Regulatory Decision Summary for GENVOYA

Health Canada considers that the benefit/risk profile of Genvoya 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 who have no known resistance to the individual components.

The benefits of Genvoya were demonstrated in clinical studies designed to test for non-inferiority to either Stribild or a combination of emtricitabine/tenofovir disoproxil fumarate and a third agent, in antiretroviral treatment-naïve and virologically suppressed adults. The primary efficacy endpoint was the percentage of subjects with HIV-1 RNA <50 copies/mL at Week 48. Genvoya showed non-inferior antiviral activity as compared to the active comparator treatment regimens, across different populations (antiretroviral treatment-naïve or virologically suppressed) 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 and 95% in virologically suppressed patients.

As compared to the tenofovir disoproxil fumarate-based regimens, treatment with Genvoya is associated with an improved bone safety profile in adults and with an improved renal safety profile in adults and adolescents with normal renal function and in adults with mild to moderate renal impairment. Genvoya offers an advantage over existing treatment options in 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 Genvoya 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 Genvoya include the bone safety profile in adolescents and the long-term effects on: bone mineral density, increased fasting serum lipids and lipodystrophy.

The risks and uncertainties associated with the use of Genvoya are manageable through the inclusion of appropriate contraindications, warnings and cautionary statements in the Genvoya Product Monograph and through the risk management plan to be effected by the manufacturer.

Overall, the anticipated benefits of Genvoya are expected to outweigh its risks under the recommended conditions of use.

For more information on Health Canadas decision, please view the Summary Basis of Decision.