Long-Acting Regimen Noninferior to Daily ART for HIV-1

MONDAY, March 11, 2019 — Monthly long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) are noninferior to daily regimens for patients with HIV-1, according to two studies presented at the Conference on Retroviruses and Opportunistic Infections, held from March 4 to 7 in Seattle.

Susan Swindells, M.B.B.S., from the University of Nebraska Medical Center in Omaha, and colleagues conducted a phase 3 study to examine whether switching to monthly LA CAB+RPV is noninferior to current three-drug oral antiretroviral therapy (ART). Participants included 616 patients with HIV-1 RNA with virologically suppressed infection. The researchers found that 1.6 and 1.0 percent of participants in the LA and ART arms, respectively, had HIV-1 RNA ≥50 copies/mL at week 48, meeting noninferiority criteria for the primary end point. For the key secondary end point of HIV-1 RNA, the LA arm was also noninferior to ART. The LA regimen was generally well tolerated.

Chloe Orkin, M.B.B.Ch., from the Queen Mary University of London, and colleagues examined whether switching to monthly LA CAB+RPV is noninferior to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). ART-naive participants received 20 weeks of induction therapy with oral DTG/ABC/3TC, and those with HIV-1 RNA who initiated induction therapy were randomly assigned to LA or DTG/ABC/3TC. The researchers found that at week 48, 2.1 and 2.5 percent of patients in the LA arm and DTG/ABC/3TC arm, respectively, had HIV-1 RNA ≥50 copies/mL, meeting noninferiority criteria for the primary end point; noninferiority criteria were also met for the key secondary end point of HIV-1 RNA.

“Overall, these results demonstrated the therapeutic potential of CAB+RPV injections, following short initial induction with oral DTG/ABC/3TC to achieve viral suppression,” Orkin and colleagues write.

One author from the Swindells study was an employee of GlaxoSmithKline; several authors from the Orkin study were employees of pharmaceutical companies.

Abstract – Swindells
Abstract – Orkin
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Posted: March 2019

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