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1. Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk: A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial

Author

Waters, Laura, Assoumou, Lambert, González-Cordón, Ana, Rusconi, Stefano, Domingo, Pere, Gompels, Mark, de Wit, Stephane, Raffi, François, Stephan, Christoph, Masiá, Mar, Rockstroh, Jürgen, Katlama, Christine, Behrens, Georg M N, Moyle, Graeme, Johnson, Margaret, Fox, Julie, Stellbrink, Hans-Jürgen, Guaraldi, Giovanni, Florence, Eric, Esser, Stefan, Gatell, José M, Pozniak, Anton, Martínez, Esteban, Vandekerckhove, Linos, Caluwé, Els, Necsoi, Coca, Frankenhuijsen, Maartje Van, Allavena, Clotilde, Reliquet, Véronique, Boutoille, David, Cavellec, Morane, André-Garnier, Elisabeth, Rodallec, Audrey, Tourneau, Thierry Le, Connault, Jérôme, Molina, Jean-Michel, Ferret, Samuel, Previlon, Miresta, Yazdanpanah, Yazdan, Landman, Roland, Joly, Véronique, Pinto, Adriana, Caby, Fabienne, Ktorza, Nadine, Schneider, Luminita, Wolf, Timo, Schüttfort, Gundolf, Wasmuth, Jan-Christian, Schwarze-Zander, Carolynne, Boesecke, Christoph, Hoffmann, Christian, Sabranski, Michael, Esser, Stephan, Jablonka, Robert, Wiehler, Heidi, Stoll, Matthias, Ahrenstorf, Gerrit, Nardini, Giulia, Beghetto, Barbara, Montforte, Antonella D’Arminio, Bini, Teresa, Cogliandro, Viola, Di Pietro, Massimo, Fusco, Francesco Maria, Galli, Massimo, Giacomelli, Andrea, Meraviglia, Paola, Torres, Berta, Mateo, Gracia, Gutierrez, Mar, Portilla, Joaquin, Merino, Esperanza, Reus, Sergio, Boix, Vicente, Gutiérrez, Félix, Padilla, Sergio, Clotet, Bonaventura, Negredo, Eugenia, Bonjoch, Anna, Casado, José L, Bañón-Escandell, Sara, Saban, Jose, Duque, Africa, Podzamczer, Daniel, Saumoy, Maria, Acerete, Laura, Gonzalez-Garcia, Juan, Bernardino, José Ignacio, Arribas, José Ramón, Hontañón, Victor, Pagani, Nicole, Bracchi, Margherita, Vera, Jaime, Clarke, Amanda, Adams, Tanya, Richardson, Celia, Winston, Alan, Mora-Peris, Borja, Mullaney, Scott, Esteban, Nahum de, Milinkovic, Ana, Pett, Sarah, Tiraboschi, Juan Manuel, Youle, Mike, Orkin, Chloe, Rackstraw, Simon, Hand, James, Jennings, Louise, Nicholls, Jane, and Johnston, Sarah

Subjects
Microbiology (medical), Infectious Diseases, Medizin
Abstract

BackgroundIn the NEAT022 trial, virologically suppressed persons with human immunodeficiency virus (HIV) at high cardiovascular risk switching from protease inhibitors to dolutegravir either immediately (DTG-I) or after 48 weeks (DTG-D) showed noninferior virological suppression and significant lipid and cardiovascular disease risk reductions on switching to dolutegravir relative to continuing protease inhibitors.MethodsIn post hoc analysis, major endpoints were 48-week and 96-week weight and body mass index (BMI) changes. Factors associated with weight/BMI changes within the first 48 weeks of DTG exposure, proportion of participants by category of percentage weight change, proportions of BMI categories over time, and impact on metabolic outcomes were also assessed.ResultsBetween May 2014 and November 2015, 204 (DTG-I) and 208 (DTG-D) participants were included. Weight significantly increased (mean, +0.810 kg DTG-I arm, and +0.979 kg DTG-D arm) in the first 48 weeks postswitch, but remained stable from 48 to 96 weeks in DTG-I arm. Switching from darunavir, White race, total to high-density lipoprotein cholesterol ratio ConclusionsSwitching from protease inhibitors to dolutegravir in persons with HIV with high cardiovascular risk led to modest weight gain limited to the first 48 weeks, which involved preferentially normal-weight or underweight persons and was not associated with negative metabolic outcomes.Clinical Trials RegistrationNCT02098837 and EudraCT 2013-003704-39.

