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SARS-CoV-2 Virologic Rebound With Nirmatrelvir-Ritonavir Therapy : An Observational Study.
Edelstein, Gregory E; Boucau, Julie; Uddin, Rockib; Marino, Caitlin; Liew, May Y; Barry, Mamadou; Choudhary, Manish C; Gilbert, Rebecca F; Reynolds, Zahra; Li, Yijia; Tien, Dessie; Sagar, Shruti; Vyas, Tammy D; Kawano, Yumeko; Sparks, Jeffrey A; Hammond, Sarah P; Wallace, Zachary; Vyas, Jatin M; Barczak, Amy K; Lemieux, Jacob E; Li, Jonathan Z; Siedner, Mark J.
Affiliation
  • Edelstein GE; Brigham and Women's Hospital, Boston, Massachusetts (G.E.E., Y.K., J.A.S.).
  • Boucau J; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts (J.B., C.M.).
  • Uddin R; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Marino C; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts (J.B., C.M.).
  • Liew MY; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Barry M; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Choudhary MC; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (M.C.C., J.Z.L.).
  • Gilbert RF; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Reynolds Z; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Li Y; Brigham and Women's Hospital and Massachusetts General Hospital, Boston, Massachusetts, and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Y.L.).
  • Tien D; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Sagar S; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Vyas TD; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Kawano Y; Brigham and Women's Hospital, Boston, Massachusetts (G.E.E., Y.K., J.A.S.).
  • Sparks JA; Brigham and Women's Hospital, Boston, Massachusetts (G.E.E., Y.K., J.A.S.).
  • Hammond SP; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Wallace Z; Massachusetts General Hospital, Boston, Massachusetts (R.U., M.Y.L., M.B., R.F.G., Z.R., D.T., S.S., T.D.V., S.P.H., Z.W.).
  • Vyas JM; Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (J.M.V.).
  • Barczak AK; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, and Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (A.K.B.).
  • Lemieux JE; Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Broad Institute, Cambridge, Massachusetts (J.E.L.).
  • Li JZ; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (M.C.C., J.Z.L.).
  • Siedner MJ; Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Africa Health Research Institute, KwaZulu-Natal, South Africa (M.J.S.).
Ann Intern Med ; 176(12): 1577-1585, 2023 12.
Article de En | MEDLINE | ID: mdl-37956428
ABSTRACT

BACKGROUND:

Data are conflicting regarding an association between treatment of acute COVID-19 with nirmatrelvir-ritonavir (N-R) and virologic rebound (VR).

OBJECTIVE:

To compare the frequency of VR in patients with and without N-R treatment for acute COVID-19.

DESIGN:

Observational cohort study.

SETTING:

Multicenter health care system in Boston, Massachusetts.

PARTICIPANTS:

Ambulatory adults with acute COVID-19 with and without use of N-R. INTERVENTION Receipt of 5 days of N-R treatment versus no COVID-19 therapy. MEASUREMENTS The primary outcome was VR, defined as either a positive SARS-CoV-2 viral culture result after a prior negative result or 2 consecutive viral loads above 4.0 log10 copies/mL that were also at least 1.0 log10 copies/mL higher than a prior viral load below 4.0 log10 copies/mL.

RESULTS:

Compared with untreated persons (n = 55), those taking N-R (n = 72) were older, received more COVID-19 vaccinations, and more commonly had immunosuppression. Fifteen participants (20.8%) taking N-R had VR versus 1 (1.8%) who was untreated (absolute difference, 19.0 percentage points [95% CI, 9.0 to 29.0 percentage points]; P = 0.001). All persons with VR had a positive viral culture result after a prior negative result. In multivariable models, only N-R use was associated with VR (adjusted odds ratio, 10.02 [CI, 1.13 to 88.74]; P = 0.038). Virologic rebound was more common among those who started therapy within 2 days of symptom onset (26.3%) than among those who started 2 or more days after symptom onset (0%) (P = 0.030). Among participants receiving N-R, those who had VR had prolonged shedding of replication-competent virus compared with those who did not have VR (median, 14 vs. 3 days). Eight of 16 participants (50% [CI, 25% to 75%]) with VR also reported symptom rebound; 2 were completely asymptomatic. No post-VR resistance mutations were detected.

LIMITATIONS:

Observational study design with differences between the treated and untreated groups; positive viral culture result was used as a surrogate marker for risk for ongoing viral transmission.

CONCLUSION:

Virologic rebound occurred in approximately 1 in 5 people taking N-R, often without symptom rebound, and was associated with shedding of replication-competent virus. PRIMARY FUNDING SOURCE National Institutes of Health.
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: SARS-CoV-2 / COVID-19 Limites: Adult / Humans Langue: En Journal: Ann Intern Med Année: 2023 Type de document: Article
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: SARS-CoV-2 / COVID-19 Limites: Adult / Humans Langue: En Journal: Ann Intern Med Année: 2023 Type de document: Article