Long-Acting Injectable ART for Women With HIV
New findings published in the Journal of Acquired Immune Deficiency Syndromes indicate that women living with HIV may prefer monthly long-acting injectable (LAI) antiretroviral therapy (ART) over daily ART pills, and that more women should be included in future LAI ART-related research.
Researchers arrived at their conclusion after performing 59 in-depth interviews with women living with HIV at 6 different Women’s Interagency HIV Study sites. The women included in the analysis currently receive health care in university settings that will administer LAI ART following FDA approval; however, they were not included in LAI ART clinical trials.
The results of the study indicated that most women “enthusiastically endorsed” LAI ART and would prefer to receive a monthly dose over taking a daily pill. The researchers noted 3 overarching reasons among women with this preference:
- Confidentiality and convenience
- Not having daily reminders of living with HIV
- Beliefs that shots are more effective than pills
However, the researchers explained, potential challenges associated with LAI ART were noted, including medical mistrust, safety and efficacy concerns, pill burden for HIV and any comorbid conditions, and barriers to attending further medical visits.
“Most women preferred LAI ART over daily pills given its benefits, including convenience, privacy, and perceived effectiveness. Future research should incorporate more women into LAI ART trials and research to better understand and align development with user concerns and preferences to enhance uptake,” the researchers concluded.
Consultant360 discussed these findings and their implications further with lead author Morgan Philbin, PhD, MHS, assistant professor of Sociomedical Sciences at the Columbia University Mailman School of Public Health in New York.
CONSULTANT360: Why are women with HIV underrepresented in long-acting injectable ART-related behavior research?
Dr Philbin: I think there are several reasons why women are not included as often as men in this type of research. There was a full-scale push by the National Institutes of Health to ensure that there was gender parity in trials. However, with HIV, because the epidemic was most known among men who have sex with men, they tend to be seen as the population that should always be included in randomized controlled trials, first and foremost. There are some instances where that makes sense, particularly since men constitute nearly 80% of people living with HIV in United States—though this is not the case internationally . However, because we need to know whether there are biological differences in the body’s response to LAI ART, it is very important to include samples of women that are representative of the entire population in more of these trials.
It is also important to include more women in this kind of research for the socio-behavioral reasons that my colleagues and I assessed in this study because a lot of women with HIV have diverse experiences compared with men that affect the management of their condition. LAI ART is currently undergoing potential approval by the US Food and Drug Administration. If and when it is approved, it is important that this intervention is scaled up in a way that meets the needs of all populations with HIV, including women, and takes into account potential barriers to treatment.
C360: Could you discuss some of the issues that may arise with daily ART pills and how LAI ART could help mitigate some of these issues?
Dr Philbin: There were a few central themes that arose among the women we interviewed, and the first had to do with convenience and confidentiality. Many women expressed that it would be much easier for them to only have to worry about a once-monthly injection compared with a daily pill. They would also love to avoid worrying about whether somebody will hear their ART pills jingling in their purse or notice the pills in their kitchen or bathroom cabinets. That ties into something else that came up, which had to do with the stigma surrounding HIV, including self-stigma. Many of the women we interviewed felt totally healthy day-to-day, but because they take a daily pill, they had that daily reminder of living with HIV. On the other hand, they felt that having an injection that they only had to remember once a month would make their lives a lot easier.
C360: In your study, you and your colleagues noted that challenges still remain when it comes to medical mistrust, concerns about safety and effectiveness, pill burden for HIV and other conditions, and barriers to additional medical visits among women with HIV. How might these challenges be overcome?
Dr Philbin: Despite the potential benefits of LAI ART, it is important to recognize that there are certain issues that LAI ART will not fix, such as medical mistrust, insurance access, travel and transportation to a clinic, missing work for an appointment, etc.
Medical mistrust is certainly not unique to HIV and is not something that will be easily solved. It needs to be addressed at all levels. Some barriers related to medical mistrust are structural barriers, such as expanding the Affordable Care Act and ensuring patients have access to health insurance, as well as finding providers who will treat patients the way they want to be treated and engage in shared decision-making with patients. I think this will be an interesting process, particularly for HIV, because there has never been an alternative to a pill thus far. It will be important for providers to sit down with their patients and gauge their potential interest in LAI ART compared with daily ART pills, and to respect and support their patients’ preferences in order to help alleviate medical mistrust.
Pill burden may also be a barrier, particularly for older populations, because many of the women we interviewed had comorbid diabetes or hypertension, or were taking vitamins, birth control, etc. Many of these women liked the idea of LAI ART, but since they were already taking numerous pills for multiple health conditions in addition to their daily ART, they felt it did not make sense for them to switch to LAI ART and add a monthly medical visit in order to take only one less pill.
C360: What is the next step in terms of future research in this area?
Dr Philbin: One potential avenue is to assess women’s awareness of, interest in, and preferences related to, and access to LAI ART on a broader, national level. It will be important to determine how to roll out LAI ART in communities in ways that will make it feasible for national scale-up. It will also be important to assess providers’ perspectives on LAI ART in future research, as well how LAI ART will affect patient capacity and health care staffing needs in a clinical setting.
Another potential avenue is ensuring that, once approved, LAI ART is scaled up in a way that will not exacerbate health care disparities. This is something that occurred when pre-exposure prophylaxis (PrEP) was initially approved. There has been a huge difference in PrEP access among states that expanded Medicaid vs those that did not, and there are some states where PrEP is available free-of-charge, including the associated labs and doctor visits. The percent of women that have started using PrEP is much lower than is indicated by the Center for Disease Control and Prevention guidelines, because many providers often do not perceive women to be at-risk of acquiring HIV and, as a result, do not offer it to them.
In terms of how LAI ART will affect the overall HIV epidemic, it may make certain individuals’ lives easier. However, if the goal is also to increase the number of patients who are adherent, this will only work if LAI ART is provided in a way that is accessible to patients who are struggling with oral medication. Thinking about how to address these health care disparities is a particularly important area of research moving forward.
C360: What are the key takeaways that you hope to leave with infectious disease specialists and other health care practitioners who treat HIV on that topic?
Dr Philbin: It is important to understand, especially in the context of quick, 10- to 15-minute visits to the doctor, that each patient’s needs are different. If and when LAI ART is approved, it will be important to engage in shared decision-making with patients about whether LAI ART may be the right option for them compared with daily ART pills, and to have appropriate follow-up to assess whether their treatment regimen is sustainable for them in the long-term. It is not a one-and-done conversation, and providers will have to strike the right balance between what is known about LAI ART and the patients’ preferences, and respecting those preferences.
—Christina Vogt
Reference:
Philbin MM, Parish CL, Kinnard EN, et al. Multisite study of women living with HIV's perceived barriers to, and interest in, long-acting injectable antiretroviral therapy. JAIDS. 2020;84(3):263-270. doi:10.1097/QAI.0000000000002337