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1. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., Ustianowski A., Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., and Ustianowski A.

Abstract

Background: Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods: We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings: Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332

Published
2019

2. Gestão clínica de comorbilidades no envelhecimento da população que vive com VIH: uma revisão de peritos – Parte II .

Author

Marques, N., Horta, A., Ferreira, A., Carneiro, F., Massano, J., Ferreira, J., Bragança, M., Tomada, N., Freitas, P., Maltez, F., Saraiva da Cunha, J., Sarmento e Castro, R., and Silva, A. R.

Abstract

Copyright of RPDI - Revista Portuguesa de Doenças Infecciosas is the property of Sociedade Portuguesa de Doencas Infecciosas e Microbiologia Clinica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

3. Prevenção da transmissão de VIH e de outras doenças infecciosas na era da terapia antirretrovírica.

Author

Guerreiro, C., Abreu, C., Miranda, A. C., Maltez, F., Saraiva da Cunha, J., Sarmento e Castro, R., and Silva, A. R.

Abstract

Copyright of RPDI - Revista Portuguesa de Doenças Infecciosas is the property of Sociedade Portuguesa de Doencas Infecciosas e Microbiologia Clinica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

6. Impact of interferon-free regimens on the glomerular filtration rate during treatment of chronic hepatitis C in a real-life cohort.

Author

Álvarez‐Ossorio, M. J., Sarmento e Castro, R., Granados, R., Macías, J., Morano‐Amado, L. E., Ríos, M. J., Merino, D., Álvarez, E. N., Collado, A., Pérez‐Pérez, M., Téllez, F., Martín, J. M., Méndez, J., Pineda, J. A., Neukam, K., Alados‐Arboledas, Juan Carlos, Albendín, Helena, Alemán, María Remedios, Alonso, María del Mar, and Asensi, Victor

Subjects
*THERAPEUTIC use of interferons, *GLOMERULAR filtration rate, *HEPATITIS C treatment, *HEPATITIS C virus, *NEPHROTOXICOLOGY
Abstract

Little data are available on renal toxicity exerted by direct-acting antivirals (DAAs) in real life. The aim of this study was to assess the impact of direct-acting antivirals against hepatitis C virus infection currently used in Spain and Portugal on the estimated glomerular filtration rate (eGFR) in clinical practise. From an international, prospective multicohort study, patients treated with DAAs for at least 12 weeks and with eGFR ≥30 mL/min per 1.73 m2 at baseline were selected. eGFR was determined using the CKD-EPI formula. A total of 1131 patients were included; 658 (58%) were HIV/HCV-coinfected patients. Among the 901 patients treated for 12 weeks, median (interquartile range) eGFR was 100 (87-107) at baseline vs 97 (85-105) mL/min per 1.73 m2 at week 12 of follow-up (FU12) post-treatment (P < .001). For HIV-coinfected subjects who received tenofovir plus a ritonavir-boosted HIV protease inhibitor (PI/r), baseline vs FU12 eGFR were 104 (86-109) vs 104 (91-110) mL/min per 1.73 m2 (P = .913). Among subjects receiving ombitasvir/paritaprevir with or without dasabuvir, eGFR did not show any significant change. Of 1100 subjects with eGFR >60 mL/min per 1.73 m2 at baseline, 22 (2%) had eGFR <60 mL/min per 1.73 m2 at FU12, but none presented with eGFR <30 mL/min per 1.73 m2. In conclusion, eGFR slightly declines during therapy with all-oral DAAs and this effect persists up to 12 weeks after stopping treatment in subjects with normal to moderately impaired renal function, regardless of HIV status. Concomitant use of tenofovir plus PI/r does not seem to have an impact on eGFR. [ABSTRACT FROM AUTHOR]

Published
2018
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7. High Therapeutic Efficiency With Ledipasvir/Sofosbuvir For The Treatment Of Genotype 1 Chronic Hepatitis C In Portugal

