P071 Cost/efficacy analysis of preferred Spanish AIDS study group regimens and the dual therapy with LPV/r + 3TC for initial ART in HIV infected adultsGatell, J*; Arribas, J; Lázaro, P; Blasco, A (Barcelona, Spain)

P072 Prices of second-line antiretroviral treatment for middle-income countries inside versus outside sub-Saharan AfricaSimmons, B*; Hill, A; Ford, N; Ruxrungtham, K; Ananworanich, J (London, UK)

P074 Incremental cost per newly diagnosed HIV infection (NDHI): routine (RTS), targeted (TTS), and current clinical practice testing strategies (CPTS) Gomez-Ayerbe, C; Pérez Elías, M*; Muriel, A; Pérez Elías, P; Cano, A; Diaz, A; Moreno, A; Casado, J; Santos, C; Martinez-Colubi, M; Uranga, A; Dronda, F; Moreno, S (Madrid, Spain)

P076 Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in FranceAllavena, C*; Jacomet, C; Pereira, B; Morand-Joubert, L; Bagheri, H; Cotte, L; Garaffo, R; Gerbaud, L; Dellamonica, P (Nantes, France)

P077 Hidden costs of HIV treatment in Spain: inefficiency of the antiretroviral drug packagingLlibre-Codina, J*; Andreu-Crespo, A; Cardona-Peitx, G; Sala-Piñol, F; Clotet-Sala, B; Bonafont-Pujol, X (Barcelona, Spain)

P079 Determinants of HIV outpatient service utilization according to HIV parametersDi Carlo, P*; Immordino, P; Mazzola, G; Colletti, P; Alongi, I; Mineo, M; Scognamillo, M; Vitale, F; Casuccio, A (Palermo, Italy)

COST-EFFECTIVENESS

*Indicates presenting author.

1,2 3 4 4

1Hospital Clinic-IDIBAPS, Head Infectious Diseases and AIDS Units, Barcelona, Spain. 2University of Barcelona, Barcelona, Spain.3La Paz Hospital, IdiPAZ, HIV Unit, Madrid, Spain. 4Advanced Techniques in Health Services Research (TAISS), Madrid. Spain.

1. Panel de Expertos de GESIDA y Plan Nacional sobre el Sida. [Consensus Statement by GeSIDA/National AIDS Plan Secretariat on antiretroviral treatment in adults infected by the human immunodeficiency virus(Updated January 2013)].. Enferm Infecc Microbiol Clin. 2013;31:602.e1-602.e98.2. Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, et al. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reversetranscriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014;14:572-80.3. Blasco AJ, Llibre JM, Arribas JR, Boix V, Clotet B, Domingo P, et al. Analysis of costs and cost-effectiveness of preferred GESIDA/National AIDS Plan regimens for initial antiretroviral therapy in humanimmunodeficiency virus infected adult patients in 2013. Enferm Infecc Microbiol Clin. 2013;31:568-78.

ab

ab

ab

ABC: abacavir; ATV: atazanavir; COBI: cobicistat; DRV: darunavir; EFV: efavirenz; EVG: elvitegravir; FTC: emtricitabine; LPV: lopinavir; NVP: nevirapine;/r: ritonavir-boosted; RAL: raltegravir; RPV: rilpivirine; TDF: tenofovir DF; 3TC: lamivudine.a Cost of initiating a regimen including all potential consequences of deciding to initiate ART with that regimen that may occur within 48 weeks.b Efficiency or cost/efficacy. Cost (Euros) of achieving one responder for the NHS.

4.500

5.500

6.500

7.500

8.500

9.500

10.500

11.500

12.500

13.500

14.500

TDF/FTC + RALABC/3TC + ATV/rABC/3TC + RALABC/3TC + LPV/rTDF/FTC + ATV/rTDF/FTC + LPV/rTDF/FTC + DRV/rABC/3TC + EFVTDF/FTC/EFVTDF/FTC + NVPTDF/FTC/RPV3TC + LPV/r

Prices of second-line antiretroviral treatment for middle-income countries inside versus outside sub-Saharan Africa Bryony Simmons1, Andrew Hill2, Nathan Ford3, Kiat Ruxrungtham4, Jintanat Ananworanich5

1Imperial College London, London, UK, 2University of Liverpool, Liverpool, UK, 3WHO, Geneva, Switzerland, 4Chulalongkorn University, Bangkok, Thailand, 5U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA 2 Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA

Correspondence to: Dr Andrew Hill PhD Pharmacology Research Labs, 1st Floor Block H, 70 Pembroke Place, Liverpool, L69 3GF Tel:+44 7834 364 608 Email: microhaart@aol.com

P072

HIV Drug Therapy Conference, Glasgow, Scotland, November 2014 [poster P072]

Background • The cost of HIV antiretrovirals (ARVs) has substantially reduced, and treatment is now

available at low cost in low-income countries and across sub-Saharan Africa. • These prices may not be consistently available for middle-income countries with large HIV

epidemics in other regions. • Over 30% of HIV infected people live in countries outside of sub-Saharan Africa. • Several key ARVs are still on patent, restricting generic production in middle-income countries. • Given that over 55 million people will require HIV treatment by 2030, and that many of these

people live in middle-income countries, it is essential that access to treatment is equitable. • The aim of this analysis was to assess price variations for key second-line ARVs across

middle-income countries inside versus outside of sub-Saharan Africa.

