ViiV Healthcare announced the start of a phase III clinical trial programme to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV.

The phase III programme comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who have already achieved viral suppression with a three drug regimen.

“As HIV care becomes an increasingly long term consideration, patients and clinicians are seeking to balance efficacy and side effects of treatment. We are able to attain initial viral suppression with a standard three drug regimen and the question is whether we can maintain viral suppression with two drugs instead of three.” said Dr John Pottage, chief scientific and medical officer, ViiV Healthcare.  “An interesting part of this phase III programme is the inclusion of measures of the patient experience -- we’re looking at health-related quality of life and adherence to treatment, in addition to the primary efficacy and safety endpoints.”

In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single-tablet in order to expand the treatment options available to people living with HIV (ViiV Healthcare announces new collaboration with Janssen).  

The phase III programme will evaluate the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-,NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed.  In the clinical trials, dolutegravir and rilpivirine will be provided as individual tablets; development of the single-tablet formulation will be concurrent with conduct of the trials.

SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug regimen of DTG + RPV compared with current antiretroviral therapy.  Each study seeks to enrol approximately 500 patients across 13 countries and aims to enrol meaningful numbers of patients from groups underrepresented in HIV clinical studies, such as women and people over 50 years of age.

The primary endpoint is proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The study will also include exploratory measures to assess change in health-related quality of life, willingness to switch, and adherence to treatment regimens.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.