Low-level viraemia among people living with HIV in Nigeria: a retrospective longitudinal cohort study

Abstract

Background: HIV transmission can occur with a viral load of at least 200 copies per mL of blood and low-level viraemia can lead to virological failure; the threshold level at which risk for virological failure is conferred is uncertain. To better understand low-level viraemia prevalence and outcomes, we analysed retrospective longitudinal data from a large cohort of people living with HIV on antiretroviral therapy (ART) in Nigeria.

Methods: In this retrospective cohort study using previously collected longitudinal patient data, we estimated rates of virological suppression (≤50 copies per mL), low-level viraemia (51-999 copies per mL), virological non-suppression (≥1000 copies per mL), and virological failure (≥2 consecutive virological non-suppression results) among people living with HIV aged 18 years and older who initiated and received at least 24 weeks of ART at 1005 facilities in 18 Nigerian states. We analysed risk for low-level viraemia, virological non-suppression, and virological failure using log-binomial regression and mixed-effects logistic regression.

Findings: At first viral load for 402 668 patients during 2016-21, low-level viraemia was present in 64 480 (16·0%) individuals and virological non-suppression occurred in 46 051 (11·4%) individuals. Patients with low-level viraemia had increased risk of virological failure (adjusted relative risk 2·20, 95% CI 1·98-2·43; p<0·0001). Compared with patients with virological suppression, patients with low-level viraemia, even at 51-199 copies per mL, had increased odds of low-level viraemia and virological non-suppression at next viral load; patients on optimised ART (ie, integrase strand transfer inhibitors) had lower odds than those on non-integrase strand transfer inhibitors for the same low-level viraemia range (eg, viral load ≥1000 copies per mL following viral load 400-999 copies per mL, integrase strand transfer inhibitor: odds ratio 1·96, 95% CI 1·79-2·13; p<0·0001; non-integrase strand transfer inhibitor: 3·21, 2·90-3·55; p<0·0001).

Interpretation: Patients with low-level viraemia had increased risk of virological non-suppression and failure. Programmes should revise monitoring benchmarks and targets from less than 1000 copies per mL to less than 50 copies per mL to strengthen clinical outcomes and track progress to epidemic control.

Funding: None.

Figure 1:. Study profile

Exclusion criteria were applied independently and patients could have met several exclusion criteria; therefore disaggregated exclusion criteria numbers do not sum to the total number of patients excluded. ART=antiretroviral therapy. VLNS=virological non-suppression. *Non-standard regimens include ART combinations other than nucleos(t)ide reverse transcriptase inhibitor plus non-nucleoside reverse transcriptase inhibitor, nucleos(t)ide reverse transcriptase inhibitor plus integrase strand transfer inhibitor, or nucleos(t)ide reverse transcriptase inhibitor plus protease inhibitor. Insufficiently potent ART denotes monotherapy or dual therapy.

Figure 2:. Prevalence of low-level viraemia (LLV) and virological non-suppression* 2016–2021, by calendar year (A) and years on ART (B)

ART=antiretroviral therapy. VLNS=viral load non-suppression. VS=virological suppression. *Prevalence was calculated using the first viral load result of each year to avoid bias from repeated measurements within the same year.