Two-Drug Combination Demonstrates Efficacy in Treating HIV

Janssen recently announced positive results from a pair of phase 3 studies, SWORD 1 and SWORD 2, which analyzed the safety and efficacy of an investigational 2-drug regimen in patients with HIV.

In the clinical trials, virologically suppressed patients were switched from a 3- or 4-drug antiretroviral regimen to a 2-drug regimen that includes ViiV Healthcare’s dolutegravir and Janssen’s rilpivirine. The results were presented at the annual conference on Retroviruses and Opportunistic Infections.

The primary endpoint of the studies was the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter at 48 weeks, and the secondary endpoints include viral resistance, safety, tolerability, and changes in bone and cardiovascular markers.

The SWORD studies also aim to determine patients’ health-related quality of life, willingness to switch treatments, and adherence, according to the press release.

The investigators found that the 2-drug regimen demonstrated non-inferiority in terms of virologic suppression, compared with a 3- or 4-drug regimen at 48 weeks in both trials. Janssen reported that virologic suppression was similar between the treatment arms.

The authors found that virologic failure occurred in less than 1% among patients in the 2-drug treatment arm, while it was 1% in the 3- and 4-drug regimen arms, according to Janssen.

The studies are ongoing, and are planned to continue to 148 weeks to determine the efficacy and safety of a longer-term treatment switch.

Commonly reported adverse events among patients treated with the 2-drug regimen included nasopharyngitis, headache, diarrhea, and upper respiratory tract infection.

The rate of serious adverse events was comparable among each group. However, there were slightly more patients who withdrew in the 2-drug regimen due to expected adverse events resulting from switching from a stable treatment to 2 new drugs, Janssen reported.

If approved, the dolutegravir-rilpivirine combination would be the first 2-drug regimen approved for patients with HIV. The dolutegravir-rilpivirine regimen could also offer virologically suppressed patients with a more streamlined treatment option that does not include a nucleotide reverse transcriptase inhibitor (NRTI), according to Janssen.

Reducing pill burden for patients with HIV may be an important factor in increasing adherence, and improving outcomes.

“The SWORD Phase III results represent an important step forward in our efforts to deliver a two-drug regimen that may help simplify dosing regimens and reduce pill burden for people living with HIV,” said Lawrence M. Blatt, global R&D head, Infectious Diseases & Vaccines, Janssen. “As HIV is increasingly treated as a life-long condition, we remain committed to ongoing research and development of further medicines to treat HIV more simply and to help all those living with HIV to achieve an undetectable viral load and have an improved quality of life.”