BACKGROUND:Some individuals with human immunodeficiency virus (HIV-1) have acquired multidrug-resistant (MDR) strains of HIV and/or are nonadherent to antiretroviral (ARV) medication. Injectable ARVs can provide salvage therapy for those with limited therapeutic options and may be preferred by some people with HIV (PWH). Real-world evidence may contribute to a more comprehensive understanding of the barriers to adherence and the utility of injectable ARVs in PWH. Currently, there is a lack of data on combined use of injectable ibalizumab (IBA) and lenacapavir (LEN) with optimized background regimen (OBR). METHODS:A retrospective observational study examined medical charts from people with MDR HIV across 8 facilities in the United States. All PWH used a combination of both IBA + LEN ± OBR for at least 6 months. Viral loads and CD4+ counts were collected. RESULTS:A total of 21 PWH were included. Four-class resistance at baseline was reported in 38.1% of PWH. Within 12 to 24 weeks of combined IBA + LEN treatment, a median reduction of -2710 copies/mL HIV RNA was observed. Median increase to CD4+ count was 67.5 cells/mm3 within 4 to 44 weeks of treatment initiation. Few intolerances required changes to treatment. Therapy with IBA + LEN continued for an average of 30 months and 20 months, respectively. CONCLUSIONS:In this small group of individuals with MDR HIV who were heavily treatment-experienced and/or faced adherence challenges, the use of IBA + LEN ± OBR was well tolerated and led to clinically significant reductions in viral loads and improvements in CD4+ counts.

Respiratory viral infections like influenza, RSV, and COVID-19 cause significant healthcare strain, especially during seasonal surges. Traditional surveillance often fails to provide early warnings, but wastewater surveillance offers a promising real-time alternative. This study evaluates whether wastewater viral loads predict hospitalizations and identifies the lead time between detection and hospitalization surges. Correlation Between Wastewater Viral Load and Hospitalization Rates for Flu, RSV, and COVID-19 Granger Causality Analysis of Wastewater Data and Hospitalization Trends This retrospective observational study analyzed the relationship between wastewater viral loads and hospitalization trends for influenza, RSV, and COVID-19 across all 50 U.S. states from January 2021 to February 2025. Weekly viral concentrations were obtained from the National Wastewater Surveillance System and hospitalization rates from CDC reports, with datasets standardized by calendar week and no missing data. Pearson correlations, cross-correlation function analysis, granger causality testing, and distributed lag models were used to assess associations, lead times, causality, and effect sizes. Statistical significance was set at p< 0.05, and analyses were performed using R (v4.2.0). IRB approval was not required as only publicly available, de-identified data were used. Distributed Lag Model Results: Effect of Wastewater Viral Load on Hospitalizations Wastewater viral loads predicted hospitalizations, with a lead time of 2 weeks for Flu and 3 weeks for RSV and COVID-19 (p< 0.01). Correlations were observed for Flu (r = 0.93), RSV (r = 0.92), and COVID-19 (r = 0.88) (Table 1). Granger causality confirmed that RSV and COVID-19 wastewater signals predicted future hospitalizations (p< 0.01, Table 2). A one-unit rise in wastewater viral concentration corresponded to hospitalization rate increases of 0.54 for Flu, 0.34 for RSV, and 1.15 for COVID-19 (Table 3). However, Flu did not show a causal predictive relationship. Our study is the first to establish a causal relationship between wastewater viral loads and RSV and COVID-19 hospitalizations using Granger causality analysis, demonstrating that wastewater surveillance is a valuable tool for predicting hospitalizations weeks in advance and enabling timely public health interventions. This real-time monitoring system can improve hospital preparedness, optimize resource allocation, and guide vaccination strategies. All Authors: No reported disclosures

