gave data from the open-label phase of the trial when, from November 2014, all
participants were given the option to use Truvada
Among the 400 participants
initially enrolled in IPERGAY, 336 were eligible to join the open-label study
(the remainder having dropped out of the study for various reasons) and all but
three joined. Another 29 new participants were enrolled, making 362. All but
one transgender woman were gay men.
The data shown at this conference were for
the ten months up to the end of September 2015 and the cumulative follow-up
time was 248 participant-years. Study retention was good with only 13 participants
discontinuing follow-up (3.6%).
Their average age was 35, and 84% were of French or European
origin. At the start of the open-label phase, 10% had had no anal intercourse in the previous month and the
average number of partners in the previous two months was seven.
During the open-label phase, one person became HIV positive.
Like the two people allocated to PrEP who acquired HIV during the randomised phase,
he had stopped using PrEP. He was in the randomised trial for eight months and
was diagnosed one month and ten days into the open-label study. By self-report
he had not used PrEP since starting the open-label study and had had no drug
detectable in in his blood. His HIV had no drug resistance mutations.
Putting together HIV incidence in the randomised and open-label phases, HIV incidence
was 0.4% a year in people allocated to PrEP. This compared with 0.91% in people allocated
to PrEP in the randomised phase alone and to 6.6% in people allocated to placebo; it implies 94% fewer HIV infections in those given PrEP versus those given
Participants used an average of 18 pills a month according
to pharmacy returns but this is probably an overestimate because, after the
results from the randomised study were announced, participants became reluctant
to return their PrEP bottles in case PrEP became unavailable after the trial (in
fact, fully reimbursable
PrEP became available in France from the beginning of this year.)
During the open-label study a third of participants were
diagnosed with a new sexually transmitted infection. Of these 38% were diagnosed
with gonorrhoea, 42% with chlamydia and 21% with syphilis. Three individuals
(1%) were diagnosed with hepatitis C.
There was no significant change between the randomised phase
and the open-label phase in the median number of occasions of sex or sexual
partners. But there was a significant decrease in condom use for receptive anal
intercourse Condom use as the receptive partner varied between 40 and 25% during the randomised study. During the
open-label study, it varied between 20 and 30%.
Safety was good with a low rate of serious adverse events
(4%). One participant discontinued PrEP because of a decrease in creatinine clearance,
but more as a precaution as high actual relative loss in kidney function was
slight: his creatinine clearance was 81 millilitres per minute at the start of
the open-label study and 76 at discontinuation.
Drug-related gastrointestinal adverse events were fairly common.
Diarrhoea was reported by 10% of participants, nausea by 11%, abdominal pain by 8%
and other gastrointestinal symptoms. The only life-threatening adverse event was
a stroke, in a participant who already
had a cerebral aneurysm (blood vessel dilation). This was not regarded as
Further data will be forthcoming from IPERGAY and the French
health ministry has made the collection of behavioural and safety data a
requirement for joining the rollout programme.