2015年1月29日，美国FDA批准了两种固定剂量HIV药，它们均为蛋白酶抑制剂组合，其一由百时美施贵宝公司开发，另一则由强生公司开发，两者都含吉利德科学公司生产的一种增效剂。
施贵宝的药物Evotaz是含每日一次丸剂，含蛋白酶抑制剂Reyataz（atazanavir，阿扎那韦，以cobicistat为增效剂。强生公司的每日一次Prezcobix，则将蛋白酶抑制剂达芦那韦（darunavir，Prezista/辈力）与cobicistat组合
Generic Name: darunavir + cobicistat
Trade Name: Rezolsta (EU), Prezcobix (US)
Entry Type: New formulation
Development and Regulatory status
UK: Launched
EU: Launched
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date: December 2014
Comments
Feb 15: Approved in the US [7].
03/02/2015 16:04:35
Dec 14: Launched in the UK [6].
17/12/2014 12:02:11
Nov 14: European Commission has approved REZOLSTA® (darunavir/cobicistat) in combination with other antiretrovirals (ARV) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older [5].
26/11/2014 14:57:28
Sep 14: EU positive opinion for treatment of antiretroviral therapy (ART)-naïve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs) [4].
29/09/2014 12:06:57
Apr 14: Filed in the US. If approved, the fixed-dose combination pill will be marketed under a new brand name by Janssen [3].
02/04/2014 12:00:28
Oct 13: A Marketing Authorisation Application has been submitted to the EMA seeking approval for a once-daily single tablet fixed-dose containing darunavir with cobicistat for use in combination with other HIV-1 medicines. [2]
16/10/2013 16:08:44
Jan 13: PIII in US & EU [1].
05/03/2013 10:20:56
Trial or other data
According to Johnson & Johnson, there are 34.5 million people living with HIV globally with 2.5 million newly infected each year. But, after just eight months of treatment, only 65% achieve 100% compliance, highlighting the scope for improvement [3].
02/04/2014 12:00:51
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002819/WC500178955.pdf
References
Available only to registered users
Category
BNF Category: Antiviral drugs (05.03)
Pharmacology: Protease inhibitor & pharmacoenhancing agent - increases systemic levels of coadministered agents that are metabolised by CYP3A
Epidemiology: An estimated 83,000 people were living with HIV in 2008 in the UK; about 27% were unaware of their infection. In 2008, there were 7,298 new diagnoses of HIV.
Indication: HIV infection
Additional Details: in treatment-naive & experienced pts
Method(s) of Administration
Oral
Company Information
Name: Janssen-Cilag
US Name: Janssen-Cilag
Further Information
Anticipated Commissioning route (England) NHSE
In timetable: -
PbR Yes
Comments |
