Expert Conversations: Hypertension, Diabetes, and Hyperlipidemia in Patients Taking Antiretroviral Therapy

In this podcast, Niha Idrees, PharmD, and Melissa Badowski, PharmD, MPH, BCIDP, speak about their team's research evaluating the incidence of hypertension, diabetes, and hyperlipidemia in patients on INSTI-based regimens compared with NNRTI-based and PI-based regimens. They also talk about weight gain and obesity in patients living with HIV. They presented on these topics at IDWeek 2021.

Additional Resource: 

 

Niha Idrees, PharmD

Niha Idrees, PharmD, is a visiting clinical assistant professor and clinical pharmacist at the antithrombosis clinic at the University of Illinois at Chicago College of Pharmacy.

Melissa Badowski, PharmD

Melissa Badowski, PharmD, MPH, BCIDP, is a clinical associate professor at the University of Illinois at Chicago College of Pharmacy, and she manages an infectious disease and HIV outpatient clinic and telehealth clinic with the Illinois Department of Corrections. 


 

TRANSCRIPTION:

Jessica Bard: Hello everyone. Welcome to another installment of "Podcast 360," your go‑to resource for medical news and clinical updates. I'm your moderator Jessica Bard with Consultant360 Specialty Network.

There are survival and quality of life benefits to managing patients with HIV using antiretroviral therapy. However, those benefits can come at a cost of possible metabolic complications.

Dr Niha Idrees and Dr Melissa Badowski are here to speak with us about their research, evaluation of the incidence of hypertension, diabetes and hyperlipidemia in patients on antiretroviral therapy at IDWeek 2021.

Dr Idrees is a visiting clinical assistant professor and clinical pharmacists at the antithrombosis clinic at the University of Illinois, Chicago College of Pharmacy.

Dr Badowski is a clinical associate professor at the University of Illinois at Chicago College of Pharmacy. She manages an infectious disease and HIV outpatient clinic and telehealth clinic with the Illinois Department of Corrections.

Thank you for joining us on the podcast. Can you please give us an overview of your session?

Dr Melissa Badowski: Sure. The concept of this study came from post‑marketing data showing an association between integrase inhibitors or INSTIs, use, and weight gain. INSTI‑based regimens have evolved into first‑line treatment for most people living with HIV due to their high efficacy and relative safety profile.

The weight gain seen in post‑marketing studies brought up the question of whether INSTIs were associated with long‑term metabolic consequences. We decided to study type 2 diabetes, hypertension, and hyperlipidemia. We conducted this study within the Illinois Department of Corrections or something we refer to as IDOC.

To provide a little bit of a background on the study population, these are patients that are diagnosed with HIV and incarcerated within the state of Illinois. These patients are provided interdisciplinary telemedicine services for HIV care.

We have an infectious diseases physician, a clinical pharmacist being myself, and a social work supervisor. We're all on campus here at the University of Illinois.

We call into one of 26 prisons throughout the state of Illinois, where we see the patient and we have a nurse that assists us in performing this telehealth visit. These patients have uninterrupted access to their medications.

We, thankfully, do not face a lot of the medication access barriers that other patients may struggle with. They receive routine follow‑up with this service. It provides for an ideal study population to help us understand the effects that these medications have.

Previous research within our group that was conducted within this population also demonstrated that there was weight gain, in fact, with INSTI use.

A little bit more about our study, we conducted a retrospective cohort study on patients that did not have diabetes, hypertension, or hyperlipidemia. We evaluated the effect of INSTI‑based therapy on the development of these metabolic comorbidities compared to NNRTI and protease inhibitor‑based regimens.

The time frame of this study was from the start of our telemedicine services, which was what I like to say, "Before telehealth was cool." It was back in July of 2010. This was through the end of 2019.

Our endpoints were defined by diagnostic criteria, a set forth from the American Diabetes Association, the American College of Cardiology, as well as American Heart Association, as well as the JNC 8 guidelines. That was depending on the time frame of this review.

Jessica: What are the risk factors associated with hypertension, diabetes, and hyperlipidemia?

Dr Niha Idrees: There are some risk factors that are consistent across the board for these diseases. Some of these are age, lack of physical activity, smoking, and family history. Being overweight or obese also increases the risk of developing hypertension, diabetes, and hyperlipidemia.

That goes back to our research question of if the weight gain associated with INSTI‑based regimens does increase the risk of developing any of these comorbidities.

Diet can also play a role in many ways. Patients that have a high salt intake have a higher risk of developing hypertension. Those with a diet high in saturated fats are at higher risk of developing hyperlipidemia.