Published
2022

2. The association between hepatitis B virus infection and nonliver malignancies in persons living with HIV: results from the EuroSIDA study

Author

Mocroft, Amanda, Miro, Jose M., Wandeler, Gilles, Llibre, Josep M., Boyd, Anders, van Bremen, Kathrin, Beniowski, Marek, Mikhalik, Julia, Cavassini, Matthias, Maltez, Fernando, Duvivier, Claudine, Uberti Foppa, Caterina, Knysz, Brygida, Bakowska, Elzbieta, Kuzovatova, Elena, Domingo, Pere, Zagalo, Alexandra, Viard, Jean Paul, Degen, Olaf, Milinkovic, Ana, Benfield, Thomas, Peters, Lars, Harxhi, A., Losso, M., Kundro, M., Schmied, B., Zangerle, R., Karpov, I., Vassilenko, A., Mitsura, V. M., Paduto, D., Clumeck, N., De Wit, S., Delforge, M., Florence, E., Vandekerckhove, L., Hadziosmanovic, V., Begovac, J., Machala, L., Sedlacek, D., Kronborg, G., Gerstoft, J., Katzenstein, T., Pedersen, C., Johansen, I. S., Ostergaard, L., Wiese, L., Moller, N. F., Nielsen, L. N., Zilmer, K., Smidt, J., Aho, I., Lacombe, K., Pradier, C., Fontas, E., Rockstroh, J., Behrens, G., Hoffmann, C., Stellbrink, H. J., Stefan, C., Bogner, J., Fätkenheuer, G., Chkhartishvili, N., Sambatakou, H., Adamis, G., Paissios, N., Szlávik, J., Gottfredsson, M., Devitt, E., Tau, L., Turner, D., Burke, M., Shahar, E., Wattad, L. M., Elinav, H., Haouzi, M., Elbirt, D., D’Arminio Monforte, A., Esposito, R., Mazeu, I., Mussini, C., Mazzotta, F., Gabbuti, A., Lazzarin, A., Castagna, A., Gianotti, N., Galli, M., Ridolfo, A., Uzdaviniene, V., Matulionyte, R., Staub, T., Hemmer, R., Dragas, S., Stevanovic, M., vd Valk, M., Trajanovska, J., Reikvam, D. H., Maeland, A., Bruun, J., Szetela, B., Inglot, M., Flisiak, R., Grzeszczuk, A., Parczewski, M., Maciejewska, K., Aksak-Was, B., Mularska, E., Jablonowska, E., Kamerys, J., Wojcik, K., Mozer-Lisewska, I., Rozplochowski, B., Mansinho, K., Radoi, R., Oprea, C., Gusev, D., Trofimova, T., Khromova, I., Borodulina, E., Ranin, J., Tomazic, J., Miró, J. M., Laguno, M., Martinez, E., Garcia, F., Blanco, J. L., Martinez-Rebollar, M., Mallolas, J., Callau, P., Rojas, J., Inciarta, A., Moreno, S., del Campo, S., Clotet, B., Jou, A., Paredes, R., Puig, J., Santos, J. R., Gutierrez, M., Mateo, G., Sambeat, M. A., Laporte, J. M., Svedhem, V., Thalme, A., Sönnerborg, A., Brännström, J., Flamholc, L., Kusejko, K., Braun, D., Calmy, A., Furrer, H., Battegay, M., Schmid, P., Kuznetsova, A., Sluzhynska, M., Johnson, M. A., Simons, E., Edwards, S., Phillips, A., Orkin, C., Winston, A., Clarke, A., Leen, C., Lundgren, J., Rasmussen, L. D., Kowalska, J. D., Guaraldi, G., Larsen, J. F., Bojesen, A., Neesgaard, B., Jaschinski, N., Fursa, O., Sather, M., Raben, D., Hansen, E. V., Kristensen, D., Fischer, A. H., Jensen, S. K., Elsing, T. W., Reekie, J., Cozzi-Lepri, A., Amele, S., Pelchen-Matthews, A., Roen, A., Tusch, E. S., Bannister, W., Mocroft, A., Miro, J. M., Wandeler, G., Llibre, J. M., Boyd, A., van