BIKTARVY

What it is

BIKTARVY is a film-coated tablet containing bictegravir sodium (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg). The tablets are capsule shaped and purplish-brown in colour, debossed with 'GSI' on one side and '9883' on the other.

Approved indications

— Treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy-naïve — Treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to bictegravir or tenofovir

Dosing overview

In adults and paediatric patients weighing at least 25 kg, the dose of BIKTARVY is one tablet taken orally once daily with or without food. No dose adjustment is required for elderly patients. No dose adjustment of BIKTARVY is required in adult patients with estimated creatinine clearance ≥ 30 mL/min or in adult patients with end stage renal disease who are receiving chronic haemodialysis. No dose adjustment of BIKTARVY is required in patients with mild or moderate hepatic impairment.

Key safety warnings

Discontinuation of BIKTARVY therapy in patients co-infected with HIV-1 and hepatitis B virus may be associated with severe acute exacerbations of hepatitis due to the emtricitabine and tenofovir alafenamide components. Patients co-infected with HIV-1 and hepatitis B virus who discontinue BIKTARVY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. Post-marketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy, and Fanconi syndrome have been reported with tenofovir alafenamide containing products. Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents, including non-steroidal anti-inflammatory drugs, are at increased risk of developing renal-related adverse reactions. Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of BIKTARVY. Treatment with BIKTARVY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Contraindications

BIKTARVY is contraindicated in patients with known hypersensitivity to bictegravir, emtricitabine, tenofovir alafenamide or to any of the excipients. Coadministration with dofetilide is contraindicated due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events. Coadministration with rifampicin is contraindicated due to decreased bictegravir plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to BIKTARVY.

PBS listing

BIKTARVY is listed on the Pharmaceutical Benefits Scheme from July 2018 with a streamlined authority required restriction on a weighted price cost-minimisation basis with alternative treatments.

Regulatory history

BIKTARVY was first registered on the ARTG on 12 July 2018. The PBAC initially did not recommend BIKTARVY in November 2017 due to uncertain cost-effectiveness and clinical benefit in the proposed population, but subsequently recommended it in November 2017 for treatment of HIV-1 infection, with PBS listing approved in July 2018. This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications, which will allow quick identification of new safety information.