DESCOVY

What it is

DESCOVY contains emtricitabine (FTC) and tenofovir alafenamide (TAF) fumarate. DESCOVY is available in two strengths: 200 mg emtricitabine with 25 mg tenofovir alafenamide, and 200 mg emtricitabine with 10 mg tenofovir alafenamide. DESCOVY is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment of HIV-1 infection in combination with other antiretroviral agents in adults and paediatric patients weighing at least 25 kg. — HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

Dosing overview

For treatment of HIV-1 infection in adults and paediatric patients weighing ≥ 25 kg, DESCOVY 200/25 mg is taken orally once daily with or without food. If DESCOVY is used with an HIV-1 protease inhibitor administered with ritonavir or cobicistat, the recommended dose is DESCOVY 200/10 mg. For HIV-1 PrEP in HIV-uninfected adults and adolescents weighing ≥ 35 kg, the recommended dose is DESCOVY 200/25 mg taken orally once daily with or without food.

Key safety warnings

Discontinuation of DESCOVY in individuals infected with hepatitis B virus may be associated with severe acute exacerbations of hepatitis and should be closely monitored. If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis. DESCOVY for PrEP should only be used in individuals confirmed to be HIV-negative, as HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection taking only DESCOVY. HIV-uninfected individuals must strictly adhere to the recommended dosing schedule, as the effectiveness of DESCOVY in reducing HIV-1 acquisition risk is strongly correlated with adherence. Post-marketing cases of renal impairment, including acute renal failure and Fanconi syndrome, have been reported with tenofovir alafenamide-containing products. Patients with impaired renal function or taking nephrotoxic agents are at increased risk of developing renal-related adverse reactions. Prior to or when initiating DESCOVY and during treatment, serum creatinine, estimated creatinine clearance, urine glucose, and urine protein should be assessed. In patients with chronic kidney disease, serum phosphorus should also be assessed. DESCOVY should be discontinued in patients developing clinically significant decreases in renal function or evidence of Fanconi syndrome. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with antiretroviral nucleoside analogues including emtricitabine. Treatment should be suspended in any patient developing clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Contraindications

DESCOVY is contraindicated in patients with known hypersensitivity to any of the active substances or any other component of the tablets. DESCOVY should not be used for PrEP in individuals with unknown or positive HIV-1 status. DESCOVY should not be coadministered with products containing TAF or FTC, or with products containing lamivudine or tenofovir disoproxil fumarate.

Regulatory history

DESCOVY 200/25 mg and 200/10 mg tablets were first listed on the ARTG on 1 July 2016. The TGA approval date was 28 June 2016. The PBAC recommended DESCOVY in November 2016 for HIV infection on a cost minimisation basis, and again in November 2017 for treatment of HIV-1 infection in adult patients in combination with other antiretroviral agents.