Low Isoniazid Concentrations and Outcome of Tuberculosis Treatment with Once-Weekly Isoniazid and Rifapentine

Weiner, Marc; Burman, William J.; Vernon, Andrew; Benator, Debra; Peloquin, Charles A.; Khan, Abdul Qadir; Weis, Stephen E.; King, Barbara J.; Shah, Nishant K.; Hodge, Thomas

doi:10.1164/rccm.200208-951oc

Cited by 185 publications

(144 citation statements)

References 15 publications

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“…When it is used for ALBC, especially, isoniazid in bone cement could result in variable concentrations which can result in underdosage and development of resistance [3]. Considering the reported high prevalence of multidrugresistant tuberculosis [43], additional studies are needed with second-line agents that could be used with isoniazid for ALBC. Third, isoniazid is widely distributed in body fluids and tissues [20,36] and could cause toxicity, especially to the liver [14,19].…”

Section: Discussionmentioning

confidence: 99%

Isoniazid Could Be Used for Antibiotic-loaded Bone Cement for Musculoskeletal Tuberculosis: An In Vitro Study

Han

Cho

et al. 2013

Clinical Orthopaedics &Amp; Related Research

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Background Antibiotic-loaded bone cement (ALBC) has been used in serious cases of musculoskeletal tuberculosis, but the type and amount of antibiotic that should be used in ALBC have not been determined. Questions/purposes We therefore determined the (1) elution characteristics and (2) antimycobacterial activity of isoniazid-and rifampicin-loaded bone cement. Methods A total of 240 elution samples of each of three discs from 40 g bone cement mixed with one of eight dosages: 1 g, 2 g, and 4 g isoniazid, 1 g, 2 g, and 4 g rifampicin, and a combination of 1 + 1 g or 2 + 2 g of isoniazid and rifampicin. The polymerization of rifampicin-loaded bone cement was delayed to mean 122.5 ± 31.1 minutes. We measured the quantity of isoniazid and rifampicin and the antimycobacterial activity on Days 1, 3, 7, 14, and 30.

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Section: Discussionmentioning

confidence: 99%

Isoniazid Could Be Used for Antibiotic-loaded Bone Cement for Musculoskeletal Tuberculosis: An In Vitro Study

Han

Cho

et al. 2013

Clinical Orthopaedics &Amp; Related Research

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“…While P is approved for twice-weekly administration at a dose of 10 mg/kg during the initial phase of therapy (11), several influential clinical trials have focused attention on the use of once-weekly administration of P in combination with H during the continuation phase. In Tuberculosis Trials Consortium Study 22, once-weekly PH was less effective than twice-weekly RH, and was associated with rifamycin-resistant relapse among HIVinfected patients (12)(13)(14)(15). As a result, once-weekly PH is recommended only for HIV-seronegative patients at low risk for relapse (4).…”

mentioning

confidence: 99%

Potent Twice-Weekly Rifapentine-containing Regimens in Murine Tuberculosis

Rosenthal

Williams²,

Tyagi³

et al. 2006

Am J Respir Crit Care Med

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Rationale: Recent studies have demonstrated that intermittent administration of rifamycin-based regimens results in higher rates of tuberculosis relapse and treatment failure compared with daily therapy. Twice-weekly treatment with rifampin, isoniazid, and pyrazinamide may be improved by increasing Mycobacterium tuberculosis exposure to rifamycin by substituting rifapentine for rifampin. Methods: To test this hypothesis, we compared the activities of standard daily and twice-weekly rifampin plus isoniazid-based regimens to those of twice-weekly rifapentine plus isoniazid-or moxifloxacin-containing regimens in the murine model of tuberculosis. Relapse rates were assessed after 4, 5, and 6 mo of treatment to assess stable cure. Single-and multiple-dose pharmacokinetics of rifampin and rifapentine were also determined. Results: After 2 mo of treatment, twice-weekly therapy with rifapentine (15 or 20 mg/kg), moxifloxacin, and pyrazinamide was significantly more active than standard daily or twice-weekly therapy with rifampin, isoniazid, and pyrazinamide. Stable cure was achieved after 4 mo of twice-weekly rifapentine plus isoniazid-or moxifloxacincontaining therapy, but only after 6 mo of standard daily therapy. Twice-weekly rifapentine (15 mg/kg) displayed more favorable pharmacodynamics than did daily rifampin (10 mg/kg). In the treatment of drug-susceptible pulmonary tuberculosis (TB), daily administration of a standardized 6-mo regimen including rifampin (R), isoniazid (H), and pyrazinamide (Z; collectively, RHZ) is highly effective in achieving cure (1). But, because supervision of daily treatment imposes a substantial burden on both patients and treatment programs (2, 3), intermittent regimens with predominantly twice-or thrice-weekly drug administration are recommended for supervised therapy (4, 5). Although at least one randomized clinical trial has shown that daily and thrice-weekly RHZ-based regimens have similar efficacy, more recent observational studies suggest intermittent therapy is not as effective as daily therapy, particularly in patients at high risk for relapse (6-8). Recent experience in the murine model of TB supports the latter observations. Daily administration of the 6-mo RHZ-based regimen is significantly more effective than the same regimen administered according to a predominantly twice-weekly schedule (9).The rifamycins are the key drugs in modern short-course therapy. Rifapentine (P) is a rifamycin with a lower minimum inhibitory concentration (MIC) against Mycobacterium tuberculosis and a much longer serum half-life compared with R (10). While P is approved for twice-weekly administration at a dose of 10 mg/kg during the initial phase of therapy (11), several influential clinical trials have focused attention on the use of once-weekly administration of P in combination with H during the continuation phase. In Tuberculosis Trials Consortium Study 22, once-weekly PH was less effective than twice-weekly RH, and was associated with rifamycin-resistant relapse among HIVinfected patients (12...

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“…In this method, no differences between these concentrations were observed; thus, the lowest concentration (10 %) was selected. CS choices for INH and PZA were made based on their ranges in TB patients found in other studies [5][6][7]18,19]. QCS concentrations were selected based on the recommendations of the FDA guideline for bioanalytical method validation [20].…”

Section: Discussionmentioning

confidence: 99%

“…In vitro studies show that both PZA and INH exhibit a concentration-dependent effect [3,4]. Poor patient outcomes were associated with low levels of INH or PZA [5][6][7]. Thus, individualization of INH and PZA doses based on their blood concentration could be helpful in optimizing the drug therapy for some patients with poor response.…”

Section: Isoniazidmentioning

confidence: 99%

Simultaneous determination of isoniazid and pyrazinamide in plasma by high performance liquid chromatography

Mahjoub¹,

Khan²,

Sulaiman³

et al. 2016

Trop. J. Pharm Res

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Low Isoniazid Concentrations and Outcome of Tuberculosis Treatment with Once-Weekly Isoniazid and Rifapentine

Cited by 185 publications

References 15 publications

Isoniazid Could Be Used for Antibiotic-loaded Bone Cement for Musculoskeletal Tuberculosis: An In Vitro Study

Isoniazid Could Be Used for Antibiotic-loaded Bone Cement for Musculoskeletal Tuberculosis: An In Vitro Study

Potent Twice-Weekly Rifapentine-containing Regimens in Murine Tuberculosis

Simultaneous determination of isoniazid and pyrazinamide in plasma by high performance liquid chromatography

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