Febrile neutropenia (FN) is a medical emergency typically seen in immunocompromised patients with neutrophil counts below 500 cells/µL. It is often associated with chemotherapy, hematologic malignancy, and advanced human immunodeficiency virus (HIV) infection. Severe neutropenia in a low-level viremia and preserved CD4 T-helper cell (CD4) is uncommon and warrants evaluation for alternative etiologies. A 68-year-old man with HIV presented with fever and an absolute neutrophil count (ANC) of zero, without recent chemotherapy or other known myelosuppressive medications. Gram-negative bacteremia was identified, which is often attributed to gut translocation in neutropenic patients. Despite early initiation of tbo-filgrastim, the neutrophil count failed to respond; thus, a bone marrow biopsy was done to evaluate for an underlying marrow disorder. Bone marrow examination combined with genetic and molecular testing revealed a diagnosis of T-cell large granular lymphocytic leukemia (T-LGL), which explained the lack of response to tbo-filgrastim. Because the patient presented with profound neutropenia, gram-negative bacteremia, and a concern of hematologic malignancy, Strongyloides serology was ordered even without known travel or residence in endemic areas, and the result was positive. HTLV-1 serology was also obtained due to its known association with Strongyloides and gram-negative bacteremia, but it returned negative. This case emphasizes the need to broaden the differential diagnosis for severe neutropenia beyond HIV-related marrow suppression. Undiagnosed T-LGL may present with gram-negative bacteremia and failure to respond to granulocyte colony-stimulating factor (G-CSF), and Strongyloides infection should be considered in immunocompromised patients who are being evaluated for occult malignancy, even without identifiable epidemiological risk factors. Early recognition of these conditions can guide timely evaluation and appropriate therapy in complex immunocompromised hosts.

Patients with multidrug-resistant HIV (Human Immunodeficiency Virus) face limited treatment options, increasing their risk of virologic failure. Fostemsavir, a novel attachment inhibitor, has shown efficacy and safety in clinical trials, but real-world data is lacking. We aimed to evaluate virologic suppression, immunologic response, and safety outcomes in treatment-experienced individuals in a real-world clinical setting.Trends in CD4 Count and HIV Viral Load Over 12 Months in Patients Receiving Fostemsavir We conducted a retrospective chart review of patients living with HIV >18 years old in a Ryan White funded HIV clinic in Newark , NJ who were treated with Fostemsavir for more than 6 months. Data on viral load, CD4 counts, adverse effects, and adherence were collected and descriptive statistics was used to analyze outcomes over 12 months. Primary outcomes were virologic suppression (HIV RNA < 20 copies/mL) and CD4 count change from baseline. Secondary outcomes assessed adherence, adverse effects, and reasons for discontinuation. 17 patients met the inclusion criteria, with a mean age of 57.2 years. The majority were male gender (70.6%). 58.8% were Black or African American, 17.6% White, and 23.5% identified as other races. At baseline, the mean viral load was 56,402 copies/mL, which declined to 400 copies/mL at month 3, 84 copies/mL at month 6, and 53 copies/mL at month 12. Mean CD4 count increased from 439 cells/mm³ at baseline to 492 cells/mm³ at month 3, remained stable at 491 cells/mm³ at month 6, and rose further to 619 cells/mm³ by month 12 as shown in Figure 1. Virologic suppression was achieved in most patients by month 12. Adherence was high with 82.4% fully compliant, 11.8% intermittently compliant, and 5.9% non-compliant. Adverse effects were minimal; 76% reported none, while 11.8% experienced muscle wasting, and 5.9% each reported insomnia or arthralgia. Fostemsavir was discontinued in two patients: due to virologic failure (5.9%), oral intolerance (5.9%). Fostemsavir demonstrated effective virologic suppression and immune recovery, with a favorable safety profile, in a real-world cohort of treatment-experienced HIV patients. These findings support its clinical utility. Ongoing research in larger populations will build on these findings to further characterize long-term outcomes. Jihad Slim, MD, FACP, gilead: Honoraria|merck: Honoraria|Thera: Honoraria|ViiV: Honoraria

