Innovative Albuvirtide-Based Combination Regimen in Critically Ill HIV-1-Infected Patients: Evidence of Viral Suppression and Safety Outcomes

doi:10.21203/rs.3.rs-7981064/v1

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Innovative Albuvirtide-Based Combination Regimen in Critically Ill HIV-1-Infected Patients: Evidence of Viral Suppression and Safety Outcomes

https://doi.org/10.21203/rs.3.rs-7981064/v1

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Background

To control HIV-1 viral load, reduce drug resistance, and maintain optimal immune function, albuvirtide (ABT) combined with antiretroviral therapy (ART) is used in designated AIDS hospitals in China. However, the standard weekly 320-mg ABT injection regimen poses adherence-related challenges. This study aimed to evaluate the safety and efficacy of an optimized ABT regimen in HIV-1-infected patients.

Methods

Twenty HIV-1-infected patients received ABT 320 mg intravenously for three consecutive days every four weeks, alongside their baseline ART regimens. Peripheral blood samples were collected to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglyceride (TAG), cholesterol, CD4⁺ T-cell counts, and HIV-RNA levels, and ABT concentrations (pre-dose and 2 hours after dose).

Results

All patients maintained high adherence and reported reduced psychological burden. No drug-related adverse events (e.g., injection-site reactions, hepatotoxicity, nephrotoxicity) were observed. Laboratory parameters remained stable, with no significant changes from baseline (P > 0.05). Pharmacokinetic analysis demonstrated sustained therapeutic exposure, with mean trough concentrations of 4.71 mg/L, 3.83 mg/L, and 4.53 mg/L at Weeks 4, 8, and 12, respectively exceeding 50× the IC₉₀. The mean viral load decreased from 1.65 log₁₀ copies/mL at baseline to 0.59 log₁₀ copies/mL at Week 12 (mean reduction: 1.06 log₁₀ copies/mL; P = 0.0007). Among patients with baseline HIV-RNA > 20 copies/mL, the viral load decreased from 2.55 to 1.43 log₁₀ copies/mL. Although both CD4⁺ and CD8⁺ T-cell counts increased, the changes were not statistically significant.

Conclusion

The innovative ABT regimen, administered every four weeks, demonstrated effective viral suppression and a favorable safety and tolerability profile. Sustained plasma drug concentrations above the PA-IC₉₀ support its potential as a promising long-acting antiretroviral agent with improved patient adherence and applicability for managing HIV-1. These findings suggest that this approach may offer a promising therapeutic option for treatment-refractory HIV-1 populations.

Albuvirtide

Safety

Viral Suppression

HIV-1-infected patients

Antiretroviral therapy (ART) remains one of the most effective approaches for controlling the HIV epidemic. It not only extends the lifespan and improves the life quality of people living with HIV (PLHIV) but also reduces HIV transmission. However, with prolonged treatment duration, individuals may experience treatment interruption (discontinuation) or suboptimal adherence, which not only substantially compromises the effectiveness of ART but may also accelerate the emergence and transmission of drug-resistant strains.^{[1, 2]} Against the backdrop of ongoing ART scale-up efforts globally, investigating the impact of treatment interruption and suboptimal adherence on HIV transmission and the spread of drug-resistant strains in China is essential to provide a scientific basis for formulating national HIV control strategies.

Long-acting antiretroviral regimens (LA-ARV regimens), such as albuvirtide (ABT), cabotegravir combined with rilpivirine (CAB + RPV), lenacapavir (LEN), and monoclonal antibodies, are increasingly being used in clinical practice.^[3–6] ABT, China’s first independently developed long-acting fusion inhibitor, inhibits HIV replication by binding to the viral transmembrane glycoprotein gp41, thereby blocking membrane fusion between the virus and host cells.^[7]

