REZOLSTA (darunavir/cobicistat), antiretroviral

INFECTIOLOGY - New medicinal product
Opinions on drugs - Posted on Apr 06 2016

Reason for request

Inclusion

Insufficient clinical benefit as an alternative to darunavir/ritonavir

  

  • REZOLSTA contains 800 mg of darunavir and 150 mg of cobicistat (pharmacokinetic enhancer). It has Marketing Authorisation in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV-1) in adults aged 18 years and older.
  • Its benefit as an alternative to darunavir/ritonavir is not established; REZOLSTA has not demonstrated benefit in terms of efficacy, safety or adherence and exposes patients to a potential risk of drug interactions or abstention from treatment, while the combination darunavir/ritonavir has demonstrated its efficacy and good safety. Consequently, it has no role in the therapeutic strategy.

 

 


Clinical Benefit

Insufficient

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