HIV drug regimens are arguably the most famous ‘cocktails’ in medicine, comprising three or four primary drugs and many others that help alleviate side effects and improve patients’ quality of life.
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Over the years, the recipe for these cocktails has been refined. This week, at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, more potential improvements were on display.
On Monday, ViiV Healthcare, GlaxoSmithKline’s specialist HIV company with shareholders Pfizer and Shionogi, delivered results from two Phase 3 trials performed in collaboration with Johnson & Johnson’s Janssen Sciences Ireland.
Dubbed SWORD 1 and SWORD 2, the studies looked at the dual efficacy of dolutegravir (ViiV) and rilpivirine (Janssen), cutting back from the standard three- or four-drug cocktail.
If approved, the treatment could be the first two-drug regimen for HIV, allowing some treatment-experienced patients to remove nucleotide reverse transcriptase inhibitors (NRTIs) from their daily dosing.
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In a phone interview, Brian Woodfall, head of development and global medical affairs for Janssen’s infectious diseases and vaccines unit, said the SWORD trials targeted patients who were virally suppressed — their infection was already under control.
Enrolling this patient cohort was an important step to overcome the failure of previous two-drug regimen attempts. In 2017, it also speaks to the necessary evolution of the field.
The HIV population is aging; half of all U.S. HIV patients are now over 50 and that number is rising. By 2030, it is estimated over 70 percent will be 50 or older.
It’s a cause for celebration but it also brings a new set of challenges. After decades taking antiretroviral drugs (ARTs), patients may develop severe side effects or drug resistance.
Beyond efficacy in suppressing the virus, companies must deliver tolerable, safe drugs and regimens that are easy for patients to adhere to.
Gilead is working on that next generation as well. On Monday it announced Phase 2 data for bictegravir. As an integrase strand transfer inhibitor (INSTI), bictegravir would compete with ViiV’s dolutegravir.
In the head-to-head study, bictegravir held its own. It’s too early to tell if the drug will outshine ViiV’s. Either way, it’s improtant for patients to have options within each class.
Woodfall entered the field as an HIV/AIDS physician in the late 1980s and has watched the field progress. Early on it became apparent that combination therapies would be the key to sustained success, he said. No single company had — or currently has — all the necessary elements.
“Collaboration between the companies in this field started very early on for the benefit of patients and to advance science,” Woodfall said. “And that has continued, now that we’re in a better situation in terms of available therapies where we have highly effective drugs, drugs that are much more tolerable than they were in the early days and really drugs that can now provide convenience with a single tablet once a day.”
Advances in diagnostics and assays that can measure viral loads have also helped further the field. There remains a long way to go, but the collective work of the companies is delivering measurable gains in quality of life.
Photo: Sezeryadigar, Getty Images