HIV treatment which may offer benefits for your PATIENTS LIVING WITH DIABETES

Building on 20 years’ triple therapy experience in HIV*

ODEFSEY® rilpivirine 25mg, emtricitabine 200mg & tenofovir alafenamide 25mg is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine and with a viral load ≤100,000 HIV-1 RNA copies/mL.1

DESCOVY® emtricitabine 200mg & tenofovir alafenamide 10mg or emtricitabine 200mg & tenofovir alafenamide 25mg is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).2

*Any regimen including 2 NRTIs plus a third agent RFTAF/UK/17-10/MI/1010b Date of preparation: January 2018

how much more likely is it for your patients to have diabetes than non-HIV-infected individuals?

Overall diabetes incidence is three times higher at 10.68 per 100 patient-years in HIV-positive individuals versus 2.91 in non-HIV-infected individuals (p<0.0001)4

This study examined diabetes rates in adults with and without HIV in a total of 7,101,180 person-years*4

Adapted from Currier J. et al. 2002 * The product of the number of years times the number of members of the population who have been infected by HIV.4

ART may further increase the risk of developing diabetes

There is a four-fold increase in the incidence of diabetes in HIV-infected men on ART compared with non-HIV-infected individuals5

How does diabetes influence the risk of MI?6

Patients with diabetes have the same risk of death from cardiovascular causes as a ‘high risk’ individual who has suffered a prior MI4

The East-West Study evaluated the 7-year incidence of MI* among 1059 diabetic subjects and 1373 non-diabetic subjects enrolled in a Finnish population-based prospective cohort study†6

Patients with DM but not CHD experience a similar rate of MI as patients without DM but with CHD6

Adapted from Haffner S. et al. 1998. * Fatal or non-fatal MI. † Study conducted in non-HIV-infected individuals.

WHAT IS THE RISK OF CKD IN YOUR PATIENTS IF THEY HAVE DIABETES?

The progression of CKD can be more rapid when a patient has both HIV and diabetes7

Additive effect of HIV infection and diabetes on CKD progression7

Adapted from Medapalli R et al. 2012

Annual assessment is recommended for people with diabetes due to the risk of developing diabetic nephropathy:8

  • Serum creatinine to determine eGFR
  • Urine albumin/creatinine ratio

Some HIV medicines can have an impact on renal markers9

  • How much would HCPs (who do not care for patients with HIV) understand about the impact that some ARVs can have on kidney markers?

how likely are patients to EXPERIENCE a heavy pill burden?

In the general population, almost 20% of patients over 65 years of age are taking 10 or more medications in a given week10

Polypharmacy is more common in diabetics

  • Associated with increased risks of drug–drug interactions, medication non-adherence and adverse events11

Polypharmacy is also more common in HIV-infected individuals than the general population12

  • Independent predictor of non-adherence to ART13

ODEFSEY® MAY BE A MORE SIMPLE AND CONVENIENT OPTION FOR YOUR HIV PATIENT WITH DIABETES

Odefsey® uses targeted tenofovir delivery to reduce plasma levels by 90%, compared with TDF14–18

Tenofovir Alafenamide (TAF) prodrug molecule mode of action

mode of action

The conversion of TAF into TFV occurs primarily in lymphoid cells, minimising systemic exposure and reducing off-target effects

HIGH RATES OF VIROLOGICAL SUPPRESSION ARE MAINTAINED WHEN SWITCHING TO ODEFSEY® FROM A TDF-BASED REGIMEN AT WEEK 48

Odefsey® reached its primary endpoint of non-inferiority and delivered high levels of virological suppression vs. continuing on RPV/FTC/TDF at Week 48 (94% [296/316] vs. 94% [294/313])19

Adapted from Orkin C, et al. 2017.

High rates of virological suppression were maintained regardless of age, gender or geographic region19,20

Adapted from DeJesus E, et al. 2017.

Patients experience statistically significant improvements in renal parameters

At Week 48, Odefsey® reduced proteinuria in patients switching from RPV/FTC/TDF or EFV/FTC/TDF in clinical trials19,20

Adapted from Orkin C, et al. 2017.

There were zero cases of proximal renal tubulopathy with Odefsey® at Week 4819,20

ODEFSEY HAS A LOWER PROPENSITY FOR DRUG-DRUG INTERACTIONS WITH DRUGS COMMONLY USED TO TREAT DIABETES

An Odefsey® STR has a low propensity for drug–drug interactions with medicines commonly used to manage a person with diabetes, such as metformin, compared with other ARV treatments, potentially reducing the risk of harmful drug errors between HIV and diabetes medications21

The SmPC for each medicine should always be the primary source when assessing the risk of potential drug–drug interaction.

Adapted from University of Liverpool drug interaction website.

COULD YOUR PATIENTS benefit from taking the smallest single-tablet regimen in HIV?

Consider this option for patients with complex pharmacological needs

Pill burden is often a challenge for people with diabetes. A small, single tablet for HIV management may help overall pill management and adherence.

