(IRAPEP)

Candidacy for TasP and PrEP in the
PEP population: an analysis of
the Italian Registry of
Antiretroviral Post-Exposure Prophylaxis
(IRAPEP)
Gabriella De Carli, Elisabetta Schifano, Silvia Pittalis, Francesco M. Fusco, Fosca
Niero, Alfredo Franco, Liana Signorini, and Vincenzo Puro;
the Italian Registry of Antiretroviral Post-Exposure Prophylaxis (IRAPEP) Group
G. De Carli has received an unrestricted research
grant by Gilead Fellowship Program
Background and Methods
• HIV-uninfected individuals use Post-Exposure
Prophylaxis (PEP) in case of unanticipated sexual
exposure carrying a potential risk of HIV transmission.
In several situations, alternative strategies could be
considered, such as Treatment as Prevention (TasP) in
the source or Pre-Exposure Prophylaxis (PrEP) in the
exposed individual.
• Retrospective analysis of the characteristics of sexual
exposures (SE) receiving PEP and of involved sources,
reported to the Italian Registry of Antiretroviral
Prophylaxis (IRAPEP) between January 1997 and
December 2013.
Time trend of cases starting HIV PEP
(6217 cases, IRAPEP 1996-2012)
Absolute cases by type of exposure and year
400
62%
350
300
73%
250
200
150
14%
15%
100
22%
9%
2%
50
3%
0
1996
1997
1998
1999
HCWs
2000
2001
2002
Occ not HCW
2003
2004
2005
Sexual exp
2006
2007
2008
2009
Not Occ- not Sex exp
2010
2011
2012
Study population
Italian Registry of Antiretroviral Post-Exposure Prophylaxis (IRAPEP)
1996-2013
Subjects starting PEP
6379
Exposed to
HIV-negative
sources
39 (2%)
Exposed to source of
unknown serostatus
914 (45%)
HIV+ at baseline
5(0.5%)
All MSM, casual sex
Detectable viremia
313 (29.2%):
82% stable couples
18% casual partners
Sexual exposure
2038 (32%)
Exposed to
HIV-infected
sources
1085 (53.2%)
Subjects entering the
analysis
1072 (52.6%)
Unknown/NR
363 (33.9%)
45% stable couples
55% casual partners
HIV+ at baseline
13 (1.2%)
6 in stable couples
7 MSM casual sex
Undetectable viremia
396 (36.9%)
84% stable couples
16% casual partners
Source viremia
HCWs (%)
<2008
Sexual exp (%)
OR (95% CI)
Total (%)
Undetectable
202 (35)
191 (53)
441 (42)
Detectable
371 (65)
170 (47)
613 (58)
126 (66)
205 (59)
346 (61)
2009+ Undetectable
Total
OR (95% CI)
Detectable
64 (34)
Undetectable
328 (43)
396 (56)
787 (48)
Detectable
435 (57)
313 (44)
835 (52)
OR 0.28
(0.19-0.40)
143 (41)
OR 0.78
(0.58-1.07)
222 (39)
Sources with detectable viremia
engaged in stable couples
Type of relationship
PEP in Stable couples
Infected partners:
Men-Heterosexual
Men having Sex with Men (MSM)
Women
N
%
258
82
144
61
53
56
24
20
Type of intercourse
R
I
Anal intercourse – no condom
5
3
11.4
33
28
87.1
6
4
5.6
121
42
92.1
9
-
81.8
Use of condom in stable couples Condom broke or slipped
Vaginal intercourse – no condom
Condom broke or slipped
Oral intercourse – no condom
Untreated
1st treatment
133
52
43
17
Experienced
47
18
Structured/voluntary inter.
9
3
Unknown/not reported
26
10
60
23
Viral load
<103
103 - 104
Relative Risk of HIV infection
increases by 2.89 per log10 copies/mL
62
24
>104 – 105
111
43
>105
25
10
Source TARV
PEP for Sexual Exposure (SE)
to HIV+ source (N=1072)
Source
Viral
Load
N. of PEP for SE
N. of PEP
by source VL
for SE by
in stable
source VL
couples
N (%)
N (%)
N. PEP in
HIV- stable
partners with
multiple SE
N (%)
Stable couples
with multiple
SE
N (%)
Multiple PEP
SE to Casual
partner of
unknown
serostatus
N=909
Detectable
313 (29)
258 (82)
73 (28)
30 (of 215; 14%)
N (%)
Undetectable
396 (37)
331 (84)
80 (24)
35 (of 286;12%)
2 PEP: 34 (3.7)
Unknown/NR
363 (34)
163 (45)
28 (17)
13 (of 148; 9%)
3 PEP: 11 (1.3)
Total
1072
752
181
78 (of 649; 12%)
Total: 45 (5)
An example
Partner 2
1stPEP
June 2012
No partner seroconverted
Case « resolved » by Paola Scognamiglio and Gianpiero D’Offizi
PEP for SE to HIV+ sources with
undetectable viral load, by type of exposure
and risk factors
No risk