Methods • HIV ARV prices used in national programmes between 2010 and 2014 were extracted from

the World Health Organisation Global Price Reporting Mechanism database for all reporting middle-income countries as classified by the World Bank.

• Procurements were analysed by manufacturer type: originator pharma company or generic. • Median treatment costs were compared for countries inside sub-Saharan Africa versus those

outside. For each individual country, treatment costs were also compared with the per capita gross national income.

• ANCOVA was used to assess the difference between groups, adjusted for year of purchase. • Five key second-line ARVs were analysed: abacavir (ABC), atazanavir (ATV), darunavir

(DRV), lopinavir/ritonavir (LPV/r), and raltegravir (RAL).

Results • As shown in Table 1 and Figure 1, the prices paid for ARVs from pharma companies were

significantly higher outside sub-Saharan Africa compared with inside (p<0.001, adjusted for year of purchase).

• For example, the median (interquartile range) price of darunavir from Janssen was US$732 (US$732-806) per person-year in sub-Saharan Africa versus US$4,690 (US$4,075-5,727) in non-African middle-income countries, an increase of 541%.

• However, when supplied by generic companies (Table 1, Figure 2), most ARVs were similarly priced across countries in sub-Saharan Africa and other regions.

• Figures 3 and 4 show the median treatment cost paid by each country for LPV/r and DRV, respectively, compared with gross national income. The cost of the generic ARVs remained low regardless of location or gross national income.

• In contrast, the cost of pharma ARVs was higher in countries outside of sub-Saharan Africa, however there is no clear relationship between price paid and gross national income.

Antiretroviral

Sub-Saharan Africa Non-Africa Price rise non-Africa vs Africa

No. of countries analysed*

Median cost† (US$)

No. of countries analysed*

Median cost† (US$)

Originator pharmaceutical company

ABC (300mg) 2 (93) $315 (294-315) 3 (10) $547 (299-602) +74%

ATV (300mg) 2 (170) $357 (124-357) 2 (4) $1910 (1910-3496) +435%

DRV (600mg) 7 (84) $732 (732-806) 9 (31) $4690 (4075-5717) +541%

LPV/r (200mg/50mg) 15 (492) $319 (272-374) 23 (128) $720 (456-932) +125%

RAL (400mg) 3 (52) $883 (883-1010) 1 (2) $3589 (3589-3589) +306%

Generic

ABC (300mg) 18 (290) $192 (167-213) 33 (215) $178 (155-205) -7%

ATV (300mg) 6 (34) $296 (251-309) 14 (36) $245 (219-265) -17%

DRV (600mg) 2 (2) $990 (964-1016) 1 (1) $2964 (2964-2964) +199%

LPV/r (200mg/50mg) 18 (164) $391 (282-429) 33 (187) $397 (349-435) +2%

RAL (400mg) 2 (28) $373 (373-634) 0 - -

*Number in brackets shows number of individual transactions made †Cost is median treatment cost per person per year (interquartile range), US$

Conclusions • Originator pharmaceutical companies are selling ARVs to non-African middle-income

countries at prices 74% to 541% higher than to those countries in sub-Saharan Africa with similar gross national incomes.

• However, generic companies are selling most of these drugs at similar prices across regions.

• Mechanisms to ensure fair pricing for patented antiretrovirals across both African and non-African high burden middle-income countries need to be improved to ensure sustainable treatment access.

Table 1. Median (IQR) cost of treatment by country and procurement type (originator pharma or generic)

Figure 1. Median cost of treatment produced by originator pharmaceutical companies sold to middle-income countries inside of sub-Saharan Africa vs outside. After adjusting for year of purchase, pharmaceutical company prices were significantly higher in countries outside Africa compared to sub-Saharan Africa (p<0.001).

Figure 2. Median cost of treatment produced by generic companies sold to middle-income countries inside of sub-Saharan Africa vs outside. After adjusting for year of purchase, only ABC was significantly higher in price in countries outside Africa compared to sub-Saharan Africa (p<0.001).

Figure 4. Median (IQR) cost of darunavir by country and procurement type

Figure 3. Median (IQR) cost of lopinavir/ritonavir by country and procurement type

The views expressed are those of the authors and should not be construed to represent the positions of the authors’ respective organisations.

