Preview of Hot Topics at CROI 2019: My Picks

David A. Wohl, MD

Professor of Medicine
School of Medicine
Site Leader, Global Infectious Diseases
Clinical Trials Unit
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

David A. Wohl, MD, has disclosed that he has received consulting fees from Gilead Sciences, Janssen, and ViiV and funds for research support from Gilead Sciences and ViiV.

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Released: March 1, 2019

At the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), important results from many clinical trials will be reported. Here is a summary of the data that I look forward to, which we will cover online as part of CCO’s Independent Conference Coverage of CROI 2019.

HIV Prevention
Scanning the program, it is not hard to glean some clinically relevant themes (although I never underestimate the potential for an unexpected abstract to cause a stir), beginning with pre-exposure prophylaxis (PrEP). The highly anticipated results of the phase III DISCOVER trial comparing tenofovir DF/emtricitabine vs tenofovir alafenamide/emtricitabine for daily oral PrEP therapy in cisgender men and transgender women who have sex with men will certainly draw attention. Several presentations will focus on challenges related to adherence and persistence of PrEP and its impact on circulating HIV drug resistance, including a report from New York City on PrEP and drug resistance in acute HIV infections and data from a study in Atlanta evaluating PrEP persistence among a critical high-risk group, young, black men who have sex with men. All of these studies are anticipated to shed light on important aspects of PrEP therapy.

Current HIV Treatment Strategies
In the realm of treatment, a major issue swirling throughout the conference will be differential weight gain among ARVs, particularly INSTIs. Recent reports suggesting increased weight gain with INSTI-based ART regimens have garnered considerable attention, and there is much interest in further exploring this potential association. Look out for a number of cohort studies and clinical trials to present data on weight change, including an assessment of risk factors associated with weight gain in patients who switched to INSTI-based regimens.

We will also see new data from the phase III DAWNING trial of dolutegravir vs lopinavir/ritonavir (each paired with 2 NRTIs) for second-line treatment. At CROI 2019, investigators will report efficacy according to baseline NRTI resistance and NRTIs used in second-line therapy, providing clinicians with additional insights into the role of dolutegravir plus 2 NRTIs for patients who have experienced virologic failure of first-line ART.

In addition, we will learn about HBV virologic failure in patients with HIV/HBV coinfection who are receiving tenofovir-based ART. Finally, there will be a generous amount of time dedicated to neurologic issues. It will be interesting to see how much of the neurologic data will be clinically relevant.

Several studies will address the safety and efficacy of newer ARV agents in specific populations, including Week 48 data from a study evaluating bictegravir/emtricitabine/tenofovir alafenamide in children and adolescents, a pooled analysis for tenofovir DF vs tenofovir alafenamide in women with HIV, and studies evaluating initiation of raltegravir or dolutegravir during pregnancy.

Investigational HIV Approaches
Another area of great interest is the development of long-acting injectable strategies for ART. In a set of highly anticipated reports, investigators will report 48-week data on long-acting injectable cabotegravir plus rilpivirine, dosed monthly as maintenance therapy, from the phase III ATLAS and FLAIR trials.

We will also get a chance to see early data from other agents in clinical development, including the following:

  • GS-6207: data on the safety and pharmacokinetics of this novel HIV-1 capsid inhibitor administered by subcutaneous injection
  • GSK2838232: phase IIa data evaluating this novel HIV maturation inhibitor in patients with HIV infection

Additional Studies
Many other anticipated studies will be presented this year, including the following:

  • A report on decreased HCV incidence among men who have sex with men living with HIV in London after rollout of expanded HCV direct-acting antiviral therapy access
  • Phase I study evaluating ledipasvir/sofosbuvir for HCV treatment during pregnancy
  • A report on HIV remission after hematopoietic stem cell transplant from an homozygous CCR5Δ32 allogeneic donor

All in all, CROI 2019 seems poised to meet expectations for being one of the most interesting and relevant HIV conferences. As the meeting unfolds, remember to check the CCO Web site often for downloadable slidesets summarizing the data from these and other studies and plan to join us for a series of live Webinars hosted by expert faculty providing their take on the clinical implications of the data. After the meeting, look for more ClinicalThought™ commentaries and a CME-certified online activity featuring expert perspectives on integrating new data into practice.

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