factors, and
source on
TARV since >6
months
Undefinable
(not enough
data)
Type of exposure
Total
High risk (by type,
or presence of
STD, bleeding,
lesions)
Receptive anal sex
Risk 6 x 10000 (1-29)
60
60
Insertive anal sex
Risk 0.4 x 10000 (0.1-3)
46
12
5
29
Receptive vaginal sex
Risk 0.32 x 10000 (0.06-1.7)
210
12
72
126
Insertive vaginal sex
Risk 0.16 x 10000 (0.02-1.3)
58
4
13
41
Fellatio w/ejaculation
18
6
5
7
Other
4
0
0
4
Total
396
94 (24%)
95 (24%)
207 (52%)
Patel P et al. Estimating per-act HIV transmission risk: a systematic review. AIDS 2014;28:( e-Pub ahead of print)
Study population
Italian Registry of Antiretroviral Post-Exposure Prophylaxis (IRAPEP)
1996-2013
Sexual exposure
2038 (32%)
Exposed to
HIV-negative
sources
39 (2%)
HIV+ at baseline
5(0.5%)
All MSM, casual sex
Exposed to source of
unknown serostatus
914 (45%)
Detectable viremia
313 (29.2%)
4 cases of infection
Stable viremic partners (3
poor adherence; 1 PHI)
2 cases of
infection
Casual sex
1 failure (HIV+HCV)
1 new exposure
after 1st PEP
Exposed to
HIV-infected
sources
1085 (53.2%)
HIV+ at baseline
13 (1.2%)
Unknown/NR
363 (33.9%)
6 in stable couples
7 MSM casual sex
Undetectable
viremia
396 (36.9%)
2 cases of infection (PHI)
After 1 & 2 PEP respectively
with stable nonviremic
partners, casual sex with
different partners unaware of
their HIV infection
No case of
infection
IRAPEP Study Group
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INMI L. Spallanzani – Roma: Scognamiglio P.
Ospedale L. Sacco - Milano: Niero F.
Spedali Civili - Brescia: Signorini L.
AORN "Ospedale dei Colli" - Napoli: Franco A.
Policlinico “A. Gemelli” - Roma: Fantoni M.
Ospedale Amedeo di Savoia - Torino: Bertucci R.
AUSL 3 Spedali Riuniti - Pistoia: Vivarelli A.
Ospedale degli Infermi - Rimini: Morigi G
A.O. S. Croce - Cuneo: Vitullo D.
Ospedale Niguarda - Milano: Micheloni G.
Azienda Ospedaliera - Parma: Degli Antoni A.M.
Ospedale Maggiore - Bologna: Borderi M.
Policlinico Monteluce - Perugia: Moretti M.V.
AO Ospedali Riuniti - Trieste: Crosato I.
Ospedale Gen. Prov. - Macerata: Castelli P.
Ospedale Civile SS. Antonio e Biagio - Alessandria: Mantia E.
Ospedale Galliera - Genova: Cassola G.
AO Umberto I - Ancona: Orsetti E.
Ospedale SS . Giacomo e Cristoforo - Massa: Laganà S.
Azienda ULSS N°9 - Treviso: Giobbia M.
IRCCS S. Raffaele - Milano, Centro S. Luigi : Maillard M.
Arcispedale S. Maria Nuova - R. Emilia: Massari M.
Ospedale Civile - Ravenna: Ballardini G.
CRAIDS Prov. - Udine: Gnesutta D.
Ospedale S. Martino - Genova: Dodi F.
Ospedale S. Anna - Como: Longoni E.
Azienda Policlinico Universitario - Modena: Mussini C.
Ospedale Per Gli Infermi - Faenza: Albertini F.
• Azienda Policlinico Universitario - Udine: Rosa I.
• AO Careggi - Firenze: Ambu S.
• PO M. Bufalini - Cesena: Brighi S.
• Ospedali Riuniti - USL 2 - Sanremo: Dentone C.
• AOU Senese - Siena: Toscano L.
• PO Misericordia - Grosseto: Carli T.
• Ospedale. S. Paolo - Savona: Calcagno G.
• Ospedale Civile - Lecco: Folsi M.F.
• Ospedale Gen. Regionale - Valle D’Aosta: Traverso A.
• Ospedali Riuniti - Bergamo: Astuti N.
• P.O. S. Andrea - Barcellona - Pozzo di Gotto: Trifiletti F.
• Policlinico “S. Orsola- Malpighi” - Bologna: Colangeli V.
• Ospedale Belcolle - Viterbo: Caterini A.
• Ospedale Civico e Benfratelli - Palermo: Saitta M.
• Centro MST - Gorizia: Moise G.
• Ospedale Campo Di Marte - Lucca: Luchi S.
• Ospedale Umberto I - Mestre: Lorusso A.
• Ospedale S. Eugenio – Roma
• Ospedale Carlo Poma - Mantova: Costa P.
• Ospedale Gen. Provinciale - Rieti: Marchili M.
• AUSL - Piacenza: Paolillo F.
• P.O. Ospedale Uboldo-Az. Ospedale Melegnano - Milano
• Ospedale S. Andrea - Vercelli: Cristina G.
• Ospedale S. Salvatore - Pesaro: Pieretti C.
• IRCCS Policlinico S. Matteo - Pavia: Pratico L.
• Ospedale S. Maria Sopra i Ponti - Arezzo: Tacconi D.
Funding: Ricerca Corrente IRCCS