The Center for Biostatistics in AIDS Research (CBAR) at Harvard's Department of Biostatistics, under the direction of Professor Michael Hughes, has released its 2024 highlights, showcasing significant contributions to research across infectious diseases, including HIV, tuberculosis, COVID-19, and others. CBAR serves as the statistical center for major international HIV clinical trials networks, such as ACTG and IMPAACT.
Advancements in HIV Treatment and Prevention
Findings from the LATITUDE study, presented at CROI, indicated that long-acting antiretroviral therapy using cabotegravir and rilpivirine demonstrated superior efficacy compared to daily oral standard of care in people living with HIV (PLWH) who have a history of adherence challenges. According to Dr. Lu Zheng and Ms. Yajing Bao, who led the statistical analyses, this long-acting regimen offers a promising alternative for individuals struggling with treatment adherence.
Further research on adolescents living with HIV explored the acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine. The MOCHA study, a phase 1/2 trial, reported high acceptability and tolerability of these injections, suggesting they may be a preferred treatment option for some adolescents. Dr. Kristin Baltrusaitis, Mr. Ryan Milligan, and Mr. Shawn Ward spearheaded the statistical work on this study, which was published in Lancet HIV.
Semaglutide Shows Promise for Fatty Liver Disease in PLWH
The SLIM LIVER study, published in the Annals of Internal Medicine, investigated the effects of semaglutide in PLWH with central adiposity, insulin resistance or prediabetes, and fatty liver disease. The pilot study, with statistical leadership from Mr. Douglas Kitch and Ms. Amy Kantor, reported clinically significant liver fat reductions over 24 weeks. Notably, 29% of participants experienced complete resolution of Metabolic dysfunction–associated steatotic liver disease, and 58% had a relative reduction in liver fat of at least 30%. The study also observed significant improvements in anthropometric measurements, glucose regulation markers, and triglyceride concentrations.
Optimizing Tuberculosis Treatment in HIV Patients
An observational cohort study led by Dr. Michael Hughes and Ms. Caitlyn McCarthy explored the effectiveness of double-dose dolutegravir in PLWH receiving rifampin-based tuberculosis treatment. Published in Clinical Infectious Diseases, the study found the treatment to be feasible, well-tolerated, and effective in achieving high viral suppression rates in predominantly ART-naive individuals with TB/HIV.
Dolutegravir in Pregnancy
Findings from the IMPAACT 2010/VESTED Study Team, with statistical analyses led by Dr. Sean Brummel and Ms. Lauren Ziemba, support guidelines recommending dolutegravir (DTG)-based ART for women starting ART during pregnancy. The study concluded that antepartum weight gain on DTG regimens was protective against adverse pregnancy outcomes associated with insufficient weight gain.
Impact of Pitavastatin on Cardiovascular Health in PLWH
Results from a mechanistic substudy of the REPRIEVE clinical trial, a global cardiovascular disease prevention trial in PLWH, were reported in JAMA Cardiology. The substudy investigated the effects of pitavastatin on noncalcified coronary artery plaque and inflammatory biomarkers. The findings indicate that for PLWH at low to moderate CVD risk, 24 months of pitavastatin reduced noncalcified plaque volume and progression, as well as markers of lipid oxidation and arterial inflammation. Dr. Heather Ribaudo led the statistical center, working with Ms. Triin Umbleja, Mr. Jorge Leon-Cruz, Ms. Amy Kantor, and others.
COVID-19 Therapeutic Advances
Follow-up of participants in the ACTIV-2 adaptive platform trial evaluated multiple outpatient therapeutics for people with COVID-19. Results from the phase 3 trial of SAB-185, published in the Journal of Infectious Disease, showed that for those infected with the Omicron variant, time to resolution of symptoms was shorter (18 days versus greater than 25 days) with SAB-185 compared to casirivimab/imdevimab. The statistical team was led by Professor Hughes, Dr. Carlee Moser, Dr. Mark Giganti, and Mr. Justin Ritz.