Author

Ferreira, D, primary, Félix, J, additional, Almeida, J, additional, Mota, M, additional, Afonso-Silva, M, additional, Silva, P, additional, Vandewalle, B, additional, Velosa, J, additional, Marinho, R, additional, Aldir, I, additional, Carvalho, A, additional, Valente, C, additional, Macedo, G, additional, Sarmento e Castro, R, additional, and Pedroto, I, additional

Published
2015
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8. Ledipasvir / Sofosbuvir for The Treatment of Chronic Hepatitis C: A Cost-Effectiveness Analysis Across Different Genotype 1 Clinical Subgroups

Author

Félix, J, primary, Almeida, J, additional, Ferreira, D, additional, Mota, M, additional, Afonso-Silva, M, additional, Silva, P, additional, Vandewalle, B, additional, Velosa, J, additional, Marinho, R, additional, Aldir, I, additional, Carvalho, A, additional, Valente, C, additional, Macedo, G, additional, Sarmento e Castro, R, additional, and Pedroto, I, additional

Published
2015
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9. 25 Anos de Sida: história de uma pandemia: em memória de José Luís Champalimaud

Author

Sarmento e Castro, R., Lecour, Henrique, and Veritati - Repositório Institucional da Universidade Católica Portuguesa

Subjects
AIDS, Historical aspects, Antiretroviral therapy
Abstract

Twenty five years after the report of the first cases of HIV/AIDS we can consider that the evolution of this pandemic registered several successes but also significant failures. During the first 15 years of the pandemic, etiologic agent was identified, diagnostic tests were developed and the first antiretrovirals were available. During this period we could verify that the use of zidovudine had a prophylactic effect on the vertical transmission and that some drugs could prevent several opportunistic infections. However, the morbidity and the mortality associated to the infection continued to be very significant and AIDS was considered a fatal disease. Only in 1996 with the development of HAART (highly active antiretroviral therapy) AIDS became a chronic disease. The use of protease inhibitors and, later, of non-nucleoside reverse transcriptase inhibitors, the development of resistance assays and the capacity to quantify the viral load and of dosing the plasmatic concentration of the antiretrovirals, were important tools to change the course of this infection. Nevertheless, in 2007, HIV continues to resist to the efforts to find a cure or a vaccine and HIV continues to spread particularly in the poorest countries of the World and infected until now 65 millions of persons of which 25 millions died.

Published
2007

10. Population mobility and the changing epidemics of HIV-2 in Portugal

Author

Carvalho, A C, Valadas, E, França, L, Carvalho, C, Aleixo, M J, Mendez, J, Marques, Rita, Sarmento, A, Doroana, M, Antunes, F, Branco, T, Aguas, M, Sarmento E Castro, R, Lazarus, J V, Barros, H, Carvalho, A C, Valadas, E, França, L, Carvalho, C, Aleixo, M J, Mendez, J, Marques, Rita, Sarmento, A, Doroana, M, Antunes, F, Branco, T, Aguas, M, Sarmento E Castro, R, Lazarus, J V, and Barros, H

Abstract

Portugal is the European country with the highest frequency of HIV-2 infection, which is mainly concentrated in West Africa. The cumulative number of notified HIV-2 infections in Portugal was 1813 by the end of December 2008. To better characterize the dynamics of HIV-2 infection in the country and to obtain data that may be of use in the prevention of the spread of HIV-2, we evaluated a large pooled sample of patients.

Published
2012

12. Population mobility and the changing epidemics of HIV-2 in Portugal

Author

Carvalho, AC, primary, Valadas, E, additional, França, L, additional, Carvalho, C, additional, Aleixo, MJ, additional, Mendez, J, additional, Marques, R, additional, Sarmento, A, additional, Doroana, M, additional, Antunes, F, additional, Branco, T, additional, Águas, M, additional, Sarmento e Castro, R, additional, Lazarus, JV, additional, and Barros, H, additional

Published
2011
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15. Febre num doente regressado de Angola.

Author

Silva, A., Méndez, J., Abreu, M., and Sarmento e Castro, R.

