A public health value-based healthcare paradigm for HIV.

BACKGROUND: HIV patients face considerable acute and chronic healthcare needs and battling the HIV epidemic remains of the utmost importance. By focusing on health outcomes in relation to the cost of care, value-based healthcare (VBHC) proposes a strategy to optimize quality of care and cost-efficiency. Its implementation may provide an answer to the increasing pressure to optimize spending in healthcare while improving patient outcomes. This paper describes a pragmatic value-based healthcare framework for HIV care. METHODS: A value-based HIV healthcare framework was developed during a series of roundtable discussions bringing together 16 clinical stakeholder representatives from the Belgian HIV reference centers and 2 VBHC specialists. Each round of discussions was focused on a central question translating a concept or idea to the next level of practical implementation: 1) how can VBHC principles be translated into value-based HIV care drivers; 2) how can these value-based HIV care divers be translated into value-based care objectives and activities; and 3) how can value-based HIV care objectives and activities be translated into value-based care indicators. Value drivers were linked to concrete objectives and activities using a logical framework approach. Finally, specific, measurable, and acceptable structure, process and outcomes indicators were defined to complement the framework. RESULTS: Our framework identifies 4 core value areas where HIV care would benefit most from improvements: Prevention, improvement of the cascade of care, providing patient-centered HIV care and sustaining a state-of-the-art HIV disease management context. These 4 core value areas were translated into 12 actionable core value objectives. For each objective, example activities were proposed. Indicators are suggested for each level of the framework (outcome indicators for value areas and objectives, process indicators for suggested activities). CONCLUSIONS: This framework approach outlines how to define a patient- and public health centered value-based HIV care paradigm. It proposes how to translate core value drivers to practical objectives and activities and suggests defining indicators that can be used to track and improve the framework's implementation in practice.

Model informed dosing of hydroxycholoroquine in COVID-19 patients: Learnings from the recent experience, remaining uncertainties and gaps.

AIMS: In the absence of a commonly agreed dosing protocol based on pharmacokinetic (PK) considerations, the dose and treatment duration for hydroxychloroquine (HCQ) in COVID-19 disease currently vary across national guidelines and clinical study protocols. We have used a model-based approach to explore the relative impact of alternative dosing regimens proposed in different dosing protocols for hydroxychloroquine in COVID-19. METHODS: We compared different PK exposures using Monte Carlo simulations based on a previously published population pharmacokinetic model in patients with rheumatoid arthritis, externally validated using both independent data in lupus erythematous patients and recent data in French COVID-19 patients. Clinical efficacy and safety information from COVID-19 patients treated with HCQ were used to contextualize and assess the actual clinical value of the model predictions. RESULTS: Literature and observed clinical data confirm the variability in clinical responses in COVID-19 when treated with the same fixed doses. Confounding factors were identified that should be taken into account for dose recommendation. For 80% of patients, doses higher than 800 mg day on day 1 followed by 600 mg daily on following days might not be needed for being cured. Limited adverse drug reactions have been reported so far for this dosing regimen, most often confounded by co-medications, comorbidities or underlying COVID-19 disease effects. CONCLUSION: Our results were clear, indicating the unmet need for characterization of target PK exposures to inform HCQ dosing optimization in COVID-19. Dosing optimization for HCQ in COVID-19 is still an unmet need. Efforts in this sense are a prerequisite for best benefit/risk balance.

Adherence to HIV post-exposure prophylaxis: A multivariate regression analysis of a 5 years prospective cohort.

BACKGROUND: Non-occupational post-exposure prophylaxis (nPEP) is a recommended public health intervention after a sexual or percutaneous exposure to human immunodeficiency virus (HIV). METHODS: We conducted a prospective observational study recording consultations for nPEP at a reference HIV center in Brussels, Belgium from January 2011 to December 2015. We recorded attendance to follow-up, reported completion of nPEP and pharmacy records to measure adherence. Multivariate logistic regressions were performed to identify independent risk factors for adherence to nPEP and attendance to first follow-up visit at the STI clinic. FINDINGS: Among 1881 patients receiving nPEP, 66.4% had a documented completion of a 28-day course of nPEP and 87.3% attended their first follow-up clinic visit. MSM (OR, 1.40; 95%CI, 1.04-1.90), being a native Belgian (OR, 1.50; 95%CI, 1.18-1.90), older age (OR, 1.02; 95%CI, 1.01-1.04), being a sexual assault survivor (OR, 0.59; 95%CI, 0.38-0.91), having had a previous nPEP treatment (OR, 1.44; 95%CI, 1.02-2.02), consultation during daytime (OR, 1.35; 95%CI, 1.07-1.70) and benefitting from a health insurance (OR, 2.11; 95%CI, 1.58-2.89) were significant independent predictors for adherence to nPEP. Patients whose initial treatment was AZT/3TC/IDV/r had similar adherence than patients on d4T/3TC/LPV/r (OR, 0.898; 95%CI, 0.68-1.20). INTERPRETATION: Multiple independent risk factors for nPEP retention into care and adherence are present at treatment initiation and might be targeted by tailored interventions. Sexual assault victims are overexposed to deleterious consequences of the lack of health insurance on compliance.