Kenya has begun a year-long study to investigate why some patients on dolutegravir, the world’s leading HIV drug, are failing to achieve viral suppression. The research aims to determine whether these failures are primarily due to missed doses and adherence issues or if the virus is developing mutations that decrease the drug’s effectiveness.
Since the World Health Organization (WHO) recommended dolutegravir as the preferred first-line treatment in 2018, Kenya and other African countries have rapidly adopted the drug. Known for its potency and fewer side effects compared to older regimens, dolutegravir has become central to Kenya’s national HIV program.
The Ndovu study, supported by the Ministry of Health and the Gates Foundation, will enroll 6,600 participants across eight treatment sites in Kenya, Mozambique, Tanzania, and Lesotho. Recruitment began in March and will conclude in December. The study will feature a randomized controlled trial (RCT) involving 362 participants with significant drug-resistant mutations, who will either switch to ritonavir-boosted darunavir or continue with dolutegravir for 12 months.
Initial results from the cohort are expected in March 2026, with findings from the RCT anticipated in February 2027. The primary goal is to assess how many participants achieve a viral load below 200 copies by the end of the study.
Recent reports have raised alarms about resistance to dolutegravir in Kenya and neighboring countries. The WHO has noted that resistance rates among treatment-experienced patients can range from 4% to 20%. In Kenya, surveillance data indicate resistance prevalence of up to 22.6% among patients on dolutegravir.
Dr. Meg Doherty from the WHO emphasized the need for increased vigilance and enhanced HIV care delivery. The Ndovu study aims to provide crucial evidence for managing cases of dolutegravir failure and determining whether a switch to protease inhibitors is warranted.
Current Kenyan guidelines recommend switching patients with treatment failure to a protease inhibitor regimen without conducting resistance testing. The Ndovu study challenges this approach, highlighting the distinction between treatment failure—often due to missed doses or interactions—and actual drug resistance, which involves mutations in the virus.
As Kenya investigates the intricacies of dolutegravir treatment failures, the Ndovu study has the potential to reshape future HIV management strategies in the country and across Africa. The findings will inform national guidelines and enhance the understanding of drug resistance in HIV care.
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