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2014年9月17日，强生口服药物Prezcobix(darunavir/cobicistat)在加拿大上市。Prezcobix与其他抗逆转录病毒药物组合使用(每日一次)，用于治疗HIV感染。Prezcobix是第一个以片剂的形式向HIV感染患者提供达芦那韦(darunavir)治疗选择的药物。
“尽管在过去的几十年中，在治疗艾滋病方面取得了令人难以置信的进步，但是对患者来说，依从治疗方案仍是一项挑战，”多伦多医院免疫诊所临床研究部主任兼多伦多大学医学教授Sharon Walmsley医生说，“Prezcobix是治疗艾滋病的一个重要的新选择，因为它可以帮助医生简化医疗方案，并减轻长期每天服用多种药物的负担。”
艾滋病患者要么每天多次服药，要么每天服用多种药物，这会让他们觉得很难坚持自己的治疗方案。研究表明，减少给予艾滋病患者的药片的数量可以显著改善患者的依从性。
PREZCOBIX™ (darunavir/cobicistat) Approved in the U.S. for the Treatment of Adults Living With HIV-1
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Prezcobix (darunavir and cobicistat)
Company: Janssen
Approval Status: Approved January 2015
Treatment for: HIV-1 infection
Areas: Immune System
General Information
Prezcobix is a once-daily, fixed-dose combination containing darunavir, a protease inhibitor, and the pharmacokinetic enhancing or boosting agent cobicistat.
Prezcobix is specifically indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Prezcobix is supplied as a tablet (800 mg of darunavir and 150 mg of cobicistat) for oral administration. The recommended dose is one tablet taken once daily with food.
Clinical Results
FDA Approval
The FDA approval of Prezcobix was based on a bioequivalence study evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations. The tolerability profile of the fixed dose-combination is similar to that of the two agents taken separately. The efficacy of Prezcobix is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir and pharmacokinetic trials showing similar exposures of darunavir when boosted with cobicistat compared to darunavir boosted with ritonavir.
Side Effects
Adverse effects associated with the use of darunavir may include, but are not limited to, the following:
diarrhea
nausea
rash
headache
abdominal pain
vomiting
Mechanism of Action
Prezcobix is a once-daily, fixed-dose combination tablet containing darunavir, a protease inhibitor, and the pharmacokinetic enhancing or boosting agent cobicistat.
New Drugs Online Report for darunavir + cobicistat
Information
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 Evaluations
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
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