ODEFSEY

What it is

ODEFSEY is a fixed-dose combination tablet containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg.

Approved indications

— Treatment of HIV-1 infection in adult patients who are virologically suppressed on a stable antiretroviral regimen for at least six months.

Dosing overview

ODEFSEY is taken orally once daily as a fixed-dose combination tablet.

Key safety warnings

Discontinuation of ODEFSEY therapy in individuals infected with hepatitis B virus may be associated with severe acute exacerbations of hepatitis. Individuals infected with hepatitis B who discontinue ODEFSEY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis since post-treatment exacerbation of hepatitis may lead to hepatic decompensation. 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 are at increased risk of developing renal-related adverse reactions. Prior to or when initiating ODEFSEY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues, including emtricitabine and tenofovir. Treatment with ODEFSEY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Contraindications

ODEFSEY is contraindicated in patients with known hypersensitivity to any of the active substances or any other component of the tablets.

PBS listing

ODEFSEY was recommended by PBAC in November 2017 for the treatment of HIV-1 infection in adult patients who are virologically suppressed on a stable antiretroviral regimen for at least six months.

Regulatory history

ODEFSEY was first listed on the Australian Register of Therapeutic Goods on 30 August 2016. The Pharmaceutical Benefits Scheme Advisory Committee recommended ODEFSEY for listing in November 2016 on a cost minimisation basis, and again in November 2017 for the treatment of HIV-1 infection in adult patients who are virologically suppressed on a stable antiretroviral regimen for at least six months. ODEFSEY is subject to additional monitoring in Australia to allow quick identification of new safety information.