HIV Drug Resistance to Dolutegravir Among Adults Investigated for Antiretroviral Treatment Failure in Malawi: A 2023 National Cross-Sectional Survey

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INTRODUCTION: In Malawi, 95.6% of adult people living with HIV (PLHIV) on antiretroviral therapy (ART) use dolutegravir-based regimens (DBR), however, prevalence of dolutegravir resistance is unknown. We conducted a national HIV drug resistance (HIVDR) survey in adults on DBR with high viral load (VL) results after intensive adherence counseling (IAC). METHODS: The survey was conducted between July 2022 and February 2023. We randomly selected 18 from 25 highest volume ART clinics in Malawi. We enrolled consenting adults (≥15 years), on DBR for ≥9 months, when returning for follow-up VL testing after a previous high VL (≥1000 copies/mL) and completing IAC. Enrolled PLHIV submitted plasma samples for VL testing and those with VL ≥1000 copies/mL (confirmed virologic failure) underwent genotypic HIVDR testing. Stanford University HIVDR Database (version 9.5) was used to interpret results. We present weighted prevalence of clinically significant HIV drug resistance (Stanford levels 3-5), accounting for correlation within clinics. RESULTS: Among 213 participants with confirmed virologic failure, 212 samples were successfully genotyped for protease, reverse transcriptase, and integrase. Prevalence of drug resistance mutations (DRMs) to nucleotide reverse-transcriptase inhibitors was 22.6% (95% CI: 17.4% to 27.8%), to non-nucleoside reverse-transcriptase inhibitors 55.1% (95% CI 48.2% to 62.1%), and to protease inhibitors 4.9% (95% CI 1.3% to 8.5%). Prevalence of major dolutegravir DRMs was 8.5% (95% CI 5.3% to 11.9%). DTG DRMs identified included G118R (8), E138K (8), R263K/A (5), Q148R (3), and T66A/I/V (3). CONCLUSIONS: Among adult Malawians on DBRs with confirmed virologic failure, 1-in-12 had dolutegravir resistance. Adherence interventions likely help achieve resuppression, making protease inhibitor-based regimen switch unnecessary for most patients with high VL.

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