Introduction Methods

Results

C. Gómez Ayerbe1 , M.J. Pérez Elías1, A. Muriel 2, M.E. Calonge3, P. Pérez Elías3, A. Cano , A. Díaz1, A. Moreno1

A. Uranga 3, J.L. Casado, C. Santos 3, Martínez-Colubi 4, F. Dronda, S Moreno1.

Contact Information: Dr. Pérez-Elías· Hosp. Ramón y Cajal· c/ Ctra Colmenar km 9 s/n · 28034 · Madrid · Spain · Tel + +34 913 368672 · e-mail : mjperez90@gmail.com

Incremental Cost per Newly Diagnosed HIV Infection (NDHI): Routine (RTS), Targeted (TTS), and Current Clinical Practice Testing Strategies (CPTS)

Incremental Cost per Newly Diagnosed HIV Infection (NDHI): Routine (RTS), Targeted (TTS), and Current Clinical Practice Testing Strategies (CPTS)

References

Conclusions

PP 074

1Hospital Ramon y Cajal, IRYCIS, Infectious Diseases, Madrid, Spain; 2Hospital Ramón y Cajal, IRYCIS, CIBERESP, Statistics, Madrid, Spain; 3Centro de Salud García Noblejas, Primary Care, Madrid, Spain; 4Hospital San Chinarro, Internal Medicine, Madrid, Spain.

Delay HIV Diagnosis is still a relevant phenomena in Europe, Universal Testing has been proposed to reduce the prevalence of this issue. Although Routine HIV Testing Strategy is cost-effective in populations with HIV Prevalence of at least 0.1%2, overall budget may be unaffordable for some countries. Different HIV Testing Strategies/programs and Clinical Care Settings had not been face to face evaluated3.

In DRIVE study Targeted Test Strategy with universal screening of RP&CC questionnaire before an HIV rapid test is cost saving, without missing NDHI, with respect to Routine Testing Strategy. Lower rates of HIV infection and RP&CC in the population, increase costs savings, while a less Sensitive RP&CC questionnaire will result in a more expensive testing strategy.

In DRIVE Study, 18-60 years old, non HIV infected population visiting a HER or a PCC, were proposed both: a structured Risk Practices and Clinical Conditions Questionnaire (RP&CC-Q) and a Rapid HIV Test (RT). From a health care perspective, using direct costs and Euros currency, we calculated overall budget, costs and incremental cost per NDHI of:

Routine Testing Strategy (RTS), all patients were HIV tested irrespective of HIV risk. We considered the cost of HIV RT test for all the population. Targeted Testing Strategy (TTS), risk practices and clinical conditions-RP&CC- questionnaire is done to all the people and only positive ones were HIV tested. We considered questionnaire cost of all the population, but the cost of HIV RT only in positive RP&CC-Q population) Clinical Practice Testing (CPTS) HIV Test was done by clinicians following its clinical criteria the year before DRIVE study was performed in the same settings. We considered Hospital HIV test cost

Unitary costs considered were: HIV RT, nurse, registry, transport and HIV confirmation when necessary. Sensitivity analyses were performed varying positivity rates of NDHI and RP&CC questionnaire in the population and different varying sensitivity (SE) to predict HIV infection by RP&CC questionnaire .

Objective

To explore Incremental cost per Newly Diagnosed HIV Infection (NDHI) associated with different Testing Strategy (TS) and in

different settings Hospital Emergency Room (HER) and in the Primary Care Center (PCC)

Study Population N 5,332 Sex Female 50.36% Age years Median (IQR)

37 (28-47)

Origin Spain Latin-America East Europe Others

74.92% 20.12% 2.53% 2.42%

Localization Primary Care Center Emergency Room

69.3% 30.7%

HIV RP&CC-Questionnaire

Sensitivity Specificity Predictive Positive Value

Predictive Negative

Value

100% (84.6%-100%)

49% (47.7%-50.4%)

0.80% (0.50%-1.22%)

100% (99.9%-100%)

In DRIVE study NDHI were 4.1‰ and in Clinical Practice 1.6‰, while HIV RP&-CC Q was positive in 51.2%.

Costs Considered DRIVE HER PCC Overall HIV test cost 8 € (Insti ®) 7,10 € (EIA) 7,60 € (EIA)

RP&CC questionnaire 0,35 € 0,45 € 0,45 €

WB confirmation 39,60 €

0

10.000

20.000

30.000

40.000

50.000

DRIVE costs HER costs PCC costs

43.50338.707 41.372

24.472 22.560 23.918

5.032 4.470 4.782

Overall budget (€) according to the HIV test strategy

RTS TTS CPTS

0

1.000

2.000

3.000

4.000

5.000

6.000

DRIVE cost HER cost PCC cost

1.977 1.759 1.8801.112 1.025 1.087

5.0324.470 4.782

Cost (€) per NDHI

RTS TTS CPT

The lowest overall budget is found in CPTS, however the cost per NDHI is the highest compared to DRIVE study, were resources and a structured program is implanted. Most favorable Incremental cost is found for the TTS compared with RTS, this difference will be higher if we compared TTS cost with CPTS 1689 €. Incremental cost decreases as the rate of NDHI increases,