One tablet once a day with food22

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Odefsey® for people living with HIV and diabetes

  1. Lower impact on renal parameters than other TDF-based regimens19,20
  2. Low propensity for drug–drug interactions, including drugs commonly used in diabetic management21
  3. Simple, convenient, smallest single–tablet regimen, which may support the management of polypharmacy23

Switching from TDF-based regimens to Descovy®-based REGIMENS offers your patients:

  • Trusted triple therapy – building on 20 years of successful treatment with triple therapy* in real-world settings8,23
  • Targeted tenofovir delivery – innovation bringing you a 90% reduction in plasma levels with Tenofovir Alafenamide (TAF)2,14–18which provides:
    • Established efficacy – maintained virological suppression (overall 95% vs. 93%)24 across varied clinical trial populations at Week 48
      • DURABLE EFFICACY – sustained to Week 144 (83%§)25
    • A LONG-TERM safety profile out to 144 weeks – zero cases of tubulopathy in clinical trials with statistically significant improvements in hip and spine bone mineral density in clinical trials at Weeks 4819,20,26–28 (n=2146), 9628,29 (n=1422), and 14425 (n=15328)
* Any regimen including 2 NRTIs plus a third agent. † HIV <50 copies/mL out to 48, 96 and 144 weeks. ‡ Difference of 1.7% (95% CI: 0.1, 3.4) – pooled data at Week 48. § For renally impaired patients switched to EVG/c/FTC/TAF. ¶ Numbers calculated to reflect the number of patients receiving TAF (excluding all discontinuations).

licensed indications

Tenofovir alafenamide (TAF) in the context of HIV and this presentation is referring to the co-formulated combinations outlined above. TAF is NOT licensed for use as a single agent for the treatment of HIV infection

Click here for prescribing information

References and abbreviations

References
  1. SmPC Odefsey®. Available at: https://www.medicines.org.uk/emc/medicine/32117 [accessed December 2017].
  2. British HIV Association (BHIVA) guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2015. (2016 interim update). Available at: http://www.bhiva.org/documents/Guidelines/Treatment/2016/treatment-guidelines-2016-interim-update.pdf [accessed December 2017].
  3. Currier J, et al. CROI 2002, Seattle, WA, USA, #677. Available at: http://www.natap.org/2002/9retro/day35.htm [accessed December 2017].
  4. Brown TT, et al. Arch Intern Med 2005; 165(10): 1179–1184.
  5. Haffner SM, et al. N Engl J Med 1998; 339(4): 229–234.
  6. Medapalli R, et al. J Acquir Immune Defic Syndr 2012; 60(4): 393-399.
  7. European AIDS Clinical Society Guidelines 9.0. October 2017. Available at: http://www.eacsociety.org/files/guidelines_9.0-english.pdf. [accessed: December 2017]
  8. Yombi JC, et al. AIDS 2014; 28(5): 621–632.
  9. Slone Epidemiology Centre, Boston Univerity 2006. Available at: http://www.bu.edu/slone/files/2012/11/SloneSurveyReport2006.pdf [accessed December 2017].
  10. Peron EP, et al. Clin Geriatr Med 2015; 31(1): 17–27.
  11. Gimeno-Gracia M, et al. Clin Intervent Aging 2016; 11: 1149–1157.
  12. Cantudo-Cuenca MR, et al. J Manag Care Spec Pharm 2014; 20(8): 844–850.
  13. Lee WA, et al. Antimicrob Agents Chemother 2005; 49(5): 1898–1906.
  14. Birkus G, et al. Antimicrob Agents Chemother 2007; 51(2): 543–550.
  15. Babusis D, et al. Mol Pharm 2013; 10(2): 459–466.
  16. Gupta S, et al. IAS 2015, Vancouver, Canada. Abstract TUAB0103.
  17. Sax PE, et al. Lancet 2015; 385(9987): 2606–2615.
  18. Orkin C, et al. Lancet HIV 2017; 4(5): e195–e204.
  19. DeJesus E, et al. Lancet HIV 2017; 4(5): e205–e213.
  20. University of Liverpool. HIV Drug Interactions. Available at: http://www.hiv-druginteractions.org/checker [accessed December 2017].
  21. Sax PE, et al. PLoS One 2012; 7(2): e31591.
  22. Department of Health and Human Services (DHHS). Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Updated October 2017. Available at: http://aidsinfo.nih.gov/guidelines. [accessed December 2017].
  23. Rockstroh J, et al. IAS 2017, Paris, France. Poster #MOPEB0289.
  24. Podzamczer D, et al. IAS 2017, Paris, France. Presentation: MOPEB0288.
  25. Gallant J, et al. Lancet HIV 2016; 3(4): e158–e165.
  26. Mills A, et al. Lancet Infect Dis 2016; 16(1): 43–52.
  27. Gilead Sciences. Data on File HIV-UK-17-03.
  28. Raffi F, et al. J Acquir Immune Defic Syndr 2017; 75(2): 226–231.
Abbreviations: ACE, angiotensin-converting-enzyme; ART, antiretroviral therapy; ARV, antiretroviral; ATV, atazanavir; BIG, biguanide; BHIVA, British HIV Association; c, cobicistat; CHD, coronary heart disease; CI, confidence interval; CKD, chronic kidney disease; COBI, cobicistat; Cr, creatinine; DM, diabetes mellitus; DPP-4, dipeptidyl peptidase-4; DRV, darunavir; DTG, dolutegravir; EFV, efavirenz; eGFR, estimated glomerular filtration rate; EVG, elvitegravir; FDA, Food and Drug Administration; FTC, emtricitabine; GI, gastrointestinal; GLP-1, glucagon-like peptide 1; HCP, healthcare professional; INSTI, integrase strand transfer inhibitor; MI, myocardial infarction; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RAL, raltegravir; RNA, ribonucleic acid; RPV, rilpivirine; RTV, ritonavir; SmPC, summary of product characteristics; STR, single-tablet regimen; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TFV, tenofovir.