BACKGROUND:Once-daily, single-tablet regimens have transformed care for persons living with human immunodeficiency virus type 1 (HIV-1); however, challenges to adherence continue to limit effective treatment. Long-acting oral-drug combinations could offer new options with less frequent dose administration. METHODS:We conducted a phase 3, double-blind, randomized, active-controlled, noninferiority trial in 12 countries to evaluate the efficacy and safety of a switch to once-weekly oral islatravir-lenacapavir (ISL/LEN) from once-daily oral bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) in adults in whom HIV-1 had been virologically suppressed for at least 6 months while they were receiving B/F/TAF. Participants were assigned in a 1:1 ratio to receive once-weekly ISL/LEN (2 mg/300 mg) or to continue once-daily B/F/TAF for 96 weeks; all received matched placebo for the alternative regimen. The primary end point was the percentage of participants with an HIV-1 RNA level of 50 copies per milliliter or higher at week 48, as determined by the Food and Drug Administration-defined snapshot algorithm. Noninferiority was determined at a margin of 4 percentage points. RESULTS:A total of 607 participants underwent randomization; 304 were assigned to the ISL/LEN group and 303 to the B/F/TAF group. A total of 21% of the participants were women, 31% were Black, 26% were Hispanic or Latine, and 15% were 65 years of age or older. At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was reported in no participants in the ISL/LEN group and 1 (0.3%) in the B/F/TAF group (difference, -0.3 percentage points; 95.002% confidence interval [CI], -1.4 to 0.8); an HIV-1 RNA level of less than 50 copies per milliliter was reported in 284 (93.4%) and 280 (92.4%), respectively (difference, 1.0 percentage point, 95% CI, -3.2 to 5.2). The mean change in the CD4+ T-cell count at week 48 was -10 cells per microliter with ISL/LEN and -18 cells per microliter with B/F/TAF (least-squares mean difference, 12 cells per microliter; 95% CI, -16 to 39). The trial regimen was discontinued owing to adverse events in 6 participants (2.0%) in the ISL/LEN group and 5 (1.7%) in the B/F/TAF group; serious adverse events occurred in 16 (5.3%) and 14 (4.6%), respectively. CONCLUSIONS:Among persons with virologically suppressed HIV-1, once-weekly oral ISL/LEN was noninferior to once-daily B/F/TAF in maintaining HIV viral load suppression. (Funded by Gilead Sciences and Merck Sharp and Dohme; ISLEND-1 ClinicalTrials.gov number, NCT06630286.).

BACKGROUND:Single-tablet regimens (STRs) revolutionised HIV-1 treatment, improving adherence and clinical outcomes; however, many people cannot take these due to resistance, contraindications, or drug-drug interactions, instead relying on complex multi-tablet regimens. Novel STRs are therefore needed. We aimed to evaluate the efficacy and safety of a novel STR, bictegravir-lenacapavir, in people with HIV-1. METHODS:ARTISTRY-1 was a randomised, open-label, active-controlled, non-inferiority phase 3 trial conducted at hospitals and clinics across 15 countries that enrolled people with HIV-1 with virological suppression on complex regimens. Participants were randomly assigned (using interactive technology, 2:1, stratified by geographical region) to switch to once-daily oral bictegravir-lenacapavir 75 mg/50 mg STR or continued complex regimen. The primary outcome was the proportion of participants with an HIV-1 RNA viral load of 50 copies per mL or higher at week 48 (US Food and Drug Administration Snapshot algorithm), assessed in all randomly assigned participants who received any dose of assigned treatment. This trial (active; enrolment complete) was registered with ClinicalTrials.gov (NCT05502341). FINDINGS:Between Jan 29 and Sept 26, 2024, 729 participants were screened; 557 were randomly assigned and treated (bictegravir-lenacapavir n=371; complex regimen n=186). At baseline, median age was 60 years (range 22-84), HIV treatment duration was 28 years (IQR 22-32); participants were taking a median of three antiretroviral pills per day (range 2-11). At week 48, an HIV-1 RNA viral load of 50 copies per mL or higher was observed in three (1%) participants receiving bictegravir-lenacapavir and two (1%) receiving a complex regimen (difference -0·3%; 95·002% CI -2·3 to 1·8), meeting the non-inferiority margin of 4%. No resistance emerged. Adverse event rates were similar between groups. Six (2%) participants discontinued bictegravir-lenacapavir and one (1%) discontinued their complex regimen due to adverse events. There were five deaths in the bictegravir-lenacapavir group, none of which were deemed related to study drug. Participants reported increased treatment satisfaction after switching to bictegravir-lenacapavir. INTERPRETATION:Bictegravir-lenacapavir STR demonstrated non-inferior efficacy to complex regimens, with a similar safety profile and increased treatment satisfaction. Bictegravir-lenacapavir offers new opportunities for HIV-1 treatment optimisation for people taking complex regimens. FUNDING:Gilead Sciences.