0

500

1.000

1.500

2.000

2.500

3.000

3.500 3.129

1.977 1.331

1.750 1.112

755

Costs (€) per NDHI according different rate of NDHI in the population

RTS TSS

0

500

1.000

1.500

2.000

2.500

25% Quest + 48% Quest +

55% Quest + 75% Quest + 100% Quest +

1.977 1.977 1.977 1.977 1.977

609 1.056 1.198

1.578 2.062

Cost (€) per NDHI according to the prevalence of HIV RP&CC positive Questionnaire in the RTS and TSS

RTS TSS

0

500

1.000

1.500

2.000

2.500

SE Quest 95% SE Quest 91% SE Ques 50%

1.977 1.977 1.977

1.167 1.223

2.185

Cost (€) per NDHI according to the sensitivity of HIV RP&CC questionnaire in the RTS and TSS

RTS TSS

-1.000

-800

-600

-400

-200

0

200

400

600

800

1.000 865 733 793

-824 -818 -856

Incremental cost in different scenarios with respect to RTS

RTS-TTS

RTS-CPTS

DRIVE HER PCC

Incremental cost decreases as the rate of NDHI increases, similarly occurs with the rate of positive RP&CC Questionnaire. Costs increased as the SE of RP&CC Questionnaire decreases if Quest decreases till 50%, incremental costs would be negative and TTS a more expense strategy with several missed infections

Acknowledgments This study has been partially supported with two competitive Grants 2 Scholarship ISCIII (FIS), PI12/00995, MSSSI EC11/144. Proyect code: EC11-144.DRIVE study group contributors Main Researcher Mª Jesús Pérez Elías Statistician Alfonso Muriel; Study Co-Designer Mª Martinez- Colubi. Working group C S Gª Noblejas: E Alonso, A Alonso, J Araujo, A Barbado, F Barcala, R Barea, R Blanco, R Blázquez, E Calonge, A Cano, F Consuegra, L Cota, M Cuenca, M Escribano, C Falcón, M Fernández, M Fraile, P García ,Garrido, J Gil, I González,J J González, M I González, P González, C Gutiérrez, A Iglesia, V Izquierdo, J Jiménez, E Llamazares, R Lerín, MJ López Bonillo, L Lorente, A Martin, E Martín Gracia, JL Martínez, S Medrano, L Naranjo, J Pascual, J Parra, P Pérez Elías, L Polo, R Ruíz Giardín, , C Santos, A Serrano, LM Serrano, P Sanz, I Susaeta, M Torres, A Treceño, J Turrientes, A Uranga. Working group HRyC: S Moreno, C Gómez-Ayerbe, A Diaz, A Moreno, B Hernandez, C Gutierrez, J L Casado, A Trueba, A Arizcorreta, F Dronda, G Robledillo, M Fernandez, S Ibarra Lorenzo, B Sanz Arias, R Curiel Serradilla, C Fernández San Pedro, M Bueno Pozo, Mª T sanchez leiva, Mª Dolores López Pérez, C Quereda, Paloma Martí-Belda, Isabel Hornero, Laura Etxeberria, Personal de enfermería de infecciosas del RyC 4ªC/A.

1.Yazdanpanah Y, Sloan CE, Charlois-Ou C, et al. Routine HIV screening in France: clinical impact and cost-effectiveness. PLoS One. 2010. 5:e13132.

Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France

ALLAVENA Clotilde1, JACOMET Christine2, PEREIRA Bruno3, MORAND JOUBERT Laurence4, BAGHERI Haleh5, COTTE Laurent6, GARRAFFO Rodolphe7, GERBAUD Laurent8 and DELLAMONICA Pierre9.

1CHU Hôtel-Dieu, Service des Maladies infectieuses et tropicales, Nantes, France, 2CHU, Service des Maladies infectieuses et tropicales, Hôpital Gabriel Clermont-Ferrand, France, 3CHU, Service de Biostatistiques (DRCI), Clermont-Ferrand, France , 4INSERM-UMR_S 1136 Pierre Louis Institute of Epidemiology and Public Health, Laboratoire de Virologie, CHU Saint Antoine, Paris, France, 5CHU, Pharmacologie Médicale et Clinique, INSERM U1027, Toulouse, France, 6Hospices Civils de Lyon, INSERM U1052, Service des Maladies infectieuses et tropicales, Lyon, France, 7CHU Pasteur, Pharmacologie Clinique Nice, France, 8CHU, EA 4681 PEPRADE, Santé Publique, Clermont-Ferrand, France, 9CHU, Service des Maladies infectieuses et tropicales, Nice, France

Since 2013, some antiretroviral generics (zidovudine, lamivudine, efavirenz, nevirapine) have been marketed in France and switching brand name medications to generics is recommended in the interest of cost effectiveness. But patients suffering from chronic conditions may be ill at ease with generics’ substitution. The study objective was to evaluate the perception of generics per se and ARV generics in HIV-infected patients and their hospital physicians, as well as factors associated to their acceptability.

