Patients Stay on Track With Injectable HIV Tx During Pandemic

During the pandemic, the vast majority of participants in ongoing clinical trials of the first injectable HIV combination long-acting antiretroviral therapy (ART) were able to receive in-person doses, a researcher reported.

In a review of data from six ongoing trials of the investigational cabotegravir and rilpivirine long-acting (CAB+RPV LA) ART, 93% of participants maintained their injection visits, with no instances of virologic failure or development of resistance through July 2020, according to Maggie Czarnogorski, MD, head of innovation and implementation science at ViiV Healthcare in Research Triangle Park, North Carolina. The agent was approved in Canada in March 2020, and was re-submitted for FDA approval in August 2020.

From Dec. 1, 2019 to Sept, 15, 2020, 129 of 1,744 (7.4%) active participants in CAB+RPV LA trials, such as LATTE-2 and ATLAS, had injection visits impacted by COVID-19, Czarnogorski said during a presentation at the virtual IDWeek.

When missed visits occurred during the pandemic, they were manageable and successfully mitigated, primarily by switching patients to short periods of daily oral CAB+RPV LA therapy, she explained.

The six trials included patients who were being treated on a monthly/every 4-week dosage schedule, and those who were treated on an every 8-week/every 2-month dosage schedule. Missed dosing varies by countries, she noted:

• U.S.: 62
• South Africa: 17
• Spain: 11
• Canada: 10

In 54 of the cases, missed doses were the result of clinic closure or staffing restraints, while in 18 cases, patients had either confirmed or suspected COVID-19. In 11 cases, the patient was self-quarantined. In 5% of the cases, patients who couldn’t maintain their scheduled treatment used oral medications to bridge the gap to the next available clinic visit; another 2% of the patients used a different ART, she reported.

“Despite the impact of the global COVID-19 pandemic on healthcare services, there have been no antiretroviral interruptions among participants in cabotegravir/rilpivirine trials. The vast majority of participants’ injection visits occurred as planned,” Czarnogorski said.

To date, there have been no suspected or confirmed virologic failures observed for any participants whose planned injection visit schedules were impacted by the pandemic, she said. Also, 110 of the 121 participants who transitioned to temporary oral therapy have since restarted CAB+RPV LA. Of those participants who transitioned back to the injectable, the median duration of oral therapy was 51 days.

Joseph P. McGowan, MD, of the Northwell Health HIV Service Line Program in Manhasset, New York, told MedPage Today that “This study touches on some of the issues regarding maintaining adherence to treatment when clinical infrastructure is being impacted, for example by the COVID-19 pandemic.”

McGowan, who was not involved in the study, explained that “an oral formulation is available and is used during the lead-in period prior to long-acting injection. This is done to ensure that adverse effects and tolerability issues, including allergic reactions, can be identified before a long-acting injection is given to prevent extended exposure and allow quicker washout.”

“This oral formulation can also act as a bridge during missed injections to maintain blood levels in the therapeutic range until the clinic is open to supply the injections,” McGowan said. “The medication requires specific handling prior to injection, so all must be available to proceed with dosing. The availability of a back-up supply of oral medications is part of the clinical trial, and would have to be assured once this new strategy is approved for clinical use to support patients in a similar scenario. This would require support and cost to be built into the insurance companies covering the medication.”

McGowan also noted that “during COVID, many clinics and states have adopted guidelines to allow reopening safely, telehealth visits and consultation, and providing 90 day refills on anti-retroviral medications to lessen the risk for treatment gaps.”