ATRIPLA (efavirenz+emtricitabine+tenofovir disoproxil fumarate), antiviral combination

VIROLOGY - FOCUS
Opinions on drugs - Posted on Sep 10 2015

Reason for request

Renewal of inclusion

Second-line treatment in the management of HIV

  • ATRIPLA has Marketing Authorisation in the treatment of HIV-1 infection in adults with virologic suppression on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in ATRIPLA prior to initiation of their first antiretroviral treatment regimen.
  • ATRIPLA must no longer be used as first-line treatment, in view of:

    - the neurological toxicity (due to efavirenz), renal toxicity and toxic effects on calcium and phosphorus metabolism (due to tenofovir disoproxil fumarate) of this fixed-dose combination;

    - the existence of better tolerated treatment alternatives that are at least as effective, such as combinations based on an integrase inhibitor (dolutegravir, elvitegravir, raltegravir).

  • It is a second-line treatment option and must be used alongside monitoring of renal function and of calcium and phosphorus metabolism. Good compliance with treatment is, moreover, advisable, on account of the low genetic barrier of efavirenz.




Clinical Benefit

Substantial

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Therapeutic use

-

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