Virological impact of HIV drug-resistance testing in children, adolescents, and adults failing first-line ART in Tanzania

Abstract

Background

Prospective data on the effectiveness of resistance testing in informing treatment decisions and outcomes in with first-line failure in these settings is limited. This study aimed to assess the virological impact of HIV drug-resistance testing in patients with virological failure in Tanzania.

Methods

Participants were randomly assigned to either the control or the experimental group. In addition to the standard of care, patients in the experimental group had access to genotypic drug-resistance testing, information used during treatment change and were followed up at six-and 12-months to determine virological suppression.

Results

A total of 261 patients with a median age of 32 (14.7–44.7) years were enrolled. In the intention-to-treat analysis, at 6-months, suppression was achieved in 58 (42.3%; 95% CI, 34.1–50.1) experimental group patients versus 51 (41.1%; 95% CI, 32.5–49.8) control group patients, with a p-value of 0.4. At-12 months, suppression was achieved in 110 (80.3%; 95% CI, 73.6–87) experimental patients versus 99 (79.8%; 95% CI, 72.8–86.9) control patients, with a P-value of 0.5. In the per-protocol analysis, at 6-months, suppression was observed in 38.46% (95% CI, 27.6–49.3) experimental patients versus 38.6% (95% CI, 26.0–51.2) control patients, with a P-value of 0.5. At 12-months, suppression was observed in 79.49% (95% CI, 70.5–88.5) of experimental patients versus 75.44% (95% CI, 64.3–86.6) of control patients, with a P-value of 0.3.

Conclusion

Conducting HIV drug-resistance testing, and switch to individualised second-line regimens did not significantly improve virological suppression in patients experiencing first-line ART failure in Tanzania.