Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers

Weiner, Marc; Egelund, Eric F.; Engle, Melissa; Kiser, Melissa; Prihoda, Thomas J.; Gelfond, Jonathan; Kenzie, William Mac; Peloquin, Charles A.

doi:10.1093/jac/dkt483

Cited by 54 publications

(26 citation statements)

References 31 publications

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“…[15, 16] Furthermore, additional studies have demonstrated that once-weekly rifapentine may be given with the integrase strand transfer inhibitor raltegravir. [17] Although studies of the effectiveness of 3HP when given with efavirenz-or raltegravir-based antiretroviral therapy are needed, these pharmacokinetic studies suggest that such regimens can be given concomitantly. Such effectiveness studies would likely include persons with lower CD4+ lymphocyte counts.…”

Section: Discussionmentioning

confidence: 99%

Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons

Sterling

Scott

Miró

et al. 2016

Aids

138

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Objective Compare the effectiveness, tolerability, and safety of three months of weekly rifapentine plus isoniazid under direct observation (3HP) vs. 9 months of daily isoniazid (9H) in HIV-infected persons. Design prospective, randomized, open-label non-inferiority trial Setting U.S., Brazil, Spain, Peru, Canada, and Hong Kong Participants HIV-infected persons who were tuberculin skin test positive or close contacts of tuberculosis cases. Intervention 3HP vs. 9H. Main Outcome Measures The effectiveness endpoint was tuberculosis; the non-inferiority margin was 0.75%. The tolerability endpoint was treatment completion; the safety endpoint was drug discontinuation due to adverse drug reaction. Results Median baseline CD4+ counts were 495 (IQR:389–675) and 538 (IQR:418–729) cells/mm3 in the 3HP and 9H arms, respectively (P=0.09). In the modified intention to treat analysis, there were two tuberculosis cases among 206 persons (517 person-years (p-y) of follow-up) in the 3HP arm (0.39 per 100 p-y) and six tuberculosis cases among 193 persons (481 p-y of follow-up) in the 9H arm (1.25 per 100 p-y). Cumulative tuberculosis rates were 1.01% vs. 3.50% in the 3HP and 9H arms, respectively (rate difference: −2.49%; upper bound of the 95% confidence interval (CI) of the difference: 0.60%). Treatment completion was higher with 3HP (89%) than 9H (64%) (P<0.001), and drug discontinuation due to an adverse drug reaction was similar (3% vs. 4%; P=0.79) in 3HP and 9H, respectively. Conclusions Among HIV-infected persons with median CD4+ count of approximately 500 cells/mm3, 3HP was as effective and safe for treatment of latent M. tuberculosis infection as 9H, and better tolerated. Trial Registration ClinicalTrials.gov (identifier: NCT00023452)

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Section: Discussionmentioning

confidence: 99%

Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons

Sterling

Scott

Miró

et al. 2016

Aids

138

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“…87–89 Highdose daily rifapentine can be safely administered with efavirenz, allowing the 3-month regimen to be administered with efavirenz-based ART. 80,90 Although raltegravir exposure was increased when administered with once-weekly rifapentine, 91 the regimen was well tolerated, supporting use of raltegravir-based regimens. There are no pharmacokinetic data on rifapentine with dolutegravir.…”

Section: Interface Of Art and Oismentioning

confidence: 92%

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Günthard

Saag

Benson

et al. 2016

JAMA

555

313

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“…Despite this, no clinically meaningful effect on efavirenz exposure was seen in 87 patients receiving a four-week course of daily rifapentine for TB prevention in ACTG 5279 23 . Rifapentine increased raltegravir exposure in a healthy volunteer study, but this was safe and tolerable; therefore, once-weekly rifapentine can be used in HIV-infected patients on raltegravir 24 .…”

Section: New Applications Of Existing Drugsmentioning

confidence: 89%

Current strategies to treat tuberculosis

Podany

Swindells

2016

F1000Res

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Tuberculosis (TB) has been a leading cause of death for more than a century. While effective therapies exist, treatment is long and cumbersome. TB control is complicated by the overlapping problems created by global inadequacy of public health infrastructures, the interaction of the TB and human immunodeficiency virus (HIV) epidemics, and the emergence of drug-resistant TB. After a long period of neglect, there is now significant progress in the development of novel treatment regimens for TB. Focusing on treatment for active disease, we review pathways to TB regimen development and the new and repurposed anti-TB agents in clinical development.

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Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers

Abstract: The increased raltegravir exposure observed with once-weekly rifapentine was safe and tolerable. Once-weekly rifapentine can be used with raltegravir to treat latent tuberculosis infection in patients who are infected with HIV.

Cited by 54 publications

References 31 publications

Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons

Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Current strategies to treat tuberculosis

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