Regulatory Affairs

ViiV Healthcare seeks EMA, FDA approvals for two-drug regimen to treat HIV-1 infection

PBR Staff Writer Published 02 June 2017

ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.

The applications were submitted for a single-tablet, including two-drug regimen of dolutegravir and rilpivirine for maintenance treatment of HIV-1 infection.

ViiV Healthcare’s Tivicay is a dolutegravir, while Janssen Sciences Ireland UC’s Edurant is a rilpivirine.

The applications have been submitted based on the results of SWORD studies that comprised of more than 1,000 patients, who previously achieved viral suppression on a three- or four-drug antiretroviral regimen.

SWORD phase III programme of dolutegravir and rilpivirine has assessed the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor, non-nucleoside reverse transcriptase inhibitor or enhanced protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen.

SWORD-1 and SWORD-2 are replicate 148-week, randomised, open-label and non-inferiority studies to evaluate the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy.

Dolutegravir and rilpivirine are offered as individual tablets in the clinical studies.

The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48, while secondary endpoints comprised of assessment of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers.

According to GSK, the use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world.

ViiV Healthcare CEO Deborah Waterhouse said: “As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment.

“At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection, we are challenging the traditional HIV treatment paradigm to develop new treatment regimens.”

Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C. Goldsmith.