January 23, 2014
1 min read

Europe approves dolutegravir for HIV patients

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The European Commission recently approved the integrase inhibitor dolutegravir for use in combination therapy for the treatment of adults and adolescents with HIV, according to a news release.

Dolutegravir (Tivicay, ViiV Healthcare) was approved by the FDA in August for HIV treatment-naive and treatment-experienced patients in the United States. The European Commission’s decision was based on data from four phase 3 clinical trials in which 2,557 adults received dolutegravir or a comparator and a fifth study that included adolescents aged at least 12 years.

Dolutegravir combined with other antiretroviral drugs demonstrated greater efficacy than comparators — including efavirenz/emtricitabine/tenofovir (Atripla, Gilead Sciences) — in two of the clinical trials and was noninferior to raltegravir (Isentress, Merck) in a third study. Patients using dolutegravir had low rates of treatment discontinuation (1% to 3%). According to ViiV Healthcare, dolutegravir’s safety profile was based on pooled data from phase 2 and phase 3 clinical studies of 980 treatment-naïve patients, 357 patients who previously received treatment but were unexposed to integrase inhibitors and 234 patients with prior treatment failure that included an integrase inhibitor. Adverse events included diarrhea (16%), nausea (15%) and headache (14%). A single patient experienced a hypersensitivity reaction that included rash and a severe liver condition.

“HIV treatment is not a question of ‘one-size fits all’ — especially now that treatment is something that patients will live with for many years,” John Pottage, MD, chief medical officer of ViiV Healthcare, said in the release. “We continue to find measurable clinical differences among the treatments now available for use in combination therapy to combat HIV. Using the clinical data for Tivicay, doctors and people living with HIV can fully consider the effectiveness against the virus and the side effect profile that Tivicay may bring.”