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1. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Orkin, Chloe, Molina, Jean-Michel, Cahn, Pedro, Lombaard, Johannes, Supparatpinyo, Khuanchai, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, Lahoulou, Rima, Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, and Inciarte Portillo, Alexy

Abstract

In two phase 3 trials for first-line therapy in adults with HIV-1, doravirine showed non-inferior efficacy, a favourable safety profile, and a superior lipid profile to darunavir and efavirenz through to 48 and 96 weeks. Here we report 192-week results from both studies.

Published
2024
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2. Weight loss as a predictor of survival and disease progression in HIV infection

Author

Wheeler, David A., Gibert, Cynthia L., Launer, Cynthia A., Muurahainen, Norma, Elion, Richard A., Abrams, Donald I., and Bartsch, Glenn E.

Subjects
HIV patients -- Health aspects, Weight loss -- Health aspects, Opportunistic infections -- Risk factors, Health
Abstract

Weight loss by an HIV patient, whether mild or severe, seems to be associated with impending death. This may be connected with increased death risk or with increased risk of opportunistic infection. The increase in the relative risk of death for those who lost 5% to 10% of body weight over four months was significant. Opportunistic infections increased significantly in this group including cytomegalovirus infections, Pneumocystis carinii pneumonia, and Mycobacterium avium complex. For those who lost 0% to 5% of their body weight, risk was also increased.

Published
1998

4. Select updates from the 16th CROI: treatment-related cardiovascular risk, pharmacokinetic issues, and interleukin-2 use

Author

Boyle, Brian A., Cohen, Calvin J., DeJesus, Edwin, Elion, Richard, Frank, Ian, Moyle, Graeme J., and Sax, Paul E.

Subjects
Bristol-Myers Squibb Co., Merck & Company Inc., Pfizer Inc., Pharmaceutical industry -- Health aspects, Cardiovascular diseases -- Risk factors, Cardiovascular diseases -- Health aspects, HIV (Viruses) -- Risk factors, HIV (Viruses) -- Health aspects, Proteases -- Health aspects, Protease inhibitors -- Health aspects, Medical research -- Health aspects, Medicine, Experimental -- Health aspects, Heart attack -- Risk factors, Heart attack -- Health aspects, Interleukins -- Health aspects, Health
Abstract

The 16th Conference on Retroviruses and Opportunistic Infections (CROI) was held in Montreal from February 8 to 11, 2009. This conference provided significant new insights into HIV therapeutics. Here we [...]

Published
2009

5. Antiretroviral therapy update from the 48th ICAAC/46th IDSA Annual Meeting

Author

Boyle, Brian A., Cohen, Calvin J., DeJesus, Edwin, Elion, Richard, Frank, Ian, Moyle, Graeme J., and Sax, Paul

Subjects
Bristol-Myers Squibb Co. -- Conferences, meetings and seminars, Merck & Company Inc. -- Conferences, meetings and seminars, Pfizer Inc. -- Conferences, meetings and seminars, Interscience Conference on Antimicrobial Agents and Chemotherapy, Pharmaceutical industry -- Conferences, meetings and seminars, Highly active antiretroviral therapy -- Conferences, meetings and seminars, Chemotherapy -- Conferences, meetings and seminars, HIV (Viruses) -- Conferences, meetings and seminars, HIV (Viruses) -- Care and treatment, Trade and professional associations -- Conferences, meetings and seminars, AIDS (Disease) -- Conferences, meetings and seminars, AIDS (Disease) -- Care and treatment, Medical research -- Conferences, meetings and seminars, Medicine, Experimental -- Conferences, meetings and seminars, Antiviral agents -- Conferences, meetings and seminars, Cancer -- Chemotherapy, Cancer -- Conferences, meetings and seminars, Health, International AIDS Society -- Conferences, meetings and seminars
Abstract

The combined 48th Interscience Conference on Antimicrobial Agents and Chemotherapy/46th Infectious Diseases Society of America Annual Meeting (ICAAC/IDSA) was held in Washington, DC, from October 24 to 28, 2008. This [...]

