BIC/FTC/TAF Effective at Virologic Suppression in HIV Presenting Late

Patients who present late in the course of their HIV infection can use the combination therapy of bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF) to start treatment, according to a study published in Open Forum Infectious Diseases.¹ The therapy was found to be both effective and tolerable in this population, who were defined as surviving with a CD4 count below 200 cells/μL or who had a CD4 count between 200 and 499 cells/μL who also met the criteria for AIDS-defining conditions.

Patients with HIV-1 (PWH) should be treated primarily with antiretroviral therapy (ART) to reduce their morbidity, mortality, and AIDS-related events.² However, those who present late could be at a disadvantage, as this increases their risk of death and could mitigate attempts at controlling the spread of HIV. Evidence of treatment efficacy in this population is limited. This study aimed to present data on the efficacy of BIC/FTC/TAF as an initial therapy in PWH who presented late.

BIC/FTC/TAF was effective in achieving virologic suppression in patients with late-presenting HIV. | Image credit: RAJCREATIONZS - stock.adobe.com

This study was conducted at the Guiyang Public Health Clinical Center in China. Patients included had late-presenting HIV and received BIC/FTC/TAF between June 2021 and June 2023. Treatment effectiveness was defined as HIV-1 RNA of less than 50 copies/mL. Patients were included if they were older than 18 years, were using ART that included BIC/FTC/TAF, had ART-naïve status prior to the study, were positive for HIV-1 antibodies, and had a CD4 count of less than 200 cells/μL. Patients who were pregnant, lost to follow-up or death, and missing data, including HIV viral load and CD4 count, were excluded.

The virologic suppression rate acted as the primary end point of the study with the secondary end points being the proportion of patients with less than 200 copies/mL of HIV-1 RNA, changes in CD4, and safety. Persistent irregular fever, diarrhea for more than 1 month, a decrease in body mass, and recurrent herpes infections were some of the conditions that could be AIDS defining. All participants had demographic data and information related to HIV collected.

There were 130 patients who were included in the study, all of whom were ART naïve and received BIC/FTC/TAF between June 2021 and June 2023. The median (IQR) age of the cohort was 45.5 (34.0-58.0) years, the median log₁₀ HIV-1 RNA was 5.0 (4.6-5.8) copies/mL, and the median CD4 count was 75.5 (28.0-141.0) cells/μL. Ease of use (23.1%), low potential of drug-drug interactions (60.8%), liver impairment (35.4%), and efficacy (55.4%) were the major reasons for starting BIC/FTC/TAF.

A total of 93.8% and 99.2% of patients had HIV-1 RNA levels below 50 copies/mL and 200 copies/mL, respectively, after 48 weeks of treatment with BIC/FTC/TAF. Patients with a baseline CD4 count of less than 200 cells/μL had a virologic suppression rate of 93.5%, and patients with 200 or more cells/μL at baseline had a virologic suppression of 100%. Patients who initiated ART in 7 or fewer days and achieved virologic suppression outnumbered those who began ART in 7 or more day, at 94.4% vs 93.6%. Patients who had 50 or more copies/mL of HIV-1 RNA after 48 weeks experienced low levels of viremia during ART in 4 cases; 3 cases discontinued the treatment for 30, 10, and 15 days during the follow-up; and 5 cases had virologic suppression after subsequent follow-up.

There were 16 adverse events (AEs) and 6 drug-related AEs reported during the study, including diarrhea and lymphoma that caused hospitalization, although these were not hospitalizations related to the drug. There were no discontinuations based on AEs or efficacy.

There were some limitations to this study. It had a retrospective design and was conducted in a single center, which could introduce selection bias. There also was also no comparator group included in the study, and the efficacy and safety of BIC/FTC/TAF was not evaluated in the patients who were excluded from the study.

The researchers concluded that BIC/FTC/TAF is an effective treatment for PWH who have late presentation, and that PWH who are treatment naïve achieved high rates of virologic suppression with a safe treatment profile.

References

1, Yang X, Xie X, Fu Y, Gan L, Ma S, Long H. Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in late-presenting people with HIV-1 infection. Open Forum Infect Dis. Published online October 18, 2024. doi:10.1093/ofid/ofae630

2. About HIV. CDC. March 17, 2024. Accessed November 12, 2024. https://www.cdc.gov/hiv/about/index.html