Once-a-Month HIV Treatment On Its Way to U.S.

GlaxoSmithKline's ViiV Healthcare has continued to lead the way when it comes to simplifying drug treatment regimens for those living with HIV, and now they are closer than ever to releasing a once-a-month injectable treatment in the United States, as reported by FiercePharma this week.

Numerous studies have shown that simplifying poz people’s treatment regimens leads to better adherence, and better adherence leads to achieving a suppressed viral load — or "undectable," which also means it's virtually impossible for one to transmit the virus to someone else.

This is why the scientific community has continued to focus on making treatment regimens with fewer drugs (which also reduces toxicity).

GlaxoSmithKline has already shown that their two-drug HIV regimen is as effective as its three-drug competitors. Juluca (containing dolutegravir 50mg/rilpivirine 25m) received approval for the treatment of HIV in November of 2017 in the U.S. and in May 2018 in Europe, and is now the most widely prescribed integrase inhibitor worldwide.

But now, the latest data released from ViiV shows that another two-drug combo could also be just as effective with administration only once per month.

Last week, ViiV revealed results from two studies, pairing its own cabotegravir with Johnson & Johnson’s rilpivirine (branded as Edurant). When given once every four weeks, the drugs can maintain viral suppression in HIV-positive adults as well as a standard three-drug regimen taken daily. The data will be part of the approval application ViiV submits to regulatory authorities later this year.

“If approved, this two-drug regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year to just 12,” John Pottage, Jr., M.D., ViiV’s chief scientific and medical officer, said in a statement.

The studies, named Atlas and Flair, revealed similar efficacy, safety, and tolerability between the two regimens. Pottage also noted that “nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy.”

Currently ViiV’s biggest competitor is Gilead, with its three-drug cocktail Biktarvy, which made about $1.18 billion in 2018 after its February approval.

If all goes well, this monthly injectable could be available in the U.S. by early 2020.