Doravirine plus lamivudine two-drug regimen as maintenance antiretroviral therapy in people living with HIV: a French observational study

Author:

Perfezou Pascale1,Hall Nolwenn1,Duthe Jean-Charles1,Abdi Basma2ORCID,Seang Sophie3,Arvieux Cédric4,Lamaury Isabelle5,Menard Amélie6,Marcelin Anne-Geneviève2,Katlama Christine3,Palich Romain3ORCID,Chirouze C,Bouiller K,Bozon F,Brunel A S,Hustache-Mathieu L,Lagoutte J,Lepiller Q,Marty-Quinternet S,Pépin-Puget L,Rosolen B,Tissot N,Jaffuel S,Ansart S,Quintric Y,Rezig S,Quaesaet L,Gazeau P,Jacomet C,Mrozek N,Theis C,Vidal M,Richaud C,Anglade F,Sauvat L,Corbin V,Aumeran C,Baud O,Goncalvez E,Mazzocolin D,Mirand A,Brebion A,Henquell C,Lamaury I,Breugnon E,Chéret A,Curlier E,Duvallon E,Fabre I,Herrmann-Storck C,Markowicz S,Marquet M,Ouissa R,Pradat-Paz L,Samar K,Tressieres B,Merrien D,Bollangier O,Boucher D,Guimard T,Laine L,Leautez S,Morrier M,Perré P,Point P,Roncato-Saberan M,Pouget-Abadie X,Chapuzet C,Faba L,Faucher J F,Cypierre A,Ducroix-Roubertou S,Durox H,Genet-Villeger C,Pascual J,Pinet P,Codde C,Rogez S,Woillard J B,Benoist C,Alfaiate D,Becker A,Cotte L,Ader F,Brochier C,Brunel-Dalmas F,Cannesson O,Conrad A,Degroodt S,Ferry T,Godinot M,Icard V,Livrozet J M,Makhloufi D,Perpoint T,Roux S,Trabaud M A,Triffault-Fillit C,Valour F,Batalla A S,Lardot H,Simon M,Javaux C,Ravaux I,Ménard A,Belkhir Y,Colson P,Dhiver C,Martin-Degioanni M,Meddeb L,Mokhtari M,Motte A,Tissot-Dupont H,Toméi C,Brégigeon S,Zaegel-Faucher O,Laroche H,Dos Santos M,Ducassou M J,Galie S,Ivanova A,Jaquet I,Obry-Roguet V,Orticoni M,Ressiot E,Ritleng A S,Benkouiten S,Cabié A,Abel S,Bigeard B,Bidelogne C,Cabras O,Carnino L,Cuzin L,Fagour L,Gros-Dubois A,Guitteaud K,Lahuna C,Louis-Michel E,Métais A,Quenard F,Pierre-François S,Robert C,Cavalli Z,Bucy L,Genet R,Schneifer C,Perez P,Reynes J,Bistoquet M,Delaporte E,Le Moing V,Lejeune J,Meftah N,Merle de Boever C,Montes B,Montoya Ferrer A,Pansu N,Reynes J,Tuaillon E,Lefèvre B,André M,Baronnet G,Bevilacqua S,Boyer L,Bouillon M P,Charmillon A,Delestan M,Emilie C,Frentiu E,Goehringer F,Hénard S,Jeanmaire E,Rabaud C,Radjabaly-Mandjee A,Raffi F,Allavena C,André-Garnier E,Asquier-Khati A,Billaud E,Biron C,Bonnet B,Bouchez S,Boutoille D,Brunet-Cartier C,Cavellec M,Deschanvres C,Drumel T,Gaborit B J,Grégoire M,Jovelin T,Lefebvre M,Lecomte R,Mahot R,Morineau P,Paredes E,Reliquet V,Soria A,Pugliese P,Bréaud S,Buscot M,Carles M,Chirio D,Cua E,Dellamonica P,Demonchy E,De Monte A,Durant J,Ferrando S,Naqvi A,Perbost I,Pradier C,Prouvost-Keller B,Risso K,Touitou I,Viot A,Wehrlen-Pugliese S,Sunder S,Schepers K,Goudet V,Dos Santos A,Rzepecki V,Hocqueloux L,Béraud G,Gubavu C,Legros V,Mille C,Peira F,Prazuck T,Sève A,Goujard C,Castro-Gordon A,David-Chevallier P,Godard V,Quertainmont Y,Teicher E,Jaureguiberry S,Joly V,Charpentier C,Descamps D,Digumber M,Gervais A,Ghosn J,Julia Z,Landman R,Lariven S,Le Gac S,Louni F,Peiffer-Smadja N,Peytavin G,Rioux C,Yazdanpanah Y,Duvivier C,Amazzough K,Benabdelmoumen G,Bossi P,Cessot G,Charlier C,Consigny P H,De La Porte Des Vaux C,Garzaro M,Gomes-Pires E,Hochedez P,Jidar K,Lafont E,Lanternier F,Lortholary O,Louisin C,Lourenco J,Melenotte C,Pacoud O,Parize P,Ruyno F,Rouzaud C,Taieb F,Palich R,Valantin M A,Katlama C,Faycal A,Agher R,Dudoit Y,Hamani N,Qatib N,Qzaibri I,Lenclume L,Schneider L,Seang S,Tubiana R,Hall N,Perfezou P,Duthe J C,Drevillon F B,Talarmin J P,Khatchatourian L,Bani-Sadr F,Berger J L,Brodard V,Hentzien M,Kmiec I,Lambert D,Marty H,N’Guyen Y,Arvieux C,Baldeyrou M,Benezit F,Chapplain J M,Dupont M,Duthé J C,Ismaël S,Jovelin T,Lebot A,Lemaitre F,Luque-Paz D,Maillard A,Morlat C,Patrat-Delon S,Picard L,Poisson-Vannier M,Pronier C,Revest M,Tattevin P,Vivent J,Gagneux-Brunon A,Botelho-Nevers E,Frésard A,Pouvaret A,Ronat V,Rey D,Cheneau C,Bernard-Henry C,De Mautort E,Fafi-Kremer S,Fischer P,Gantner P,Mélounou C,Ursenbach A,Klee P,Hansmann Y,Lefebvre N,Ruch Y,Danion F,Hoellinger B,Lemmet T,Gerber V,Bourne-Watrin M,Delobel P,Alvarez M,Biezunski N,Boumaza X,Debard A,Delpierre C,Garnier C,Lelièvre L,Martin-Blondel G,Piffaut M,Rastoll C,Saune K,Robineau O,Aïssi E,Alcaraz I,Alidjinou E,Baclet V,Bocket L,Boucher A,Derdour V,Lafon-Desmurs B,Meybeck A,Pradier M,Tetart M,Valette M,Viget N,Diarra A,Corvaisier G,Brière M,De La Chapelle M,Gousseff M,Le Goff M,Thierry M,