As an intravenous long-acting antiretroviral drug, ABT has demonstrated clear clinical efficacy and safety.^[8] Phase III clinical trial data revealed that an ABT-based regimen (weekly intravenous injection) combined with lopinavir/ritonavir (LPV/r) showed significant anti-HIV efficacy, high safety, and minimal adverse effects. This regimen was non-inferior to the WHO-recommended second-line triple-drug therapy in treatment-experienced patients who failed first-line treatment.^{[9, 10]} Additionally, ABT can be used in combination with other antiretroviral regimens in both ART-naïve and treatment-experienced patients, offering an alternative option for those with drug resistance.^[11] Owing to its unique characteristics—long-acting profile, intravenous administration, lack of CYP450 metabolism, and minimal drug–drug interactions—ABT has expanded its applications to address unmet medical needs in special populations, such as patients with hepatic or renal impairment, those undergoing abdominal surgery in the perioperative period, critically ill hospitalized patients with HIV infections, and individuals requiring HIV post-exposure prophylaxis.^{[8, 11–15]} Currently, the recommended ABT dosing regimen consists of 320 mg administered on Days 1, 2, 3, and 8, followed by a maintenance phase of 320 mg administered weekly via intravenous infusion. However, as ABT requires administration in a hospital setting, its limited accessibility in some regions forces patients to travel across cities or even provinces to receive their injections. This significantly increases the economic and time burdens on patients and reduces treatment adherence.

To address these challenges, we propose exploring whether adjusting the ABT dosing schedule and extending dosing intervals could improve convenience and adherence while maintaining antiviral efficacy and safety. Although studies are investigating extended intervals (e.g., biweekly or monthly dosing), these approaches remain under clinical evaluation and have not yet been incorporated into standard treatment guidelines.^[16] For example, an ongoing U.S. trial is evaluating ABT in combination with the broadly neutralizing antibody 3BNC117 (administered intravenously every 2–4 weeks) as a long-term maintenance therapy for virologically suppressed patients.^[17–19] Further research is needed to explore the combination of ABT with integrase inhibitors or other long-acting agents to develop complete long-acting antiretroviral regimens.

In this prospective clinical cohort study, we evaluated the safety and efficacy of an innovative ABT-based regimen (administered at 320 mg on Days 1, 2, 3, and subsequently for three consecutive days every four weeks) in 20 critically ill patients.

Study Participants

This study enrolled 20 HIV-infected patients who received intensive antiretroviral therapy (ART) in combination with ABT injections. The exclusion criteria included abnormal results in standard laboratory tests at screening: hemoglobin concentration < 9 g/dL, white blood cell count < 2 × 10⁹/L, neutrophil count < 1 × 10⁹/L, platelet count < 75 ×10⁹/L, aminotransferase levels more than three times the upper limit of normal (ULN), total bilirubin concentration more than twice the ULN, creatinine concentration more than twice the ULN, and plasma D-dimer levels more than five times the ULN.

All participants received ABT 320 mg via intravenous injections for three consecutive days every four weeks and attended at least three follow-up visits until study completion. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of Zhejiang Hospital (Reference Number 2024 − 1518). Written informed consent was obtained from all participants. The study was registered in the Chinese Clinical Trial Registry (ChiCTR2500097627, https://www.chictr.org.cn/bin/project/edit?pid=262452). The results of laboratory examinations conducted at the Day 1 visit, including blood cell count, biochemical parameters, urinalysis, CD4⁺ T-cell count, HIV RNA viral load, and plasma ABT concentration, were recorded as baseline measurements. Follow-up evaluations were conducted at Weeks 4, 8, and 12 to assess hematological and biochemical profiles, urinalysis results, medication adherence, adverse drug reactions (ADRs), CD4⁺ T-cell counts, HIV RNA viral load, and plasma ABT concentration.

Throughout the study, all ABT injections were administered by trained nurses in the hospital. Attending physicians closely monitored patients and documented any ADRs that occurred during the ABT treatment period.

