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Investigational integrase inhibitor shows promise in trials
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A once-daily HIV integrase inhibitor is showing promise in phase 3 clinical trials, according to study findings published online.
Pedro Cahn, MD, PhD, of Fundacion Huesped in Buenos Aires, and other researchers involved in the SAILING study reported on 715 patients with HIV-1 infection who were failing antiretroviral therapy. Patients in the 48-week trial were randomly assigned 50 mg dolutegravir (GlaxoSmithKline) or 400 mg raltegravir (Isentress, Merck). The patients also received another therapy that was selected by the investigator.
Seventy-one percent of the patients in the dolutegravir group had a viral load lower than 50 copies/mL at 11 months of follow-up vs. 64% of participants in the raltegravir group. Also, resistance mutations and virologic failure were less common in the dolutegravir group, Cahn and colleagues reported.
In an accompanying editorial on the findings, researchers said the “appearance of dolutegravir should help reinvigorate research to help us to extract maximum value from the available drugs in support of long and healthy lives for people living with HIV.”
Disclosure: Cahn is a member of the WHO Guidelines Panel and the IAS-USA Guidelines Panel; has served on advisory boards for GlaxoSmithKline (ViiV), Merck, Pfizer, Gilead Sciences and Tibotec (Janssen) Therapeutics. He also served as an investigator for Abbott and Avexa, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Merck, Pfizer, Pharmasset, Roche Laboratories and Tibotec Therapeutics.
Perspective
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Paul A. Volberding, MD
Compared with the first generations of potent antiretroviral drugs, today’s agents are typically convenient to administer and free of serious toxicities, while being even more potent in inhibiting HIV replication. As a result, combinations of these drugs are ever more effective, with the vast majority of patients able to continue a regimen for very prolonged periods.
HIV integrate inhibitors are, as a drug class, characterized by high potency, rapid effects on measured plasma viral load and by minimal side effects. The first approved integrate inhibitor, raltegravir, is taken twice daily, while a newer member of this family, dolutegravir, is used once daily. The current report provides data from a prospective randomized clinical trial directly comparing these two drugs with other “background” drugs in individuals who had received other HIV treatments prior to this trial. The study found that both drugs were well tolerated but that the newer drug, dolutegravir, had a statistical superiority in HIV suppression. That benefit and the convenience of once-daily administration should make the new drug a useful option once it is, as expected, approved for HIV treatment.
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