Positive Results Announced for 2-Drug HIV Regimen

Combination treatment with rilpivirine and dolutegravir demonstrated non-inferiority to other regimens.

Janssen Sciences recently announced positive results from a pair of phase 3 clinical trials evaluating an investigational combination treatment for HIV.

The trials assessed the safety and efficacy of switching patients with HIV from a 3- or 4-drug regimen to a 2-drug regimen of rilpivirine (Edurant) and dolutegravir (Tivicay), which was the primary endpoint of the trials, according to a press release from Janssen.

The SWORD-1 and SWORD-2 clinical trials were 148-week studies designed to assess the safety and efficacy of a novel regimen among virologically suppressed patients with HIV-1. The drug regimen was administered to patients as individual tablets, and not as a fixed-dose tablet.

Included in the studies were patients who switched from HIV drug regimens that included integrase inhibitors, non-nucleoside reverse transcriptase inhibitors, or boosted protease inhibitors.

The investigators found that the novel rilpivirine and dolutegravir regimen demonstrated non-inferiority at week 48, Janssen reported.

In both trials, the primary endpoint was evaluated by the amount of patients with plasma HIV-1 RN less than 50 copies per mL at week 48. Secondary endpoints included the evaluation of the development of viral resistance, safety and tolerability measures, and changes in renal, bone, and cardiovascular biomarkers, according to the press release.

The investigators also assessed health-related quality of life, willingness to change treatments, and medication adherence.

The safety profile of the drug regimen was consistent with the labelling for the marketed monotherapy drugs. Common adverse events associated with rilpivirine monotherapy include depression, headache, insomnia, and rash. Common adverse events associated with dolutegravir include insomnia, fatigue, and headache.

Both drug labels warn that patients taking these medications should not breastfeed due to the risk of passing HIV to the child. However, dolutegravir may be used during pregnancy if the benefit justifies the risk.

Janssen predicts that they will file regulatory submissions for a fixed tablet of rilpivirine and dolutegravir in 2017, the press release concluded.

“HIV has become a chronic, long-term condition in many parts of the world thanks to the availability of more than 20 approved medicines. As physicians, and those living with HIV, consider life-long treatment they must balance efficacy and the side effects of treatment,” said Lawrence M. Blatt, global R&D head, Infectious Diseases & Vaccines at Janssen. “We are committed to exploring new combination therapies to improve the lives of those facing life-long HIV treatment and these important results for a two-drug regimen support those efforts.”