Participants in clinical trials of long-acting injectable antiretroviral therapy for HIV describe expectations and experience with the investigational dosage form.
Long-acting injectable antiretroviral therapy (LA ART) for HIV will need to provide comparable efficacy, more freedom, and less stigma than daily pills, according to a survey of attitudes among participants of 3 clinical trials of the investigational dosage form.
Although persons living with HIV (PLHIV) have previously been surveyed about the prospect of, and interest in an effective LA ART, the current study is the first to elicit the views of those who have volunteered for, and received the investigational dosage form.
“Current phase 3 trials offer an important opportunity to also explore the views of treatment-experienced PLHIV regarding the transition from a daily oral to an injectable ART regimen, and to further understand the context of this potentially ‘game-changing’ option prior to its integration into routine care,” explained Andrea Mantsios, PhD, MHS, American University, Washington, DC, and colleagues.
The investigators recruited 51 of the participants from three phase 3 trials in the US and Spain. The ATLAS and ATLAS-2 M trials involved those with prior ART experience (median 4.3 years prior to trial with LA ART); with ATLAS-2M participants randomized to receive injections either monthly or every 2 months. A third trial, FLAIR, recruited treatment-naïve participants to receive their first oral regimen for 4 weeks prior to being randomized to continue oral ART or begin LA ART.
”Study participants articulated a range of questions and concerns including those related to LA ART efficacy and stigma associated with clinic visits,” Mantsios told Contagion.
A semi-structured, in-depth interview was conducted by trained interviewers in private rooms at the clinical sites.The semi-structured format, facilitated by a flexible guide of open-ended questions, explored several domains, including: living with HIV; prior HIV treatment with daily oral ART; and the process of transitioning to LA ART.
Mantsios and colleagues reported that most participants expressed positive views of, and experiences with LA ART, but also described having carefully considered the pros and cons of continuing with oral ART versus changing to the injectable, long-acting form.
Pain at the injection site and limited mobility in the first days after the injection was a common report, but did not discourage most (all but 1) from continuing the regimen.The participants generally considered the benefits—comparable efficacy without daily dosing—to outweigh the discomfort.
The participants were updated on their viral load status, which was useful to assuage their expressed concerns that daily oral administration might be more reliable in assuring active drug levels. Measures of efficacy also relieved concern about the need for frequent dosing expressed by those changing from monthly injection to every two months.
Some participants expressed concern about stigma from attending clinics for the injection, and of having to regularly ask for time off or to adjust routines in order to attend them. Others felt that there was more stigma attached to obtaining the pills; and of the potential for stigma or shame more often with taking pills daily, and even with people "hearing" the pills being transported or taken from the container. Many favored the injection for a greater freedom from dosing, and from dwelling on the infection.
"Patient-provider communication will be key in addressing efficacy questions and gaining an understanding of how providers and clinics can help support patients in their concerns around stigma,"Mantsios commented.
"A patient-centered approach which focuses on accommodating patient needs and preferences will certainly be important in supporting uptake and adherence to this treatment modality," she said.