Gilead’s new combination therapy Biktarvy has been approved by the US Food and Drug Administration for the treatment of HIV.
The once-daily single tablet regimen combines the novel investigational integrase strand transfer inhibitor bictegravir with emtricitabine/tenofovir alafenamide (FTC/TAF; marketed as Descovy).
The therapy has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.
The application centered on data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.
Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir; two in treatment-naïve patients and one in virologically suppressed patients switching from an existing DTG-containing antiretroviral regimen.
A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.
Paul Sax, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, Professor of Medicine at Harvard Medical School and a lead clinical trial investigator, said the clinical data show that “the regimen’s antiviral efficacy, tolerability profile and limited drug interactions offer an effective new treatment option for a range of people living with HIV.”
However, potentially throwing a spanner in the works, it emerged that ViiV Healthcare, which is majority-owned by GlaxoSmithKline, filed a patent infringement suit against Gilead over bictegravir in the US and Canada.
“ViiV Healthcare will seek to prove that Gilead Sciences Inc's triple combination HIV drug containing the HIV integrase inhibitor bictegravir infringes ViiV Healthcare's patent covering ViiV Healthcare's dolutegravir and many other compounds that include dolutegravir's unique chemical scaffold,” the company said in statement.
The firm also stressed that it would seek “financial redress for patent infringement.”