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PrEP in Real Life Settings:
Good Adherence and no Increase in High-Risk Behaviour
R Thomas, C Galanakis, D Longpré, J-P Kerba, L Charest,
S Lavoie, E Huchet, D Murphy, B Trottier, N Machouf
Clinique médicale l’Actuel, Montréal, Québec, Canada
Corresponding author: Nimâ MACHOUF [email protected]
“I have no conflict of interest”
BACKGROUND
METHODS
Current research suggests that PrEP use prior to intercourse diminishes the risk of HIV
acquisition. However, most results stem from randomized clinical trials. There is little
information available on PrEP use, efficacy and adherence in real life and its impact on high-risk
behaviours. PrEP has been officially recommended to prevent HIV infection in high risk
populations since 2013. However Truvada is not covered by Canadian public insurance systems
and costs to users between 800 and 1100 can$ for a month if prescribed to be taken in a
continuous manner.
We prospectively assessed patients who consulted for Preexposure prophylaxis (PrEP) at Clinique
médicale l’Actuel in Montreal, up to June 2015.
Patients received a prescription for Truvada (TVD) at the initial consultation and were subsequently
seen at 3-month follow-up (FU) intervals . Most often, it was prescribed to be taken in a continuous
manner.
Treatment adherence and behavioural data were measured by self-report at every follow-up visit.
Behavioural changes were analyzed by X2 and time to treatment discontinuation was estimated by
Kaplan-Meier analysis. All analyses were conducted using SPSS version 17.0 ©
OBJECTIVE
The aim of this study was to evaluate adherence to follow-up and treatment and behavioural
changes in a high-risk clinical population.
RESULTS
Table 1. Characteristics of patients consulting for PrEP
Figure 2. Study Flow Chart
The prescription of TVD QD as PrEP started at Clinique L’Actuel in
2011. Approval for its use in 2013 by the Quebec Health Ministry
has subsequently increased prescriptions (especially since
September 2014).
Baseline Characteristics
269 Consultations
Age (mean, Range)
3 patients refused consent
There has been a total of 269 PrEP prescriptions at l’Actuel up to
June 2015.
21 patients never started PrEP
after the initial consultation
After medical evaluation
and counselling, TVD was
prescribed for patients
who needed additional
protection against HIV.
Number of patients who
initiates PrEP @ l’Actuel
N=266
37 (18-66)
Male
262
99%
MSM
260
98%
History of STDs
205
79%
> 10 casual/stable sexual partners (last 12months)
179
73%
Sex with HIV+ partner
171
67%
Condom use* (median, IQR)
Insertive anal intercourse
Receptive anal intercourse
N=245
PrEP consultations included
in the analyses
%
Having sex under influence of any recreational drug
70 (50-90)
70 (40-95)
179
68%
*Condom use was reported as the percentage of intercourse that was protected.
Figure 1. Number of PrEP prescribed at l’Actuel
As shown in the Table 1, our PrEP patients are quite at high risk of HIV infection with 79% having had previous STDs, a median of 16 sexual partners during the last 12 months (IQR 8, 34), 73% having sex under
drug influence and inconsistent (70%) condom use for anal intercourse.
How long do they stay on PrEP?
Do they return for follow-up?
Among the 245 consultations included in this analyses, 200 patients had available FU data as 45
patients started treatment after March 2015 and had not yet completed their first FU visit.
Median follow-up time was 16 weeks (IQR: 7-32)
In the first 3 months after starting PrEP, 183 (92%) patients attended a FU visit, while 16 (8%)
did not attend. One patient (1%) discontinued treatment prior to attending his first FU visit.
Two patients (1%) were lost to FU.
Overall, 46 (23%) patients discontinued PrEP
•
•
Table 2. Adherence to PrEP in the first 3 months of FU (N=183).
PrEP Adherence
N
In our patients, TVD was prescribed to
be taken daily. Very few patients were
prescribed intermittent TVD.
%
Daily PrEP use
138
78%
Intermittent use
10
6%
Adherence problems
9
5%
Discontinued
28
19%
Figure 3. Cumulative incidence PrEP discontinuation (weeks).