Multicentric cross sectional survey on "a given day" covering all HIV-infected patients attending on the busiest day in the week of 16 to 21 September 2013 inoutpatient hospital departments. Inclusion criteria Age > 18, being aware of HIV infection > 6 months. Exclusion criteria unability to fill out the questionnaire and/or to speak French The protocol was registered and received approval from the French Advisory Committee on Data Processing Related with Health Research (CCTIRS) and National Commission for Data Protection and Liberties (CNIL).

556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics (68% in University Hospital)Patients demographic and medical characteristics (N=556)

Refusal N=129

Acceptance N=409 p-value

Male sex 80 (62.0) 321 (78.5) <0.001

Age, mean (sd) 48.9 (10.9) 48.3 (11.5) 0.64

France native 46 (36.8) 79 (19.8) <0.001

Living in the Ile-de-France region 90 (69.8) 295 (72.1) 0.60

Educational high school diploma or higher 17 (20.2) 67 (33.3) 0.04

In employment 63 (50.8) 235 (59.2) 0.10

Social security coverage 121 (94.5) 393 (96.3) 0.44

HIV duration ≥13ans 64 (51.2) 205 (51.8) 0.91

Heterosexual contamination 62 (53.9) 133 (34.9) <0.001

CDC stage A B C

64 (50.8)19 (15.1)43 (34.1)

222 (57.5)83 (21.5)81 (21.0)

0.01

Treatment duration 10.9 (7.0) 10.2 (7.1) 0.35

Current CD4 count ≥500/mm3 73 (58.4) 269 (67.1) 0.08

CD4 nadir ≥200/mm3 116 (92.8) 383 (95.5) 0.23

HCV status 18 (14.1) 49 (12.0) 0.64

HBV status 8 (6.3) 20 (4.9) 0.84

Cardiovascular comorbidities 13 (10.2) 59 (14.5) 0.35

All comorbidities 55 (42.6) 146 (35.7) 0.16

Patient agreeing with the definition of a generic 28 (21.7) 310 (76.2) <0.001

Patient having already received generics 66 (55.5) 368 (91.1) <0.001

Patient foregoing third party payment 16 (33.3) 24 (14.7) 0.01

Patient accepting generics per se 8 (7.9) 230 (79.6) <0.001

Factors associated with acceptance of generics per se by patients Factors associated with acceptance of ARV generics by patients

4 questionnaires Q 1 demographic, social and medical data collected from the medical file.Q 2 "patient" self-questionnaire concerning awareness and perception of generics including ARV generics. Q 3 for physicians concerning prescription of ARV generics for the included patient.Q 4 "physician" self-questionnaire concerning perception of generics overall

Factors associated with prescription of ARV generics by physiciansReasons for physician's refusal (N=138) associated with patient's refusal to use ARV generics Overall, pts accepted and had confidence in generics

in 76 % and 55 % of the cases, respectively.Switching ARVs for generics was accepted by 44 % ofthe pts but only by 17% if the pill burden was going toincrease. 75% of the physicians would prescribe generics, butthis decreased to only 26% if the combo had to bebroken.The main reasons for non-prescription of genericswere previous brand name ARV induced side effects(35%), refusal of generics overall (37%), lack ofunderstanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) anddepressive symptoms (25%).In multivariate analysis, factors associated withthe acceptability of ARV generics in pts were the use ofgenerics overall (p<0.001) and in physicians, theabsence of concern regarding efficacy (p<0.001) andbeing aware that the patient would accept generics(p=0.03) and ARV generics (p=0.04).No factors related to sociodemographic conditions,HIV status or comorbidities had a constrictive influenceon the use of ARV generics.

BACKGROUND

MATERIAL AND METHODS

RESULTS

DISCUSSION

Reasons quoted by the physicians PatientRefusalN= 56

Patient acceptance

N=82p-value

Fears concerning effectiveness

- Not suitable due to viral load 5 (9.3) 6 (16.7) 0,22

- Not suitable due to CD4 count 1 (1.8) 0 (0.0) 0,20

- Does not fit the treatment strategy 22 (40.7) 18 (48.7) 0,37

- Length of time under treatment 15 (27.8) 14 (38.9) 0,24

- Risk of resistance occurring 13 (24.1) 5 (13.9) 0,13

Fears related with tolerance

- previous ARV brand name side effects 18 (42.9) 4 (12.1) 0,004

Fears related with changes in formulation 16 (40.0) 22 (61.1) 0,066

Fears related with patient acceptance

- Often unwilling to accept treatment decisions 16 (36.4) 6 (17.7) 0,07

- Already expressed refusal 31 (63.3) 4 (12.1) <0,001

- Difficulties in understanding 10 (18.2) 7 (19.4) 0,54

- Compliance less good 18 (33.3) 13 (36.1) 0,84

- Anxiety 27 (58.7) 10 (32.3) 0,02

- Depression 18 (40.9) 4 (13.3 0,02

Patient who does not accept generics for another pathology 15 (37.5) 33 (94.3) <0,001

RefusalN=138N (%)

AcceptanceN=407N (%)

p-value

Physicians' profiles ( N =116)

