ABSTRACT
Background: Patients living with HIV (PLWH) with multi-drug resistance (MDR) and prior episodes of virologic failure have few therapeutic options remaining. These patients are often prescribed 'salvage' antiretroviral therapy (ART) regimens with high pill burdens, leading to potential decreased medication adherence and increased side effects and drug-drug interactions. Materials & Methods: In this retrospective, observational cohort study, we included adult patients with a diagnosis of HIV-1 who received care at our institution's Ryan White Clinic and who received 'salvage' ART, defined as three of more antiretroviral agents from at least three different HIV drug classes. Patients were grouped into two cohorts, simplified ART cohort and non-simplified ART cohort, based on whether their ART regimen was reduced by at least one tablet daily. The primary outcome was the percentage of patients who had their viral load suppressed (HIV-1 RNA <50 copies/ml) at their most recent clinic visit. Secondary outcomes were virologic failure (HIV-1 RNA ⩾200 copies/ml), percentage of time patients were virologically suppressed over the past 2 years, and the emergence of new treatment-resistant mutations. Results: There were 50 patients included in the final analysis, 28 in the simplified ART cohort and 22 in the non-simplified ART cohort. The percentage of patients who had their HIV-1 viral load suppressed at their most recent clinic visit was n = 24 (86%) in the simplified ART cohort and n = 16 (73%) in the non-simplified ART cohort (p = 0.302). There were no statistically significant differences between the two cohorts in terms of the secondary outcomes. Conclusion: Our study found that simplification of ART regimens based on HIV genotype in PLWH with a history of MDR and prior virologic failures, regardless of the presence of HIV-1 viremia at the time of simplification, resulted in similar rates of virologic suppression and virologic failure as non-simplified ART regimens.
ABSTRACT
PURPOSE: To describe a case report of antiretroviral regimen selection, with considerations for drug-supplement interactions, for a patient living with HIV with complicated nutrition needs. SUMMARY: A 56-year-old white female with a history of sleeve gastrectomy was initiated on coformulated bictegravir/emtricitabine/tenofovir alafenamide for treatment of HIV infection. Her baseline HIV viral load was 139,790 RNA copies/mL, and the baseline CD4 cell count was 544 cells/mm3. The patient additionally had a nutritional supplement regimen of twice-daily calcium and twice-daily multivitamins with minerals following sleeve gastrectomy. Due to binding interactions between polyvalent cations and bictegravir and the potential impact on antiretroviral efficacy, construction of a daily medication schedule to avoid interactions between the antiretroviral regimen and the supplements while promoting optimal dosing of each supplement was necessary; however there is currently no guidance on twice-daily cation dosing with coadministered bictegravir and limited guidance on multivitamin coadministration in this context. A review of the available literature on bictegravir interactions and pharmacokinetic parameters was performed. A dose separation strategy was utilized to design a regimen that maximized separation of doses of supplements from doses of bictegravir/emtricitabine/tenofovir alafenamide while minimizing interaction potential. At follow-up 8 weeks after regimen initiation, the HIV viral load was undetectable (<40 copies/mL) and the CD4 cell count had increased to 821 cells/mm3. CONCLUSION: Integrase strand transferase inhibitor interactions with polyvalent cations in nutritional supplements can be avoided or mitigated with attention to timing of each dose and optimizing separation strategies. This case report shows the potential for alleviating such interactions through optimal dose scheduling.
