METHODS: We determined the frequency of opportunistic infections and tuberculosis in patients receiving vedolizumab in phase 3 clinical trials and post-marketing settings. We also evaluated adverse events reported in the post-marketing setting in patients with a history of or concurrent hepatitis B/C virus infection.
RESULTS: The incidence of opportunistic infections in patients receiving vedolizumab was 0.7 (GEMINI 1 and 2 clinical trials) and 1.0 (long-term safety study) per 100 patient-years, with 217 events reported in approximately 114,071 patient-years of exposure (post-marketing setting). Most opportunistic infections were nonserious and the majority of patients continued treatment with vedolizumab. Clostridium difficile was the most commonly reported infection, with an incidence rate of 0.5 per 100 patient-years (clinical trials). Tuberculosis was reported at 0.1 per 100 patient-years (clinical trials), with 7 events in the post-marketing setting. No tuberculosis-related deaths were reported in either setting. No cases of progressive multifocal leukoencephalopathy were reported. In 29 patients with a history of or concurrent hepatitis B/C infection in the post-marketing setting, no viral reactivation was observed.
CONCLUSIONS: Clinical trials and post-marketing data showed that the rate of serious opportunistic infections in patients receiving vedolizumab was low and most patients could continue vedolizumab treatment. The frequency of tuberculosis infection was also low and no hepatitis B/C viral reactivation was reported.
METHODS: A retrospective review of all cutaneous manifestations of HIV-infected patients with skin biopsy-proven histopathological confirmation, treated in the University of Malaya Medical Centre, from 2016 till 2018, was performed. Clinical characteristics and histopathological correlation of these patients were reviewed.
RESULTS: A total of 38 cases were included where the median age was 40.5 (interquartile range (IQR) 13.3). The median duration of HIV diagnosis to the development of skin disease was 3 years (IQR 7.8). Majority of our patients were male (89.5%, n = 34), and the commonest mode of transmission is men who have sex with men (36.8%, n = 14). Most patients (92.1%, n = 35) had Acquired Immunodeficiency Syndrome when they presented with skin diseases, predominantly non-infectious types (51.4%, n = 19). Commonest skin diseases include eczema (n = 7) and pruritic papular eruption of HIV (n = 6). Papules and plaques were the commonest morphology for both infectious and non-infectious skin diseases. Duration of HIV diagnosis (P = 0.018) and non-compliance to Highly Active Antiretroviral Therapy (HAART) (P = 0.014) were significantly associated with the development of non-infectious skin diseases. Overall, clinicopathological concordance was 84.2% in our centre.
CONCLUSION: A wide spectrum of cutaneous diseases can occur in HIV patients depending on the degree of immunosuppression. skin biopsy along with appropriate stains, and microbiological cultures are important in helping clinicians clinch the right diagnosis.