Published
2009

6. Antiretroviral treatment update from the 17th International AIDS Conference

Author

Boyle, Brian, Cohen, Cal, DeJesus, Edwin, Elion, Richard, Frank, Ian, Moyle, Graeme, and Sax, Paul

Subjects
Merck & Company Inc. -- Conferences, meetings and seminars, Bristol-Myers Squibb Co. -- Conferences, meetings and seminars, Pfizer Inc. -- Conferences, meetings and seminars, International Conference on AIDS -- 2006 AD, International Conference on AIDS -- 2008 AD, Pharmaceutical industry -- Conferences, meetings and seminars, Highly active antiretroviral therapy -- Conferences, meetings and seminars, AIDS (Disease) -- Conferences, meetings and seminars, AIDS (Disease) -- Drug therapy, Antiviral agents -- Conferences, meetings and seminars, HIV (Viruses) -- Conferences, meetings and seminars, HIV (Viruses) -- Drug therapy, Health
Abstract

The 17th International AIDS Conference was held in Mexico City from August 3 to 8, 2008. This conference attracted more than 20,000 participants and provided some significant new insights into [...]

Published
2008

7. Update on antiretroviral therapy: the 15th CROI

Author

Boyle, Brian A., Cohen, Calvin J., De Jesus, Edwin, Elion, Richard, Frank, Ian, Moyle, Graeme J., and Sax, Paul

Subjects
Bristol-Myers Squibb Co., Merck & Company Inc., Pfizer Inc., Pharmaceutical industry -- Health aspects, Highly active antiretroviral therapy -- Health aspects, Medical research -- Health aspects, Medicine, Experimental -- Health aspects, Antiviral agents -- Health aspects, Health
Abstract

The 15th Conference on Retroviruses and Opportunistic Infections (15th CROI) was held in Boston from February 3 to 6, 2008. There were more than 1000 oral and poster presentations at [...]

Published
2008

8. XVI International AIDS Conference: Part 2

Author

Boyle, Brian A., Cohen, Calvin J., Moyle, Graeme J., Elion, Richard, Sax, Paul E., and Frank, Ian

Subjects
International Conference on AIDS, AIDS (Disease) -- Drug therapy, Highly active antiretroviral therapy -- Usage, Health
Abstract

[AIDS Reader. 2006;16:581-584, 591-592] Key words: HIV/AIDS - International AIDS Conference - Antiretroviral therapy This column is the second part of a 2-part summary of the XVI International AIDS Conference. [...]

Published
2006

9. XVI International AIDS Conference: Part 1

Author

Boyle, Brian A., Cohen, Calvin J., Moyle, Graeme J., Elion, Richard, Sax, Paul E., and Frank, Ian

Subjects
International Conference on AIDS -- 2006 AD, Highly active antiretroviral therapy -- Reports, AIDS (Disease) -- Reports, Health
Abstract

[AIDS Reader. 2006;16:517-521] Key words: HIV/AIDS - International AIDS Conference - Antiretroviral therapy - Guidelines The XVI International AIDS Conference (IAC) was held August 13 to 18, 2006, in Toronto. [...]

Published
2006

10. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Author

Molina, Jean-Michel, Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, DeJesus, Edwin, Lai, Ming-Tain, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Hanna, George J, Hwang, Carey, Martin, Elizabeth Anne, Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Scarsella, Anthony John, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J., Sims, James, Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Mogyoros, Miguel, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Win, Sandra S., Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Dietz, Craig A., Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Melendez-Rivera, Ivan, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos, Maria Isabel, Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, de Jager, Marleen, Portilla Segorb, Joaquin, Mallolas, Josep, Perez Elias, Maria Jesus, Gatell, Josep M., Arribas Lopez, Jose Ramon, Negredo Puigmal, Eugenia, Podzamczer Palter, Daniel, Pulido Ortega, Federico, Troya Garcia, Jesus, De los Santos Gil, Ignacio, Berenguer Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Dockrell, David Harold, and Kegg, Stephen

Abstract

Doravirine is a novel, non-nucleoside reverse transcriptase inhibitor that has shown non-inferior efficacy to ritonavir-boosted darunavir, with a superior lipid profile, in adults with HIV who were treatment naive at week 48 in the phase 3 DRIVE-FORWARD trial. Here we present the 96-week data for the study.