We evaluated the proportion of patients diagnosed with cirrhosis through our hepatitis C (HCV) elimination program in New Jersey who engaged in biannual hepatocellular carcinoma (HCC) screening. The program operates through a mobile van that collects initial bloodwork at drug addiction treatment facilities across New Jersey, followed by a telehealth consultation with an infectious disease physician for liver fibrosis staging and treatment recommendations. We conducted a cross-sectional observational study of patients diagnosed with liver cirrhosis who achieved sustained virologic response (SVR) through our HCV elimination program. Following SVR, intensive follow-up was provided by a registered nurse, case manager, 340B coordinator, and pharmacist. At the SVR visit, patients with cirrhosis were counseled to establish six-month HCC surveillance with a primary care provider or specialist. Patients diagnosed with cirrhosis on or before September 30, 2024, were contacted in April 2025 to assess their engagement in an HCC screening program. Between June 1, 2021, and September 30, 2024, 1,897 patients with HCV were evaluated; 120 (6.3%) were diagnosed with cirrhosis. The median age was 55 years (34–72), and 91 (76%) were male. Among the 120 patients contacted, 67 (56%) were lost to follow-up, 3 (2.5%) had died, 3 (2.5%) were incarcerated, and 1 (0.8%) was hospitalized. Of the 46 reachable patients, 16 (35%) reported no follow-up, 20 (43%) reported PCP follow-up, and 8 (17%) reported subspecialist follow-up. None had received a six-month surveillance liver ultrasound. Despite targeted education, referrals, and case management, engagement in HCC surveillance among cirrhotic patients treated through a mobile and telehealth model remained low. Future efforts should prioritize developing intervention strategies to strengthen linkage to HCC surveillance after HCV cure. Jihad Slim, MD, FACP, gilead: Honoraria|merck: Honoraria|Thera: Honoraria|ViiV: Honoraria Kevin Leyden, RN, RN, Abbvie Inc.: Advisor/Consultant|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support

Background Some individuals with human immunodeficiency virus (HIV-1) have acquired multidrug-resistant (MDR) strains of HIV and/or are nonadherent to antiretroviral (ARV) medication. Injectable ARVs can provide salvage therapy for those with limited therapeutic options and may be preferred by some people with HIV (PWH). Real-world evidence may contribute to a more comprehensive understanding of the barriers to adherence and the utility of injectable ARVs in PWH. Currently, there is a lack of data on combined use of injectable ibalizumab (IBA) and lenacapavir (LEN) with optimized background regimen (OBR).Methods A retrospective observational study examined medical charts from people living with MDR HIV across 8 facilities in the United States. All PWH used a combination of both IBA + LEN +/- OBR for at least 6 months. Viral loads and CD4+ counts were collected.Results A total of 21 PWH were included. Four-class resistance at baseline was reported in 38.1% of PWH. Within 12 to 24 weeks of combined IBA + LEN treatment, a median reduction of -2710 copies/mL HIV RNA was observed. Median increase to CD4+ count was 67.5 cells/mm3 within 4 to 44 weeks of treatment initiation. Few intolerances required changes to treatment. Therapy with IBA + LEN continued for an average of 30 months and 20 months, respectively.Conclusions In this small group of individuals with MDR HIV who were heavily treatment-experienced and/or faced adherence challenges, the use of IBA + LEN +/- OBR was well tolerated and led to clinically significant reductions in viral loads and improvements in CD4+ counts. A group of 21 individuals living with multidrug-resistant HIV and/or adherence challenges received injectable ibalizumab and lenacapavir plus optimized background regimen for at least 6 months. People with HIV experienced clinically significant reductions in viral load and increases in CD4+ count after combined treatment.

