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Investigation of emtricitabine-associated skin pigmentation and safety in HIV-1-infected Japanese patients.
MedLine Citation:
PMID:  21369776     Owner:  NLM     Status:  Publisher    
Emtricitabine (FTC) has been reported to cause skin pigmentation (SP), and the incidence of SP associated with FTC varied with ethnicity, with a higher rate in African-American patients (8%). We assessed the incidence of SP in Japanese HIV-1-infected patients receiving combination antiretroviral therapy (cART) with FTC for a period of 48 weeks and confirmed new findings of FTC-associated SP, including pathological characteristics. This was a multicenter, prospective, longitudinal non-randomized study. We evaluated the appearance of SP at 48 weeks as the primary endpoint in 155 Japanese patients, and secondary endpoints included the characteristics of the SP (location, color tone, size, and progression). Six cases (3.9%) of SP occurred at a median of 124 days (range: 7-259 days) within 48 weeks. The SP looked like an isolated dark spot, 1-2 mm in diameter, mainly on the hands and/or feet. The severity of all the SPs was mild. Each SP had disappeared or faded at a median of 112 days (range: 28-315 days) with continued FTC. FTC-associated SP was considered to be lentigo simplex by dermatoscopy and pathological appearance. In summary, the incidence of FTC-associated SP in Japanese patients was 3.9%, and was comparable to the previously reported incidence in Asian patients (4%). FTC-associated SP was not associated with any clinically significant symptoms and has little clinical significance.
Takuma Shirasaka; Taketsugu Tadokoro; Yasuyuki Yamamoto; Katsuyuki Fukutake; Yukihiko Kato; Takashi Odawara; Tetsuya Nakamura; Atsushi Ajisawa; Masayoshi Negishi
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-3
Journal Detail:
Title:  Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy     Volume:  -     ISSN:  1437-7780     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9608375     Medline TA:  J Infect Chemother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
AIDS Medical Center, Osaka National Hospital, National Health Organization, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan,
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