Published
2020
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11. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Molina, Jean-Michel, Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, DeJesus, Edwin, Lai, Ming-Tain, Xu, Xia, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J, Hwang, Carey, Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E., Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, Portilla, Joaquin, Gatell, Josep Maria, Perez, Maria Jesus, Arribas, Jose Ramon, Negredo, Eugenia, Podzamczer, Daniel, Pulido, Federico, Troya, Jesus, De los Santos, Ignacio, Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Kegg, Stephen, Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Dretler, Robin, DeJesus, Edwin, Sloan, Louis, Lewis, Stanley T., Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Lalezari, Jacob Paul, Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Campo, Rafael E., Dietz, Craig A., Blick, Gary, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O., Santiago, Lizette, and Santana-Bagur, Jorge L.

Abstract

Doravirine is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) with a pharmacokinetic profile supporting once-daily dosing, and potent in-vitro activity against the most common NNRTI-resistant HIV-1 variants. We compared doravirine with ritonavir-boosted darunavir, when both were given with two nucleoside reverse transcriptase inhibitors (NRTIs), in adults with previously untreated HIV-1 infection.

Published
2018
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13. Financial Incentives for Linkage to Care and Viral Suppression Among HIV-Positive Patients: A Randomized Clinical Trial (HPTN 065)

Author

El-Sadr, Wafaa M., Donnell, Deborah, Beauchamp, Geetha, Hall, H. Irene, Torian, Lucia V., Zingman, Barry, Lum, Garret, Kharfen, Michael, Elion, Richard, Leider, Jason, Gordin, Fred M., Elharrar, Vanessa, Burns, David, Zerbe, Allison, Gamble, Theresa, and Branson, Bernard

Abstract

IMPORTANCE: Achieving linkage to care and viral suppression in human immunodeficiency virus (HIV)-positive patients improves their well-being and prevents new infections. Current gaps in the HIV care continuum substantially limit such benefits. OBJECTIVE: To evaluate the effectiveness of financial incentives on linkage to care and viral suppression in HIV-positive patients. DESIGN, SETTING, AND PARTICIPANTS: A large community-based clinical trial that randomized 37 HIV test and 39 HIV care sites in the Bronx, New York, and Washington, DC, to financial incentives or standard of care. INTERVENTIONS: Participants at financial incentive test sites who had positive test results for HIV received coupons redeemable for $125 cash-equivalent gift cards upon linkage to care. HIV-positive patients receiving antiretroviral therapy at financial incentive care sites received $70 gift cards quarterly, if virally suppressed. MAIN OUTCOMES AND MEASURES: Linkage to care: proportion of HIV-positive persons at the test site who linked to care within 3 months, as indicated by CD4+ and/or viral load test results done at a care site. Viral suppression: proportion of established patients at HIV care sites with suppressed viral load (<400 copies/mL), assessed at each calendar quarter. Outcomes assessed through laboratory test results reported to the National HIV Surveillance System. RESULTS: A total of 1061 coupons were dispensed for linkage to care at 18 financial incentive test sites and 39 359 gift cards were dispensed to 9641 HIV-positive patients eligible for gift cards at 17 financial incentive care sites. Financial incentives did not increase linkage to care (adjusted odds ratio, 1.10; 95% CI, 0.73-1.67; P = .65). However, financial incentives significantly increased viral suppression. The overall proportion of patients with viral suppression was 3.8% higher (95% CI, 0.7%-6.8%; P = .01) at financial incentive sites compared with standard of care sites. Among patients not previously consistently virally suppressed, the proportion virally suppressed was 4.9% higher (95% CI, 1.4%-8.5%; P = .007) at financial incentive sites. In addition, continuity in care was 8.7% higher (95% CI, 4.2%-13.2%; P < .001) at financial incentive sites. CONCLUSIONS AND RELEVANCE: Financial incentives, as used in this study (HPTN 065), significantly increased viral suppression and regular clinic attendance among HIV-positive patients in care. No effect was noted on linkage to care. Financial incentives offer promise for improving adherence to treatment and viral suppression among HIV-positive patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01152918

