ViiV Healthcare Announces 3-Year HIV Data for Juluca 2-Drug Combo
ViiV Healthcare presented three-year 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 regiment 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.”
A recent profile of Deborah Waterhouse, ViiV Healthcare’s chief executive officer, noted that she and other executives were instrumental in bringing Juluca to market. Interestingly, Waterhouse and ViiV executives in June 2017 chose to redeem an FDA priority review voucher for Juluca. ViiV, which is a joint venture between GSK, Pfizer and Shionogi, paid $130 million for the voucher, which allowed for an expedited six-month review, cutting four months off the standard timeline for approval. Then, about a year later, in October 2018, Waterhouse utilized another priority review voucher when the company submitted a New Drug Application (NDA) to the FDA for the drug.
As Life Science Leader notes, “Submitting two priority review vouchers within a year of each other isn’t exactly common—or easy—and obviously indicates ViiV Healthcare’s commitment to getting new HIV treatments to market quickly.”
Waterhouse observes that in the 20 years she spent climbing the corporate ladder at GSK, she developed an interest—“an area of huge passion for me”—into HIV. She points out that, “When I was in college in the mid to late 1980s, those were the years where the average life expectancy of somebody living with HIV was 18 months. It was a time of horror, really, and you saw many incredibly talented people, usually young men, having their lives cut short.”
Although she had ambitions for becoming a company executive, she ultimately set the goal of becoming the chief executive officer of an HIV-focused company. The ViiV Healthcare position seemed tailor-made for her. “HIV/AIDS,” she told Life Science Leader, “is an epidemic halted through partnership between the pharmaceutical industry, the patient, and the physician. Together, we’ve transformed what was once a death sentence to a manageable chronic disease, and that makes me incredibly proud of our industry, especially during a time when people are often quite happy to criticize it.”