Abstract

Copyright of RPDI - Revista Portuguesa de Doenças Infecciosas is the property of Sociedade Portuguesa de Doencas Infecciosas e Microbiologia Clinica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2013

16. Population mobility and the changing epidemics of HIV-2 in Portugal.

Author

Carvalho, AC, Valadas, E, França, L, Carvalho, C, Aleixo, MJ, Mendez, J, Marques, R, Sarmento, A, Doroana, M, Antunes, F, Branco, T, Águas, M, Sarmento e Castro, R, Lazarus, JV, and Barros, H

Subjects
DIAGNOSIS of HIV infections, HIV infection epidemiology, BLOOD transfusion, EPIDEMICS, HIV infections, HOSPITALS, MEDICAL care, NOMADS, PATIENTS, POPULATION, PUBLIC health, DATA analysis, DESCRIPTIVE statistics
Abstract

Introduction Portugal is the European country with the highest frequency of HIV-2 infection, which is mainly concentrated in West Africa. The cumulative number of notified HIV-2 infections in Portugal was 1813 by the end of December 2008. To better characterize the dynamics of HIV-2 infection in the country and to obtain data that may be of use in the prevention of the spread of HIV-2, we evaluated a large pooled sample of patients. Patients and methods Five Portuguese hospitals provided data on HIV-2-infected patients from 1984 to the end of 2007. Data concerning demographic characteristics and clinical variables were extracted. Patients were stratified according to date of diagnosis in approximately 5-year categories. Results The sample included 442 patients, accounting for 37% of all HIV-2 infections notified in Portugal during that period. HIV-2-infected patients showed clearly different characteristics according to the period of diagnosis. Until 2000, the majority of HIV-2-infected patients were Portuguese-born males living in the north of the country. From 2000 to 2007, most of the patients diagnosed with HIV-2 infection had a West African origin, were predominantly female and were living in the capital, Lisbon. The average age at diagnosis and loss to follow-up significantly increased over time. Conclusion HIV-2 infection has been documented in Portugal since the early 1980s and its epidemiology appears to reflect changes in population movement. These include the movements of soldiers and repatriates from African territories during the independence wars and, later, migration and mobility from high-endemicity areas. The findings of this study stress the importance of promoting migrant-sensitive health care. [ABSTRACT FROM AUTHOR]

