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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 46-year-old man developed leucocytoclastic cutaneous vasculitis during treatment with dolutegravir [dose and route not stated].
The man, who had been diagnosed with HIV infection in 2007, started receiving antiretroviral therapy with once daily dolutegravir and emtricitabine/tenofovir [tenofiovir/emtricitabine]. Three days following dolutegravir initiation, he developed leucocytoclastic cutaneous vasculitis, which was confirmed by a skin biopsy. The leucocytoclastic cutaneous vasculitis was associated with normocytic normochromic anaemia and high fever.
The man discontinued the dolutegravir and emtricitabine/tenofovir antiretroviral therapy. He was treated with antihistamines. Over the following one month, his rash subsided but he had persistent low fever and night sweats due to a high HIV viral load. Thereafter, he was started emtricitabine/tenofovir and darunavir/ritonavir. He tolerated the treatment well with resolution of the night sweats and viral suppression.
Author comment: "To describe a case of vasculitis occurring in the setting of dolutegravir initiation."
- Cornelisse VJ. Case study: Cutaneous vasculitis in the setting of dolutegravir initiation. Antiviral Therapy 22 (Suppl. 1): A72 abstr. P39, Jan 2017 [abstract] - AustraliaGoogle Scholar