A sexual health clinic in central London that offered to
test drug levels in users of tenofovir/emtricitabine pre-exposure prophylaxis
(PrEP) who had bought it online found adequate levels of both drugs in their
blood, and no sample suggesting counterfeit drugs.
Nneka Nwokolo of the 56 Dean
Street clinic in Soho, London told the International Congress on Drug
Therapy in HIV Infection (HIV Glasgow) that an
increasing number of people coming for HIV and sexually transmitted infection
(STI) tests had been buying generic tenofovir/emtricitabine online. Some clinic
users wanted reassurance that the generic drugs they had been buying were
genuine, having seen stories about counterfeit drugs. In addition to HIV and STI tests, and also offering
tests for kidney function to detect
tenofovir toxicity, the clinic decided to offer drug level tests for patients either starting to
take online-sourced PrEP or changing to a new supplier.
Dr Nwokolo presented data from a sample of 234 Dean Street
patients who had PrEP drug levels measured from the start of the drug-level
service in February 2016 to September 2016.They measured levels of tenofovir
and emtricitabine in online PrEP users and compared them with a sample of
participants who had received PrEP direct from the clinic. The drug test used can reliably detect
from 25 to 10,000 nanograms per millilitre (ng/ml) of drug in the blood – the
lower level is similar to the IC90 of
tenofovir or emtricitabine in blood, which is the amount that cuts HIV
replication by 90% in treatment.
The PrEP users had come in for tests for STIs anyway and
were offered quarterly HIV, gonorrhoea, chlamydia, syphilis and renal function
tests. They were all gay men, 85% of white ethnicity, and their average age was
37 (comparable to the average age of participants in the PROUD and Ipergay trials,
which was 35). Thirty-five per cent said they were involved in the ‘chemsex’ sex-and-drugs
scene. Eighty-five per cent were taking PrEP daily, the remaining 15% when they
Of 208 PrEP users with referral details available, 191 (92%)
had made their initial enquiries about buying PrEP from the UK activist site www.iwantprepnow.co.uk, which had an
arrangement to refer them to 56 Dean Street. Thirteen (6%) heard about Dean Street
direct from the site www.alldaypharmacy.co.uk
and four from other sources.
The majority of iwantprepnow users (131 people, 63% of those
in the survey) bought their PrEP from the www.unitedpharmacies-uk.md
website. Other suppliers included www.alldaychemist.com
(18%) and www.aids-drugs-online.com.
The vast majority of generic PrEP sold – 181 out of 184 samples, where the
source was mentioned – was Cipla’s Tenvir-EM. The other three samples were Tavin-EM from Emcure and Ricovir-EM from Mylan.
The current price of Tenvir-EM
at United Pharmacies is £50.49 for 30 pills (£1.68 per pill). This compares
current British National Formulary (BNF) price of £355.73 or £11.86 per
pill, an 86% reduction.
Dr Nwokolo and her fellow physicians compared tenofovir and
emtricitabine concentrations in blood plasma from samples taken between 30
minutes and 27 hours (median, 15.5 hours) after taking a PrEP pill. They
compared these drug levels to about 30 people who took Truvada directly supplied by the clinic, either privately or in the
PROUD study – these were taken 0, 1, 3, 8 and 12 hours post-dose.
The median level of tenofovir was 103 ng/ml (range, 21-567
ng/ml) and of emtricitabine 142ng/ml (17-1876 ng/ml). Twelve men had their
levels tested twice, and results were similar. Levels in the first 12 hours
were generally similar to or higher than levels seen in people with drugs
supplied by the clinic. Kidney function was normal in all the men tested.
No HIV infections were seen in anyone and although this is a
relatively small group and follow-up time has only been about three months on
average, if HIV incidence matched that of people in the deferred PrEP arm of the PROUD study (9%), one might have expected two or more infections. A
follow-up is planned to look at data on STI and hepatitis B and C infections.
Dr Nwokolo commented that their data was not intended to be
a representative sample of all PrEP users seen at the clinic, just data to show
that fears of counterfeit drugs were not borne out.
added, “this is an important collaboration between clinic patients, community
activists and clinicians – it is a verification that online pharmacies are
genuine and results can be made available, and adds to the testimonies from
“As long as PrEP is unavailable from the National Health Service,
it is crucial that it is accessible to those who need it,” she concluded.