The prevalence of Excess Visceral Adipose Tissue (VAT) is increasing in People living with HIV (PWH), however, data supporting cost-effective methods for identifying excess VAT is limited.1-2 Excess VAT is associated with multiple comorbidities and metabolic syndrome.1-3 Directly measuring VAT through CT scan or DEXA scan can be costly and impractical.2-3 A potential solution is to use anthropomorphic measurements to predict excess VAT, as illustrated in the VAMOS Study.3-4 In the VAMOS study, the authors found that Waist Circumference (WC) and Waist-to-Hip Ratio (WHR) are the best predictors for excessive VAT in men. However, the study only had 13 women, and WC was the best predictor, but not WHR. Our study aims to expand on the VAMOS cross-sectional study with a data pool focused on women with HIV. Performance of BMI, Weight, WC and WHR in predicting excess VAT in women with HIV ROC curves evaluating performance of anthropometric measures in predicting excess VAT in women with HIV The AUC was calculated to evaluate BMI, weight, WC and WHR to identify excess VAT in women with HIV A multicenter cross-sectional study was conducted in PWH. Eligible participants were over 18 years old and had HIV viral load < 200 c/ml. Individuals with chronic hepatitis B, C or excessive alcohol consumption (AUDIT score >5) were excluded. Excess VAT was quantified by Visceral Adiposity Index (VAI). Weight, BMI, WC, and WHR were calculated for women. Statistical analysis of each variable was done using multivariate analysis, and Receiver Operating Curve (ROC) was done for each anthropometric measurement in the women data set. A total of 245 participants were enrolled in the study, of which 80 (32.6%) were women, and were included in this analysis. Median age is 58 years. 67% identify as black and 30% identify as Hispanic. BMI and WC were statistically significant predictors of excess VAT, while Weight and WHR did not show a statistically significant correlation (Table 1). Comparing AUC, BMI: 0.728, and WC: 0.711 all perform well; however, WHR: 0.517, viewed alone, is not a strong predictor (Figure 1). Our study adds evidence that WC and BMI are effective predictors of excess VAT compared to weight and WHR in women living with HIV and further reinforces the findings in the VAMOS study. Jihad Slim, MD, FACP, gilead: Honoraria|merck: Honoraria|Thera: Honoraria|ViiV: Honoraria Kevin Leyden, RN, RN, Abbvie Inc.: Advisor/Consultant|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support

BACKGROUND:Innovative HIV-1 therapies, especially those with infrequent dosing, are a promising approach to advance progress toward the UNAIDS goal of ending HIV-1 transmission. VH4011499 (VH-499) is a new capsid inhibitor in development as a long-acting antiretroviral agent for HIV-1 treatment. We present the antiviral effect, pharmacokinetics, safety, and tolerability of oral VH-499 from a proof-of-concept phase 2a trial in people with HIV-1. METHODS:The randomized, double-blind, placebo-controlled CINNAMON trial evaluated oral VH-499 monotherapy in adults naive to antiretroviral therapy (ART) with viremia. During a 10-day monotherapy period, participants received VH-499 25, 100, or 250 mg or placebo on Days 1 and 6. After monotherapy, participants initiated locally sourced standard-of-care ART starting on Day 11. The primary endpoint was maximum change from baseline in viral load through Day 11. Secondary endpoints included exposure-response relationship, safety, and tolerability. RESULTS:Twenty-three participants were enrolled (VH-499, n=20; placebo, n=3). Viral load decreased through Day 11 for all VH-499 dose groups (mean [SD] maximum decline: 25 mg, -1.8 [0.5]; 100 mg, -1.8 [0.5]; 250 mg, -2.2 [0.4]). Increasing VH-499 exposures were associated with greater viral load declines. Ninety-five percent (19/20) of participants had no emergent genotypic resistance-associated mutations. Adverse events (AEs) were mild or moderate in severity, and no serious AEs or AEs leading to withdrawal were reported. CONCLUSIONS:VH-499 monotherapy demonstrated highly potent antiviral activity, was well tolerated, and had a favorable safety profile. These results support further development of VH-499 as part of a complete long-acting regimen for HIV-1 treatment (ClinicalTrials.gov, NCT06039579).

Background:Metabolic dysfunction-associated steatotic liver disease (MASLD) is increasingly recognized among people with human immunodeficiency virus (PWH), which is likely related to metabolic alterations and fat redistribution. Anthropometric measures such as body mass index (BMI) and waist circumference (WC) are commonly used for assessing metabolic risk. However, their predictive accuracy for MASLD in this population remains uncertain. Method:This multicenter cross-sectional study enrolled adults with HIV who underwent transient elastography with controlled attenuation parameter (CAP) measurement. Anthropometric and metabolic indices, including BMI, WC, hip circumference, waist-to-hip ratio (WHR), and visceral adiposity index (VAI), were collected from the study participants. Receiver operating characteristic (ROC) curve analyses were performed to determine the diagnostic performance of these indices for detecting hepatic steatosis, defined as CAP value of ≥248 dB/m. Analyses were stratified by sex assigned at birth. Results:Altogether, 256 participants were included. WC demonstrated the numerically highest discrimination for CAP-defined steatosis (area under the ROC curve 0.769), followed by BMI and hip circumference, whereas WHR and VAI showed weaker performance. In sex-stratified analyses, WC remained the numerically highest-performing measure among males, whereas BMI, WC, hip circumference, and VAI showed similar discrimination among females. Conclusions:Simple anthropometric measures, particularly WC, show fair ability to discriminate CAP-defined hepatic steatosis in PWH and may facilitate targeted fatty liver screening in routine HIV care.