Statistical analysis

Continuous data were expressed as mean ± standard deviation, and categorical data were presented as frequencies and percentages. The χ² test or Fisher’s exact test was used to compare categorical variables, as appropriate. Continuous variables were compared using the paired t-test, and analysis of variance (ANOVA) with T-correction was used for multiple comparisons. All data analyses were performed using SPSS software (version 23.0) and GraphPad Prism (version 8.0.2). A P-value of < 0.05 was considered statistically significant.

Demographic and clinical characteristics of patients

The cohort consisted of 19 male patients and 1 female patient, with a mean age of 42.1 years. Among them, 10 patients had diagnosed with malignancies (5 with lymphoma, 3 with lung cancer, 1 with colorectal cancer, and 1 with breast cancer), and 10 had opportunistic infections (4 with nontuberculous mycobacteria, 3 with cytomegalovirus, 2 with cryptococcal meningitis, and 1 with progressive multifocal leukoencephalopathy). In total, 14 patients resided in Zhejiang Province, while the remaining 6 were from other provinces (2 from Shandong, 2 from Anhui, 1 from Jiangxi, and 1 from Guizhou). By the end of the study, 15 patients had completed ≥ 3 months of follow-up, and 10 patients continued intensive therapy beyond the study period. Two patients had previously received weekly ABT 320 mg injections before transitioning to the monthly three-day regimen. Both reported substantial improvements in treatment adherence and reduced psychological burden with the new dosing schedule.

The average duration of antiretroviral therapy (ART) in the cohort was 2.24 years, with 5 patients having received ART for ≤ 6 months and the remaining 15 patients, for > 6 months. Baseline HIV-RNA levels and CD4⁺ T-cell counts were measured in all patients before initiating treatment. The mean baseline HIV-RNA level was 1.65 log₁₀ copies/mL, with seven patients presenting with levels < 20 copies/mL. The mean CD4⁺ T-cell count was 188 cells/µL, and 14 patients had CD4⁺ T-cell counts < 200 cells/µL.

Safety and tolerability of the ABT combination regimen

In this study, clinical symptoms of the participants were monitored and recorded before and after ABT administration. No drug-related adverse events—including injection-site pain, allergic rash, nausea/vomiting, or treatment discontinuation due to adverse events—were observed. A comparative analysis of laboratory parameters (blood routine, liver and renal function, and lipid profiles) before and after treatment revealed no statistically significant differences (Table 2), further confirming the favorable safety and tolerability of the ABT regimen in this cohort.

Table 1
Demographic and Clinical Characteristics of Patients
Demographic Characteristic	Patients, No. (%)
Sex
Male	19 (95%)
Female	1 (5%)
Age (years)
< 40 years	8 (40%)
≥ 40 years	12 (60%)
Residence
Zhejiang Province	14(70%)
Other provinces	6(30%)
Transitioned from Weekly Regimen
Yes	2 (10%)
No	18 (90%)
Time since antiretroviral therapy
< 6 months	5 (25%)
≥ 6 months	15 (75%)
HIV-RNA (copies/mL)
≥ 20	13 (65%)
< 20	7 (35%)
CD4 (cells/µL)
< 200	14 (70%)
200–500	4 (20%)
> 500	2 (10%)

Table 2
Safety Results of the Innovative ABT Combined Regimen in This Cohort
Parameter	0 weeks	12 weeks	t-value	95% CI	P-value
Platelet (×10⁹/L)	181.9	192.1	0.369	[-0.746, 0.511]	0.714
Serum creatinine (µmol/L)	86.65	90.84	0.475	[-0.78, 0.478]	0.637
ALT (U/L)	24.95	27.47	0.444	[-0.77, 0.488]	0.660
Total bilirubin (µmol/L)	8.73	8.03	0.408	[-0.499, 0.758]	0.686
Triglycerides (mmol/L)	2.00	2.24	0.324	[-0.732, 0.525]	0.747
Plasma D-dimer (ng/mL)	583.50	459.47	0.772	[-0.385, 0.876]	0.445
Note: Data represent mean values at baseline (0 weeks) and after 12 weeks of treatment. Comparisons were performed using paired t-tests. ALT = alanine aminotransferase; CI = confidence interval; ABT = albuvirtide.

