Johnson & Johnson's ($JNJ) Janssen announced that a combination therapy of two intramuscular injections of HIV medications administered simultaneously monthly or bimonthly demonstrated comparability to a daily three-drug oral therapy during an ongoing Phase II trial.
At 32 weeks, the virologic response among the 309 patients in the injectable arm was similar to that in the oral-drug arm, according to a release. The viral suppression rate was 95% among those who received an injection every 8 weeks, 95% among those dosed every four weeks and 91% who continued with the oral combination therapy. All patients had already achieved suppression using the oral regimen.
The injectable drugs tested were J&J's Edurant and ViiV Healthcare's investigational cabotegravir. ViiV is majority-owned by GlaxoSmithKline ($GSK), and also counts Pfizer ($PFE) and Shionogi Limited as shareholders.
"Through scientific advances, over the past two decades, HIV has moved from a death sentence to a manageable chronic disease," says Dr. Wim Parys, the head of R&D at Janssen's global public health unit, in a statement. "Results of the LATTE-2 study show that long-acting injectable drug formulations may offer an important option for HIV maintenance therapy and we remain committed to developing such combinations as we enter phase 3 studies."
ViiV also presented positive results from its Phase II randomized trial of cabotegravir pre-exposure prophylaxis therapy in 127 healthy adult males. Following repeat injections, 74% of patients favored cabotegravir long-acting injections compared with the oral formulation. The goal of pre-exposure prophylaxis is to prevent the acquisition of HIV using antiretrovirals.
In general, long-acting injectables can increase compliance compared with oral medication by reducing the frequency of administration.
In April, J&J presented results of a study that found that the company's blockbuster, once-a-month injectable for schizophrenia, Invega Sustenna, results in better outcomes than daily oral competitors, as measured by real-world (as opposed to strictly clinical) outcomes like arrest or psychiatric hospitalization. The FDA soon thereafter approved a longer-acting version of the medication that can be injected four times a year.
- read the release from J&J
- here's the release from ViiV | more from ViiV