Abstract Background Innovative human immunodeficiency virus (HIV) therapies, especially those with infrequent dosing, are a promising approach to advance progress toward the UNAIDS goal of ending HIV transmission. VH4011499 (VH-499) is a new capsid inhibitor in development as a long-acting antiretroviral agent for HIV-1 treatment. We present the antiviral effect, pharmacokinetics, safety, and tolerability of oral VH-499 from a proof-of-concept phase 2a trial in people with HIV-1. Methods The randomized, double-blind, placebo-controlled CINNAMON trial evaluated oral VH-499 monotherapy in adults naive to antiretroviral therapy (ART) with viremia. During a 10-day monotherapy period, participants received VH-499 25, 100, or 250 mg or placebo on Days 1 and 6. After monotherapy, participants initiated locally sourced standard-of-care ART starting on Day 11. The primary endpoint was maximum change from baseline in viral load through Day 11. Secondary endpoints included exposure–response relationship, safety, and tolerability. Results Twenty-three participants were enrolled (VH-499, n = 20; placebo, n = 3). Viral load decreased through Day 11 for all VH-499 dose groups (mean [SD] maximum decline: 25 mg, −1.8 [0.5]; 100 mg, −1.8 [0.5]; 250 mg, −2.2 [0.4]). Increasing VH-499 exposures were associated with greater viral load declines. Ninety-five percent (19/20) of participants had no emergent genotypic resistance-associated mutations. Adverse events (AEs) were mild or moderate in severity, and no serious AEs or AEs leading to withdrawal were reported. Conclusions VH-499 monotherapy demonstrated highly potent antiviral activity, was well tolerated, and had a favorable safety profile. These results support further development of VH-499 as part of a complete long-acting regimen for HIV-1 treatment. Clinical Trials Registration NCT06039579.

Abstract Background Most current guidelines recommend hepatitis A (HAV) and hepatitis B (HBV) vaccination for people living with hepatitis C (HCV) and lacking immunity to those viruses. We were interested in studying the prevalence of immunity to those 2 viruses in patients with chronic active HCV infection (CAH C) in NJ, to evaluate the resources needed to vaccinate those who are not immune. Methods We reviewed prospectively collected data in people with CAH C living in NJ, and retrieved their age, sex, race, ethnicity, HAV IgG, HBV surface antigen, HBV surface antibody, and HBV total core antibody. We calculated the prevalence of immunity to each virus, and specifically targeted the difference for HBV immunity in those born after 1991, when implementation of universal HBV vaccination of newborns started in the US. Results Between 09/01/2020 and 12/31/2023 we collected data on 1586 people living with HCV. The overall prevalence of HAV immunity was 46% (726/1586); for HBV, 36% (578/1586) were immune through vaccination (only HBV surface antibody positive), when divided by age group those born in 1991 and earlier had 34 % immunity compared to 52.5% for those born after 1991 (p< .0001). The prevalence of exposure to HBV was 24% (380/1586) with 7 having Hep B s Ag positive, and 126 only Hep B core antibody positive; when divided by the same age group categories, only 7 % of those < 32 years old had HBV exposure, as compared to 26% of those 33 years and older at a p value < .0001. Prevalence of people with all 3 markers negative for HBV (requiring vaccination) is 40% (628/1586); with no statistical difference between the two-age group, 40.5% for < 32 years old, and 39.5% for those 33 years and older. Conclusion Our study shows an urgent need to implement hepatitis A and hepatitis B vaccinations in people living with HCV in NJ, almost half of them are not immune to either virus. On the other hand, it also highlights the success of universal vaccination of newborn for HBV, since we found a statistically significant number of those born after 1991 to be immune and have less HBV exposure. Disclosures Jihad Slim, MD, FACP, AbbVie: Grant/Research Support|AbbVie: Honoraria|AbbVie: Speaker Bureau|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Speaker Bureau|Merck: Grant/Research Support|Merck: Honoraria|Merck: Speaker Bureau|Theratechnologies: Advisor/Consultant|Theratechnologies: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speaker Bureau

