FDA Approves New Once-Daily Treatment Option for HIV

By Wheeler, Kathryn | Drug Topics, December 2013 | Go to article overview

FDA Approves New Once-Daily Treatment Option for HIV


Wheeler, Kathryn, Drug Topics


NEW DRUG REVIEW

FDA approved dolutegravir (Tivicay, GlaxoSmithKline) in August 2013, for treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and weighing at least 40 kg, as part of combination antiretroviral therapy. Dolutegravir is an integrase strand transfer inhibitor (INSTI), which prohibits HIV-1 virus multiplication by interfering with HIV integrase, an enzyme required for viral replication. Dolutegravir is indicated for treatment of both INSTI-naive and INSTI-experienced adults, but is indicated for pediatric patients only if they are INSTT-naive. A new, once-daily option, dolutegravir may allow improved personalization of a patient's medication regimen.

Efficacy

FDA based its approval of dolutegravir for adults on four Phase m trials. In the studies, patients received dolutegravir or raltegravir, plus additional appropriate antiretroviral therapy.

TWo trials, SPRING-2 (n=822) and SINGLE (n=833) evaluated once-daily dolutegravir in INSTI treatment-naive patients. By 48 weeks, dolutegravir demonstrated statistically equal or superior virological suppression, achieving <50 copies/mL of HIV-1 RNA in participants, vs. raltegravir comparison regimens.

Use of dolutegravir in treatment-experienced patients was investigated in two studies, SAILING (n=719) and VIKING-3 (n=183). In both studies, the addition of dolutegravir to patients' background therapy improved virologie suppression at 24 weeks. VIKING-3 investigated the use of twice-daily dolutegravir in patients with multidrug-resistant infection, including resistance to other approved integrase inhibitors (raltegravir, elvitegravir). Subjects with INSTI resistance Q148 and two or more additional INSTI resistance substitutions demonstrated poor virologie response with the addition of twice-daily dolutegravir treatment to their background regimen.

FDA based its approval for use of dolutegravir as part of combination antiretroviral therapy in pediatric patients ¿12 years of age and weighing a minimum of 40 kg on a 24-week open-label trial of INSTI-naive participants. Findings were similar to those for adults: At week 24, 70% of participants taking dolutegravir demonstrated viral suppression by achieving a viral load of <50 copies/mL, with improved CD4+ cell count compared to baseline levels. Dolutegravir therapy has not been studied in INSTI treatment-experienced pediatric patients and is not indicated for this patient population. …

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FDA Approves New Once-Daily Treatment Option for HIV
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