Two-Drug HIV Regimen Shows Promise in Late-Stage Trials

Regulatory submission of single-tablet product expected next year

Two phase 3 studies designed to evaluate the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to the two-drug regimen of rilpivirine (Edurant, Janssen) and dolutegravir (Tivicay, ViiV Healthcare) have met the primary endpoint of noninferiority at week 48. In both studies, the subjects achieved plasma human immunodeficiency virus-1 (HIV-1) RNA levels of less than 50 copies/mL.

It is expected that regulatory submissions for the investigational two-drug regimen of rilpivirine and dolutegravir as a single tablet will be made in 2017.

The phase 3 development program evaluated the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimens in HIV-1–infected adults who were virologically suppressed with a three- or four-drug regimen. In the clinical trials, dolutegravir and rilpivirine were provided as individual tablets.

The SWORD-1 and SWORD-2 studies were duplicate 148-week, randomized, open-label, noninferiority trials. The primary endpoint in both studies was the proportion of patients with plasma HIV-1 RNA levels of less than 50 copies/mL at week 48. Key secondary endpoints included the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone, and cardiovascular biomarkers. The study also included exploratory measures to assess changes in health-related quality of life; the patients’ willingness to switch; and adherence to treatment regimens.

Rilpivirine is a prescription HIV medication that is used with other antiretroviral drugs to treat patients with HIV-1 infection who have never received HIV medications and who have a viral load of no more than 100,000 copies/mL. Rilpivirine is not recommended for use in patients younger than 12 years of age.

Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

Source: Janssen; December 19, 2016.