Dataset Information

The Effect of Timing of Initiation of Antiretroviral Therapy on Loss to Follow-up in HIV-Tuberculosis Coinfected Patients in South Africa: An Open-Label, Randomized, Controlled Trial.

ABSTRACT: OBJECTIVE:To evaluate the effect of early integrated, late-integrated, and delayed antiretroviral therapy (ART) initiation during tuberculosis (TB) treatment on the incidence rates of loss to follow-up (LTFU) and to evaluate the effect of ART initiation on LTFU rates within trial arms in patients coinfected with TB and HIV. METHODS:A substudy within a 3-armed, open label, randomized, controlled trial. Patients were randomized to initiate ART either early or late during TB treatment or after the TB treatment completion. We reported the incidence and predictors of LTFU from TB treatment initiation during the 24 months of follow-up. LTFU was defined as having missed 4 consecutive monthly visits with the inability to make contact. RESULTS:Of the 642 patients randomized, a total of 96 (15.0%) were LTFU at a median of 6.0 [interquartile range (IQR), 1.1-11.3] months after TB treatment initiation. Incidence rates of LTFU were 7.5 per 100 person-years (PY) [95% confidence interval (CI): 4.9 to 11], 10.9 per 100 PY (95% CI: 7.6 to 15.1), and 11.0 per 100 PY (95% CI: 7.6 to 15.4) in the early integrated, late-integrated, and delayed treatment arms (P = 0.313). Incidence rate of LTFU before and after ART initiation was 31.7 per 100 PY (95% CI: 11.6 to 69.0) vs. 6.1 per 100 PY (95% CI: 3.7 to 9.4); incidence rate ratio (IRR) was 5.2 (95% CI: 2.1 to 13.0; P < 0.001) in the early integrated arm; 31.9 per 100 PY (95% CI: 20.4 to 47.5) vs. 4.7 per 10 PY (95% CI: 2.4 to 8.2) and IRR was 6.8 (95% CI: 3.4 to 13.6; P < 0.0001) in the late-integrated arm; and 21.9 per 100 PY (95% CI: 14.6 to 31.5) vs. 2.8 per 100 PY (95% CI: 0.9 to 6.6) and IRR was 7.7 (95% CI: 3.0 to 19.9; P < 0.0001) in the sequential arm. CONCLUSION:LTFU rates were not significantly different between the 3 trials arms. However, ART initiation within each trial arm resulted in a significant reduction in LTFU rates among TB patients.

SUBMITTER: Yende-Zuma N

PROVIDER: S-EPMC4927384 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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The Effect of Timing of Initiation of Antiretroviral Therapy on Loss to Follow-up in HIV-Tuberculosis Coinfected Patients in South Africa: An Open-Label, Randomized, Controlled Trial.

Yende-Zuma Nonhlanhla N Naidoo Kogieleum K

Journal of acquired immune deficiency syndromes (1999) 20160801 4

<h4>Objective</h4>To evaluate the effect of early integrated, late-integrated, and delayed antiretroviral therapy (ART) initiation during tuberculosis (TB) treatment on the incidence rates of loss to follow-up (LTFU) and to evaluate the effect of ART initiation on LTFU rates within trial arms in patients coinfected with TB and HIV.<h4>Methods</h4>A substudy within a 3-armed, open label, randomized, controlled trial. Patients were randomized to initiate ART either early or late during TB treatmen ...[more]

PMID: 26990824

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Project description:The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial.In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim-sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause.This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P=0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups.The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (ClinicalTrials.gov number, NCT00398996.)

Project description:BACKGROUND:Although antiretroviral therapy (ART) is known to be associated with time-dependent reductions in tuberculosis (TB) incidence, the long-term impact of ART on incidence remains imprecisely defined due to limited duration of follow-up and incomplete CD4 cell count recovery in existing studies. We determined TB incidence in a South African ART cohort with up to 8 years of follow-up and stratified rates according to CD4 cell count recovery. We compared these rates with those of HIV-uninfected individuals living in the same community. METHODOLOGY/PRINCIPAL FINDINGS:Prospectively collected clinical data on patients receiving ART in a community-based cohort in Cape Town were analysed. 1544 patients with a median follow-up of 5.0 years (IQR 2.4-5.8) were included in the analysis. 484 episodes of incident TB (73.6% culture-confirmed) were diagnosed in 424 patients during 6506 person-years (PYs) of follow-up. The TB incidence rate during the first year of ART was 12.4 (95% CI 10.8-14.4) cases/100PYs and decreased to 4.92 (95% CI 3.64-8.62) cases/100PYs between 5 and 8 years of ART. During person-time accrued within CD4 cell strata 0-100, 101-200, 201-300, 301-400, 401-500, 501-700 and ?700 cells/µL, TB incidence rates (95% CI) were 25.5 (21.6-30.3), 11.2 (9.4-13.5), 7.9 (6.4-9.7), 5.0 (3.9-6.6), 5.1 (3.8-6.8), 4.1 (3.1-5.4) and 2.7 (1.7-4.5) cases/100PYs, respectively. Overall, 75% (95% CI 70.9-78.8) of TB episodes were recurrent cases. Updated CD4 cell count and viral load measurements were independently associated with long-term TB risk. TB rates during person-time accrued in the highest CD4 cell count stratum (>700 cells/µL) were 4.4-fold higher that the rate in HIV uninfected individuals living in the same community (2.7 versus 0.62 cases/100PYs; 95%CI 0.58-0.65). CONCLUSIONS/SIGNIFICANCE:TB rates during long-term ART remained substantially greater than rates in the local HIV uninfected populations regardless of duration of ART or attainment of CD4 cell counts exceeding 700 cells/µL.

Dataset Information

The Effect of Timing of Initiation of Antiretroviral Therapy on Loss to Follow-up in HIV-Tuberculosis Coinfected Patients in South Africa: An Open-Label, Randomized, Controlled Trial.

Publications

The Effect of Timing of Initiation of Antiretroviral Therapy on Loss to Follow-up in HIV-Tuberculosis Coinfected Patients in South Africa: An Open-Label, Randomized, Controlled Trial.

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