Drug Regimen For HIV Shows Non-Inferiority to Antiretroviral Therapies
These findings are shared as late-breaking data at the 32nd Conference on Retroviruses and Opportunistic Infections (CROI) being held in San Francisco, California.
Doravirine/islatravir (DOR/ISL [100mg/0.25mg]), a 2-drug therapy being investigated for adults with HIV infection, met the primary end point of success criterion for non-inferiority to the comparator antiretroviral therapies (ART) at 48 weeks, according to data from trials MK-8591A-052 (NCT05630755) and MK-8591A-051 (NCT05631093). These findings were shared as late-breaking data at the 32nd Conference on Retroviruses and Opportunistic Infections (CROI) being held in San Francisco, California.1
Investigators of MK-8591A-052 aimed to evaluate the antiretroviral activity of DOR/ISL compared with continued BIC/FTC/TAF at week 48. Image Credit: jarun011 | stock.adobe.com
“Despite the availability of multiple daily antiretroviral therapies, the needs of people living with HIV are evolving. Many people living with HIV are older and also managing comorbidities, making it important to have daily treatment options that can help meet each person’s unique health needs,” Chloe Orkin, dean for health care transformation at the Queen Mary University of London, United Kingdom, said in a news release.1 “I’m excited to see that DOR/ISL has potential as a new daily treatment option for people living with HIV who may benefit from this two-drug regimen.”
Investigators of MK-8591A-052 aimed to evaluate the antiretroviral activity of DOR/ISL compared with continued bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) at week 48 as well as evaluating the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF. Patients included in the trial were positive for HIV with plasma HIV-1 RNA of less than 50 copies/mL and were receiving BIC/FTC/TAF therapy.
Patients received DOR/ISL or BIC/FTC/TAF once daily for days 1 to week 144. Eligible participants continued or switched to DOR/ISL until week 240. The primary outcomes included the percentage of individuals with HIV RNA 50 copies/mL or more, the percentage of individuals who experienced adverse events, and the percentage of individuals who discontinued the intervention due to AEs at week 48.2
In MK-8591A-51, investigators evaluated the safety and tolerability of switching to DOR/ISL compared with continued baseline ART through week 48 and evaluated the antiretroviral activity of switching to DOR/ISL compared with continued baseline ART. Individuals included were HIV positive with plasma HIV-1 RNA of less than 50 copies/mL and were receiving continuous and stable oral 2-drug or 3-drug ART regimens with documented viral suppression for 3 or more consecutive months. The primary end points for this study were similar to the ones from study MK-8591A-052.3
The results for MK-8591A-052 showed that 1.5% of individuals who switched to DOR/ISL had a viral load of 50 copies/mL or more, compared with 0.6% for those on BIC/FTC/TAF. At week 48, 91.5% of patients who switched DOR/ISL maintained viral suppression compared with 94.2% on BIC/FTC/TAF. In MK-8591A-051, the results showed 1.4% of individuals on DOR/ISL had a viral load of 50 copies/mL or more compared with 4.9% on ART. Further, at the end of the 48 weeks, 95.6% of individuals who switched maintained viral suppression compared with 91.9% of patients who received ART, according to the news release.1
For safety, DOR/ISL was generally comparable to other ART regiments, including BIC/FTC/TAF. The mean percentage of total lymphocyte and CD4 counts were similar for the various regimens.1
