Risk of window period hepatitis-C infection in high infectious risk donors: systematic review and meta-analysis

Area of Science:

• Organ Transplantation
• Infectious Diseases
• Public Health

Background:

• The Organ Procurement and Transplantation Network (OPTN) classifies high infectious risk donors (HRDs) using criteria originally for HIV risk.
• These criteria are now applied to identify deceased donors at increased risk for window period (WP) hepatitis C virus (HCV) infection, despite not being designed for this purpose.
• The actual risk of WP HCV infection in HRDs remains unknown.

Purpose of the Study:

• To systematically review and quantify the incidence of WP HCV infection in HRD populations in the United States and Canada.
• To estimate the risk of WP HCV infection for different HRD categories.
• To assess the impact of nucleic acid testing (NAT) on reducing WP HCV risk.

Main Methods:

• Systematic review of 3476 abstracts to identify 37 eligible estimates of HCV incidence in HRD populations.
• Pooled HCV incidence data were derived to calculate WP infection risks.
• Risks were calculated using both ELISA and NAT for WP detection across various HRD categories.

Main Results:

• Estimated WP HCV infection risks varied significantly by HRD category, ranging from 0.027 to 32.4 per 10,000 donors by NAT.
• Injection drug users exhibited the highest risk (32.4/10,000 by NAT WP), followed by commercial sex workers and high-risk sexual behavior donors (12.3/10,000).
• Nucleic acid testing (NAT) demonstrated a tenfold reduction in WP risk across all assessed HRD categories compared to ELISA.

Conclusions:

• Current HRD criteria, while useful for HIV, may overestimate or underestimate WP HCV risk.
• Specific HRD categories, notably injection drug users, present a quantifiable risk for WP HCV infection.
• NAT significantly mitigates the risk of WP HCV transmission from HRDs, highlighting its importance in donor screening.