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Department of Infectious Diseases
Hôtel Dieu, APHP
Laurence Slama, MD, PhD: consultant/advisor/speaker: Gilead Sciences, Merck Sharpe and Dohme, ViiV Healthcare; researcher: ViiV Healthcare.
Despite the efficacy, tolerability, and convenience of oral combined antiretroviral therapy (ART), these regimens require lifelong daily use and may have a negative effect on patient quality of life. For some patients, long-acting (LA) injectable antiretroviral drugs may improve quality of life. Several studies demonstrated the efficacy of LA cabotegravir (CAB) + rilpivirine (RPV), and this regimen is now available where I practice in France. Below, I discuss the real-world efficacy of this regimen, guidance on patient selection, and strategies to implement it sustainably in the clinic.
The phase IIIb CARISEL study enrolled 430 people with HIV to receive LA CAB + RPV every 2 months in 18 clinics across Europe. At 12 months, 87% of the patients had HIV-1 RNA counts of <50 copies/mL. Cases of confirmed and suspected viral failure were rare and occurred in the presence of resistance-associated mutations (RAMs). Injection-site reactions affected 84% of participants but were mostly grade 1/2, with a median duration of 3 days. Most injection-site reactions resolved within 7 days, and their incidence decreased over time. LA CAB + RPV is approved and recommended for adults with HIV with viral suppression and no suspected resistance to either drug.
The most common question I hear from patients is whether they are a candidate for LA ART. I explain to them that, at our institution, we have a checklist to determine their eligibility and that the use of LA CAB + RPV is contraindicated in some patients. One major contraindication is RAMs, which increase the risk for virologic failure, as shown by the CARISEL study. Patients with RAMs or a history of prior resistance to integrase strand transfer inhibitors or nonnucleoside reverse-transcriptase inhibitors should not receive this regimen. At my institution, if the information is not available, it is recommended to do baseline resistance testing with proviral DNA genotyping.
Another contraindication is chronic hepatitis B virus (HBV) infection or the absence of HBV immunity, as a separate drug would be necessary to control HBV infection if present.
When recommending an ART, I always ask women whether they plan to have children. Data on the safety of LA CAB + RPV in pregnant women are lacking, so I avoid using the regimen in this patient population. I also do not feel comfortable using this regimen in patients receiving anticoagulants or who may need anticoagulants because it is an IM injection, and I always check for drug‒drug interactions with a patient’s concomitant medications.
Although a BMI ≥30 kg/m2 slightly increases the risk of virologic failure, I do not use that as an exclusion criterion on its own. I also consider the person’s previous treatment adherence and whether it was very good, average, or very poor. For those with good adherence, I may consider injecting LA CAB + RPV using a larger needle size.
In my clinic, if I determine that a patient may be a good candidate for LA CAB + RPV, I will discuss advantages and drawbacks with them. If we both agree to start the LA treatment, and the option is approved after our monthly multidisciplinary meeting, I will refer the patient to one of our nurses to start the process. I have found that a well-prepared patient is a satisfied patient.
It is important to remember that oral lead-in is optional based on the FLAIR extension study, but it still can be offered to people. At our clinic, patients receive the first 3 injections on site, and then they can receive subsequent injections in the hospital or through an outpatient nurse. Most of our patients return to the hospital for future injections because they are comfortable with their nurse at the hospital and wish to avoid stigma, but approximately 8% to 10% feel comfortable using a community nurse.
When a patient selects a community nurse, a nurse from my hospital talks with them to explain the regimen and how it works. I recommend that patients receive the medication from a local pharmacy or the hospital and then go immediately to see the nurse and get the injection. This minimizes the chance that the drug will be handled improperly. Nurses also can go directly to a patient’s home to administer the injection, but I find that patients, especially those who work, typically prefer not to have to wait for a nurse at home.
Personally, I think community administration of LA injectables is the way for this treatment to be sustainable long term. Otherwise, clinics will not be able to give it to all of their patients who want it because they will be too busy.
What characteristics do you or your clinic use to determine whether a patient is a suitable candidate for LA CAB + RPV? Add a comment below to join the discussion.