Maintenance of high plasma drug concentrations

The standard ABT dosing regimen consists of 320 mg administered on Days 1, 2, 3, and 8, followed by a weekly maintenance dose of 320 mg via intravenous infusion. This study explored whether modifying the regimen to 320 mg administered daily over three consecutive days every four weeks could maintain the antiviral efficacy and safety profile. Blood samples were collected from all participants to measure plasma ABT concentrations before treatment initiation. Baseline (Week 0) ABT concentrations were undetectable (0 mg/L) in all patients except for two who had previously received weekly ABT 320 mg therapy. Based on previous in vitro studies, the 90% inhibitory concentration (IC₉₀) for ABT is 0.075 mg/L. Trough concentration analysis revealed mean ABT concentrations of 4.71 mg/L, 3.83 mg/L, and 4.53 mg/L at Weeks 4, 8, and 12, respectively, corresponding to 62.8×, 51.07×, and 60.4× the IC₉₀. Intergroup comparisons showed no statistically significant differences in drug concentrations between the three timepoints (Fig. 1a), indicating that the modified regimen effectively sustained plasma drug levels well above the therapeutic threshold.

Retention of robust antiviral effectiveness

HIV-RNA levels were measured and analyzed in all participants before and after ABT treatment. At baseline, seven patients had undetectable viral loads (HIV-RNA < 20 copies/mL), with a mean baseline viral load of 1.65 log₁₀ copies/mL. By Week 12, 15 patients had achieved HIV-RNA levels < 20 copies/mL, with the mean viral load reducing to 0.59 log₁₀ copies/mL, representing a 1.06-log₁₀ reduction from baseline. Intergroup analysis demonstrated a statistically significant difference in HIV-RNA levels following treatment (P = 0.0007; Fig. 1b).

To evaluate whether the optimized ABT regimen affected immune cell dynamics, CD4⁺ T-cell counts, CD8⁺ T-cell counts, and the CD4/CD8 ratio were measured at all timepoints before and after treatment. Although both CD4⁺ and CD8⁺ T-cell counts increased following ABT optimization, no statistically significant differences were observed in intergroup comparisons (Fig. 2).

As mentioned above, the innovative ABT combination regimen demonstrated favorable antiviral efficacy in the overall study cohort. However, its effectiveness in patients with suboptimal long-term antiviral outcomes remains an important consideration. Further analysis of patients who maintained HIV-RNA levels > 20 copies/mL despite receiving ≥ 6 months of prior antiretroviral therapy revealed that after 12 weeks of ABT treatment, HIV-RNA levels significantly decreased from 2.55 log₁₀ copies/mL at baseline to 1.43 log₁₀ copies/mL, with statistically significant differences observed between pre- and post-treatment values (P < 0.05, Figs. 3a and 3b). In contrast, no statistically significant changes were observed in CD4⁺ T-cell counts, CD8⁺ T-cell counts, or CD4/CD8 ratios before and after treatment (Figs. 3c–3e).

ART remains the most critical determinant for sustained viral suppression and the prevention of drug-resistant variants.^[20] To address adherence challenges and reduce the risk of resistance, this study implemented a modified ABT dosing schedule in combination with participants’ baseline ART regimens. Considering ABT’s prolonged half-life, after obtaining informed consent from HIV-infected participants, ABT was administered at 320 mg/day intravenously for three consecutive days every four weeks. Throughout the study, plasma ABT concentrations, safety, and antiviral efficacy were closely monitored and evaluated.

Previous studies have reported common adverse effects of ABT, including dyslipidemia, elevated liver enzymes, diarrhea, headache, dizziness, and rash.^{[15, 16, 21]} In this study, participants underwent regular monitoring of blood counts, liver and kidney function, gastrointestinal symptoms, and injection-site reactions before each ABT administration. No significant drug-related adverse events were observed, confirming the favorable safety profile of the innovative ABT combination regimen.

