DOR/ISL for HIV

This trial explores a new daily pill combination for individuals with HIV-1 who have not yet started treatment. Researchers aim to determine if this new combination works as well as or better than an existing HIV treatment. Participants will be divided into two groups, receiving either the new pill, Doravirine/Islatravir (DOR/ISL), or the existing treatment, Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF). Their progress will be compared over time. Individuals diagnosed with HIV-1 who have not used HIV medication for more than 10 days are suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a significant advancement in HIV treatment.

The trial does not specify if you need to stop taking your current medications, but you cannot take certain immune system drugs or participate in other clinical studies during the trial. It's best to discuss your specific medications with the study team.

Research has shown that the combination of doravirine and islatravir (DOR/ISL) is generally well-tolerated. Studies have found that DOR/ISL causes only minor changes in weight and body shape and does not significantly affect cholesterol levels. Thus, the treatment is unlikely to cause major side effects related to weight or cholesterol. Additionally, DOR/ISL has a safety profile similar to other HIV-1 treatments, indicating it does not cause more side effects than other common options. Overall, the evidence supports that DOR/ISL is safe for people with HIV-1.¹²³⁴⁵

Researchers are excited about Doravirine/Islatravir (DOR/ISL) for HIV treatment because it offers a novel mechanism of action combining two active ingredients. Unlike many standard HIV treatments like Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), DOR/ISL incorporates Islatravir, a new nucleoside reverse transcriptase translocation inhibitor, which could potentially improve viral suppression. This combination might also simplify regimens with a once-daily, single-tablet formula, making it easier for patients to adhere to their treatment. These features hold the promise of improved patient outcomes and could represent a significant advancement in HIV care.

Research has shown that the combination of doravirine and islatravir (DOR/ISL), which participants in this trial may receive, effectively treats HIV-1. In one study, 85.7% of people taking DOR/ISL experienced a significant drop in their HIV levels from Day 1 to Day 8, while none in the placebo group did. By Week 48, 91.5% of those on DOR/ISL maintained very low HIV levels, similar to those on the comparison treatment. In this trial, another group will receive bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), which has been found to be just as effective as DOR/ISL in controlling the virus. These results highlight DOR/ISL's potential as a strong option for managing HIV-1.¹²³⁴⁵