NEW HIV DRUG INJECTION COULD REVOLUTIONIZE TREATMENT
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. C abotegravir—an integrase strand transfer inhibitor
similar to dolutegravir (Edurant)—is still in trials; if the injectable version
is approved, it will also become available for oral use.
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