Milestone in HIV as Every-Other-Month Shot Blocks Virusby
If proven in later trials, could revolutionize HIV treatment
Injection by J&J, Glaxo compared with daily regimen of pills
A long-acting shot to suppress HIV worked as well as a combination of three daily pills, a study from GlaxoSmithKline Plc and Johnson & Johnson found. If borne out in larger trials, such a treatment could revolutionize treatment of the deadly virus.
Patients in the trial got injections of two drugs, rilpivirine and cabotegravir, every four or eight weeks, while another group got a combination of daily pills including an oral version of cabotegravir. The injections, which could be given once a month or every other month, were as effective as the pills, J&J said in a statement Tuesday.
“Going from many pills a day -- like 10, 20 pills a day -- to now one pill, to now one injection every two months is I think a huge medical technical achievement," said Paul Stoffels, J&J’s chairman of pharmaceuticals, said on a conference call with reporters.
While there is no cure for HIV, the virus is now subdued with a once-daily pill such as Gilead Sciences Inc.’s Atripla. A monthly or every-other-month injection could further alter treatment of the disease, making more patients more likely to stick to the drug and helping them keep a regular amount of virus-suppressing medicine in their system.
There is still work to be done to improve the experimental injection. The drug needs to be refrigerated and requires too great a dose to be given in personally-injected shots right now, Stoffels said. The J&J executive started his career as a doctor in Africa focusing on research on HIV and tropical diseases.
“I was back in the late ’80s in Africa when the HIV epidemic was in full growth and was devastating,” he said.
Rilpivirine is from J&J, while cabotegravir is being developed by ViiV Healthcare Co., a joint venture of London-based Glaxo, New York-based Pfizer Inc. and Osaka, Japan-based Shionogi & Co.
Stoffels said J&J hoped to get the product to market “significantly before 2020,” and aimed to have it sold globally. “It’s far too early to say anything about the pricing of this but, as always, I think we have been responsible pricing in this area so that is for later,” he said.
In the trial, patients getting the injection every four weeks had viral suppression rates of 94 percent, and patients dosed every eight weeks had suppression rates of 95 percent. That compared with a rate of 91 percent in patients taking the daily pills.
Five percent of those on the four-week dose stopped taking the drug because of negative side effects, more than the 2 percent among those on the eight-week dose and 2 percent in those on the pills. The most common negative side effect reported by patients was pain at the site of the injection.