GlaxoSmithKline’s ViiV Healthcare commences trial of HIV PrEP treatment

GlaxoSmithKline's ViiV Healthcare business has announced the commencement of a phase III trial of a long-acting new HIV therapy.

The global specialist HIV company, which is owned by GlaxoSmithKline, Pfizer and Shionogi, has begun a study that aims to assess long-acting injectable cabotegravir for the prevention of HIV infection.

It will evaluate injections of cabotegravir given every two months compared to daily oral PrEP with Gilead Sciences' Truvada, and is being conducted in collaboration with Gilead, the HIV Prevention Trials Network and the US National Institute of Allergy and Infectious Disease.

The trial will be called HPTN 083 and will seek to enrol 4,500 men and transgender women who have sex with men at more than 40 sites in North and South America, Asia and Africa.

A second phase III study to evaluate long-acting cabotegravir for the prevention of HIV infection in young women is also planned and is expected to start in 2017.

Dr John Pottage Jr, chief scientific and medical officer at ViiV Healthcare, said: "Through our public-private collaboration on this large phase III study, we will evaluate whether long-acting injectable cabotegravir could be an option in the pre-exposure prophylaxis setting."

This comes after the European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended approval of a Type II variation and extension applications to reduce the weight and age limit for its HIV drug Tivicay in children and adolescents.

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