ViiV hails data showing switch from Truvada to two-drug HIV regimen
ViiV is continuing its assault on arch-rival Gilead in HIV, with phase 3 results aimed at giving doctors confidence that patients can switch from rival triple therapies to its new two-drug regimen.
ViiV, a joint venture between majority owner GlaxoSmithKline, Pfizer, and Shionogi, has data showing that its two-drug regimen is able to suppress the disease after switching from a triple regimen including drugs such as Gilead’s Truvada.
Results from the TANGO study showed that after 48 weeks adults treated with Dovato (dolutegravir+lamivudine) were still able to suppress the HIV virus after switching from a tenofovir alafenamide fumarate-containing regimen.
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA of 50 copies per millilitre (c/mL) or less using an FDA Snapshot algorithm at week 48.
No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.
The safety results for the two drug regimen of dolutegravir plus lamivudine were consistent with the product labelling for the medicines.
TANGO is a phase 3, randomised, open-label, active-controlled, multicentre study to assess the antiviral efficacy and safety of switching to a two-drug regimen consisting of dolutegravir plus lamivudine in HIV-infected adults who are virally suppressed and stable on a TAF-containing regimen.
The single pill was approved by the FDA earlier this year and received EU approval last week, for treatment of HIV infection in adults and adolescents above 12 years of age.
Patients must weigh at least 40 kg and have no known resistance to integrase inhibitors or lamivudine to be eligible for treatment.
Dovato does away with the need for two pills, and using only two active ingredients could also help to limit side effects.
HIV medicines have for years been based on three-drug regimens based on an integrase inhibitor such as dolutegravir, and two nucleoside reverse transcriptase inhibitors (NRTIs).
The two drug “backbone” is used in case the HIV virus resident in the patient’s body develops resistance to one of the two NRTIs, but ViiV is challenging this treatment paradigm by producing the two-drug regimen that seems to avoid problems with resistance.
In a separate development Gilead and Lyndra Therapeutics have joined forces to develop and market ultra-long-acting oral HIV therapies.
Under the deal California-based Gilead has picked up exclusive rights to Lyndra’s long-acting drug platform.
Based in Watertown, Massachusetts, Lyndra focuses on reformulating oral drugs so that they can be taken less often, based around a star-shaped capsule that unfolds in the stomach and slowly releases the drug over an extended period of time.