Studying Islatravir/Doravirine for HIV Treatment-Naïve and Experienced Patients

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“The combination of the 2 drugs was shown in this trial to be noninferior to the standard 3-drug regimen,” said Jean Michel Molina, MD, PhD, lead investigator of Merck’s islatravir/doravirine study.

Jean Michel Molina, MD, PhD, is a professor of infectious diseases at Paris University. He’s also the lead trial investigator of Merck’s islatravir/doravirine study.

The study included people living with HIV who had already achieved viral suppression with a baseline regimen. In the randomized study, half of the participants switched to the dual drug combination of islatravir/doravirine.

“It was interesting to see that after 48 weeks of follow-up, all participants in the islatravir/doravirine arm maintained a viral load below 50 copies per mL,” said Molina, “The rate of viral suppression was indeed noninferior to the rate we’ve seen in the control arm.”

Notably, no study patients failed. “In terms of effectiveness, the combination was great,” said Molina. “The only issue with the drug was we’ve seen a slight decline in CD4 cell count and lymphocyte counts in those receiving this dual combination.”

Molina pointed out that this decline in CD4 cell and lymphocyte counts was not associated with an increased risk of infection. However, a new trial with a lower dose of islatravir in combination with doravirine is underway to address these safety concerns. “The next step is to confirm that using a lower dose, the effectiveness is going to be as good, with better safety,” said Molina.

It has been proven that a lower dose of islatravir/doravirine is just as effective, but Molina explained this trial with a higher dose was intended to meet the needs of treatment-naïve patients as well as experienced patients with resistance mutations.

“People are interested to get new options,” Molina emphasized, “In particular with fewer drugs, with better long-term safety.”

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