Table 3. Raisons for PrEP Discontinuation
Reasons for PrEP D/C*
For patients attending a FU visit in the first 3 months after
starting PrEP. Data not available for 22 patients.
The major concerns of physicians cited in
the literature regarding PrEP is the level
of efficacy, the risk of patients not
adhering, the potential for drug
resistance, side effects, and the inscrease
of risky behaviour (1).
Does PrEP promote the increase of risky behaviour?
At each follow up visit, patients had to fill out a questionnaire regarding their sexual
behaviour to assess any changes since their last PrEP visit.
Unlike the perceptions and worries of
Canadian physicians, PrEP seems to raise
awareness about sexual risk behaviours
among patients and globally they seem
to reduce their risk after initiating PrEP.
However, reducing condom use in this
high risk population raises concerns.
Figure 4 illustrates their responses at the first visit 3 months after the initiation of PrEP.
• 13% used less drugs
• 9% used less alcohol
• 34% had less sexual partners
Risk
• 14% asked more about the HIV status of their partners
• 12% asked more about the VL of their HIV+ partners
Figure 4. Behavioural changes since starting PrEP.
Risk
No Change
100%
More
More over, adherence to treatment was
quite high and side effects were not that
common or important.
Less
90%
87%
86%
83%
84%
%
Side Effects
Elevated Creatinine
Nausea, vomiting, diarrhea
5
5
10%
10%
No HIV+ partner
6
13%
Protected intercourse
5
10%
Partner VL < 50
4
8%
Feels no longer needed/not at risk
4
8%
Failed to resume after vacation
4
8%
Too expensive
2
4%
Exclusive relationship
2
4%
Incarcerated
1
2%
Seroconverted
1
2%
Referred to Ipergay trial
1
2%
Abstinent
2
4%
Steatosis and elevated ALT/AST
1
2%
Other
2
4%
Missing data
4
8%
Overall 2 patients seroconverted:
75%
60%
• 1 patient on PrEP seroconverted 2 months after starting PrEP. This patient had a rash 2 days after
initiating TVD, which could be related to an acute HIV infection, thereby suggesting the occurrence of
HIV infection prior to treatment initiation.
59%
50%
34%
40%
30%
13%
20%
10%
N=46
*Reasons for PrEP discontinuation are not mutually exclusive.
80%
70%
The reasons for treatment discontinuation are
presented in Table 3.
weeks
Among the 10 patients taking PrEP
intermittently,
4 patients were
prescribed PrEP PRN while the
remaining 6 patients switched from
daily use.
While,
• 16% used less condoms
22/200 (11%) stopped by week 12
33/200 (17%) stopped by week 24
14%
9%
3%
4%
16%
12%
7%
• 1 patient who never started PrEP seroconverted 7 months after his initial PrEP visit.
9%
2%
3%
0%
Drug Use
Alcohol use
Nb Sexual
Partners
Ask about HIV+
status
Ask about VL
status
Condom Use
CONCLUSION
LIMITATIONS
Adherence and behavioural changes were self-reported by patients and are thus subject to
social desirability bias.
Reference:
Sharma M, Wilton J, Senn H, Fowler S, Tan DHS, Preparing for PrEP: Perceptions and Readiness of Canadian Phisicians for the Implementation of HIV Pre-Exposure
Prophylaxis, PLoS ONE 9(8): e105283.
The authors would like to thank Yalda Machouf-Khadir, the research assistant; physicians, nurses and patients who participated in this study and FRQS-MI for funding.
• Most patients receiving PrEP adhered to treatment and to follow-up. However, 23% of patients
discontinued prophylaxis, almost half of which occurred in the first 3 months after initiating PrEP.
• Only one patient seroconverted in our study. The infection probably occurred prior to PrEP
initiation and can therefore not be considered a PrEP failure. Our results support the efficacy of
PrEP in the real world in this population of MSM at high risk of infection.
• PrEP did not promote an increase in high risk behaviours as most patients reported no significant
changes in their behaviour since starting PrEP .