Updated | A long-acting and injectable form of two HIV drugs could change the face of health care for patients with the disease. This week, ViiV Healthcare announced that its phase 2b trial—Long-Acting AntireTroviral Treatment Enabling trial, or LATTE 2—has delivered the preliminary results necessary for further testing. The trial was undertaken in partnership with pharmaceutical giants GlaxoSmithKline, Janssen and Pfizer.
The treatment is comprised of two antiretroviral drugs: cabotegravir (produced by ViiV Healthcare) plus rilpivirine (produced by Janssen), administered to patients once every four or eight weeks. The injections have proven to be as effective at suppressing the HIV virus as taking three daily antiretroviral medications, the number of drugs currently prescribed to most patients. In fact, early indications suggest it might be even more effective.
The treatment will now progress to a phase 3 trial, in which it will be tested on a larger patient population. John Pottage, chief scientific and medical officer for ViiV Healthcare, says if the next trial is successful, he expects the therapy will earn approval from the U.S. Food and Drug Administration and the European Medicines Agency. Pottage says the companies are aiming to complete the phase 3 trial by 2019.
Patients who received injections once every four weeks achieved a viral suppression rate of 94 percent, while those who received the injections every eight weeks achieved a viral suppression rate of 95 percent. Patients on a three-pill oral regimen had a viral suppression rate of 91 percent. The researchers say the side effects of the drugs were minimal; the most commonly reported adverse event was pain at the injection site. Patients in the LATTE trials were positive for HIV 1, the strain of the virus that is responsible for most infections worldwide.
Advances in drug development have ostensibly turned HIV into a chronic illness rather than the death sentence it was in the 1970s and '80s. But today, HIV patients don't always adhere fully to a drug treatment plan. For many, it's logistically and financially challenging to obtain maintenance medications or to remember to take them every day. A report released last year by the U.S. Centers for Disease Control and Prevention found only 30 percent of 1.2 million Americans living with HIV actually have the disease under control.
"When you think about people with HIV you're going to treat them for a lifetime and you have to treat them with a combination of drugs. Monotherapy is not enough," says Pottage. "There are patients who get tired of taking daily pills, or have lifestyles that don't lend themselves to that."
This new development in HIV management may also improve overall lifelong outcomes for the HIV patient population. Having more treatments that are effective means a patient who develops a resistance to one—or several—drugs will still have other options.
LATTE (the study that preceded LATTE 2) examined the safety and efficacy of the two drugs, but in oral form. The oral version of rilpivirine—a non-nucleoside reverse transcriptase inhibitor—is currently available to patients under the brand name Edurant. Cabotegravir—an integrase strand transfer inhibitor similar to dolutegravir—is still in trials; if the injectable version is approved, it will also become available for oral use.
Correction: A previous version of this story misidentified the brand name of dolutegravir as Edurant; it is not. Edurant is the brand name for rilpivirine oral.
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