Tolerability and Adherence of Antiretroviral Regimens Containing Long-Acting Fusion Inhibitor Albuvirtide for HIV Post-Exposure Prophylaxis: A Cohort Study in China

Abstract

Introduction: There have been no prospective clinical studies investigating adherence and tolerability of HIV post-exposure prophylaxis (PEP) in China. Tolerability, adherence, and transmitted drug resistance are concerns, especially when single-tablet regimen (STR) usage is low. The present study aimed to explore the safety, tolerability, and adherence of regimens containing albuvirtide (ABT) compared with recommended non-STR antiretrovirals for HIV PEP. Methods: This was a prospective, open-label, multicenter cohort study. The subjects were stratified into 3 groups based on their preference: ABT ? Dolutegravir (DTG) (Group 1), ABT ? Tenofovir disoproxil fumarate (TDF) ? Lamivudine (3TC) (Group 2), and DTG ? TDF ? 3TC (Group 3). All enrolled subjects received PEP within 72 h after exposure and continued for 28 days, and were followedup for 12 weeks. Results: A total of 330 participants were enrolled in the three groups. Most participants were male (87.2%). Sexual contact was the most frequent mode of exposure (91.9%). The average time from exposure to treatment was 26.8 ± 19.5 h. There were no statistically significant differences between the three study groups with respect to completion of oral medication at 28 days. The 28-day completion rate was shown to be significantly higher with ABT versus oral (88.9% vs. 64.0%; p\0.0001), and adherence with ABT was 94.4% compared to 75.7% with oral PEP (p\0.0001). Subjects in ABT-containing Group 1 exhibited higher adherence than those in Group 3 (87.3% vs. 72.9%; p\0.05). None of the participants reported serious adverse drug reactions which led to withdrawal from the study. All the drug regimens were found to be safe and well tolerated. No HIV incident case was observed during the study period.Conclusions: ABT-containing regimens (ABT ? DTG or ABT ? TDF ? 3TC) offer a good option for HIV PEP due to higher completion rates and adherence than the DTG ? TDF ? 3TC regimen. The overall safety was comparable and acceptable among the three groups.Jingmin Nie and Feng Sun have contributed equally to this work.

Chinese Guidelines for the Diagnosis and Treatment of HIV/AIDS (2021 Edition)

“…AZT/3TC can be used in individuals with decreased renal function and no HBV infection. A study has shown that PEP regimen containing ABT (ABT + DTG, or ABT + TDF + 3TC) had high treatment completion rate, compliance, and good safety, but more researches needed on this regimen [52] …”

“…A study has shown that PEP regimen containing ABT (ABT + DTG, or ABT + TDF + 3TC) had high treatment completion rate, compliance, and good safety, but more researches needed on this regimen. [52] Timing of PEP initiation and recommended duration: PEP should be initiated as soon as possible after HIV exposure (within 2 hours where possible). It is best to start PEP within 24 hours after exposure, but no later than 72 hours.…”

Nicotinamide mononucleotide impacts HIV-1 infection by modulating immune activation in T lymphocytes and humanized mice

“… 26 , 27 The daily cART treatment for mice contains 61.5 mg/kg lamivudine (3TC), 10.25 mg/kg dolutegravir (DTG), and 61.5 mg/kg tenofovir disoproxil fumarates (TDF), equivalent to the combination of 300 mg 3TC/50 mg DTG/300 mg TDF for human. 32 , 33 , 34 The dose of NMN was 300 mg/kg/day for mice, which is equivalent to 25 mg/kg/day for human. 34 , 35 HIV-infected huPBL mice were used for negative control.…”

Personalizing prevention: Advances in pharmacotherapy for HIV prevention

“…The data to support expansion of these newer treatment agents to PEP have increased over time and select STRs have already been incorporated into treatment guidelines in other countries 98 . Finally, future long‐acting ARVs could also play a role in improved adherence to HIV PEP, with an early study showing potential benefit in combination with oral therapy for 28 days 100 . Future long‐acting injectables with the capability to provide one injection for the entirety of PEP therapy should be explored to further enhance adherence.…”