April 22, 2020 — A new qualitative study by researchers at Columbia University Mailman School of Public Health found that the majority of women living with HIV would endorse a monthly long acting injectable (LAI) antiretroviral therapy over current daily pills. LAI HIV therapy has completed Phase III trials and is awaiting Food and Drug Administration approval. Study participants were recruited from the Women’s Interagency HIV Study – the largest national study of women living with and at risk for HIV infection. Over half of the 59 women interviewed (56 percent) would choose LAI HIV therapy over daily pills for reasons of convenience, privacy, and perceived effectiveness: in contrast, 34 percent would prefer daily oral pills and 10 percent would prefer neither. This study is the first to exclusively explore women’s interest in LAI HIV therapy, and one of the first among a non-clinical trial sample, who more accurately represents the population that will be using LAI HIV therapy. The findings are published in JAIDS: Journal of Acquired Immune Deficiency Syndrome.

“Adherence to antiretroviral therapy is imperative for viral suppression and reducing HIV transmission, but many people living with HIV report difficultly sustaining long-term adherence over the lifespan,” said Morgan Philbin, PhD, assistant professor of sociomedical sciences at Columbia Mailman School. We found that long acting injectable antiretroviral therapy was a compelling option among the women we interviewed.”

The researchers conducted 59 in-depth interviews with women living with HIV in six Women’s Interagency HIV Study (WIHS) sites: New York, Chicago, Washington DC, Atlanta, Chapel Hill, and San Francisco from November 2017 – October 2018. The women received care at university settings that will be among the first to administer LAI antiretroviral therapy once it is approved; none of these women were enrolled in clinical trials for LAI HIV therapy.

Nearly one-quarter of people living with HIV in the United States are women. Of these, 89 percent know their diagnosis, 65 percent receive care, and 51 percent are virally suppressed. Women living with HIV have historically been underrepresented in HIV treatment research, including trials for LAI HIV therapy. “It is therefore imperative to understand their interest in this new technology, since it has the potential to transform HIV treatment,” said Philbin.

The mostly male participants in ATLAS and FLAIR LAI ART trials reported a high preference (97 percent in FLAIR, 91 percent in ATLAS) for LAI over daily oral pills and said the side effects — including fatigue, fever, headache and nausea — rarely led to trial discontinuation.

While the majority of women in the Columbia University-led WIHS study would also prefer LAI HIV therapy over daily pills, they also raised significant challenges. This includes more frequent doctors’ visits (every month versus ever 3 or 4 months) and related transportation barriers, a distrust of new and perceived untested technologies and frustration that LAI would relieve some–but not all–of their current pill burden, noted the researchers.

“Our study demonstrated that women living with HIV are open to long acting injectable antiretroviral therapy, and many believe it will provide distinct benefits over daily pills,” noted Philbin. “However, women also described challenges unique to them as women that would need to be addressed in order to ensure that they fully benefit from these new technologies, including the role of children and childbearing, caregiving responsibilities and long histories of medical mistrust. As a result, we want to highlight the need to incorporate women into the process of LAI ART roll out to ensure their inclusion.”

Co-authors: Carrigan Parish, Elizabeth,Kinnard, Sarah Reed, Lisa Metsch, Columbia Mailman School of Public Health; Deanna Kerrigan, American University; Maria Alcaide, Margaret Fischl, University of Miami Miller School of Medicine; Maridge Cohen, John H. Stroger Jr. Hospital of Cook County, Chicago; Oluwakemi Sosanya, Montefiore Hospital, New York; Anandi Sheth, Emory University School of Medicine; Adaora Adimora, University of North Carolina School of Medicine; Jennifer Cocohoba, University of California at San Francisco School of Pharmacy; Lakshmi Goparaju, Georgetown University Medical Center; and Elizabeth Golub, Johns Hopkins Bloomberg School of Public Health

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human, the National Cancer Institute, the National Institute on Drug Abuse, and the National Institute on Mental Health.