New modality, new challenges
“We’re constantly searching for new modalities to expand our repertoire of what we can provide patients, especially those folks with the highest need for PrEP,” Lina Rosengren-Hovee, MD, assistant professor of medicine and infectious disease specialist at UNC-Health, Chapel Hill, N.C., said in an interview. “Being able to offer an injectable option is going to be a game changer, but it will be critical to pinpoint structural factors that affect adherence,” she added.
Dr. Rosengren-Hovee also pointed to cases of integrase inhibitor resistance (both in the study and the larger clinical arena), which she believes are concerning. “It’s still a conversation that you’ll want to have with a patient; I wonder if we need more discussion about how we handle that in the clinical setting, even if it’s fairly uncommon,” she said.
When asked, Dr. Landovitz emphasized the rarity of breakthrough cases but acknowledged that there appears to be a pattern whereby the first breakthrough occurs with a trickle of virus and then bursts out with higher levels of virus at some point.
“CDC is actually thinking very hard about whether these long-acting PrEP agents obligate a change to the HIV screening process [e.g., a viral load or RNA-based test] rather than a conventional HIV test,” Dr. Landovitz said. He went on to say that in the ongoing, open-label portion of the study, investigators hope to learn whether one can avoid resistance by catching the first breakthrough earlier. That would help inform clinical implementation, he explained. He said that he challenges practitioners and health care communities to avoid some of the mistakes made with the oral PrEP rollout, namely, universal access without proper implementation of planning and testing protocols.
“By default, PrEP is much more decentralized and demedicalized, especially in primary care,” said Dr. Rosengren-Hovee. “We need more studies looking at real-world scenarios.”
Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.
A version of this article first appeared on Medscape.com.