Product Dossier
GENVOYA
Product Dossier for GENVOYA (cobicistat, Gilead Sciences). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Gilead Sciences
- Active ingredient: cobicistat
- Therapeutic area: Infectious Disease
- Related brand: SYMTUZA
- Related brand: PREZCOBIX
- Related brand: STRIBILD
- Same area: Savacol Antiseptic Mouth & Throat Rinse
- Same area: RETROVIR
What it is
GENVOYA is a fixed dose combination tablet containing elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg) and tenofovir alafenamide (as fumarate) (10 mg).
Approved indications
— HIV-1 infection in adults and adolescents aged 12 years of age and older with body weight at least 35 kg who are either treatment-naive or virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen.
Key safety warnings
Patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of GENVOYA.
Regulatory history
GENVOYA was first listed on the ARTG on 15 January 2016. The medicine was approved as a single tablet regimen for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older. In November 2017, the PBAC recommended an amendment to the PBS listing to expand the eligibility criteria for GENVOYA to include patients with HIV-1 infection who are initiating antiretroviral therapy.