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Impact of low-level viremia on clinical and virological outcomes in treated HIV-1-infected patients

Background:The goal of antiretroviral therapy (ART) is to reduce HIV-related morbidity and mortality by suppressing HIV replication. The prognostic value of persistent low-level viremia (LLV), particularly for clinical outcomes, is unknown. Objective:Assess the association of different levels of LLV with virological failure, AIDS event, and death among HIV-infected patients receiving combination ART. Methods:We analyzed data from 18 cohorts in Europe and North America, contributing to the ART Cohort Collaboration. Eligible patients achieved viral load below 50 copies/ml within 3–9 months after ART initiation. LLV50–199 was defined as two consecutive viral loads between 50 and 199 copies/ml and LLV200–499 as two consecutive viral loads between 50 and 499 copies/ml, with at least one between 200 and 499 copies/ml. We used Cox models to estimate the association of LLV with virological failure (two consecutive viral loads at least 500 copies/ml or one viral load at least 500 copies/ml, followed by a modification of ART) and AIDS event/death. Results:Among 17 902 patients, 624 (3.5%) experienced LLV50–199 and 482 (2.7%) LLV200–499. Median follow-up was 2.3 and 3.1 years for virological and clinical outcomes, respectively. There were 1903 virological failure, 532 AIDS events and 480 deaths. LLV200–499 was strongly associated with virological failure [adjusted hazard ratio (aHR) 3.97, 95% confidence interval (CI) 3.05–5.17]. LLV50–199 was weakly associated with virological failure (aHR 1.38, 95% CI 0.96–2.00). LLV50–199 and LLV200–499 were not associated with AIDS event/death (aHR 1.19, 95% CI 0.78–1.82; and aHR 1.11, 95% CI 0.72–1.71, respectively). Conclusion:LLV200–499 was strongly associated with virological failure, but not with AIDS event/death. Our results support the US guidelines, which define virological failure as a confirmed viral load above 200 copies/ml.