395 Hindering Generic Antiretroviral Treatment Competition for Human Immunodeficiency Virus: Anti-Competitive Agreements and HIV Disease Management Concerns

OBJECTIVES/GOALS: To understand the implications of minimal HIV generic drug availability on long-term HIV disease management, including anti-competitive agreements and patent strategies that hinder (ART) competition and ART medication safety and efficacy improvement. METHODS/STUDY POPULATION: Individuals living with Human Immunodeficiency Virus (HIV) require sustained ART treatment. Despite excessive ART costs, the treatments use active ingredients known to be toxic, causing bone and renal impairments. A review of pharmaceutical legal cases examined the role of strategic patenting–product hopping–and anti-competitive agreements, which prevent generic competition and contribute to minimal ART improvement. A literature review explored the long-term safety effects of ART medications on HIV patients and disease management. A cost analysis of HIV disease management assessed the implications of using treatments with known toxins and their contribution to comorbidities and their effect on the cost of overall HIV disease management. RESULTS/ANTICIPATED RESULTS: Ongoing lawsuits of major ART medication manufacturers demonstrate the intentional agreements made to hinder generic competition, which is an inherently anti-competitive strategy. Thus, prices for ART medications remained high, causing treatment costs to be a significant barrier to treatment access. Further, the entry of a new ART, Tenofovir Alafenamide Fumarate (TAF), was delayed despite knowing the key active ingredient in Tenofovir Disoproxil Fumarate (TDF) was toxic to patients long-term. As a result, patients were more likely to experience comorbidities, significantly increasing the cost of HIV care. The average cost of HIV care without comorbidities is $30,312. However, HIV care is $46,000 for two comorbidities and about $219,000 for people with 11 or more. DISCUSSION/SIGNIFICANCE: Abuse of patent rights prevents more effective HIV medication and generic option development. Thus, HIV disease management is inhibited. The only method of HIV disease management is patient adherence to ARTs. Patients taking less effective medications increase the development of comorbidities from toxic treatments, magnifying the cost of HIV care.