Bremen, K., Beniowski, M., Mikhalik, J., Cavassini, M., Maltez, F., Duvivier, C., Uberti Foppa, C., Knysz, B., Bakowska, E., Kuzovatova, E., Domingo, P., Zagalo, A., Viard, J. -P., Degen, O., Milinkovic, A., Benfield, T., Peters, L., Harxhi, A., Losso, M., Kundro, M., Schmied, B., Zangerle, R., Karpov, I., Vassilenko, A., Mitsura, V. M., Paduto, D., Clumeck, N., De Wit, S., Delforge, M., Florence, E., Vandekerckhove, L., Hadziosmanovic, V., Begovac, J., Machala, L., Sedlacek, D., Kronborg, G., Gerstoft, J., Katzenstein, T., Pedersen, C., Johansen, I. S., Ostergaard, L., Wiese, L., Moller, N. F., Nielsen, L. N., Zilmer, K., Smidt, J., Aho, I., Lacombe, K., Pradier, C., Fontas, E., Rockstroh, J., Behrens, G., Hoffmann, C., Stellbrink, H. J., Stefan, C., Bogner, J., Fatkenheuer, G., Chkhartishvili, N., Sambatakou, H., Adamis, G., Paissios, N., Szlavik, J., Gottfredsson, M., Devitt, E., Tau, L., Turner, D., Burke, M., Shahar, E., Wattad, L. M., Elinav, H., Haouzi, M., Elbirt, D., D'Arminio Monforte, A., Esposito, R., Mazeu, I., Mussini, C., Mazzotta, F., Gabbuti, A., Lazzarin, A., Castagna, A., Gianotti, N., Galli, M., Ridolfo, A., Uzdaviniene, V., Matulionyte, R., Staub, T., Hemmer, R., Dragas, S., Stevanovic, M., vd Valk, M., Trajanovska, J., Reikvam, D. H., Maeland, A., Bruun, J., Szetela, B., Inglot, M., Flisiak, R., Grzeszczuk, A., Parczewski, M., Maciejewska, K., Aksak-Was, B., Mularska, E., Jablonowska, E., Kamerys, J., Wojcik, K., Mozer-Lisewska, I., Rozplochowski, B., Mansinho, K., Radoi, R., Oprea, C., Gusev, D., Trofimova, T., Khromova, I., Borodulina, E., Ranin, J., Tomazic, J., Laguno, M., Martinez, E., Garcia, F., Blanco, J. L., Martinez-Rebollar, M., Mallolas, J., Callau, P., Rojas, J., Inciarta, A., Moreno, S., del Campo, S., Clotet, B., Jou, A., Paredes, R., Puig, J., Santos, J. R., Gutierrez, M., Mateo, G., Sambeat, M. A., Laporte, J. M., Svedhem, V., Thalme, A., Sonnerborg, A., Brannstrom, J., Flamholc, L., Kusejko, K., Braun, D., Calmy, A., Furrer, H., Battegay, M., Schmid, P., Kuznetsova, A., Sluzhynska, M., Johnson, A. M., Simons, E., Edwards, S., Phillips, A., Johnson, M. A., Orkin, C., Winston, A., Clarke, A., Leen, C., Lundgren, J., Rasmussen, L. D., Kowalska, J. D., Guaraldi, G., Larsen, J. F., Bojesen, A., Neesgaard, B., Jaschinski, N., Fursa, O., Sather, M., Raben, D., Hansen, E. V., Kristensen, D., Fischer, A. H., Jensen, S. K., Elsing, T. W., Reekie, J., Cozzi-Lepri, A., Amele, S., Pelchen-Matthews, A., Roen, A., Tusch, E. S., Bannister, W., and Infectious diseases

