert et. al. CID 1997; 24:
28 Diagnosis-Sputum Culture Culture status N=189 HIV+ N=165 HIV- N=124 Culture+, Number (%) % Culture-, Number (%) % % % Crampin et. al. IJTLD 2001; 5(11):
29 Diagnosis-Xpert MTB/RIF HIV Status Overall Sensitivity Smear Negative Sensitivity Smear Positive Sensitivity All 86 (76, 92) 67 (60-74) 98 (97-99) Positive 79 (70, 86) 61 (40-81) 97 (90-99) Steingart et. al. Cochrane Review 2014.
30 Diagnosis-Xpert Sample Pooled Sensitivity Estimate CSF Cannot Calculate Pleural Fluid 34 (24-44%) Non-pleural serous Fluid Cannot Calculate All tissue 88 (77-95%) Lymph node 96 (72-99%) Gastric Aspirate 78 (69-86%) Smear positive 95 (91-100%) Smear negative 69 (60-80%) Maynard-Smith et. al. BMD Infec Dis 2014; (14): 709.
31 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons Clinical Manifestations Diagnosis Treatment Timing of HAART Initiation
32 Initiation Phase=2 months HRZE Interval Daily throughout (5-7 days per week) as DOT Intermittent therapy associated with treatment failure or relapse with acquired rifamycin resistance CDC. MMWR Vol 52. No-RR11.
33 Initiation Phase=2 months HRZE Regimen INH 300mg daily No ART interactions PZA dosed by weight No ART interactions EMB dosed by weight and discontinued when susceptibilities known (unless PZA not used) No ART interactions CDC. MMWR Vol 52. No-RR11.
34 Initiation Phase=2 months HRZE Rifampin 600mg daily If patient is on NNRTI (usually Nevirapine or Efavirenz) based regimen Weight-based dosing of Efavirnez is not required Rifabutin 300mg daily If patient is on PI-based regimen, decrease Rifabutin dose to 150mg daily If patient is on Integrase Inhibitor based therapy (Raltegravir), no dosing changes are needed CDC. MMWR Vol 52. No-RR11.
35 Question The dosing interval in the continuation phase for HIV-infected persons can be: A. Daily B. Once-weekly C. Twice-weekly D. Three times weekly E. A or D
36 Continuation Phase Interval Daily throughout (5-7 days per week) as DOT Once or twice weekly intermittent therapy associated with treatment failure or relapse with acquired rifamycin resistance Thrice weekly intermittent therapy Not studied adequately in clinical trials No increased risk of adverse outcomes in observational studies and meta-analyses CDC. MMWR Vol 52. No-RR11.
37 Continuation Phase Regimen INH 300mg daily or 900mg tiw RIF 600mg daily /tiw OR RBT 300mg daily /tiw Duration-optimum unknown 4 months is recommended 4-7 months for bone/joint 7 months +ve cultures after intensive phase 7-10 months for CNS disease CDC. MMWR Vol 52. No-RR11.
38 HIV and Relapse Adjusted Odds of Relapse Stratified by Use of ART Khan et. al. CID 2012; 55:
39 Therapeutic Drug Monitoring HIV-infected persons have MANY reasons for low anti-tb drug levels Drug-drug interactions due to Antiretroviral medications Treatment for other opportunistic infections Multi-way interactions between treatment for both of the above Malabsorption in the setting of malnutrition or diarrhea Alsultan& Peloquin. Drugs 2014; 74:
40 Therapeutic Drug Monitoring *Significant correlation between CD4 and urinary RMP. Gurumurthy et. Al. CID 2004; 38:
41 Outline Epidemiology of TB/HIV co-infection Risk of TB disease among HIV-infected persons Clinical Manifestations Diagnosis Treatment Timing of HAART Initiation
42 When to Start ART Favors early start: Improved survival Decreased risk of additional opportunistic infections May improve TB outcomes Favors delayed start: Large pill burden leads to decreased adherence Drug-drug interactions Overlapping side effects Immune reconstitution inflammatory syndrome (IRIS)
43 ACTG 5221 STRIDE Study Immediate (within 2 weeks of TB tx) to early ART (within 8-12 weeks of TB tx) Havlir et. al. NEJM 2011; 365 (16):
44 Guidelines-When to Start ART ART is recommended in all HIV-infected persons with TB (AI) Sequential treatment NOT recommended Within 2 weeks if CD4<50 (AI) Within 8-12 weeks if CD4>50 (AI)
45 Conclusions TB/HIV coinfection remains an important public health problem in the US. CD4, antiretroviral therapy, and latent TB infection are all important risk factors for TB disease in HIVinfected person. TB disease can be difficult to diagnose in HIVinfected persons. If clinical improvement is slower than expected, consideration should be given to longer continuation phase duration and/or therapeutic drug monitoring.
46 Questions?
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