Abstract Background Understanding the real-world experiences of people with HIV-1 (PWH) is essential to tailoring HIV treatment to PWH needs. PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC) (PAIRED) examined PWH experiences in the United States. Methods PAIRED comprised a cross-sectional survey and in-depth qualitative interviews of stable-switch PWH ≥ 18 years, receiving DTG/3TC for ≥ 3 months. A mixed recruitment methodology (site-led and community outreach) was employed, and the survey included validated instruments [HIV-Treatment Satisfaction Questionnaire (HIV-TSQs), Adelphi Adherence Questionnaire™ (ADAQ), PoZQoL]. The survey results presented here are descriptive. Results PAIRED represented a diverse sample of 474 participants (31% female sex at birth, 48% non-White, and 50% ≥ 50 years) (Table 1). Median time since HIV diagnosis was 13.5 years (IQR: 7.0-23.0) and most (74%) had taken ≥ 2 previous antiretroviral (ART) regimens. The majority switched from either bictegravir/emtricitabine/tenofovir alafenamide (28%) or abacavir/dolutegravir/lamivudine (28%) to DTG/3TC, and 73% had taken their immediate previous treatment for > 12 months. Majority of participants (62%) had taken DTG/3TC for > 12 months. When asked to rank factors influencing switch to DTG/3TC, PWH reported avoidance of side effects and minimizing long-term impact as top 2 factors (Figure 1). Using the HIV-TSQs, PWH reported high satisfaction with dolutegravir/lamivudine. Out of a maximum score of 60, the median total HIV-TSQs score was 57.0 (IQR: 52.0-60.0). Out of a maximum score of 65, participants had an overall median PozQoL score of 47.0 (IQR: 38.5-55.0), indicative of high quality of life. PWH reported improved treatment satisfaction with DTG/3TC compared with their previous ART regimen (68% vs 31% very satisfied) (Figure 2) and reducing the number of medicines was extremely or very important to 79% of PWH (Figure 3). Good adherence was observed using the ADAQ [median ADAQ© score 0.4 (IQR: 0.2-0.5); possible scores 0-4], with 89% of PWH reporting never or rarely missing a DTG/3TC dose. Conclusion PAIRED represented a diverse sample of PWH switching to DTG/3TC who were highly satisfied with treatment resulting in good adherence and high quality of life. Disclosures Jihad Slim, MD, FACP, AbbVie: Grant/Research Support|AbbVie: Honoraria|AbbVie: Speaker Bureau|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Speaker Bureau|Merck: Grant/Research Support|Merck: Honoraria|Merck: Speaker Bureau|Theratechnologies: Advisor/Consultant|Theratechnologies: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speaker Bureau Andrew P. Brogan, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Gavin Harper, BA, Adelphi Real World: Employee|ViiV Healthcare: Contract for this analysis Katie L. Mycock, MChem, Adelphi Real World: employee|ViiV Healthcare: Contract for this analysis Abigail McMillan, MSc, Adelphi Real World: employee|ViiV Healthcare: Contract for this analysis Deanna Merrill, PharmD, MBA, AAHIVP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Gustavo Verdier, BSc, BPharm, MBA, ViiV Healthcare: Employee

BACKGROUND:Complex antiretroviral therapy (ART) regimens, such as those requiring multiple tablets, several doses per day, or both, can negatively affect quality of life and treatment adherence among people with human immunodeficiency virus (HIV). METHODS:ARTISTRY-1 is a phase 2/3, operationally seamless, randomized, open-label, multicenter, active-controlled study (GS-US-621-6289; NCT05502341). Phase 2 of the study enrolled adults with plasma HIV-1 RNA <50 copies/mL receiving a complex ART regimen for ≥6 months. Efficacy and safety outcomes were evaluated after a switch to bictegravir (BIC) (75-mg) + lenacapavir (LEN) (25- or 50-mg) regimens, compared with continuing on a complex ART regimen through 24 weeks. RESULTS:Overall, 128 participants were assigned randomly to begin BIC 75 mg + LEN 25 mg (n = 51) or BIC 75 mg + LEN 50 mg (n = 52) or continue on their complex ART regimen (n = 25). At week 24, HIV-1 RNA was ≥50 copies/mL in 0 of 51, 1 of 52 (1.9%), and 0 of 25 participants in the 3 groups, respectively. CD4 cell counts and percentages remained stable through week 24; the median change from baseline in CD4 cell count (interquartile range) was 18 (-39 to 70), -16 (-80 to 93), and 42 (-36 to 90) cells/µL, respectively. There were no study discontinuations due to a serious adverse event through week 24. Both BIC + LEN dosing regimens were well tolerated, with similar safety profiles observed between groups. CONCLUSIONS:These data support the continued evaluation of the combination of BIC and LEN to optimize treatment in people with HIV and virologic suppression who are receiving complex ART regimens.