Age, mean (sd) 49.8 (10.3) 47.5 (10.6) 0,03

Experience, mean (sd) 21.1 (10.9) 19.1 (10.8) 0,05

Smaller number of patients in his active file, mean (sd) 125.6 (93.9) 85.1 (84.7) <0,001

In practice in the Ile-de-France region 112 (27.5) 295 (72.5) 0,49

Fear of less measured chemical entity 66 (50.0) 205 (50.4) 0,94

No fear of less active chemical entity 74 (56.1) 134 (32.9) <0,001

No fears related with excipients/galenics 70 (53.0) 149 (36.6) 0,001

No fear of undesirable side effects 70 (53.0) 166 (40.8) 0,01

Role in preservation of healthcare system 77 (58.3) 273 (67.1) 0,07

Low price highlighted 106 (80.3) 320 (78.6) 0,68

Agreement concerning financing of innovation by the savings made 20 (15.2) 88 (21.6) 0,11

Awareness of costs for health insurance system 50 (62.5) 157 (51.8) 0.09

Awarehness of savings achieved by a generic 33 (41.8) 134 (45.1) 0.60

Patients' profiles (N=545)

Male sex 91 (65.9) 312 (76.7) 0,01

Age, mean (sd) 49.8 (11.1) 48.1 (11.5) 0,12

Country of birth = France 104 (77.0) 298 (71.1) 0,64

Highest level of education > Baccalaureate 21 (22.3) 63 (24.8) 0,64

In employment 0,004

Social security coverage 130 (94.2) 392 (96.6) 0,27

HIV dating back ≥13ans 76 (56.7) 192 (48.6) 0,11

Means of contaminationHomosexual/BisexualHeterosexualIDU

58 (45.7)52 (40.9)17 (13.4)

187 (49.7)153 (40.7)36 (9.6)

0,44

CDC stageABC

62 (47.7)31 (23.8)37 (28.5)

223 (57.3)76 (19.5)90 (23.1)

0,16

Duration of treatment ≥11ans 83 (60.1) 220 (54.1) 0,21

CD4 count ≥500/mm3 88 (64.2) 256 (64.3) 0,98

CD4 nadir ≥200/mm3 130 (94.9) 377 (94.7) 0,94

Co-infection HCV 20 (14.5) 46 (11.3) 0,09

Co-infection HBV 10 (7.3) 19 (4.7) 0,19

Cardiovascular comorbidity 26 (18.8) 48 (11.8) 0,11

All comorbidities (without any) 27 (19.6) 62 (15.2) 0,06

Patient agreeing with the definition of a generic 66 (48.5) 269 (66.9) <0,001

Patient having already received generics 105 (80.1) 327 (83.6) 0,36

Patient accepting generics for another pathology 81 (60.5) 319 (81.2) <0,001

Patient accepting ARV generics 38 (27.5) 200 (50.6) <0,001

Percentage or median (IQR)

Country of birth

FranceAfricaEuropeOther

77%18%4%2%

Highest level of education

No qualificationPrimary schoolSecondary school diplomaInitial professional diplomaHigh school diplomaUniversity degree

6%9%11%24%16%34%

In employment Full or part-time 57%

Social security coverageGeneral systemUniversal health insurance coverage (CMU)State medical assistance (AME)

90%10%0%

Additional coverageTop-up insurance policyCMU top-up coverageNone

78%8%14%

HIV duration 13 (5-21)

Route of contamination

Homo/bisexualHeterosexualIDUOther

46%38%10%5%

CDC stageABC

55%20%24%

ARV treatmentyesduration (years)> 6 months< 6 months

95%11 (3-16)85%10%

CD4 Most recent CD4 count/mm3

Nadir/mm3580 (420-799)224 (103-240)

HIV viral load < 50 copies/ml>50 copies/ml < 6 months>50 copies/ml > 6 months

79%2%19%

Comorbidity

None Co-infection HCVCo-infection HBVOther chronic pathology - Arterial hypertension- Cardiovascular pathology- Diabetes- Kidney failure- Cancer- Other

60%13%6%23%16%14%5%4%2%5%

Hospital monitoring

Every monthEvery 3 monthsEvery 6 monthsEvery year

10%56%33%1%

ARV deliveryPharmacy in townHospital pharmacyBoth

49%30%21%

CONCLUSIONAcceptability of ARV generics in this Frenchpopulation is mostly dictated by the patient’sand physician’s knowledge and use ofgenerics overall. Switching ARV brand nameto a generic would be better accepted if thepill burden remained unchanged.

