Regulatory Decision Summary for Genvoya

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate

Therapeutic area:

Antivirals for Systemic Use

Type of submission:

Supplement to a New Drug Submission

Control number:

207251
What was the purpose of this submission?

 

The purpose of this Supplemental New Drug Submission was to revise the indication to include pediatric patient population weighing at least 25 kg; and to provide longer term (144 weeks) safety and efficacy data.

 

Why was the decision issued?

 

Health Canada considers that the benefit/risk profile of Genvoya is favourable when used as directed in the treatment HIV-1 infection in adults and pediatric patients weighing ≥ 25 kg who have no known mutations associated with resistance to the individual components of Genvoya.

Genvoya is formulated as a fixed dose combination tablet containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 25 mg tenofovir alafenamide hemifumarate.

The clinical safety and efficacy in adults for Genvoya for up to 144 weeks was based on two non-inferiority Phase 3 clinical trials conducted with Genvoya compared to Stribild, as well as a 96 week Phase 3 clinical trial in virologically suppressed adult patients with mild to moderate renal impairment. The clinical safety and efficacy for use in adolescents aged 12-17 and weighing ≥ 40 kg for Genvoya is based on the data submitted in support of the original New Drug Submission. The clinical safety and efficacy for use in pediatric patients ≥ 25 kg is based on a 24 Phase 2/3 study in 23 virologically suppressed patients treated with Genvoya for 24 weeks. Despite the limited data, it was deemed that the benefit of Genvoya for this population outweighed the risks, noting more favourable bone and renal safety profiles, and the very limited number of drugs available for use in this population. This limitation has been noted in the Product Monograph.

The harms associated with Genvoya are consistent with those associated with other antiretroviral combination regimen such as the post-treatment exacerbation of hepatitis B virus, lactic acidosis/severe hepatomegaly with steatosis, immune reconstitution inflammatory syndrome, pancreatitis and various drug-drug interactions.

The uncertainties associated with the use of Genvoya are long-term effects on bone mineral density and long term clinical significance on the renal system, specifically the potential for Fanconi syndrome.

The harms 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.

The overall benefit-harm-uncertainty profile of Genvoya supports the approval of this fixed dose combination for the treatment of HIV-1 infection in adults and adults and pediatric patients weighing ≥ 25 kg who have no known mutations associated with resistance to the individual components of Genvoya.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.