Investigation of emtricitabine-associated skin pigmentation and safety in HIV-1-infected Japanese patients.

Abstract

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.

• Authors: Takuma Shirasaka, Taketsugu Tadokoro, Yasuyuki Yamamoto, Katsuyuki Fukutake, Yukihiko Kato, Takashi Odawara, Tetsuya Nakamura, Atsushi Ajisawa, Masayoshi Negishi
• Journal: Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy (J Infect Chemother) Vol. 17 Issue 5 Pg. 602-8 (Oct 2011) ISSN: 1437-7780 [Electronic] Netherlands
• PMID: 21369776 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Anti-HIV Agents
• Deoxycytidine
• Emtricitabine

Topics

• Adult
• Aged
• Analysis of Variance
• Anti-HIV Agents (adverse effects, therapeutic use)
• Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
• Dermoscopy
• Emtricitabine
• Female
• HIV Infections (drug therapy, epidemiology)
• Hand
• Humans
• Incidence
• Japan
• Lentigo (chemically induced, pathology)
• Male
• Middle Aged
• Pigmentation Disorders (chemically induced, pathology)
• Prospective Studies
• Skin (drug effects, pathology)
• Skin Pigmentation (drug effects)
• Viral Load