Refusal N=129

Acceptance N=409 p-value

Male sex 80 (62.0) 321 (78.5) <0.001

Age, mean (sd) 48.9 (10.9) 48.3 (11.5) 0.64

France native 46 (36.8) 79 (19.8) <0.001

Living in the Ile-de-France region 90 (69.8) 295 (72.1) 0.60

Educational high school diploma or higher 17 (20.2) 67 (33.3) 0.04

In employment 63 (50.8) 235 (59.2) 0.10

Social security coverage 121 (94.5) 393 (96.3) 0.44

HIV duration ≥13 years 64 (51.2) 205 (51.8) 0.91

Heterosexual contamination 62 (53.9) 133 (34.9) <0.001

CDC stage A B C

64 (50.8)19 (15.1)43 (34.1)

222 (57.5)83 (21.5)81 (21.0)

0.01

Treatment duration 10.9 (7.0) 10.2 (7.1) 0.35

Current CD4 count ≥500/mm3 73 (58.4) 269 (67.1) 0.08

CD4 nadir ≥200/mm3 116 (92.8) 383 (95.5) 0.23

HCV status 18 (14.1) 49 (12.0) 0.64

HBV status 8 (6.3) 20 (4.9) 0.84

Cardiovascular comorbidities 13 (10.2) 59 (14.5) 0.35

All comorbidities 55 (42.6) 146 (35.7) 0.16

Patient agreeing with the definition of a generic 28 (21.7) 310 (76.2) <0.001

Patient having already received generics 66 (55.5) 368 (91.1) <0.001

Patient foregoing third party payment 16 (33.3) 24 (14.7) 0.01

Patient accepting generics per se 8 (7.9) 230 (79.6) <0.001

This poster presents independent research by CHU Clermont-Ferrand, the promoter of the survey. Mylan provided funding for data capture. AcknowledgementsG. Jacques, D. Bastide Ales, S. Rehaiem, E. Pichard Angers, S. Trouillier Aurillac M. Dulucq, JF. Delfraissy Bicetre, JC. Duthe, L. de Saint Martin Brest, P. Goubin, R. Verdon Caen, D. Coban, H. Laurichesse Clermont-Ferrand, S. Gothier, P. Chavanet Dijon, C. Cerland, A. Cabié Fort de France, H. Berthe, C. Perrone Garches, I. Suaud, P. PerréLa Roche sur Yon, I. AISSI, S. Vandamme Lens, E. Garcia, D. Peyramond Lyon Croix-Rousse, I. Ahmed Y. Belkhir, P. Brouqui Marseille Hôpital Nord, E. Nehmée, O. Antoniotti Montluçon, M. Benomar, G. Beck Wirth Mulhouse, H. Hue, F. Raffi Nantes, P. Dellamonica Nice, R. Doncesco, A. Sotto Nimes, S. Le Gac, Y. Yazdanpanah Paris-Bichat, M. Pietri, D. Salmon, Paris Cochin, PM. Girard, Paris Saint-Antoine, S. Souak, JF Bergman, Paris Lariboisière, JL Ecobichon, H. Masson Poissy-Saint-germain, M. Mallet, H. Aumaitre Perpignan, P. Hutin Quimper, I. Kmiec, R. Jaussaud Reims, P. Lotton, C. Michelet, Rennes, O. Guerin, F. Caron, Rouen, D. Bornarel, D. Zuckman Suresnes, D. Line Soissons, P. Choisy, A. Cheret Tourcoing, P. Choisy, C Fontier Valenciennes, M. Delestan, T. May Vandoeuvre les Nancy.

Clotilde.allavena@chu-nantes.fr

P 076

Hidden costs of HIV treatment in Spain: inefficiency of the antiretroviral drug packaging

Llibre-, Josep M1; Andreu-Crespo, Àngels2; Cardona-Peitx ,Glòria2; Sala-Piñol, Ferran2; Clotet-Sala , Bonaventura1; Bonafont-Pujol , Xavier2

1Hospital Universitari Germans Trias i Pujol, Fundació LLuita Contra la Sida, HIV, Barcelona, Spain; 2Hospital Universitari GermansTrias i Pujol, Pharmacy, Barcelona, Spain;

Background Antiretroviral drugs in Spain are delivered by law only in hospital pharmacies. Commercial packages meet variable qualitystandards when dispensed drugs are returned due to treatment changes or adherence problems. Nearly 20-25% of the initialregimens will be changed at 48 weeks for different reasons. We evaluated the economic impact on public health system of theinability of using returned drugs due to inefficient packaging.

Class C - Drug packed in plastic containers with complete info written only on a label over the container, that would allow repackaging only before its initial delivery, but not when returned to the pharmacy.

Class D - Drug packed in plastic containers with manufacturer’s warning that the product can not be placed outside of the original package due to special conditions of conservation (fridge, humidity ) that doesn’t allow a unit dose

Class A - Drug packed in unit doses with complete info (name of drug, dosage in mg, lot number, and expiring date) in each unit, maintaining complete information of the drug if returned when theexternal package is opened.

Class B – Drug packed in blisters with complete info in the blister, but not in all unit doses, without special conservation Conditions.

