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ViiV Healthcare Announces FDA Approval of Selzentry (maraviroc) for Use in Children and Adolescents Living With HIV

Research Triangle Park, NC — On November 4, 2016, ViiV Healthcare received approval from the U.S. Food and Drug Administration (FDA) to market Selzentry for the treatment of only CCR5-tropic HIV-1 infection, in combination with other antiretroviral agents, in pediatric patients 2 years of age or older who weigh at least 10 kilograms (kg).[1] Selzentry is a first-in-class CCR5 co-receptor antagonist designed to inhibit entry into the immune system’s CD4+ T-cells by CCR5-tropic HIV-1. Selzentry is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.

In addition to the 150 milligram (mg) and 300 mg Selzentry tablets currently available, new 25 mg and 75 mg tablets and a 20 mg per milliliter (mL)oral solution will be available in January 2017. The dose of Selzentry in pediatric patients 2 years of age and older should be based on the patient’s body weight and the drug interaction potential for other medications the patient is currently taking.

This approval is based on results of an open-label trial (Trial A4001031) in which 103 treatment-experienced pediatric patients infected with only CCR5-tropic HIV-1, who were 2 to 18 years of age and weighed at least 10 kg, received Selzentry twice daily in combination with optimized background therapy (OBT). At 48 weeks, 48 percent of patients treated with Selzentry and OBT achieved plasma HIV-1 RNA less than 48 copies per mL and 65 percent of patients achieved plasma HIV-1 RNA less than 400 copies per mL. The mean CD4+ T-cell count increase from baseline to Week 48 was 247 cells per cubic millimeter.

In the study, each patient’s dose of Selzentry was based on body surface area and whether he or she was receiving potent cytochrome P450 3A inhibitors and/or inducers.The median duration of therapy with Selzentry was 131 weeks with 72 percent of patients receiving study treatment for more than 48 weeks and 62 percent receiving maraviroc for 96 weeks.

Results of the study showed that among the 103 pediatric patients included, the safety profile of Selzentry through 96 weeks was similar to that for adults. Most of the reported adverse events (AEs) were mild to moderate; severe adverse events occurred in 2 percent of subjects. The most common AEs reported with twice-daily therapy with Selzentry were vomiting (12 percent), abdominal pain (4 percent), diarrhea (4 percent), nausea (4 percent) and dizziness (3 percent). Through 48 weeks, Selzentry-related gastrointestinal AEs, including nausea, vomiting, diarrhea, constipation and abdominal pain/cramps, were observed more commonly in patients who received the Selzentry oral solution (21 percent) compared with those who received Selzentry tablets (16 percent). Three patients (3 percent) discontinued due to AEs.

“Children and adolescents continue to need new options in HIV therapy, which we at ViiV Healthcare are committed to addressing,” said Bill Collier, head of ViiV Healthcare, North America. “We recognize that HIV disproportionately impacts certain populations, including youth. ViiV Healthcare is dedicated to reducing disparities and helping improve the lives of all people living with HIV. We want to ensure no one is left behind.”

According to estimates in the U.S., 2,037 people 19 years of age and younger became infected with HIV in 2014, and 8,952 in this age group were living with HIV in 2013.[2]

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company and its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

About Selzentry

Selzentry (maraviroc) is an oral CCR5 coreceptor antagonist. It is approved in the U.S. for the treatment of only CCR5-tropic HIV-1 infection, in combination with other antiretroviral agents, in adults and pediatric patients 2 years of age and older who weigh at least 10 kg. Selzentry is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1. Selzentry is known as Celsentri® outside of the U.S.

[1] SELZENTRY® (maraviroc) U.S. prescribing information. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Selzentry/pdf/SELZENTRY-PI-MG.PDF
[2] Centers for Disease Control and Prevention. HIV Surveillance Report, 2014; vol. 26. Published November 2015. Accessed November 4, 2016. Available at: http://www.cdc.gov/hiv/library/reports/surveillance/.

Source: ViiV Healthcare

Posted: November 2016

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