People with HIV often face tough choices when their bodies show signs of resistance to common medicines. This study looked at a specific drug mix called dolutegravir plus lamivudine compared to a standard mix involving tenofovir or emtricitabine. The researchers focused on a group of 211 people who had never taken antiretroviral drugs before. These participants had specific genetic markers known as tRAMs that can signal resistance to older treatments. The main question was whether the new mix could still work effectively for them. After 48 weeks, the results showed that 85.7 percent of people on the new mix had their virus levels drop below the detection limit. In the standard mix group, 91.7 percent achieved the same goal. The difference between these numbers was not statistically significant, meaning the new mix performed just as well as the standard one for this specific group. The study did not report any safety issues or reasons for people to stop taking their medication during the trial. However, the researchers noted that they did not know the full resistance status of the participants until the study ended. This lack of information limits how broadly these results can be applied right now. The findings suggest that this specific drug combination is a viable option for people with these resistance markers, but more data is needed to confirm this for everyone.
Preplanned subanalysis shows comparable viral suppression rates for two dolutegravir-based regimens in antiretroviral-naive people with HIV at week 48New HIV drug combo shows similar virus control to standard care in people with resistance markers
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Key Takeaway
Viral suppression rates at week 48 were comparable between dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate with emtricitabine or lamivudine in participants with baseline resistance mutations.
This preplanned subanalysis examined a randomized, open-label, phase IV study involving 211 antiretroviral-naive individuals with HIV. The primary objective was to assess the proportion of participants achieving HIV-1 RNA levels below 50 copies per milliliter at week 48 specifically among those with baseline treatment resistance-associated mutations.
The intervention group received dolutegravir plus lamivudine, while the comparator group received dolutegravir plus tenofovir disoproxil fumarate with either emtricitabine or lamivudine. In the modified intent-to-treat analysis, 85.7% of participants in the intervention arm achieved viral suppression compared to 91.7% in the comparator arm. This difference was not statistically significant with a p-value of 0.67.
An observed analysis yielded similar results, showing 96.0% suppression for the intervention group versus 95.7% for the comparator. Additionally, within the intervention arm, suppression rates were 96.0% for those with mutations and 98.6% for those without, a difference that was also not statistically significant. Safety data were not reported in this specific subanalysis.
What this means for you:
This drug mix controlled the virus as well as the standard mix in people with resistance markers. More on HIV
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View Original Abstract ↓
BACKGROUND: Dolutegravir plus lamivudine (DTG+3TC) is a recommended first-line regimen for people with HIV (PWH), based on its efficacy and safety. However, pivotal trials excluded individuals with transmitted resistance-associated mutations (tRAMs), even when these did not affect regimen activity. The impact of such mutations on DTG+3TC efficacy remains unknown.
METHODS: This was a preplanned subanalysis of the D2ARLING trial, a randomized, open-label, phase IV study comparing DTG+3TC vs. DTG+tenofovir disoproxil fumarate with emtricitabine or lamivudine (DTG+TDF/XTC) in antiretroviral-naïve PWH without baseline resistance test results. Per protocol, baseline genotypic resistance testing was performed on day 1 but remained blinded throughout the study and was only unblinded after completion. Participants with successfully amplified samples were included. The primary endpoint was the proportion with HIV-1 RNA <50 copies/ml at week 48 among those with baseline tRAMs, using both mITT-exposed and observed analyses.
RESULTS: Among 211 participants (DTG+3TC: 104; DTG+TDF/XTC: 107), tRAMs were detected in 24.6%, mainly nonnucleoside reverse transcriptase inhibitors tRAMs. At week 48, viral suppression among participants with tRAMs was achieved in 85.7% (24/28) with DTG+3TC and 91.7% (22/24) with DTG+TDF/XTC ( P = 0.67; mITT). In the observed analysis, suppression rates were 96.0% and 95.7%, respectively. Within the DTG+3TC arm, week-48 suppression was 96.0% in participants in whom tRAMs were detected and 98.6% in those without detected tRAMs ( P = 0.45). No protocol-defined virological failures occurred in participants with tRAMs receiving DTG+3TC.
CONCLUSIONS: :DTG/3TC showed high efficacy in participants with tRAMs not affecting this regimen. The detection of such tRAMs did not compromise treatment outcomes in treatment-naïve individuals in this setting.
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