This article is part of an ongoing blog series profiling the 12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.
The 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics, predicted that Gilead’s Biktarvy, a once-daily tablet containing the new integrase inhibitor bictegravir, plus the nucleoside reverse transcriptase inhibitor tenofovir alafenamide and the nucleoside reverse transcriptase inhibitor emtricitabine, would achieve blockbuster status within five years of market entry. Biktarvy was made available in the U.S. in February 20181, and in July 2018, it was launched in Germany and several other countries.2 Pricing and reimbursement discussions in Europe are anticipated by Gilead over the next 12 months.2
Biktarvy’s integrase inhibitor component, bictegravir, has shown equivalent safety and efficacy to GlaxoSmithKline (GSK)’s Tivicay, and like Tivicay, is a true once-per-day integrase inhibitor and does not require combination with a boosting agent.3
In previously untreated patients infected with HIV-1 and in virologically suppressed adults who switched to Biktarvy, the drug demonstrated high rates of virological suppression (~93%) similar to therapy regimens containing Tivicay. No treatment-emergent resistance has been associated with Biktarvy through 48 weeks of treatment in phase 3 trials.3
“Biktarvy’s integrase inhibitor component, bictegravir, has shown equivalent safety and efficacy to GlaxoSmithKline (GSK)’s Tivicay, and like Tivicay, is a true once-per-day integrase inhibitor and does not require combination with a boosting agent.”
With the entry of the generic version of tenofovir disoproxil in December 20174, potential launches of generic versions of Atripla (tenofovir disoproxil fumarate/emtricitabine/efavirenze) and Truvada (tenofovir disoproxil fumarate/emtricitabine) expected in the short term, and GSK’s increasing market share for its Tivicay-based regimens, Gilead is likely to heavily promote Biktarvy to help claw back market share and cement the company’s leading position in the market.1,5,6 Biktarvy’s composition as a true once-daily combination of best-in-class tenofovir alafenamide and an integrase inhibitor non-inferior to Tivicay is also likely to garner physician support.3
U.S. Biktarvy sales were $183 million in 2Q18, its first full quarter of sales since launch. Moreover, Biktarvy became the number one regimen for switch patients during the quarter, with 85% of Biktarvy prescriptions resulting from switches, one quarter of which came from patients switching from Genvoya (tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat). In 2Q18, Biktarvy was ranked second behind Genvoya for the top prescribed HIV regimens in the U.S.2
“U.S. Biktarvy sales were $183 million in 2Q18, its first full quarter of sales since launch. Moreover, Biktarvy became the number one regimen for switch patients during the quarter.”
Following launch in the U.S. and in certain EU countries, while Cortellis Consensus Forecast data (source Thomson Reuters I/B/E/S) for 2018 are slightly lower at $852 million compared with $896 million at the time of writing the Drugs to Watch report, longer-term forecasts are now significantly higher (see figure 1). Biktarvy is expected to reach blockbuster status rapidly with forecast sales of $2.764 billion predicted in 2019, rising to $5.145 billion in 2022 (up from $2.282 billion and $3.716 billion in 2019 and 2022, respectively, as forecast in March 2018). This sales trajectory now outpaces the figures for GSK’s Triumeq (dolutegravir/lamivudine/abacavir), which had sales of $1.115 billion in 2015 (its first full year in the market after launch). Anticipated sales for Triumeq in 2018 (i.e., five years after launch) are $3.741 billion.