To assess whether the adjusted dosing regimen maintained effective drug levels, trough concentrations of ABT were measured before each administration. At Weeks 4, 8, and 12, the mean ABT concentrations were 62.8-fold, 51.07-fold, and 60.4-fold above the protein-adjusted IC₉₀ (PA-IC₉₀), respectively. These findings align with prior research in virologically suppressed patients with HIV-1 infections receiving ABT 640 mg every four weeks in combination with daily dolutegravir, where steady-state trough concentrations of ABT were 31.1-fold above the PA-IC₉₀ after 24 weeks, demonstrating sustained therapeutic levels throughout the dosing interval.

By Week 12, the innovative ABT combination regimen achieved a mean HIV RNA reduction of 1.06 log₁₀ copies/mL, with eight participants reaching virological suppression—a statistically significant improvement compared to baseline. Additionally, among 10 participants with suboptimal virological responses (defined as detectable HIV-RNA after 6 months of ART), 5 achieved virological suppression after 12 weeks of ABT intensification. These findings highlight ABT’s potential to accelerate viral load reduction, even in treatment-experienced populations. While previous studies have confirmed ABT’s efficacy in maintaining viral suppression, they have primarily focused on individuals who were already virally suppressed at baseline.^[8]

It is evident that the sample size in this study is limited. However, expanding enrollment remains challenging, as our cohort primarily comprises HIV-infected patients with malignancies and opportunistic infections—a population that is relatively difficult to recruit and follow longitudinally. Moreover, although significant antiviral efficacy was observed during the 12-week study period, the short duration of follow-up is insufficient to fully capture long-term immune reconstitution and virological durability.

This study innovatively explores an adjusted ABT regimen in critically ill HIV-1-infected patients with opportunistic infections or malignancies, particularly those with suboptimal virological responses. The modified regimen demonstrated a favorable safety profile, rapid reductions in HIV-RNA levels, and potential benefits for immune recovery. These findings suggest that this approach may offer a promising therapeutic option for treatment-refractory HIV-1 populations.

Conflicts of interest:

All authors have declared that no competing interests exist.

Informed Consent Statement

Informed consent was obtained from all participants involved in the study. Written informed consent was also obtained from the patient(s) for publication, where applicable.

Institutional Review Board Statement

The study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the Ethics Committee of First Affiliated Hospital, Zhejiang University School of Medicine (Reference Number 2024 − 1518).

Funding

This research was funded by the State Key Laboratory for Diagnosis and Treatment of Infectious Diseases under Grant 202508 and the National Key Research and Development Program of China under Grant 2024YFC2311105.

Author Contribution

Conceptualization, Hu Caiqin, Zhou Xiaotang, and Zhu Biao; Funding acquisition, Zhu Biao, Methodology, Hu Caiqin, Zhou Xiaotang, He Lingling, Zhu Xueling, Cao Qing, Dai Bohao and Liu Huiting; Resources, Su Junwei, and Zhu Biao; Software, Qin Jiaying and Wang Jingjing; Writing—original draft, Hu Caiqin, and Zhou Xiaotang; Writing—review and editing, All authors.

Acknowledgements

The authors sincerely thank all study participants for their contribution.

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No competing interests reported.

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You are reading this latest preprint version

Innovative Albuvirtide-Based Combination Regimen in Critically Ill HIV-1-Infected Patients: Evidence of Viral Suppression and Safety Outcomes

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Introduction

Materials and methods

Study Participants

Statistical analysis

Results

Demographic and clinical characteristics of patients

Safety and tolerability of the ABT combination regimen

Maintenance of high plasma drug concentrations

Retention of robust antiviral effectiveness

Discussion

Declarations

Conflicts of interest:

Informed Consent Statement

Funding

Author Contribution

Acknowledgements

References

Additional Declarations

Status:

Version 1