Published
2017
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14. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial

Author

Markowitz, Martin, Frank, Ian, Grant, Robert M, Mayer, Kenneth H, Elion, Richard, Goldstein, Deborah, Fisher, Chester, Sobieszczyk, Magdalena E, Gallant, Joel E, Van Tieu, Hong, Weinberg, Winkler, Margolis, David A, Hudson, Krischan J, Stancil, Britt S, Ford, Susan L, Patel, Parul, Gould, Elizabeth, Rinehart, Alex R, Smith, Kimberly Y, and Spreen, William R

Abstract

Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection.

Published
2017
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15. Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services

Author

Liu, Albert Y., Cohen, Stephanie E., Vittinghoff, Eric, Anderson, Peter L., Doblecki-Lewis, Susanne, Bacon, Oliver, Chege, Wairimu, Postle, Brian S., Matheson, Tim, Amico, K. Rivet, Liegler, Teri, Rawlings, M. Keith, Trainor, Nikole, Blue, Robert Wilder, Estrada, Yannine, Coleman, Megan E., Cardenas, Gabriel, Feaster, Daniel J., Grant, Robert, Philip, Susan S., Elion, Richard, Buchbinder, Susan, and Kolber, Michael A.

Abstract

IMPORTANCE: Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). OBJECTIVE: To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States. DESIGN, SETTING, AND PARTICIPANTS: Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015. INTERVENTIONS: A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. MAIN OUTCOMES AND MEASURES: Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. RESULTS: Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion. CONCLUSIONS AND RELEVANCE: The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

Published
2016
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16. Once-daily antiretroviral therapies for HIV infection: Consensus statement of an Advisory Committee of the International Association of Physicians in AIDS Care

Author

Cohen, Calvin, Elion, Richard A., Frank, Ian, Kloser, Patricia, Sherer, Renslow, Squires, Kathleen E., Steinhart, Corklin, and Tebas, Pablo

Abstract

Objective:Adherence is essential to successful virologic outcome of highly active antiretroviral therapy (HAART). Documented factors contributing to poor adherence include toxicity, food requirements, and pill burden. Once-daily antiretroviral therapies for HIV infection offer potential benefit by decreasing pill burden and dosing frequency, which may subsequently improve treatment adherence. This Consensus Statement is intended to offer guidance to physicians actively involved in HIV/AIDS care.Participants:Eight physicians with expertise in HIV medicine were invited by the International Association of Physicians in AIDS Care (IAPAC) to serve on an ad hoc Advisory Committee.Consensus process:IAPAC convened the Advisory Committee in June 2002 to develop a draft Consensus Statement. Scientific and clinical research, and other data in published literature and abstracts from scientific conferences were considered by strength of evidence. A Subcommittee updated the Consensus Statement in October 2002 to reflect relevant data presented at the XIV International AIDS Conference and the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy. This document represents consensus agreement of the Advisory Committee.Conflict of interest disclosure:The International Association of Physicians in AIDS Care sponsored and coordinated the development of this Consensus Statement with an unrestricted educational grant from Bristol-Myers Squibb. The opinions expressed in this Consensus Statement represent only those of the Advisory Committee.

Published
2002
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18. The insomnia of ‘sleeping in a strange place’: Effects of l-tryptophane

Author

Hartmann, Ernest and Elion, Richard

Abstract

Forty-two normal human subjects were studied in the sleep laboratory for one night each. Fourteen were given placebo at bedtime, 14 took l-tryptophane 1 g, and 14 took l-tryptophane 3 g. Both tryptophane groups had significantly lower sleep latency than the placebo group. The usually discarded ‘first laboratory night’ produces a mild situational insomnia in normal persons and thus can be useful in certain sleep studies.

Published
1977
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