Regulatory Decision Summary for DESCOVY

Health Canada considers that the benefit/risk profile of Descovy is favorable when used as directed in the treatment of HIV-1 infection in adults and adolescents (12 years or older and weighing more than 35 kg).

There were no Phase II or Phase III clinical safety and efficacy trials conducted specifically for Descovy. The data to support Descovy was based on comparative bioavailability studies for Descovy as compared to Genvoya, a fixed dose combination product (emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat) that contains 2 of the active ingredients in Descovy (emtricitabine and tenofovir alafenamide). The efficacy and safety of Genvoya have been established in clinical studies designed to test for non-inferiority of Genvoya to either Stribild (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) or a combination of emtricitabine/tenofovir disoproxil fumarate and a third agent, in antiretroviral treatment-naïve adults. The primary efficacy endpoint was the percentage of subjects with HIV-1 ribonucleic acid < 50 copies/millilitre (mL) at Week 48. Genvoya showed non-inferior antiviral activity as compared to the active comparator treatment regimens, across different populations with normal to moderate renal function and across a wide range of ages (12 through 80 years). The percentage of patients achieving the primary endpoint with Genvoya was 92% in antiretroviral treatment-naïve patients.

As compared to the tenofovir disoproxil fumarate-based regimens, treatment with Descovy is expected to be associated with an improved bone safety profile in adults, with an improved renal safety profile in adults and adolescents with normal renal function, and in adults with mild to moderate renal impairment as observed with Genvoya.

Descovy provides another treatment option for adults at risk for bone and renal toxicities and in adolescents who at the present time have no access to fixed dose combination treatments in Canada.

The risks associated with Descovy are consistent with those associated with other antiretroviral combination regimens such as lactic acidosis and severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, immune reconstitution inflammatory syndrome, pancreatitis and drug-drug interactions.

The uncertainties associated with the use of Descovy include bone safety profile in adolescents and the long-term effects on: bone mineral density, increased fasting serum lipids and lipodystrophy.

The overall benefit-risk assessment is favorable for Descovy in HIV-1 infection in adults and adolescents (12 years or older and weighing more than 35 kg) under the conditions of use as described in the Product Monograph.