Treatment of tuberculosis in HIV-infected patients: safety and antiretroviral efficacy of the concomitant use of ritonavir and rifampin

Moreno, Santiago; Podzamczer, Daniel; Blázquez, R.; Iribarren, José Antonio; Ferrer, Elena; Repáraz, Jesús; Pena, José M.; Cabrero, Esther; Usán, Luis

doi:10.1097/00002030-200106150-00018

Cited by 39 publications

(19 citation statements)

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“…This limits the direct application of our results to many countries with high rates of HIV-related TB in which rifampin is the only available rifamycin antibiotic. However, some potent antiretroviral regimens (e.g., efavirenz or ritonavir with two nucleoside analogs) can be used with rifampin-based TB therapy (11,34), and should allow patients to obtain the benefits of potent antiretroviral therapy given during TB treatment.…”

Section: Discussionmentioning

confidence: 99%

“…Rifampin markedly decreases serum concentrations of the HIV-1 protease inhibitors (11), and has substantial effects on concentrations of two of the available nonnucleoside reversetranscriptase inhibitors (delavirdine and nevirapine) (12), thus limiting the choice of antiretroviral drugs. An alternate rifamycin antibiotic, rifabutin, has much less effect on serum concentrations of these antiretroviral drugs (12) and appears to be as potent as rifampin for the treatment of TB (13)(14)(15).…”

mentioning

confidence: 99%

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Acquired Rifamycin Resistance with Twice-Weekly Treatment of HIV-related Tuberculosis

Burman

Benator

Vernon

et al. 2006

Am J Respir Crit Care Med

135

114

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Rationale: Rifabutin was recommended in place of rifampin during treatment of HIV-related tuberculosis (TB) to facilitate concomitant potent antiretroviral therapy, but this approach has not been evaluated in a prospective study. Objective: To evaluate the activity of intermittent rifabutin-based therapy. Methods: Patients with culture-confirmed TB were treated under direct supervision with 2 mo of rifabutin, isoniazid, pyrazinamide, and ethambutol (given daily, thrice-weekly, or twice-weekly per the local tuberculosis control program), followed by 4 mo of twiceweekly rifabutin plus isoniazid. Measurements: Culture-positive treatment failure or relapse. Main Results: A total of 169 eligible patients were enrolled. Most had advanced HIV disease; the median CD4 cell count and HIV-RNA level were 90 cells/mm 3 (interquartile range, 35-175) and 5.3 log 10 copies/ml (interquartile range, 4.8-5.7), respectively. Nine (5.3%) patients had culture-positive treatment failure (n ϭ 3) or relapse (n ϭ 6). Eight of these nine (89%) cases had isolates with acquired rifamycin resistance. Treatment failure or relapse was associated with baseline CD4 lymphocyte count, being 12.3% (9/73; 95% confidence interval, 6.5-22.0%) among patients with CD4 Ͻ 100 cells/mm 3 versus 0% (0/65; 95% confidence interval, 0.0-4.5%) among those with higher CD4 lymphocyte counts (p Ͻ 0.01). One hundred thirty-seven (81%) patients received antiretroviral therapy during TB treatment. Adverse events were common, but only two patients (1%) permanently discontinued study drugs. Conclusions: Intermittent rifabutin-based therapy for HIV-related TB was well tolerated, but there was a high risk of treatment failure or relapse with acquired rifamycin resistance among patients with low CD4 lymphocyte counts.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Acquired Rifamycin Resistance with Twice-Weekly Treatment of HIV-related Tuberculosis

Burman

Benator

Vernon

et al. 2006

Am J Respir Crit Care Med

135

114

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“…Blood samples were collected for intensive pharmacokinetic evaluation on day 6 (ATV 400), day 16 (ATV/RTV 300/100), and day 26 (ATV/RTV/RIF/des-RIF) prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3,4,5,6,8,12,16, and 24 h after dosing. In addition, trough blood samples were collected on selected days during study drug administration.…”

Section: Methodsmentioning

confidence: 99%

Effect of Rifampin on Steady-State Pharmacokinetics of Atazanavir with Ritonavir in Healthy Volunteers

