GSK reports positive results from two-drug HIV regime study

Pharmaceutical giant GlaxoSmithKline said it achieved positive results from a phase three HIV study, which assessed the efficiency of a two-drug regimen.

ViiVHealthcare, which is majority owned by the company with stakes owned by Pfizer and Shionogi, said the first phase three study showed the efficacy of a two-drug regimen, as opposed three or four drugs, as maintenance therapy for HIV.

In June 2014, ViiV Healthcare and Janssen Sciences Ireland, from pharmaceutical Johnson & Johnson, teamed up to investigate potentially combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HIV.

The study assessed the safety and efficacy of switching virologically suppressed patients from a three or four drug antiretroviral regimen to a two-drug regimen of ViiVHealthcare’s dolutegravir and rilpivirine, from Janssen Sciences Ireland.

The company said the study met the primary endpoint of non-inferiority at week 48, which based on the US Food and Drug Administration's snapshot analysis, was the portion of patients with plasma HIV-1 RNA with less than 50 copies per milliliter.

Dominique Limet, chief executive of ViiV Healthcare, said: "These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated. The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017."