Methodology: We defined socially efficient packaging as the best adapted one to being delivered in unit dose to outpatients, and classified:

P077Correspondence : aandreu.germanstrias@gencat.cat

Conclusions: A significant economic budget is lost through socially inefficient antiretroviral packages thatprevent reusing drugs returned to hospital pharmacy.Newer treatments are packaged in C and D categories, therefore favouring the maintenance of these hiddencosts in the near future.Any improvement in the excellence of packaging by the manufacturer, and favouring the choice of drugs suppliedthrough efficient packages (when efficacy, toxicity and convenience are similar) should minimize the treatmentexpenditures paid by National health budgets.

that doesn’t allow a unit dose repackaging or reusing once the container has been opened.

We analyzed a 12-month period (July 2011-june 2012) in a Hospital-based HIV outpatient Pharmacy that serves 2413 HIV treated individuals .

47.139.91 €

One year study Totally lostReturned medication

Results: Patients generated 23574 visits to Pharmacy, and received 48325 drug packages, with 2.529.137 pills delivered.Subjects suffered 1051 treatment changes for any reason. A total amount of 122.945 € in treatment were returned topharmacy in opened packages during the study period. 75.805 € came from returned packages in good condition that couldpotentially be reused. 47.139.91 € would be totally lost, mainly due to being packaged up in class C and D boxes, theequivalent of treating 78 patients with Rilpivirine/TDF/FTC during 1 month. Class A and B packages in bad conditionrepresented only 1.1% of the cost.Most of the treatment changes were not foreseeable.

Di Carlo, Paola1; Immordino, Palmira1 ;Mazzola, Giovanni2; Colletti, Pietro2; Alongi, Ilenia1; Mineo,Maurizio2; Scognamillo, Marco1; Vitale, Francesco1; Casuccio, Alessandra1

1University of Palermo, Department of Sciences for Health Promotion, Palermo, Italy;2University Hospital “Paolo Giaccone”, Infectious disease Unit, Palermo, Italy;

Background: The increased lifeexpectancy of HIV patients in the eraof highly active antiretroviral therapyhas had profound consequences forthe health care systems that providetheir care. It is useful to assesswhether health care resources need tobe adapted to the different stages ofHIV infection or to patientcharacteristics (1).To study how patientfeatures influence utilization of outpatient services, we retrospectivelyanalyzed the Electronic Health Recordof HIV-positive patients who hadfollowed day-care programs at theAIDS Center of the University ofPalermo, Italy.

Materials and Methods: 223 HIV-infected subjects were recruited and dividedinto two groups according to CD4 cell counts (117 with a CD4 count ≤ 500/mm3and 106 with CD4 count ≥ 500/mm3). Data on age, gender, race, lifestyle habits(including educational level, drug abuse history, smoking status, alcoholconsumption, sexual behaviour) BMI, HIV-RNA, CD4+ T-cell count, antiretroviraltherapy (ART), comorbidities such as HCV co-infection, osteoporosis biomarker,dyslipidemia, diabetes, renal function and systolic and diastolic blood pressurewere recorded in a purposely-designed database and were analyzed in relationto AIN by uni- and multivariable logistic regression.

Results: Table 1 shows thecharacteristics of enrolled patients; theaverage age of the recruited patientswas 45.4 ± 9.5 years. 163 individualswere male (73%), 26 were immigrants(12%) and 91 (40%) were treatment-naïve. Mean day care access forlaboratory tests to evaluate stage ofHIV and for treatment monitoring was6.5 days for CD4 cell countmeasurements and 9.6 for HIVRNA/Drug-resistance testing. Whenpatients were stratified according toCD4 count, mean day care access forlaboratory tests to evaluate HIV stageand to monitor treatment wasnegatively correlated with CD4 cellcounts.

Conclusions: only patients with CD4 counts ≤ 500/mm3showed higher rates of health care utilization; these datamay be useful for monitoring and revising implementationplans for the different phases of HIV disease.

Variable HIV with a CD4 count ≤ 500/mm3 n=117

HIV with a CD4 count ≥ 500/mm3 n=106

P

Age years SD 45.4 45.8 NsMale/Female 84/33 79/27 ns

BMI (Kg/m2) SD 23.4 24.6 nsEthnicity (n, %):

Caucasian /African 99/18 98/8 ns

high-risk sexual behaviours

Heterosex/homosex/bisexual men

20/29/10 35/22/20 ns

CD4+ T-cell count (cells/μL) (mean) 310 1044 ///

HIV-RNA copies/mL (mean) 25.728 6.669 ns

25-Hydroxyvitamin D (ng/mL) 28.9 25.1 ns

Drug addiction (n, %) 33 22 nsTreatment-naïve (n, %) 46 45 ns

ARV therapy ( < 5 years) 52 30 0.014ARV therapy (5-10 years) 17 20 nsARV therapy (> 10 years) 45 52 ns

mean day care access for laboratory tests

CD4/Viral load7.0/10.1 6.2/9.4 0.045/ns

Table 1. Selected characteristics of 223 HIV-infected patients

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell’Università degli Studi di Palermo

References and Legends1.Brennan A, Morley D, O'Leary AC, Bergin CJ, Horgan M.Determinants of HIV Outpatient Service Utilization: ASystematic Review. AIDS Behav. 2014 Jun 8.