Using patient-reported outcomes to improve the management of co-infection with HIV and HCV: the ANRS CO13 HEPAVIH cohort

Abstract

The management of co-infection with HIV and hepatitis C virus (HCV) is complicated by viral and drug-drug interactions, treatment-related side effects, and the poor response to therapy of certain HCV genotypes. Current or past drug use may also have a negative impact. HEPAVIH (ANRS CO13) is an ongoing French cohort study of co-infected individuals which combines medical and socio-behavioral follow-up. This cohort study aims at analyzing the course of HCV infection and access to HCV treatment in HIV–HCV co-infected patients, using both clinical and patient-reported outcomes. This article documents the main lessons learned to date from the HEPAVIH data and published literature, while describing research prospects and needs requiring further investigation in the field of patient-reported outcomes.

Keywords::

• co-infection
• hepatitis C virus
• HIV
• patient-reported outcomes
• peg-interferon
• ribavirin

Acknowledgements

The authors would like to thank all members of the ANRS CO13-HEPAVIH Study Group. The authors especially thank all physicians and nurses who are involved in the follow-up of the cohort and all patients who took part in this study. Finally, the authors give their thanks to J Sweeney for the English revision and editing of our manuscript.

Scientific Committee of the ANRS CO13 HEPAVIH Study Group: D Salmon (principal investigator), F Dabis (principal investigator), L Wittkop, MA Loko, P Sogni, Y Benhamou, P Trimoulet, J Izopet, V Paradis, B Spire, P Carrieri, C Katlama, G Pialoux, MA Valantin, J Chas, I Poizot-Martin, B Marchou, E Rosenthal, D Garipuy, O Bouchaud, A Gervais, C Lascoux-Combe, C Goujard, K Lacombe, C Duvivier, D Vittecoq, D Neau, P Morlat, F BaniSadr, L Meyer, F Boufassa, L Piroth, B Autran, AM Roque, C Solas, H Fontaine, L Serfaty, G Chêne, D Costagliola, D Zucman, A Simon, S Dominguez, E Billaud, P Miailhes, J Polo Devoto, S Couffin-Cadiergues (ANRS).

Clinical Centers (ward/participating physicians): CHU Cochin, Paris (Médecine Interne et Maladies Infectieuses/D Salmon, H Mehawej; Hépato-gastro-entérologie/P Sogni; Anatomo-pathologie/B Terris, Z Makhlouf, G Dubost, F Tessier, L Gibault, F Beuvon, E Chambon, T Lazure; Virologie/A Krivine); CHU Pitié-Salpétrière, Paris (Maladies Infectieuses et Tropicales/C Katlama, MA Valantin, H Stitou; Hépato-gastroentérologie/Y Benhamou; Anatomo-pathologie/F Charlotte; Virologie/S Fourati); CHU Pitié-Salpétrière (Médecine Interne/A Simon, P Cacoub, S Nafissa; Anatomo-pathologie/F Charlotte; Virologie/S Fourati), CHU Sainte-Marguerite, Marseille (Service d'Immuno-Hématologie Clinique – CISIH/I Poizot-Martin, O Zaegel, N Cloarec, Virologie/C Tamalet); CHU Tenon, Paris (Maladies Infectieuses et Tropicales/G Pialoux, J Chas, F Bani-Sadr, L Slama; Anatomo-pathologie/P Callard, F Bendjaballah; Virologie/C Le-Pendeven); CHU Purpan Toulouse (Maladies Infectieuses et Tropicales/B Marchou; Hépato-gastro-entérologie/L Alric, K Barange, S Metivier; A Fooladi, Anatomo-pathologie/J Selves; Virologie/F Nicot); CHU Archet, Nice (Médecine Interne/E Rosenthal; Infectiologie/J Durant; Anatomo-pathologie/J Haudebourg, MC Saint-Paul); CHU Avicenne, Bobigny (Médecine Interne – Unité VIH/O Bouchaud; Anatomo-pathologie/ M Ziol; Virologie/Y Baazia); Hôpital Joseph-Ducuing, Toulouse (Médecine Interne/M Uzan, A Bicart-See, D Garipuy; MJ Ferro-Collados, Anatomo-pathologie/J Selves; Virologie/F Nicot); CHU Bichat – Claude-Bernard, Paris (Maladies Infectieuses/Y Yazdanpanah, A Gervais; Anatomo-pathologie/H Adle-Biassette); CHU Saint-Louis (Maladies infectieuses/JM Molina, C Lascoux Combe; Anatomo-pathologie/P Bertheau, J Duclos; Virologie/P Palmer); CHU Saint Antoine (Maladies Infectieuses et Tropicales/PM Girard, K Lacombe, P Campa; Anatomo-pathologie/D Wendum, P Cervera, J Adam; Virologie/C Viala); CHU Bicêtre, Paris (Médecine Interne/JF Delfraissy, C Goujard, Y Quertainmont; Virologie/C Pallier); CHU Bicêtre, Paris (Maladies Infectieuses/ D Vittecoq); CHU Necker, Paris (Maladies Infectieuses et Tropicales/O Lortholary, C Duvivier, M Shoai-Tehrani), CHU Pellegrin, Bordeaux (Service des Maladies Infectieuses et Tropicales/D Neau, A Ochoa, E Blanchard, S Castet-Lafarie, C Cazanave, D Malvy, M Dupon, H Dutronc, F Dauchy, L Lacaze-Buzy; Anatomo-pathologie/P Bioulac-Sage; Virologie/P Trimoulet, S Reigadas), Hôpital Saint-andré, Bordeaux (Médecine Interne et Maladies Infectieuses/P Morlat, D Lacoste, F Bonnet, N Bernard, M Bonarek Hessamfar, J Roger-Schmeltz, P Gellie, P Thibaut, F Paccalin, C Martell, M Carmen Pertusa, M Vandenhende, P Mercier, D Malvy, T Pistone, M Catherine Receveur, S Caldato; Anatomo-pathologie/P Bioulac-Sage; Virologie/P Trimoulet, S Reigadas); Hôpital du Haut-Levêque, Bordeaux (Médecine Interne/JL Pellegrin, JF Viallard, E Lazzaro, C Greib; Anatomo-pathologie/P Bioulac-Sage; Virologie/P Trimoulet, S Reigadas), Hôpital FOCH, Suresnes (Médecine Interne/D Zucman, C Majerholc ; Virologie/F Guitard), CHU Antoine Béclère, Clamart (Médecine Interne/F Boue, J Polo Devoto, I Kansau, V Chambrin, C Pignon, L Berroukeche, R Fior, V Martinez; Virologie/ C Deback), CHU Henri Mondor, Créteil (Immunologie Clinique/Y Lévy, S Dominguez, JD Lelièvre, AS Lascaux, G Melica), CHU Hôtel Dieu, Nantes (Maladies Infectieuses et Tropicales/F Raffi, E Billaud, C Alavena; Virologie/A Rodallec), Hôpital de la Croix Rousse, Lyon (Maladies Infectieuses et Tropicales/D Peyramond, C Chidiac, P Miailhes, F Ader, F Biron, A Boibieux, L Cotte, T Ferry, T Perpoint, J Koffi, F Zoulim, F Bailly, P Lack, M Maynard, S Radenne, M Amiri; Virologie/ Le-Thi Than-Thuy), CHU Dijon, Dijon (Département d'infectiologie/P Chavanet, L Piroth, M Duong Van Huyen, M Buisson, A Waldner Combernoux, S Mahy, R Binois, A Laure Simonet Lann, D Croisier-Bertin).

