This article features an interview with Professor Lv Wei, offering a comprehensive analysis of the clinical diagnosis and treatment strategies for late-presenting HIV patients. This group is a significant challenge in China’s HIV/AIDS prevention and treatment efforts due to their higher hospitalization and transmission rates, heavier economic burdens, and poorer long-term prognosis.
The 19th European AIDS Conference (EACS 2023)
Held in Warsaw, Poland from October 18-20, 2023, EACS 2023 attracted considerable attention. At the conference, Professor Lv Wei from Beijing Union Medical College Hospital presented a randomized controlled clinical study on late-presenting HIV patients in China, comparing antiviral efficacy among different treatment regimens. The study’s insights provide valuable guidance for selecting appropriate treatment plans for this group.
Latest Definitions and Epidemiological Features of Late-Presenting HIV Patients
Professor Lv Wei explains that there is no unified international standard for defining late-presenting HIV patients. While some use a CD4 cell count of <200 cells/μL as a criterion, where patients have a higher risk of opportunistic infections, many studies consider <350 cells/μL as the threshold. Data from the China AIDS Comprehensive Prevention and Treatment Information Management System (CRIMS) from 2006-2014 show that 34.0% of 528,234 registered HIV patients were late presenters. These late presenters, who did not receive antiretroviral therapy (ART), had a first-year post-diagnosis mortality rate of 46.1%.
A more recent study analyzed adult HIV/AIDS cases reported by medical institutions in China from 2009 to 2017. Out of 293,187 new cases, 68.4% (200,503) were late presenters (diagnosed with HIV and a CD4 count of <350 cells/μL within 91 days). The prevalence of late presenters constitutes a significant portion of HIV infections in China, regardless of the diagnostic criteria used.
Clinical Characteristics, Prognosis, and Treatment Status of Late Presenters
Late presenters, with reduced CD4 cell counts, face a higher risk of severe opportunistic infections and even tumors, compared to those with higher counts. European data indicate that the mortality rate of late presenters is 6-13 times higher than that of early presenters. A Chinese study found that the five-year mortality risk for late presenters was 2.89 times higher.
From a long-term perspective, CD4 cells are not only independent risk factors for opportunistic infections but also play a crucial role in long-term treatment efficacy, immune reconstitution, and chronic inflammation-related complications. Late presenters often have a lower treatment success rate and are prone to complications, including Immune Reconstitution Inflammatory Syndrome (IRIS). Their treatment is complicated due to low CD4 counts, opportunistic infections, tumors, and poor immune recovery, leading to longer hospital stays and increased personal and public healthcare costs.
B/F/TAF Regimen as an Initial Choice for Late Presenters in China
Professor Lv Wei reported a clinical study at EACS 2023, comparing the virological and immunological responses of the Biktarvy/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) regimen with the Tenofovir/Lamivudine/Efavirenz (TDF/3TC/EFV) regimen in late presenters. This open-label, randomized controlled trial enrolled treatment-naïve HIV-1 late presenters from six AIDS centers in China between June 2021 and December 2022. The study’s primary endpoint was the proportion of patients with HIV RNA < 50 copies/mL at 12 weeks, with additional measurements at 4, 12, and 24 weeks.
The trial included 200 participants with an average age of 43.0±13.8 years, 83.5% male, and a baseline HIV viral load of 4.7±0.7 Log copies/mL. The B/F/TAF regimen showed superior early virological suppression compared to TDF/3TC/EFV. At 24 weeks, both regimens had similar effects on immune function improvement.
The Need for Improved Diagnosis and Management Strategies for Late Presenters in China
In recent years, there has been increasing attention to the late presenter group in China. Early detection and treatment are crucial, as highlighted in the United Nations AIDS Agency’s “3×95%” target. The updated Chinese AIDS treatment guidelines (2021 edition) and accumulating clinical data emphasize the importance of early detection and treatment. Effective management involves heightened societal awareness, attention to high-risk groups, sensitive detection methods, pre-exposure prophylaxis, and rapid initiation of treatment upon diagnosis.
Choosing effective, rapid antiviral drugs is vital for the rapid treatment initiation strategy for late presenters, as recommended in the US DHHS and European guidelines. Due to potential complications like poor immune recovery, chronic inflammation, adverse drug reactions, and bone loss, comprehensive and detailed management throughout the treatment process is essential. Further research outcomes will guide frontline clinicians in managing late presenters, ultimately benefiting more HIV patients.
Professor Lv Wei
Beijing Union Medical College Hospital
