STRIBILD

What it is

STRIBILD is a fixed-dose combination tablet containing tenofovir disoproxil fumarate, emtricitabine, elvitegravir and cobicistat. Each tablet contains 300 mg tenofovir DF (equivalent to 245 mg of tenofovir disoproxil), 200 mg emtricitabine, 150 mg of elvitegravir and 150 mg of cobicistat. The tablets are film-coated, capsule shaped and green in colour. STRIBILD is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.

Approved indications

— Treatment of HIV infection in treatment-naive adults as a single tablet regimen. — Treatment in certain virologically suppressed (HIV1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy to replace their current antiretroviral treatment regimen, provided patients have no history of treatment failure or known mutations associated with resistance to the antiretroviral components of STRIBILD.

Dosing overview

The recommended dose of STRIBILD for adults is one tablet once daily taken orally with a meal. STRIBILD is not recommended for use in children or adolescents below 18 years of age due to insufficient data on safety and efficacy.

Key safety warnings

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues including the tenofovir DF component of STRIBILD. A majority of these cases have been in women, and obesity and prolonged nucleoside exposure may be risk factors. Treatment with STRIBILD should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Renal failure, renal impairment, elevated creatinine, hypophosphataemia and Fanconi syndrome have been reported with the use of tenofovir DF. Estimated creatinine clearance, urine glucose, and urine protein should be documented in all patients prior to initiating therapy with STRIBILD, and STRIBILD should not be initiated in patients with estimated creatinine clearance below 70 mL/min. Routine monitoring of estimated creatinine clearance should be performed during STRIBILD therapy in patients, additionally, serum phosphorus should be measured in patients at risk for renal impairment. The safety and efficacy of STRIBILD have not been established in patients coinfected with HIV and HBV. Discontinuation of STRIBILD therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine and tenofovir DF components of STRIBILD.

Contraindications

STRIBILD is contraindicated in patients with known hypersensitivity to any of the active substances or any other component of the tablets. STRIBILD must not be administered to children or adolescents under the age of 18 years. Coadministration is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events, and with drugs that are potent inducers of CYP3A due to the potential for loss of virologic response and possible resistance to STRIBILD. STRIBILD should not be administered concurrently with other medicinal products containing any of the same active components: tenofovir DF, emtricitabine, elvitegravir or cobicistat.

PBS listing

No information on PBS listing is available in the provided sources.

Regulatory history

STRIBILD (tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, elvitegravir 150 mg, cobicistat 150 mg tablet) was first listed on the ARTG on 22 February 2013. The TGA approved the extension of indications for STRIBILD on 1 July 2015, which allows its use as a single tablet regimen in treatment-naive adults and in certain virologically suppressed adult patients without known resistance mutations. Studies demonstrated continued efficacy of STRIBILD in treatment-naive HIV subjects and supported its use in virologically suppressed HIV-1 infected subjects, with the drug maintaining a favourable safety and tolerability profile over 144 weeks and no new safety issues identified.