Data collection, management and statistical analyses: D Beniken, M Guignard, M Azar, P Honoré, S Breau, A Joulie, M Mole, C Bolliot, F Chouraqui, F Touam, F André, C Partouche, G Alexandre, A Mélard, J Baume, H Hue, L Larmet, C Brochier, V Thoirain, M Rannou, D Bornarel, S Gohier, C Chesnel, S Gillet, J Delaune, C Gilbert, L Dequae Merchadou, A Frosch, O Cheminat, G Maradan, C Taieb, F Marcellin, M Mora, C Protopopescu, C Lions, MA Loko, M Winnock.

Financial & competing interests disclosure

This study was sponsored and funded by the French National Agency for Research on Aids and Viral Hepatitis (ANRS), with the participation of Abbott France, Glaxo-Smith-Kline, Roche, Schering-Plough and INSERM's ‘Programme Cohortes TGIR’. The authors are French researchers working in a multidisciplinary team. F Marcellin, P Roux, C Lions, B Spire and M-P Carrieri work in the area of social sciences in health, with a focus on psychosocial issues associated with HIV infection and co-infection with viral hepatitis. Their work is mainly devoted to encouraging the integration of patient-reported outcomes in HIV research, as an essential complement to clinical endpoints. They are involved in the design and analysis of cohort studies and clinical trials conducted both in high- and low-income settings, mostly funded by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS). Since 2007, B Spire has been the National President of AIDES, the main nongovernmental HIV organization in France. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Patient-reported outcomes (PROs) are useful tool for an effective management of coinfection with HIV and hepatitis C virus (HCV).

• Routine collection of a minimum set of PROs – including adherence to treatment, addictive behaviors, and coffee intake – using standardized tools may facilitate interpretation of clinical research findings.

• Self-reports can be used to effectively screen for alcohol abuse in coinfected patients.

• Efforts toward developing trustful and nonstigmatizing relationships between HCV care providers and coinfected patients should be maintained.

• The fear of reduced adherence to antiretroviral therapy because of addictive behaviors should not delay HCV treatment initiation.

• Successful HCV treatment has a positive impact on co-infected patients' quality of life and may be associated with a reduction of addictive behaviors in this population.

• An effective treatment for depressive symptoms can relieve the functional impact of fatigue and help maintaining good adherence to antiretroviral therapy among co-infected patients.

• PROs will be an important tool to help developing interventions to prevent re-infection with HCV.