Dovato approval key for Glaxo in HIV treatment

The FDA has approved the two-drug single-tablet regimen (STR) HIV treatment Dovato, opening up a new front in the battle for supremacy in the field.

Dovato (dolutegravir/lamivudine) is marketed by GSK-led joint venture ViiV,and is the first ever once-a-day two-drug STR for treating treatment-naïve patients.

By giving patients a simpler regimen containing fewer drugs, the expectation is that long term management of the condition will be easier, with patients less likely to develop side-effects.

This gives the company the upperhand over its chief rival, Gilead, which has come to dominate this segment since it launched Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [TAF]) in February 2018.

Christopher Pace, senior director of Infectious Diseases and Respiratory at data and analytics company GlobalData, predicts the new entrant will be a blockbuster.

“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 [ViiV's] Triumeq (abacavir/dolutegravir/lamivudine) due to abacavir hypersensitivity.”

ViiV already have another two-in-one STR, Juluca (dolutegravir/rilpivirine), but this is only approved for HIV patients who have achieved viral suppression with another antiretroviral therapy. Recent studies have set Juluca up to be a strong contender in the long-term maintenance therapy, but ViiV needs Dovato to target the treatment-naïve patients, where switching patients from one regimen is complicated.

The HIV therapy market is also likely to be affected by the arrival of generic versions of lamivudine.

Christopher Pace says: “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.”

In March, GSK presented encouraging phase 3 data from another potentially practice-changing candidate: A once-a-month HIV treatment that could free people with the virus from having to take daily pills. This combines ViiV’s integrase inhibitor cabotegravir and Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.

Gilead’s GS-6207 is a novel HIV-1 capsid inhibitor is seen as a potential component in a future long-acting therapy. It is further behind in development, but showed promising results in a phase 1 trial last month, demonstrating potential as a treatment given just once every three months.