ViiV Healthcare's 2-Drug Combo for HIV Approved by FDA

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The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before. ViiV Healthcare is a division of GlaxoSmithKline.

The approval of the drug was built on the GEMINI 1 and 2 clinical trials that evaluated more than 1,400 adults with HIV-1 infections. In those trials, DTG + 3TC showed non-inferiority based on HIV-1 RNA levels of less than 50 copies per milliliter, a standard measurement of HIV-1 control, at Week 48 compared to a three-drug combination of DTG and two nucleoside reverse transcriptase inhibitors (NRTI’s).

Dolutegravir is an integrase strand transfer inhibitor (INSTI), which prevents HIV replication by keeping the viral DNA from integrating into the genetic material of T-cells. Lamivudine is an NRTI that interferes with the conversion of viral RNA into DNA. This prevents the virus from multiplying.

“Building on our innovative portfolio of medicine, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine,” stated Deborah Waterhouse, chief executive officer of ViiV. “With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting—a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.”

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It was just last week that ViiV announced 3-year data for another of its two-drug HIV combos, Juluca. They presented the data from the SWORD 1 and 2 clinical trials in HIV. The data was presented at the 25th Annual Conference of the British HIV Association (BHIVA) in Bournemouth, UK.

The studies found that 84% of patients who switched from a three- or four-drug antiretroviral regimen to the two-drug combo Juluca maintained viral suppression. Juluca is a two-drug combination of ViiV Healthcare’s dolutegravir and Johnson & Johnson’s Janssen Sciences Ireland’s rilpivirine.

In June 2014, ViiV Healthcare and Janssen Sciences Ireland partnered to investigate the possible combination of dolutegravir and rilpivirine. Juluca has been approved in the U.S., the European Union (EU) and in other countries as a complete regimen for HIV-1 infection in adults who are virologically suppressed, which is defined as less than 50 copies of HIV-1 RNA per mL. Dolutegravir is an integrase inhibitor. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor. The pill is taken once a day.

The SWORD Phase III program is studying the efficacy, safety and tolerability of switching to dolutegravir plus rilpivirine from current combination therapies. The primary endpoint is the proportion of patients with plasma HIV-1 RNA less than 50 copies per milliliter at week 48. Key secondary endpoints include evaluation of viral resistance development, safety and tolerability, and changes in renal, bone and cardiovascular markers. Health-related quality of life measures are assessed as well.

“The SWORD 1+2 studies are the first Phase III HIV studies to show long-term data for switching from three-drug combination to an oral 2-drug regimen,” stated John C. Pottage, Jr., ViiV’s chief scientific medical officer, “and the efficacy, tolerability and barrier to resistance out to three years demonstrated in the study provides further reassurance of the suitability of Juluca for many virologically suppressed adults living with HIV.”

Of the Dovato approval, Jeff Berry, of the Test Positive Aware Network (TPAN), stated, “The approval of Dovato is a welcome paradigm shift, as it brings an innovative treatment approach to newly diagnosed adults with HIV-1. By exposing patients to fewer drugs at the start of treatment, the hope is to help address concerns arising from overall management of prolonged ARV therapy.”

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