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    Jan 27, 2021
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    Safety, efficacy, and pharmacokinetics of rilpivirine: systematic review with an emphasis on resource-limited settings.

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    Authors
    Ford, Nathan
    Lee, Janice
    Andrieux-Meyer, Isabelle
    Calmy, Alexandra
    Affiliation
    Médecins Sans Frontières, Geneva, Switzerland; Centre for Infectious Disease Epidemiology and Research, University of Cape Town, Cape Town, South Africa; Service of Infectious Diseases, Geneva University Hospital, Geneva, Switzerland
    Issue Date
    2011-04-28
    
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    Journal
    HIV/AIDS - Research and Palliative Care
    Abstract
    The vast majority of people living with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome reside in the developing world, in settings characterized by limited health budgets, critical shortages of doctors, limited laboratory monitoring, a substantial burden of HIV in children, and high rates of coinfection, in particular tuberculosis. Therefore, the extent to which new antiretrovirals will contribute to improvements in the management of HIV globally will depend to a large extent on their affordability, ease of use, low toxicity profile, availability as pediatric formulations, and compatibility with tuberculosis and other common drugs. We undertook a systematic review of the available evidence regarding drug interactions, and the efficacy and safety of rilpivirine (also known as TMC-278), and assessed our findings in view of the needs and constraints of resource-limited settings. The main pharmacokinetic interactions relevant to HIV management reported to date include reduced bioavailability of rilpivirine when coadministered with rifampicin, rifabutin or acid suppressing agents, and reduced bioavailability of ketoconazole. Potential recommendations for dose adjustment to compensate for these interactions have not been elaborated. Trials comparing rilpivirine and efavirenz found similar outcomes up to 96 weeks in intent-to-treat analysis; failure of rilpivirine was mainly virological, whereas failure among those exposed to efavirenz was mainly related to the occurrence of adverse events. Around half of the patients who fail rilpivirine develop non-nucleoside reverse transcriptase inhibitor resistance mutations. The incidence of Grade 2-4 events was lower for rilpivirine compared with efavirenz. Grade 3-4 adverse events potentially related to the drugs were infrequent and statistically similar for both drugs. No dose-response relationship was observed for efficacy or safety, and the lowest dose (25 mg) was selected for further clinical development. The potential low cost and dose of the active pharmaceutical ingredient means that rilpivirine can potentially be manufactured at a low price. Moreover, its long half-life suggests the potential for monthly dosing via nonoral routes, with promising early results from studies of a long-acting injectable formulation. These characteristics make rilpivirine an attractive drug for resource-limited settings. Future research should assess the potential to improve robustness and assess the clinical significance of interaction with antituberculosis drugs.
    Publisher
    DovePress
    URI
    http://hdl.handle.net/10144/220333
    DOI
    10.2147/HIV.S14559
    PubMed ID
    22096405
    Additional Links
    http://www.dovepress.com/safety-efficacy-and-pharmacokinetics-of-rilpivirine-systematic-review--peer-reviewed-article-HIV
    Type
    Article
    Language
    en
    ISSN
    1179-1373
    ae974a485f413a2113503eed53cd6c53
    10.2147/HIV.S14559
    Scopus Count
    Collections
    HIV/AIDS

    entitlement

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