GlaxoSmithKline will start a clinical trial on a combination of long-acting anti-HIV drugs --cabotegravir and rilpivirine (product name: Edurant) -- in Korea.
The Ministry of Food and Drug Safety on Tuesday approved the company’s phase-3b clinical trial to test safety, efficacy, and drug tolerance of the combo therapy of the two agents. Twenty-four 24 adults infected with HIV-1 in viral suppression will participate in the trial, which will verify the effectiveness of the combo every eight or four weeks.
“This study is to confirm the potency of eight-week combination therapy of cabotegravir and rilpivirine,” a GSK official said.
Cabotegravir is a long-acting anti-HIV injection under development by GSK. The company is testing it as a single treatment or as a combination with rilpivirine in clinical trials.
GSK expects the investigational long-acting injection will help to alleviate HIV patients’ burden to take medications every day.
As the drug candidate is long-acting, it should prove its potency in suppressing HIV. According to the result of a clinical trial called LATTE-2 unveiled in July, the viral suppression rate of the combination of cabotegravir and rilpivirine was similar to that of the combination of three oral drugs, oral cabotegravir with two nucleoside reverse-transcriptase inhibitors (NRTIs).
After maintaining treatments for 96 weeks, the viral suppression rate of the patient group who received two-drug combo once in eight weeks was 94 percent, whereas that of patients who received the same medication once in four weeks was 87 percent. The patient group that took the three-drug combo showed 84 percent viral suppression rate. A total of 309 patients participated in the study.
Two patients whose viral suppression failed were among those with eight-week injections. Patients with four-week doses did not show any failure in viral suppression. In the control group, one patient failed in viral suppression.
GSK also received a green light last year to conduct a phase-3 clinical trial in Korea on switching to the combination of cabotegravir and rilpivirine from antiretroviral drugs (integrase strand-transfer inhibitor (INI), non-nucleoside reverse-transcriptase inhibitors (NNRTIs), or protease inhibitor (PI)-based) for HIV-1 infected adult patients in viral suppression. It has since been carrying out the test in Korean patients.
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