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.
OBJECTIVE
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.
Health Economics, United BioSource Corporation, Bethesda, Maryland 20814, USA. lael.cragin@unitedbiosource.com
Lael
L
Cragin
Feng
F
Pan
Siyang
S
Peng
Jonathan M
JM
Zenilman
Julia
J
Green
Cynthia
C
Doucet
Donald B
DB
Chalfin
Greg
G
de Lissovoy
D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D003362:Cost-Benefit Analysis; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D019057:Quality-Adjusted Life Years
D015483:HIV Antibodies; D016655:HIV Core Protein p24