Risk of HIV-1 low level viremia to treatment. Germany. Nadine Lübke Düsseldorf

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1 Risk of HIV-1 low level viremia to treatment failure in the AREVIR-RESINA cohort in Germany Nadine Lübke Düsseldorf

2 FDA Approval of antiretroviral drugs Zidovidine Didanosine Tipranavir 1981 First reported AIDS cases 1992 Zalcitabine 1995 Lamivudine Saquinavir 1996 Indinavir Ritonavir Nevirapine 2000 Didanosine Trizivir Kaletra 2001 Tenofovir 2006 Atripla Darunavir 2011 Eviplera Nevirapine XR Rilpivirine 2012 Stribild 2015 Evotaz Genvoya Prezcobix 2016 Descovy Odefsey 1994 Stavidine 1997 Combivir Delavirdine Nelfinavir 2003 Emtricitabine Atazanavir Fosamprenavir Enfuvirtide 2007 Raltegravir Maraviroc 2013 Dolutegravir 1998 Abacavir Efavirenz 1999 Amprenavir 2004 Kivexa Truvada 2008 Etravirine 2014 Triumeq Elvitegravir Cobicistat 2014 Triumeq Elvitegravir Cobicistat NRTI: Nucleoside Reverse Transcriptase Inhibitor; NNRTI: Non-Nucleoside Reverse Transcriptase Inhibitor; PI: Protease Inhibitor; INI: Integrase Inhibitor; EI: Enty Inhibitors; FDC: Fixed-Dose Combination 2

3 Antiretroviral Therapy (ART) NNRTI Regimen PI Regimen INI Regimen NRTI NRTI NRTI NNRTI PI INI NRTI NRTI NRTI AIM: Viral suppresion below the limit of detection NRTI nucleoside reverse transcriptase inhibitor NNRT non- nucleoside reverse transcriptase inhibitor PI protease inhibitor INI integrase inhibitor 3

4 Low Level Viremia and Virological failure 2013: Persistent LLV between 50 and 999 cop/ml associated with increased risk of VF 2016: HIV-RNA >200 cop/ml was strongest predictor of VF HIV-1 low level viremia (LLV) is predictive for virological failure (VF) 4

5 Objectives Analysis of the association of LLV and virological failure to ART. 5

6 Definitions therapeutic success: reduction of the HIV-1 viral load (VL) below 50 copies/ml (German-Austrian guidelines for the treatment of HIV infection) Low level viremia (LLV): repeated VL measurements between 50 and 200 copies/ml after initial therapeutic success Virological failure (VF): confirmed viral load greater than 200 copies/ml following therapeutic success 6

7 AREVIR/RESINA database: Material & Methods clinical and virological data of therapy-naïve (TN) and therapy-experienced (TE) HIV-1-infected patients in North Rhine-Westphalia, Germany Query of the database: therapies with VL measurements at least once every 24 weeks patients who attained confirmed therapeutic success under ART and experienced confirmed LLV thereafter 2,485 first line and 3657 further-line therapies (6142 total) 7

8 Frequency of Low Level Viremia LLV occurred in 294/6142 documented therapies (4.8%) Mean time to LLV: 27 months (σ=20.7) LLV rate increased in TE patients versus TN patients 8

9 Virological failures subsequent to LLV VF occurred in 56/294 (19%) cases subsequent to LLV Median viral load at failure: 472 copies/ml (range cop/ml) Mean LLV episode: 77.4 weeks (σ=68.0) VF rate increased in TE patients versus TN patients 9

10 Risk of LLV and VF according to drug approval Risk of LLV and subsequent virological failure is significantly increased with drugs approved

11 Risk of LLV and VF according to drug class Most risk of LLV with PI regimens: 165/294 (56.1%) and NNRTI regimens: 76/294 (25.9%) Comparable VF rates of NRTI-, NNRTI- and PI-based therapies (Ø=20%, range %) 11

12 Risk of LLV and VF according to the drug * Approved 2004 VF after LLV was never related to integrase or entry inhibitors Low risk of VF subsequent to LLV with drugs approved 2005 (p<0.001) 12

13 Summary and Conclusion low prevalence of LLV in patients on suppressive ART (4.8%) VF subsequent to LLV observed in 19% of the cases LLV and subsequent VF increased in therapy-experienced patients Strongest predictor for VF subsequent to LLV was a treatment regimen containing drugs approved before 2005 Episodes of LLV in patients treated with drugs with high potency and a high barrier to resistance are not predictive for VF 13

14 Thanks to Institute of Virology, University of Düsseldorf Jörg Timm Andreas Walker Jennifer Camdereli Iris Hermann Wiebke Moskorz Robin Folgnandt AREVIR- and RESINA-partners Institute of Virology, University of Cologne Rolf Kaiser Elena Knops Veronica Di Cristanziano Maria Neumann-Fraune Eugen Schülter Claudia Müller Saleta Sierra-Aragon Eva Heger Alejandro Pironti, Thomas Lengauer, MPI of Informatics, Saarbrücken Mark Oette, Dept. Gastroenterologie, Augustinerinnen Hospital, Cologne Stefan Esser, Dept. Dermatology, University Hospital Essen Björn Jensen, Dept. Gastroenterology, Hepatology and Infectious Diseases, UKD Norbert Bannert, Barbara Bartmeyer, Osama Hamouda, Klaus Jansen, Claudia Kücherer, Robert Koch Institut (RKI), Berlin Funding by MASTER-HIV/HEP (RKI) 14

15 Questions? 15

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