ARTISTRY-1 is a phase 2/3 trial of bictegravir (BIC; 75 mg) plus lenacapavir (LEN; 25 mg or 50 mg) versus complex antiretroviral therapy regimens in 128 virologically suppressed people with HIV-1. At 48 weeks, BIC + LEN (at either LEN dose) was highly effective at maintaining virologic suppression and was well tolerated.

Abstract Background The risk of chronic kidney disease (CKD) is higher in PWH than HIV-negative persons. Black communities are not only disproportionately affected by HIV but also more at risk for kidney disease than other races. Despite Black PWH generally being underrepresented in clinical trials, the BRAAVE trial showed switching to bictegravir/emtricitabine/TAF demonstrated non-inferior efficacy and similar tolerability, including renal safety, compared to prior ART regimens in this group. With this analysis, we aim to assess whether these trial results translate to the real-world setting among Black PWH using a retrospective cohort analysis. Methods The descriptive analysis was conducted using IQVIA ambulatory electronic medical record (EMR) database (November 2015 – July 2023). The study population included PWH (≥ 18 years) who were newly prescribed with ART regimens. Study endpoints evaluated the incidence of azotemia, Fanconi syndrome, renal tubular acidosis (RTA), renal toxicity, acute kidney injury (AKI), and CKD stages using diagnosis codes, stratified by racial group (Black and non-Black) and treatment with TAF-based regimens using prescription codes. Incidence rates were reported. The analysis was conducted using ATLAS Version 2.12.1. Results Overall, 4,562 Black and 5,946 non-Black PWH were identified on TAF-containing regimen, with 7,933 and 10,198 person-years of follow-up, respectively (Table 1). Compared to non-Black PWH, Black PWH were more likely to be female, have diabetes and hypertension. Black PWH on TAF had a higher incidence of advanced CKD and similar incidence rates of azotemia, renal toxicity, AKI, and RTA compared to non-Black PWH on TAF (Table 2). When stratified by baseline hypertension, no significant differences in the incidence of renal disease were observed between Black and non-Black PWH. There were no cases of Fanconi syndrome in the study cohort. Conclusion Despite the inherent limitations of real-world data, this analysis included a large cohort of Black PWH on TAF-containing ART and showed a low incidence of RTA and AKI, despite predisposition to increased rates of renal decline or safety outcomes in Black PWH starting ART. Disclosures Samir K. Gupta, MD, Gilead Sciences, Inc.: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Sarjita Naik, PharmD, MPH, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Xiwen Huang, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Amy Weinberg, DNP, MS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Lauren Temme, PharmD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Li Tao, MD, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Betty Chiang, MD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Anand Chokkalingam, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Jihad Slim, MD, FACP, AbbVie: Grant/Research Support|AbbVie: Honoraria|AbbVie: Speaker Bureau|Gilead Sciences, Inc.: Grant/Research Support|Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Speaker Bureau|Merck: Grant/Research Support|Merck: Honoraria|Merck: Speaker Bureau|Theratechnologies: Advisor/Consultant|Theratechnologies: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speaker Bureau

Clostridium difficile infection (CDI), characterized by diarrheal illness with serious complications, is a common pathology in clinical practice. We present a series of five patients with CDI who underwent treatment with fidaxomicin following the failure of oral vancomycin. To our knowledge, no evidence in the literature suggests that fidaxomicin is more effective than vancomycin in treating acute infection. This paper emphasizes the importance of utilizing a large study to determine the relative effectiveness of vancomycin versus fidaxomicin in treating CDI. We also provide a literature review on CDI and management evolution.