Burger

Agarwala

Child

et al. 2006

Antimicrob Agents Chemother

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Mycobacterium tuberculosis is a concern in patients with human immunodeficiency virus (HIV) infection. Rifampin (RIF), an agent used against M. tuberculosis, is contraindicated with most HIV protease inhibitors. Atazanavir (ATV) has clinical efficacy comparable to a standard of care regimen in naive patients and, when dosed with low-dose ritonavir (RTV), also in treatment-experienced patients. We evaluated here the safety and pharmacokinetics of ATV, resulting from three regimens of ATV, RTV, and RIF in 71 healthy subjects. The pharmacokinetics for ATV and RTV were assessed after 6 and 10 days of dosing with ATV 400 mg (n ‫؍‬ 53) and with ATV-RTV at 300 and 100 mg (ATV/RTV 300/100; n ‫؍‬ 52), respectively. Steady-state pharmacokinetics for ATV, RTV, RIF, and desacetyl-rifampin (des-RIF) were measured after 10 days of dosing of ATV/RTV/RIF 300/100/600 (n ‫؍‬ 17), ATV/RTV/RIF 300/200/600 (n ‫؍‬ 17), or ATV/RTV/RIF 400/200/600 (n ‫؍‬ 14). An RIF 600-alone arm was enrolled as a control group (n ‫؍‬ 18). With ATV/RTV/RIF 400/200/600, ATV area under the concentration-time curve values were comparable, but the C min values were lower relative to ATV 400 alone. ATV exposures were substantially reduced for the other RIF-containing regimens relative to ATV 400 alone and for all regimens relative to ATV/RTV 300/100 alone. RIF and des-RIF exposures were 1.6-to 2.5-fold higher than with RIF 600 alone. The incidence of grade 3/4 alanine aminotransferase/aspartate aminotransferase values was limited to 1 subject each in both the ATV/RTV/RIF 300/200/600 and the ATV/RTV/RIF 400/200/600 treatments. Coadministration of ATV with RIF was safe and generally well tolerated. Since ATV exposures were reduced in all regimens, ATV and RIF should not be coadministered at the dosing regimens studied.

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“…El presente estudio aportó una protección del 80%, la cual no presentó una diferencia estadísticamente significativa, posiblemente por limitaciones en el tamaño muestral; sin embargo, se considera que es un efecto protector importante que también se ha reportado en estudios realizados en poblaciones de alta prevalencia, como Madrid, Haití y Zambia, en donde los niveles de protección encontrados para la profilaxis han sido de 87%, 71% (estimados con base en los datos de los estudios) y de 40%, respectivamente (12)(13)(14). Esta protección en el presente estudio no pudo ser evaluada en relación con el resultado de la prueba de tuberculina, ya que ésta no se aplicó en el grupo control; sin embargo, otros estudios han reportado que la protección persiste de manera independiente al resultado de esta prueba (12,(14)(15)(16)(17).…”

Section: Discussionunclassified

Efectividad de la profilaxis para enfermedad tuberculosa en pacientes infectados por el virus de la inmunodeficiencia humana, Medellín, 2002-2005

Arbeláez¹,

Arbeláez²,

Posada-Gómez³

et al. 2010

biomedica

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Introducción. La profilaxis para tuberculosis ha sido aceptada mundialmente para prevenir las formas activas de la enfermedad, especialmente, en pacientes positivos para VIH; pero en los países de alta prevalencia es aún controvertida su efectividad y sus indicaciones. Objetivo. Establecer en pacientes positivos para VIH el nivel de efectividad de dos esquemas de profilaxis contra la tuberculosis: con isoniacida durante nueve meses o pirazinamida/ rifampicina durante 60 días, suministrados en forma autoadministrada, independientemente de la respuesta a la prueba de tuberculina. Materiales y métodos. Estudio observacional de cohorte. Se conformaron dos grupos, uno con 131 pacientes, quienes voluntariamente aceptaron recibir uno de los dos esquemas profilácticos, si el de pirazinamida/rifampicina no estaba contraindicado. El grupo control estuvo conformado por 200 pacientes seleccionados retrospectivamente, a partir de los registros de un programa de control de pacientes con VIH/sida. El seguimiento para ambos grupos se realizó durante dos años, mediante revisión de la historia clínica. Resultados. Los grupos no presentaron diferencias estadísticas significativas cuando se compararon sus características clínicas, ni demográficas. Una mayor proporción de pacientes del grupo control tuvieron recuento de CD4<200/ml y carga viral>100.000. En el grupo con profilaxis, 8% manifestó efectos adversos, una persona presentó tuberculosis (0,8%) y en el grupo control 10 (5%) [RR=0,15, IC95% 0,18, p=0,07], la protección de la profilaxis fue del 80%, independiente de CD4, carga viral y terapia antirretroviral recibida. Conclusión. La profilaxis para tuberculosis mostró ser efectiva en pacientes positivos para VIH, independientemente del estado inmune, virológico y el tratamiento antirretroviral recibido.Palabras clave: tuberculosis/terapia, profilaxis antibiótica, VIH, síndrome de inmunodeficiencia adquirida, terapia antirretroviral altamente activa, efectividad, Colombia.

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Treatment of tuberculosis in HIV-infected patients: safety and antiretroviral efficacy of the concomitant use of ritonavir and rifampin

Cited by 39 publications

References 0 publications

Acquired Rifamycin Resistance with Twice-Weekly Treatment of HIV-related Tuberculosis

Acquired Rifamycin Resistance with Twice-Weekly Treatment of HIV-related Tuberculosis

Effect of Rifampin on Steady-State Pharmacokinetics of Atazanavir with Ritonavir in Healthy Volunteers

Efectividad de la profilaxis para enfermedad tuberculosa en pacientes infectados por el virus de la inmunodeficiencia humana, Medellín, 2002-2005

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