In the management of HIV,

TIMES ARE CHANGING

Now is the time for a 2-drug regimen (2DR) for your treatment-naïve adult patients.

TIVICAY▼ (dolutegravir) + lamivudine was studied in HBV-negative patients with viral loads up to 500,000 copies/mL

This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine.

Do patients still need 3 drug regimens for life?

Is it time to rethink the way we treat HIV?

No one should take more medicines than they need

2DRs: Meeting a clinical need

The HIV treatment landscape has changed dramatically over the past 30 years, with each decade serving as a foundation for the next to build upon. We have now entered a new era of HIV treatment...THE 2DR ERA.
 

Timeline

*JULUCA▼ (dolutegravir/rilpivirine) is indicated for HIV-1 virologically suppressed adults on a stable regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any NNRTI or INI.

TIVICAY + lamivudine was studied in HBV-negative patients with viral loads up to 500,000 copies/mL. This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine

   
   

All medicines have side effects and the potential to cause harm

        • A 20-year-old starting a 3-drug regimen may be on therapy for nearly 6 DECADES, which translates to MORE THAN 60,000 DOSES of individual medications6
        • Long-term use of ARVs may cause POTENTIAL TOXICITIES
        • Comorbidities and polypharmacy increase the RISK OF DRUG-DRUG INTERACTIONS
        • The availability of EFFICACIOUS ARVs WITH HIGHER BARRIERS TO RESISTANCE LIKE DOLUTEGRAVIR (DTG), have made it possible to establish a 2DR TREATMENT PARADIGM, creating the opportunity for TIVICAY + lamivudine and JULUCA to:

 

  

Achieve and maintain the same level of efficacy as traditional 3-drug regimens with fewer drugs in treatment-naïve and virologically suppressed patients, respectively7,8

Reduce ARV exposure and potential for associated toxicities7,8

Adverse event profiles are consistent with the individual ARV labels9-11

  

  

See how a 2DR can benefit your patients

Is it time to rethink the way we treat HIV?

Reducing the long-term effects of HIV medication on the body ranked as the most important improvement among people living with HIV (PLHIV).12

Question 1:

Do your patients ever raise concerns about the long-term effects of their HIV medication?

Findings from Positive Perspectives—a recent global survey of over 1,111 PLHIV—showed that:

of patients sometimes worried about long-term effects
(n=783/1,085), with 67% raising concerns with their HCPs (n=525/1,085).
12

Findings from Positive Perspectives—a recent global survey of over 1,111 PLHIV—showed that:

of patients sometimes worried about long-term effects
(n=783/1,085), with 67% raising concerns with their HCPs (n=525/1,085).
12

Question 2:

Would any of your patients be open to changing their current regimens to ones composed of fewer drugs?

Findings from Positive Perspectives—a recent global survey of over 1,111 PLHIV—showed that:

of global participants were open to changing their current regimens to ones composed of fewer drugs as long as their viral load remained suppressed (n=675/1,085).12

Findings from Positive Perspectives—a recent global survey of over 1,111 PLHIV—showed that:

of global participants were open to changing their current regimens to ones composed of fewer drugs as long as their viral load remained suppressed (n=675/1,085).12

 

Explore more about the perspectives and attitudes of PLHIV by visiting the patient information site LIV Life.

What makes DTG an optimal core agent to power a 2DR?

Only dolutegravir...

Figure based on IMS data as of March 2018.23

Learn more

Explore dolutegravir-based, 2-drug regimens for your diverse patient needs

 

 

References:

  1. A timeline of HIV/AIDS. https://www.hiv.gov/sites/default/files/aidsgov-timeline.pdf. Accessed September 19, 2018.
  2. Llibre JM, Walmsley S, Gatell JM. Backbones versus core agents in initial ART regimens: one game, two players. J Antimicrob Chemother. 2016;71:856-861.
  3. Antiretroviral drugs used in the treatment of HIV infection. http://www.fda.gov/ForPatients/Illness/HIVAIDS/Treatment/ucm118915.htm. Accessed September 19, 2018.
  4. ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV [news release]. London, UK; ViiV Healthcare group of companies; May 21, 2018. https://www.viivhealthcare.com/en-gb/media/press-releases/2018/may/viiv-healthcare-receives-eu-marketing-authorisation-for-juluca-dolutegravirrilpivirine-the-first-2-drug-regimen-once-daily-single-pill-for-the-treatment-of-hiv/
  5. https://www.viivhealthcare.com/en-gb/media/press-releases/viiv-healthcare-receives-chmp-positive-opinion-for-tivicay-eu-label-update-with-gemini-study-data-for-the-2-drug-regimen-of-tivicay-plus-lamivudine/
  6. The Antiretroviral Therapy Cohort Collaboration. Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies. Lancet HIV. 2017;4:e349-e356.
  7. Aboud M, Orkin C, Podzamczer D, et al. Durable suppression 2 years after switch to DTG + RPV 2-drug regimen: SWORD-1 and SWORD-2 studies. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. Poster THPEB047.
  8. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Cahn et al. The Lancet. Published online November 9, 2018 http://dx.doi.org/10.1016/S0140-6736(18)32462-0
  9. TIVICAY Summary of Product Characteristics.
  10. EPIVIR Summary of Product Characteristics.
  11. Edurant Summary of Product Characteristics.
  12. Data on file. Positive Perspectives survey data. ViiV Healthcare group of companies. Research Triangle Park, NC.
  13. Walmsley S, Baumgarten A, Berenguer J, et al. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naive patients: week 96 and week 144 results from the SINGLE randomized clinical trial. J Acquir Immune Defic Syndr. 2015;70(5):515-519.
  14. Molina J-M, Clotet B, van Lunzen J, et al; on behalf of the FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2(4):e127-e136.
  15. Orrell C, Hagins DP, Belonosova E, et al; on behalf of the ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017;4:e536-e546.
  16. Aboud M, Kaplan R, Lombaard J, et al. Superior efficacy of dolutegravir (DTG) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) compared with lopinavir/ritonavir (LPV/RTV) plus 2 NRTIs in second-line treatment—interim data from the DAWNING Study. Presented at: Annual International AIDS Conference; July 23-26, 2017; Paris, France.
  17. Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.
  18. Raffi F, Jaeger H, Quiros-Roldan E, et al; on behalf of the extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13(11):927-935.
  19. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063-2072.
  20. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380–1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;4;390(10107):2073-2082.
  21. Molina J-M, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018;5(7):e357-e365.
  22. Data on file. IMS INI molecules by prescription volume globally, January 2015 to March 2018 (estimate). ViiV Healthcare group of companies. Research Triangle Park, NC.
  23. Data on file. Global dolutegravir (TIVICAY + TRIUMEQ + JULUCA) patient exposure expressed as total patient years (absolute). ViiV Healthcare group of companies. Research Triangle Park, NC.

Atripla is owned by or licensed to Bristol-Myers Squibb & Gilead Scienes, LLC.

Edurant is owned by or licensed to Janssen-Cilag Ltd.

UK/DTGRPV/0033/18(3) - December 2018