Following ViiV Healthcare’s announcement on 8th April 2019 that its investigational 2-drug single-tablet regimen (STR) Dovato (dolutegravir/lamivudine) received FDA approval for the treatment of adults with human immunodeficiency virus (HIV),

Christopher Pace, Senior Director of Infectious Diseases and Respiratory at GlobalData, a leading data and analytics company, offers his view on how Dovato is expected to impact the HIV treatment landscape:

“With Dovato, ViiV now possesses the only 2-drug STR approved for treatment-naïve patients, allowing the GlaxoSmithKline (GSK)-led joint venture to more effectively compete against Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [TAF]), which has garnered sales off over $1.1bn globally since its approval in February 2018. Based on the solid data from the GEMINI 1 and 2 studies, I expect Dovato will quickly gain traction as a first-line option for patients newly diagnosed with HIV, particularly those who would otherwise be precluded from receiving Triumeq (abacavir/dolutegravir/lamivudine) due to abacavir hypersensitivity.

“Juluca (dolutegravir/rilpivirine), ViiV’s other marketed 2-drug regimen, has struggled out of the gate against Biktarvy, largely due to the fact that it is only approved for HIV patients who have achieved viral suppression with another antiretroviral therapy. While recently reported data from the SWORD 1 and 2 studies have strengthened Juluca’s position as an attractive long-term maintenance therapy, its inability to access treatment-naïve patients remains a key limitation in a market where switching patients from one regimen to another can prove challenging.

“ViiV’s pricing strategy with Dovato will be worth closely monitoring, as inexpensive generic versions of lamivudine are widely available. Historically, payers have been willing to reimburse branded 3- and 4-drug STRs to ensure improved compliance over less expensive, multi-tablet regimens, but it remains to be seen whether or not the same will be true for 2-drug STRs such as Dovato. If the cost of prescribing Tivicay (dolutegravir) plus generic lamivudine is substantially lower than the cost of Dovato, it’s possible clinicians and payers could consider this approach.

“ViiV’s pricing strategy notwithstanding, Dovato represents a key advance in the management of treatment-naïve individuals, providing clinicians with another good option that potentially offers a superior long-term side effect profile. As a result, I expect Dovato will achieve blockbuster status in the coming years.”