Published
2012
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23. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Pedro Cahn, Juan Sierra Madero, José Ramón Arribas, Andrea Antinori, Roberto Ortiz, Amanda E Clarke, Chien-Ching Hung, Jürgen K Rockstroh, Pierre-Marie Girard, Jörg Sievers, Choy Man, Alexander Currie, Mark Underwood, Allan R Tenorio, Keith Pappa, Brian Wynne, Anna Fettiplace, Martin Gartland, Michael Aboud, Kimberly Smith, Lidia Cassetti, Daniel David, Laura Figueras, Marcelo Losso, Gustavo Lopardo, Sergio Lupo, Norma Porteiro, Marisa Sánchez, Mark Bloch, David Cooper, Robert Finlayson, Anthony Kelleher, Kenneth Koh, David Lewis, James McMahon, Richard Moore, Norman Roth, Matthew Shields, Stephane De Wit, Eric Florence, Jean-Christophe Goffard, Remy Demeester, Patrick Lacor, Bernard Vandercam, Linos Vandekerckhove, Jonathan Angel, Jean-Guy Baril, Brian Conway, Alexandra De Pokomandy, Jason Szabo, Sharon Walmsley, Olivier Bouchaud, Christian Chidiac, Pierre Delobel, Cecile Goujard, Christine Katlama, Jean-Michel Molina, Gilles Pialoux, Patrick Philibert, Johannes Bogner, Stefan Esser, Ivanka Krznaric, Clara Lehmann, Christoph Spinner, Hans-Jurgen Stellbrink, Christoph Stephan, Albrecht Stoehr, Enrico Barchi, Pietro Caramello, Francesco Castelli, Anna Maria Cattelan, Antonella D'Arminio Monforte, Antonio Di Biagio, Giovanni Di Perri, Andrea Gori, Franco Maggiolo, Barbara Menzaghi, Guglielmo Migliorino, Cristina Mussini, Giovanni Penco, Massimo Puoti, Giuliano Rizzardini, Roberto Gulminetti, Adriano Lazzarin, Tiziano Quirino, Laura Sighinolfi, Pierluigi Viale, Gerardo Amaya Tapia, Jaime Andrade Villanueva, Enrique R Granados Reyes, Alma Perez Rios, Mario Santoscoy Gomez, Jan Den Hollander, Bart Rijnders, José A Hidalgo, Luis Hercilla Vasquez, Luis Illescas, Anita Olczak, Kamal Mansinho, Patricia Paula Correia Pacheco, Eugénio Teófilo, Jose Saraiva da Cunha, Rui Sarmento e Castro, Rosário Serrão, Manuela Arbune, Cristian Jianu, Anca Oprea, Liliana Preotescu, Liviu-Jany Prisacariu, Elena Belonosova, Olga Borodkina, Oxana Chernova, Natalia Gankina, Svetlana Kizhlo, Valeriy Kulagin, Nadezhda Kurina, Firaya Nagimova, Vadim Pokrovsky, Elena Ryamova, Evgeny Voronin, Alexey Yakovlev, Richard Kaplan, Sun Hee Lee, Shin-Woo Kim, Sang-Il Kim, Woo Joo Kim, Antonio Antela Lopez, Jose L Casado Osorio, Manuel A Castaño Carracedo, Ignacio De Los Santos Gil, Vicente Estrada Perez, Vicenç Falco Ferrer, Luis Force, Maria Jose Galinda Puerto, Miguel Garcia Deltoro, Josep M Gatell, Miguel A Goenaga Sanchez, Ana González Cordón, Hernando Knobel, Juan Carlos Lopez Bernaldo de Quiros, Juan E Losa Garcia, Mar Masia, Marta Montero-Alsonso, Antonio Ocampo Hermida, Juan Pasquau Liaño, Joaquin Portilla Sogorb, Federico Pulido Ortega, Antonio Rivera Roman, Jose Ramon Santos Fernandez, Rafael Torres Perea, Jesus Troya Garcia, Pompeyo Viciana Fernandez, Alexandra Calmy, Christoph Hauser, Jan Fehr, Shu-Hsing Cheng, Wen-Chien Ko, Hsi-Hsun Lin, Po-Liang Lu, Yu-Ting Tseng, Ning-Chi Wang, Wing-Wai Wong, Chia-Jui Yang, Roberto Arduino, Paul Benson, Mezgebe Berhe, Fritz Bredeek, Cynthia Brinson, Thomas Campbell, Gordon Crofoot, Douglas Cunningham, Edwin DeJesus, Robin Dretler, Joseph Eron, Kenneth Fife, Carl Fichtenbaum, Jason Flamm, Deborah Goldstein, Samir Gupta, Debbie Hagins, Margaret Hoffman-Terry, Dushyantha Jayaweera, Clifford Kinder, Daniel Klein, Cheryl McDonald, Anthony Mills, Ronald Nahass, Olayemi Osiyemi, Edgar Overton, David Parks, David Prelutsky, Moti Ramgopal, Shannon Schrader, Beverly Sha, Gary Simon, James Sims, Daniel Skiest, Jihad Slim, Karen Tashima, Blair Thedinger, Brian Gazzard, Julie Fox, Margaret Johnson, Stephen Kegg, Saye Khoo, Charles Mazhude, Chloe Orkin, Gabriel Schembri, Andrew Ustianowski, Clinical sciences, Microbiology and Infection Control, Internal Medicine, Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, and Ustianowski, A

