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Single-Tablet Dolutegravir / Rilpivirine Regimen Submitted to FDA
ViiV Healthcare has made a regulatory submission to the FDA for a single-tablet, two-drug regimen of dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland). If approved, it will be the first two-drug regimen for the maintenance treatment of patients with human immunodeficiency virus 1 (HIV-1) infection and will offer virally suppressed patients the option to switch to a regimen that does not include a nucleotide reverse transcriptase inhibitor (NRTI).
The submission was based on results from the phase 3 SWORD trials, which included more than 1,000 patients who had achieved viral suppression with a three- or four-drug antiretroviral regimen. The findings were presented at the 2017 Conference on Retroviruses and Opportunistic Infections in February.
The SWORD program evaluated the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-NRTI-, or boosted protease inhibitor-based antiretroviral regimens in adults infected with HIV-1 who were virologically suppressed after a three- or four-drug regimen. In two clinical trials––SWORD-1 and SWORD-2––dolutegravir and rilpivirine were provided as individual tablets. Both studies were replicate 148-week, randomized, open-label, noninferiority trials conducted to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with that of current antiretroviral therapy.
The studies’ primary endpoint was the proportion of patients with plasma HIV-1 RNA of less than 50 copies per milliliter at week 48. Key secondary endpoints included an evaluation of the development of viral resistance; measurements of safety and tolerability; and changes in renal, bone, and cardiovascular biomarkers. The studies also included exploratory measures to assess the change in health-related quality of life, the patient’s willingness to switch, and adherence to treatment regimens.
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. Rilpivirine is a non-NRTI.
The use of dolutegravir and rilpivirine as a two-drug regimen for HIV maintenance therapy is investigational and is not approved anywhere in the world.
In June 2014, ViiV Healthcare and Janssen Sciences Ireland 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 patients with HIV infection.
Source: Janssen; June 1, 2017.