Looking at HIV regimens, we already are aware that protease inhibitors are associated with diabetes and hyperlipidemia, along with certain NNRTIs being associated with hyperlipidemia.

For integrase inhibitors, the data that we do have associates integrase inhibitors with weight gain.

They've identified a few risk factors. That includes being female, having a lower baseline BMI, being African American or Hispanic and also which NRTI is used with TAF‑containing regimens being at higher risk of weight gain compared to TDF‑containing regimens.

Jessica: Let's dive into the meat of this study here. What is the incidence of hypertension, diabetes, and hyperlipidemia in patients on antiretroviral therapy?

Dr Badowski: Generally speaking, I want to take a 10,000‑foot overview of this. For patients living with HIV and having a diagnosis of hypertension. People on antiretroviral therapy tend to have higher rates of hypertension than those who are naive or not on any therapy.

Antiretroviral naive vs those on treatment in terms of being compared one class vs another, that hasn't been elicited.

For diabetes, one study showed there's no difference when comparing INSTIs to either NNRTIs or protease inhibitors. Those other anchor drugs. An overall incidence in the diabetes risk was seen in patients on integrase inhibitors.

In terms of hyperlipidemia, our group also performed a study. This was presented at IV League last year. It showed that 30 percent of our patients were not actually receiving appropriate statin therapy, regardless of the antiretroviral regimen that they use.

There is a possibility that there's a gap in appropriately identifying and managing patients with high ASCVD risk specifically in this population. There's not a lot of great data showing these medical comorbidities and the true incidence.

Dr Idrees: Going back to our research study and the results of that, in our retrospective cohort study, we evaluated a total of 206 patients and did find a statistically significant difference in the incidence of a metabolic comorbidity in the INSTI group compared to the other HIV regimen classes.

Majority of the patients, about 72 percent, were already virally suppressed with undetectable viral loads. Majority were African American and male with a baseline BMI of 26.5 kilograms per meter squared. Specifically, what we saw was a difference in the incidence of hypertension, with more patients in the INSTI group developing hypertension.

When looking at the secondary outcome of a weight gain and BMI, these outcomes were actually increased in all three groups. Some of that can be attributed to the fact that at baseline, this specific population has a lower baseline weight than the general population, which is for a variety of reasons.

Some of that could be due to drug use, due to lack of regular food access, and could also be due to housing insecurity prior to being incarcerated.

Jessica: Knowing all of this, how do you believe this information will impact clinical practice going forward?

Dr Idrees: This research hopefully will help us better monitor our patients by encouraging clinicians to actively assess blood pressure, weight, and lab values like lipid panels and glucose values. A lot of times these metabolic comorbidities are a deferred to a patient or to doctors.

Hopefully, this information can motivate a shift to any provider or their medical team that manages their HIV to take more ownership of helping diagnose, manage and monitor these comorbidities since it is related to their HIV medications. This can subsequently lead to a more comprehensive care for our patients moving forward.

Jessica: Are there any knowledge gaps that you would say exist in this area?

Dr Badowski: Yeah. There are still a lot of questions that need to be answered. What we don't know yet is when in therapy that we can expect this outcome to occur. There is some data that earlier on, but is it a plateau effect? Will we see it years out?

We do know that those trends, like I said, will happen within that first year.

In this study, the duration of the study wasn't long enough to assess if we're looking at mortality data, so more of these longer-term consequences. It would be interesting to see if these causing significant changes would be in the morbidity and mortality aspects.

We are also not sure if this is a reversible side effect, or if there is a difference when we separate between different agents aside from just the integrase inhibitors. If we switch a patient off of a medication to another medication, will the weight loss reverse, will it stop accumulating?

There's a lot that still needs to be found out from that part of it. We may also want to consider a certain threshold of weight increase to be used toward switching to a different regimen.

As Niha started to say, employing this preventative care to avoid additional weight gain, and subsequently additional comorbidities in this population. There's still a lot of work that needs to be done since we started to uncover a lot of this post‑marketing data.

Jessica: Can you sum it all up for us? What are the overall take-home messages from this research?

Dr Idrees: One of the overall take-home messages is that while INSTI‑ based regimens have been considered to be safer than alternative agents, they still require monitoring for metabolic abnormalities. We should be comprehensively evaluating patients for changes in their weight, changes in their labs, and changes in their vitals at every visit.

In addition to that, information from the post‑marketing studies like the weight gain side effect is not mentioned in the package inserts of INSTIs. I would say another take‑home message is that we need to be proactively educating patients on the possibility of weight gain as a side effect from integrase inhibitors.

Jessica: Thank you all so much for your time today. Is there anything else that you'd like to add?

Dr Badowski: Not at this point. Thank you again for having us.

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