Subjects
Male, HIV Dolutegravir, HIV Infections, 030204 cardiovascular system & hematology, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Abacavir, Heterocyclic Compounds, Emtricitabine, 030212 general & internal medicine, Viral, Tenofovir/adverse effects, Lamivudine/adverse effects, Medicine(all), education.field_of_study, Adult, Anti-HIV Agents, Anti-Retroviral Agents, Double-Blind Method, Drug Therapy, Combination, Female, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Lamivudine, Middle Aged, RNA, Viral, Tenofovir, Viral Load, Heterocyclic Compounds, 3-Ring/adverse effects, General Medicine, Emtricitabine/adverse effects, Tolerability, Dolutegravir, Combination, medicine.drug, medicine.medical_specialty, Pyridones, Population, HIV Infections/drug therapy, Anti-Retroviral Agents/adverse effects, 3-Ring, 03 medical and health sciences, Drug Therapy, SDG 3 - Good Health and Well-being, Internal medicine, Oxazines, medicine, HIV-1/isolation & purification, RNA, Viral/blood, education, business.industry, Viral Load/drug effects, Regimen, chemistry, RNA, Anti-HIV Agents/adverse effects, Ritonavir, business
Abstract

Summary Background Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332 (93%) of 358 receiving the three-drug regimen achieved plasma HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −2·6%, 95% CI −6·7 to 1·5); in GEMINI-2, 335 (93%) of 360 in the two-drug regimen and 337 (94%) of 359 in the three-drug regimen achieved HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −0·7%, 95% CI −4·3 to 2·9), showing non-inferiority at a −10% margin in both studies (pooled analysis: 655 [91%] of 716 in the two-drug regimen vs 669 [93%] of 717 in the three-drug regimen; adjusted treatment difference −1·7%, 95% CI −4·4 to 1·1). Numerically, more drug-related adverse events occurred with the three-drug regimen than with the two-drug regimen (169 [24%] of 717 vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen). Two deaths were reported in the two-drug regimen group of GEMINI-2, but neither was considered to be related to the study medication. Interpretation The non-inferior efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended three-drug regimen at 48 weeks in ART-naive adults supports its use as initial therapy for patients with HIV-1 infection. Funding ViiV Healthcare.

Published
2019

24. Trimethoprim-Based multicomponent solid Systems: Mechanochemical Screening, characterization and antibacterial activity assessment.

Author

Piccirillo G, Aroso R, Baptista JA, A E Castro R, da Silva GJ, Calvete MJF, Pereira MM, Canotilho J, and Ermelinda S Eusébio M

Subjects
Microbial Sensitivity Tests, Acetaminophen chemistry, Acetaminophen pharmacology, Curcumin chemistry, Curcumin pharmacology, X-Ray Diffraction methods, Chemistry, Pharmaceutical methods, Ciprofloxacin chemistry, Ciprofloxacin pharmacology, Drug Liberation, Trimethoprim chemistry, Trimethoprim pharmacology, Anti-Bacterial Agents pharmacology, Anti-Bacterial Agents chemistry, Solubility, Escherichia coli drug effects
Abstract

In this work, multicomponent trimethoprim-based pharmaceutical solid systems were developed by mechanochemistry, using coformers from the GRAS list and other active pharmaceutical ingredients. The choice of coformers took into account their potential to increase the aqueous solubility/dissolution rate of TMP or its antibacterial activity. All the binary systems were characterized by thermal analysis, powder X-ray diffraction and infrared spectroscopy, and 3 equimolar systems with FTIR pointing to salts, and 4 eutectic mixtures were identified. The intrinsic dissolution rate of TMP in combination with nicotinic acid (a salt) and with paracetamol (eutectic mixture) were 25% and 5% higher than for pure TMP, respectively. For both Gram-positive and -negative strains, the antibacterial activity of TMP with some of the coformers was improved, since the dosage used was lower than the TMP control. A significant increase in antibacterial activity against E. coli was found for the eutectic mixture with curcumin, with the best results being obtained for the eutectic and equimolar mixtures with ciprofloxacin. Combining trimethoprim with coformers offers an interesting alternative to using trimethoprim alone: multicomponent forms with enhanced TMP dissolution rates were identified, as well as combinations showing enhanced antibacterial activity relatively to the pure drug., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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