O015 Establishment of a monitoring service for men who have sex with men (MSM) taking generic co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) as pre-exposure prophylaxis (PrEP) against HIV infection. (30th June 2016)

• Record Type: Journal Article
• Authors: Nwokolo, Nneka; Wang, Xinzhu; Boffito, Marta; McClure, Myra; Suchak, Tara; Whitlock, Gary
• Is Part Of: Sexually transmitted infections. Volume 92(2016)Supplement 1
• Page Start: A6
• Page End: A6
• Publication Date: 2016-06-30
• Subjects: Sexually transmitted diseases -- Periodicals; HIV infections -- Periodicals; 616.951005
• DOI: 10.1136/sextrans-2016-052718.14
• Languages: English
• ISSNs: 1368-4973

Abstract

Abstract : Background/introduction: Truvada® (TDF/FTC) PrEP taken daily or intermittently reduces HIV acquisition by over 86%. However, PrEP is only available privately in the UK, costing upwards of £400 for 30 tablets. Online generic TDF/FTC is significantly cheaper at £35-£50 for 30 tablets. There are, however, authenticity concerns about online medicines. Additionally, HIV infection should be excluded in individuals taking PrEP and baseline assessments of hepatitis B and renal function performed which may not occur with online PrEP. Since February 2016, we have provided assessment and therapeutic drug monitoring to individuals on generic TDF/FTC to ensure safety and medication integrity. Aim(s)/objectives: To review characteristics of individuals taking generic TDF/FTC. Methods: Service evaluation of individuals taking generic TDF/FTC attending a London sexual health service. Data on the first 44 patients were collected: demographics, HIV and renal function testing, hepatitis B status, baseline STIs, regimen, source of PrEP. Results: All MSM; mean age 41 years (28–73); 77% White; 33/44 (75%) on PrEP at time of attendance; all HIV antibody negative prior to commencement. Mean eGFR 81.5 ml/min, 65% had documented hepatitis B immunity. One STI (syphilis) was identified at baseline. 93% were taking daily PrEP and 86% obtained Cipla manufactured Tenvir-EM® from United Pharmacies. Tenofovir and FTC levels were measured in 18/44 (41%), all results demonstrating presence of adequate active compound. Discussion/conclusion: Numbers of individuals requiring monitoring on generic TDF/FTC are increasing. It is reassuring that so far, drug levels suggest appropriate quantities of tenofovir and FTC in Tenvir-EM®; however, more data are needed.