Cost-effectiveness of a fourth-generation combination immunoassay for human immunodeficiency virus (HIV) antibody and p24 antigen for the detection of HIV infections in the United States

Purpose: The US Food and Drug Administration recently approved the first 4th-generation HIV test. This study evaluated the cost-effectiveness of the 4th-generation assay versus a 3rd-generation test in screening for HIV infections in the United States. Methods: An exploratory microsimulation model was developed that follows hypothetical individuals and simulates the course of HIV/AIDS, treatment with highly active antiretroviral therapy, and transmissions. Results: With a 1% HIV prevalence, screening 1.5 million individuals with the 4th-versus 3rd-generation assay resulted in detection of 266 additional HIV cases at an incremental cost per additional HIV case detected of $63,763, an additional 489 life years and 395 quality-adjusted life years (QALYs), and 26 HIV transmissions prevented. Although lifetime costs were increased by $33.6 million, the incremental cost/QALY gained was $85,206. The 4th-generation test was more cost-effective in high incidence settings. The number needed to screen to detect one additional HIV case was 5,635. Conclusions: Screening using the 4th-generation assay may be cost-effective for HIV detection in appropriate settings, resulting in increased case identification, fewer transmissions, extended life, and increased quality of life. With early and accurate detection, this 4th-generation test may provide a suitable alternative to current 3rd-generation tests.