Antivirals - Post-Approval Insights

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Antiviral drug approvals over the last decade have been dominated by drugs aimed at treating Hepatitis C (HCV) and human immunodeficiency virus (HIV). An estimated 2.4 million to 4.7 million people are living with HCV in the US, while about 1.2 million people in the US live with HIV.

While these are both huge markets that continue to attract big pharma development efforts, the competitive landscape has become multi-layered and complex with long-standing therapies being evaluated alongside newly approved combinations. While better options become available to patients – even a possible cure for HCV patients – research shows that the prior authorization process is the biggest factor contributing to delayed treatment for patients suffering from both HIV and HCV. This becomes a material factor for overall patient outcomes as delayed treatments – while an obvious inconvenience and frustration for patients – can also contribute to viral resistance and disease worsening. For manufacturers, eventual sales aren’t always a reflection of therapeutic merit as a more laborious authorization process can often translate to lower sales. 

As the treatment paradigm grows, there is a high unmet need to improve processes within healthcare systems to match eligible patients to the most appropriate treatments in a seamless and timely manner. Here’s a snapshot of some of the blockbuster HIV and HCV drugs with annual sales over $1 billion, that were approved between 2015 - 2018 and how they’ve fared on the market over recent years.

Drug: Genvoya

Company: Gilead

Generic: fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Indication: Complete regimen for HIV treatment for adults and pediatrics over 12

Approval date: 5 November 2015

Analyst peak sales forecasts: $4 billion by 2021

Actual peak sales: $3.6 billion (US); $4.7 billion (global) in 2018

Full year 2021 sales: $2.9 billion

Market reception: Genvoya had a strong launch which continued in its first few years on the market, but the entry of Gilead’s other HIV drug Biktarvy, approved in 2018, chipped away at Genvoya’s market share. While sales in 2021 were still impressive, the two-drug regimen has greater contraindications to competition and may have a lower barrier to viral resistance.

Drug: Zepatier

Company: Merck

Generic: elbasvir and grazoprevir

Indication: chronic HCV genotypes 1 and 4 in adults

Approval date: 28 January 2016

Analyst peak sales forecast: $2 billion by 2020

Actual peak sales: $772 million (US); $1.6 billion (global) in 2017

Full year 2021 sales: not material

Market reception: Initially expected to be a bigger blockbuster drug, Zepatier suffered stiff competition from a couple of game-changing drug approvals (see below) in its first two years after launch. Its market was also limited in that it was only indicated for two HCV genotypes. In 2018, Merck cut the price of Zepatier by 60%.

Drug: Epclusa

Company: Gilead

Generic: sofosbuvir and velpatasvir

Indication: HCV

Approval date: 28 June 2016

Actual peak sales: $2.4 billion (US); $3.5bn in 2017 (global)

Full year 2021 sales: $815 million (US); $1.46 billion (global)

Market reception: Epclusa was a major advance in the HCV space, indicated for all six HCV genotypes. The drug reached an impressive blockbuster status a year after its launch, however sales began to decline faster than expected, again due to yet another market improvement.

Drug: Mavyret

Company: Abbvie

Generic: glecaprevir and pibrentasvir

Indication: chronic HCV for all adults

Approval date: 3 August 2017

Actual peak sales: $1.6 million (US); $3.44 billion (global) in 2018

Full year 2021 sales: $754 million (US); $1.7 billion (global)

Market reception: Mavyret represented yet another incremental improvement for patients with HCV, with a reduced 8-week regimen compared to Epclusa’s 12-week regimen, whilst it was also offered at a discount to existing options. With recent HCV therapies offering patients a cure, the decline in sales after its first year was a reflection of the overall HCV market peaking in 2015. Generic options of earlier approved drugs have also put pressure on Mavyret’s market penetration. 

Drug: Biktarvy

Company: Gilead

Generic: bictegravir, embitcitabine, tenofovir alafenamide

Indication: HIV

Approval date: 7 February 2018

Analyst peak sales forecast: $11 billion by 2024

Full year 2021 sales: $7 billion (US)  $8.6 billion (Global)

Market reception: With a competitive safety profile and a high barrier to viral resistance, Biktarvy, the three-drug combo, has reared itself as the poster child of HIV drugs. It superseded records made by Gilead’s predecessor (Genvoya) and is also beating out GSK’s triple and doublet therapies. Biktarvy’s sales grew 19% from 2020 and shows no signs of stopping. The drug remains the leading prescribed treatment for naive and switch patients in the US.

Innovative and new therapies will inevitably face reimbursement and access challenges as they launch. The process of getting medications in the hands of the patient can be cumbersome due to difficulties with prior authorization, reimbursement, and delivery. Phil dramatically improves patient outcomes by enabling access to life saving medications. For more information on how Phil works with manufacturers to streamline the patient access channel, visit us at phil.us

Sales data taken from biomedtracker.com

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