Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection.


Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
19 03 2020
Historique:
pubmed: 5 3 2020
medline: 26 3 2020
entrez: 5 3 2020
Statut: ppublish

Résumé

Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection. We conducted a phase 3, randomized, open-label trial in which adults with HIV-1 infection who had not previously received antiretroviral therapy were given 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine. Participants who had an HIV-1 RNA level of less than 50 copies per milliliter after 16 weeks were randomly assigned (1:1) to continue the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by monthly injections of long-acting cabotegravir plus rilpivirine. The primary end point was the percentage of participants who had an HIV-1 RNA level of 50 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm). At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was found in 6 of 283 participants (2.1%) who received long-acting therapy and in 7 of 283 (2.5%) who received oral therapy (adjusted difference, -0.4 percentage points; 95% confidence interval [CI], -2.8 to 2.1), a result that met the criterion for noninferiority for the primary end point (margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 93.6% who received long-acting therapy and in 93.3% who received oral therapy (adjusted difference, 0.4 percentage points; 95% CI, -3.7 to 4.5), a result that met the criterion for noninferiority for this end point (margin, -10 percentage points). Of the participants who received long-acting therapy, 86% reported injection-site reactions (median duration, 3 days; mild or moderate severity, 99% of cases); 4 participants withdrew from the trial for injection-related reasons. Grade 3 or higher adverse events and events that met liver-related stopping criteria occurred in 11% and 2%, respectively, who received long-acting therapy and in 4% and 1% who received oral therapy. Treatment satisfaction increased after participants switched to long-acting therapy; 91% preferred long-acting therapy at week 48. Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral therapy with dolutegravir-abacavir-lamivudine with regard to maintaining HIV-1 suppression. Injection-site reactions were common. (Funded by ViiV Healthcare and Janssen; FLAIR ClinicalTrials.gov number, NCT02938520.).

Sections du résumé

BACKGROUND
Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection.
METHODS
We conducted a phase 3, randomized, open-label trial in which adults with HIV-1 infection who had not previously received antiretroviral therapy were given 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine. Participants who had an HIV-1 RNA level of less than 50 copies per milliliter after 16 weeks were randomly assigned (1:1) to continue the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by monthly injections of long-acting cabotegravir plus rilpivirine. The primary end point was the percentage of participants who had an HIV-1 RNA level of 50 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm).
RESULTS
At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was found in 6 of 283 participants (2.1%) who received long-acting therapy and in 7 of 283 (2.5%) who received oral therapy (adjusted difference, -0.4 percentage points; 95% confidence interval [CI], -2.8 to 2.1), a result that met the criterion for noninferiority for the primary end point (margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 93.6% who received long-acting therapy and in 93.3% who received oral therapy (adjusted difference, 0.4 percentage points; 95% CI, -3.7 to 4.5), a result that met the criterion for noninferiority for this end point (margin, -10 percentage points). Of the participants who received long-acting therapy, 86% reported injection-site reactions (median duration, 3 days; mild or moderate severity, 99% of cases); 4 participants withdrew from the trial for injection-related reasons. Grade 3 or higher adverse events and events that met liver-related stopping criteria occurred in 11% and 2%, respectively, who received long-acting therapy and in 4% and 1% who received oral therapy. Treatment satisfaction increased after participants switched to long-acting therapy; 91% preferred long-acting therapy at week 48.
CONCLUSIONS
Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral therapy with dolutegravir-abacavir-lamivudine with regard to maintaining HIV-1 suppression. Injection-site reactions were common. (Funded by ViiV Healthcare and Janssen; FLAIR ClinicalTrials.gov number, NCT02938520.).

Identifiants

pubmed: 32130806
doi: 10.1056/NEJMoa1909512
doi:

Substances chimiques

Anti-HIV Agents 0
Anti-Retroviral Agents 0
Pyridones 0
RNA, Viral 0
Rilpivirine FI96A8X663
cabotegravir HMH0132Z1Q

Banques de données

ClinicalTrials.gov
['NCT02938520']

Types de publication

Clinical Trial, Phase III Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1124-1135

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2020 Massachusetts Medical Society.

Auteurs

Chloe Orkin (C)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Keikawus Arasteh (K)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Miguel Górgolas Hernández-Mora (M)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Vadim Pokrovsky (V)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Edgar T Overton (ET)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Pierre-Marie Girard (PM)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Shinichi Oka (S)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Sharon Walmsley (S)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Chris Bettacchi (C)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Cynthia Brinson (C)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Patrick Philibert (P)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Johan Lombaard (J)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Marty St Clair (M)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Herta Crauwels (H)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Susan L Ford (SL)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Parul Patel (P)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Vasiliki Chounta (V)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Ronald D'Amico (R)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Simon Vanveggel (S)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

David Dorey (D)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Amy Cutrell (A)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Sandy Griffith (S)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

David A Margolis (DA)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Peter E Williams (PE)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Wim Parys (W)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

Kimberly Y Smith (KY)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

William R Spreen (WR)

From Queen Mary University of London, London (C.O.), and ViiV Healthcare, Brentford (V.C.) - both in the United Kingdom; EPIMED, Berlin (K.A.); Fundación Jiménez Díaz, Madrid (M.G.H.-M.); Central Research Institute of Epidemiology, Moscow (V.P.); the University of Alabama at Birmingham, Birmingham (E.T.O.); Hôpital Saint Antoine, Paris (P.-M.G.), and Hôpital Européen, Marseille (P. Philibert) - both in France; the National Center for Global Health and Medicine, Tokyo (S.O.); the University Health Network, University of Toronto, Toronto (S.W.), and GlaxoSmithKline, Mississauga (S.L.F., D.D.) - both in Ontario, Canada; North Texas Infectious Disease Consultants, Dallas (C. Bettacchi), and Central Texas Clinical Research, Austin (C. Brinson); Josha Research, Bloemfontein, South Africa (J.L.); ViiV Healthcare, Research Triangle Park, NC (M.S.C., P. Patel, R.D., A.C., S.G., D.A.M., K.Y.S., W.R.S.); and Janssen Research and Development, Beerse, Belgium (H.C., S.V., P.E.W., W.P.).

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