CROI 2016 Abstract eBook

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Poster Abstracts

constructed for HIV-infected patients to determine whether ART use during MDR-TB therapy is independently associated the following outcomes: 1) increased treatment success and 2) reduced death. Results: Of the 437 MDR-TB patients included in the analysis, 301 (68.9%) were HIV infected and 261 (86.7%) of those received ART. Overall, 343 (78.5%; 95% confidence interval [CI]=74.4%-82.1%) achieved treatment success, 79 (18.1%; 95% CI=14.8%-22.0%) died, and 15 (3.4%; 95% CI=2.1%-5.6%) failed treatment of defaulted. Treatment success rates were 82.3%, 81%, and 55.0% among patients who were HIV-uninfected, HIV-infected and on ART, and HIV-infected and not on ART, respectively ( P < 0.001; Figure). Death during treatment occurred among 13.2%, 19.2%, and 27.5% of patients who were HIV-uninfected, HIV-infected and on ART, and HIV-infected and not on ART, respectively ( P < 0.093; Figure). Among HIV-infected patients, ART use remained independently associated with treatment success (adjusted odds ratio [aOR]=3.5; 95% CI=1.5-8.0) after controlling for age, baseline CD4 count, number of drugs in the original regimen, and year of treatment initiation. The effect of ART use on preventing death did not reach statistical significance in multivariable analysis (aOR=0.6; 95% CI=0.3-1.5). Conclusions: High rates of treatment success can be achieved programmatically among HIV-infected MDR-TB patients on ART, similar to that among HIV-uninfected patients. HIV-infected MDR-TB patients continue to experience unacceptably high rates of death, particularly among patients not on ART.

756 Hearing Loss and Laboratory Adverse Events in Patients With MDR TB and HIV on ART James C. Brust 1 ; N. Sarita Shah 2 ; Salim Allana 3 ;Thuli Mthiyane 4 ; Koleka Mlisana 5 ; Pravi Moodley 5 ; Iqbal Master 6 ;Yuming Ning 7 ; Neel Gandhi 8 1 Albert Einstein Coll of Med, Bronx, NY, USA; 2 CDC, Atlanta, GA, USA; 3 Rollins Sch of PH, Emory Univ, Atlanta, GA, USA; 4 Univ of KwaZulu-Natal, Westville, South Africa; 5 Univ of KwaZulu-Natal, Durban, South Africa; 6 King Dinuzuu Hosp Complex, Durban, South Africa; 7 Montefiore Med Cntr, Bronx, NY, USA; 8 Emory Univ Rollins Sch of PH, Atlanta, GA, USA Multidrug-resistant tuberculosis (MDR TB) is associated with poor outcomes and high mortality in patients with HIV. Concurrent treatment for both diseases is recommended, but there are concerns about potentially additive toxicities, given the known and frequent side effects fromMDR TB therapy and HIV treatment individually, as well as organ toxicity from HIV itself. South Africa has one of the world’s worst epidemics of MDR TB and more than 80% of patients are HIV co-infected. Current guidelines are based on expert opinion, given the lack of high-quality prospective data. Methods: We conducted an observational study of patients with culture-confirmed MDR TB with and without HIV co-infection. Subjects were followed monthly to assess treatment response and adverse effects. Audiology was performed monthly during the intensive phase; safety labs were performed every month throughout therapy and thyroid stimulating hormone (TSH) was tested every 3 months. Abnormal laboratory results were graded using the DAIDS Toxicity Table. We calculated the proportion of subjects experiencing hearing loss, and changes in creatinine, ALT, TSH, and potassium. Results: Among the 206 enrolled subjects, 150 were HIV-infected, all of whom received antiretroviral therapy (ART). 131 (64%) were female, and the median age was 33 years (IQR 26-41). 56% of subjects experienced some degree of hearing loss (grade ≥1) and 9% developed severe (grade ≥3) loss. 40% developed hypothyroidism necessitating levothyroxine replacement therapy. Abnormalities of creatinine, ALT and potassiumwere common (23%, 20%, & 49% of subjects, respectively), but most were Grade 1 and resolved spontaneously. Grade ≥3 abnormalities were seen in only 5%, 4% and 5% of subjects respectively. None of the laboratory AEs examined were more common or more severe in subjects co-infected with HIV and receiving concurrent ART. Conclusions: Hearing loss and laboratory AEs are common among all MDR TB patients, yet co-infection with HIV and the addition of ART does not significantly increase their frequency or severity, despite the frequent co-administration of kanamycin and tenofovir. Given the high incidence of hearing loss and hypothyroidism, programs should ensure that proper monitoring, as recommended, occurs for all patients, regardless of HIV status. Although nephrotoxicity, hepatitis, and hyper/hypokalemia occurred, these events were rarely severe and were not more common in patients with HIV receiving concurrent ART. 757 Burden of Tuberculosis in HIV+ Pregnant & PostpartumWomen in Cape Town, South Africa Jasantha Odayar 1 ; Molebogeng Rangaka 2 ; Allison Zerbe 3 ; Greg Petro 1 ;Tamsin Phillips 1 ; James McIntyre 4 ; Elaine J. Abrams 5 ; Landon Myer 1 1 Univ of Cape Town, Cape Town, South Africa; 2 Univ Coll London, London, UK; 3 ICAP at Columbia Univ, New York, NY, USA; 4 Anova Hlth Inst, Johannesburg, South Africa; 5 ICAP, Columbia Univ Mailman Sch of PH, New York, NY, USA Background: Tuberculosis (TB) is a major concern in HIV+ individuals and antiretroviral therapy (ART) programmes but little attention is paid to TB in the context of pregnancy and PMTCT services. We investigated the burden of tuberculosis before, during and after pregnancy in a cohort of HIV+ women accessing antenatal care services under Option B+. Methods: Consecutive women making their first visit at a primary care antenatal clinic completed a brief questionnaire, underwent CD4 enumeration, and had an ultrasound for pregnancy dating. TB diagnoses were via passive detection by routine public sector services based on symptom screening with or without bacteriologic confirmation. TB diagnoses were obtained through TB notification data for the period extending from 18 months before the estimated date of conception to 6 months postpartum. In analysis Poisson methods were used to compare the incidence of TB pre-conception, during pregnancy and postpartum per 100 person-years (py). Results: Among 1507 HIV+ women (mean age, 29 years), 989 initiated ART in pregnancy (66%; median CD4 377 cells/uL, IQR 250-543) and 34% (n=518; median CD4 391 cells/ uL, IQR 271-527) were already on ART at the time of conception. Overall incidence of TB pre-conception, during pregnancy and postpartumwas 2.4 (95% CI, 1.8-3.2), 1.1 (95% CI, 0.6-1.9) and 1.4 (95% CI, 0.7-2.7) per 100py, respectively. 79% of cases were first TB episodes, with 21% retreatment cases; retreatment cases accounted for 18%, 23% and 40% of cases in the pre-conception, pregnancy and postpartum periods. 78% of TB cases were pulmonary (66% bacteriologically confirmed) and 22%were extrapulmonary (18% bacteriologically confirmed); this did not vary by pregnancy status. Overall TB incidence was doubled in women with CD4 cell count <200 cells/uL (IRR 1.96; p=0.007). After

Poster Abstracts

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CROI 2016