Johnson & Johnson's ($JNJ) Janssen announced that a Phase IIb study of a combination regimen of two investigational long-acting injectable HIV drugs found that the therapy performed similarly to a regimen consisting of three oral medications. The oral medications are given daily, while the injectables are administered once every 4 to 8 weeks, meaning the results have implications for improving medication adherence.
The injectable combination therapy consists of Janssen's investigational rilpivirine (the daily oral formulation of which is marketed as Edurant) and ViiV Healthcare's investigational nanosuspension formulation of cabotegravir, an investigational integrase strand transfer inhibitor. It was compared to a regimen of an investigational oral tablet formulation of cabotegravir and two nucleoside reverse transcriptase inhibitors.
Three hundred and nine adult patients were randomized into the oral regimen arm or one of two injectable regimen arms (one dosing every 4 weeks, the other dosing every 8 weeks). Patients in all three arms of the 96-week open-label trial had comparable viral suppression rates at 32 weeks, Janssen said in a release.
|J&J CSO Dr. Paul Stoffels|
"Despite great progress in HIV treatments, the burden of treating HIV patients remains high," said Dr. Paul Stoffels, chief scientific officer of J&J's pharmaceutical unit, in a statement. "Long-acting injectable drug formulations may offer another option for HIV maintenance therapy. Our hope in studying such combinations is to make HIV infection manageable with a potentially transformational all injectable regimen."
If successful, the injectable combination regimen would mark a big change in HIV treatment. J&J said the standard of care for HIV maintenance therapy consists of three oral meds: two oral nucleoside reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor, protease inhibitor or integrase inhibitor.
J&J said 35 million people around the world have HIV, with 2.5 million additional infections being added to the total every year. Nearly 75 million have been infected since the start of the epidemic.
Following the announcement, Gilead Sciences ($GILD) won FDA approval for its oral tablet Genvoya, which is approved for patients with HIV genotype 1 who have either never taken an antiviral or whose virus is already suppressed.
J&J and ViiV's injectables will be among its biggest competitors pending FDA approval. ViiV is majority-owned by GlaxoSmithKline ($GSK).
- here's FierceBiotech's take
- read the release from J&J
- read the release from ViiV Healthcare