376 The Role of Antiretroviral Treatment Patenting on Consumer Pricing: Declining Viral Suppression and Treatment Non-Adherence Among HIV Patients in Los Angeles County

Abstract

OBJECTIVES/GOALS: Antiretroviral treatments (ART) suppress retroviruses, like the human immunodeficiency virus (HIV). The goal is to understand how antiretroviral drug patents contribute to overpriced HIV medications, thereby causing cost-related treatment non-adherence and inhibiting viral suppression. METHODS/STUDY POPULATION: Currently, HIV affects 57,700 individuals in Los Angeles County (LAC). Data was compiled from Centers for Disease Control and Prevention (CDC), hiv.gov, lacounty.HIV, publichealth.lacounty.gov, and the U.S. Patent and Trade Office. A review of existing literature examined the role of ART patents on cost-related non-adherence and declining viral suppression on individuals living with HIV in LAC. Lastly, a comparison of HIV medication prices of expired and non-expired patents was conducted, indicating the effects of undue extensions of market exclusivity on ART regimen pricing, and how this affects treatment adherence. RESULTS/ANTICIPATED RESULTS: Of the ten ARTs examined, four had expired patents and six had active patents. Those with active patents cost more than those with inactive patents because active patent status prevents price reductions. Patent strategies–pay-for-delay settlements and patent evergreening–unduly extend market exclusivity, keeping ART at prohibitive costs and preventing generic competition. Individuals facing cost-related non-adherence were less virally suppressed at their last viral load test (64%) and at all tests during the year (54%). Thus, over-patented ARTs increase treatment prices, causing cost-related non-adherence to ART regimens. The implications include disease progression and less viral suppression. DISCUSSION/SIGNIFICANCE: The U.S. has the highest ART prices, yet the lowest rate of HIV viral suppression (54%) among all well-resourced countries. Undue extensions of market exclusivity cause ARTs to remain at prohibitive costs, preventing some patients from affording ART treatments, minimizing their viral suppression.