Affiliation:

1. Public Health Center, Quimper Hospital , Quimper , France

2. Virology Department, Sorbonne University, Pitié-Salpêtrière Hospital, AP-HP, Pierre Louis Epidemiology and Public Health Institute (iPLESP), INSERM 1136 , Paris , France

3. Infectious Diseases Department, Sorbonne University, Pitié-Salpêtrière Hospital, AP-HP, Pierre Louis Epidemiology and Public Health Institute (iPLESP), INSERM 1136 , Paris , France

4. Infectious Diseases and Intensive Care Unit, University Hospital , Rennes , France

5. Infectious and Tropical Diseases Department, University Hospital of Guadeloupe , Pointe-à-Pitre , France

6. IHU-Méditerranée Infection, Aix Marseille University, AP-HM , Marseille , France

Abstract

Abstract Background Two-drug regimens based on integrase strand transfer inhibitors (INSTIs) and boosted PIs have entered recommended ART. However, INSTIs and boosted PIs may not be suitable for all patients. We aimed to report our experience with doravirine/lamivudine as maintenance therapy in people living with HIV (PLWH) followed in French HIV settings. Methods This observational study enrolled all adults who initiated doravirine/lamivudine between 1 September 2019 and 31 October 2021, in French HIV centres participating in the Dat’AIDS cohort. The primary outcome was the rate of virological success (plasma HIV-RNA < 50 copies/mL) at Week (W)48. Secondary outcomes included: rate of treatment discontinuation for non-virological reasons, evolution of CD4 count and CD4/CD8 ratio over follow-up. Results Fifty patients were included, with 34 (68%) men; median age: 58 years (IQR 51–62), ART duration: 20 years (13–23), duration of virological suppression: 14 years (8–19), CD4 count: 784 cells/mm3 (636–889). Prior to switching, all had plasma HIV-RNA < 50 copies/mL. All but three were naive to doravirine, and 36 (72%) came from a three-drug regimen. Median follow-up was 79 weeks (IQR 60–96). Virological success rate at W48 was 98.0% (95% CI 89.4–99.9). One virological failure occurred at W18 (HIV-RNA = 101 copies/mL) in a patient who briefly discontinued doravirine/lamivudine due to intense nightmares; there was no resistance at baseline and no resistance emergence. There were three strategy discontinuations for adverse events (digestive disorders: n = 2; insomnia: n = 1). There was no significant change in CD4/CD8 ratio, while CD4 T cell count significantly increased. Conclusions These preliminary findings suggest that doravirine/lamivudine regimens can maintain high levels of viral suppression in highly ART-experienced PLWH with long-term viral suppression, and good CD4+ T cell count.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

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