Subjects
Hepatitis B virus, Hepatitis B Surface Antigens, Health Policy, virus diseases, HIV Infections, Hepatitis B, digestive system diseases, HBV DNA, hepatitis B, nonliver cancer, Infectious Diseases, Hepatitis B, Chronic, Neoplasms, DNA, Viral, Humans, Pharmacology (medical), 610 Medicine & health
Abstract

Objectives: The aim of this study was to assess the impact of hepatitis B virus (HBV) infection on non-liver malignancies in people living with HIV (PLWH). Methods: All persons aged ≥18 years with known hepatitis B virus (HBV) surface antigen (HBsAg) status after the latest of 1January 2001 and enrolment in the EuroSIDA cohort (baseline) were included in the study; persons were categorized as HBV positive or negative using the latest HBsAg test and followed to their first diagnosis of nonliver malignancy or their last visit. Results: Of 17485 PLWH included in the study, 1269 (7.2%) were HBV positive at baseline. During 151766 person-years of follow-up (PYFU), there were 1298 nonliver malignancies, 1199 in those currently HBV negative [incidence rate (IR)8.42/1000 PYFU; 95% confidence interval (CI) 7.94–8.90/1000 PYFU] and 99 in those HBV positive (IR10.54/1000 PYFU; 95% CI8.47–12.62/1000 PYFU). After adjustment for baseline confounders, there was a significantly increased incidence of nonliver malignancies in HBV-positive versus HBV-negative individuals [adjusted incidence rate ratio (aIRR)1.23; 95% CI 1.00–1.51]. Compared to HBV-negative individuals, HBsAg-positive/HBV-DNA-positive individuals had significantly increased incidences of nonliver malignancies (aIRR 1.37; 95% CI 1.00–1.89) and NHL (aIRR 2.57; 95% CI 1.16–5.68). There was no significant association between HBV and lung or anal cancer. Conclusions: We found increased rates of nonliver malignancies in HBsAg-positive participants, the increases being most pronounced in those who were HBV DNA positive and for NHL. If confirmed, these results may have implications for increased cancer screening in HIV-positive subjects with chronic HBV infection.

Published
2021

3. HCV reinfection after HCV therapy among HIV/HCV���coinfected individuals in Europe

Author

Amele, Sarah, Sandri, Anastasia Karachalia, Rodger, Alison, Vandekerckhove, Linos, Benfield, Thomas, Milinkovic, Ana, Duvivier, Claudine, Stellbrink, Hans���J��rgen, Sambatakou, Helen, Chkhartishvili, Nikoloz, Caldeira, Luis, Laguno, Monserrat, Domingo, Pere, Wandeler, Gilles, Gisinger, Martin, Kuzovatova, Elena, Dragovic, Gordana, Knysz, Brygida, Matulionyte, Raimonda, Rockstroh, J��rgen Kurt, Lundgren, Jens Dilling, Mocroft, Amanda, and Peters, Lars

Subjects
610 Medicine & health
Published
2021
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4. Efficacy and Safety of Switching From Boosted Lopinavir to Boosted Atazanavir in Patients With Virological Suppression Receiving a LPV/r-Containing HAART: The ATAZIP Study

Author

Mallolas, Josep, Podzamczer, Daniel, Milinkovic, Ana, Domingo, Pere, Clotet, Bonaventura, Ribera, Esteve, Gutierrez, Felix, Hernando Knobel, Cosin, Jaime, Ferrer, Elena, Alberto Arranz, Jose, Roca, Victor, Vidal, Francesc, Murillas, Javier, Pich, Judit, Pedrol, Enric, Llibre, Josep M., Dalmau, David, Garcia, Isabel, Aranda, Miquel, Cruceta, Ana, Martinez, Esteban, Blanco, Jose L., Lazzari, Elisa, Gatell, Jose M., and Atazip, Study Grp

Subjects
Adult, Male, medicine.medical_specialty, HAART, Anti-HIV Agents, Pyridines, Atazanavir Sulfate, HIV Infections, Pyrimidinones, Gastroenterology, Lopinavir, law.invention, protease inhibitor, Randomized controlled trial, law, Antiretroviral Therapy, Highly Active, Internal medicine, Drug Resistance, Viral, medicine, Humans, Pharmacology (medical), Aspartate Aminotransferases, Adverse effect, atazanavir, biology, business.industry, HIV, Alanine Transaminase, Drug Tolerance, Middle Aged, Lipids, Confidence interval, Discontinuation, Atazanavir, Surgery, lopinavir, Infectious Diseases, Liver, Alanine transaminase, Mutation, HIV-1, biology.protein, Female, Safety, business, Oligopeptides, medicine.drug
Abstract

Objectives: To evaluate the efficacy and safety of switching from boosted lopinavir (LPV/r) to boosted atazanavir (ATV/r) in virologically suppressed HIV-1-infected patients versus continuing LPV/r. Methods: Forty-eight weeks analysis of a randomized, open-label, noninferiority trial including patients with virological suppression (= 6 months) on LPV/r-containing triple highly active antiretroviral therapy. Patients (n = 248) were randomized 1:1 either to continue LPV/r twice a day (n = 127) or to switch to ATV/r every day (ATV/r; n = 121), with no change in nucleoside reverse transcriptase inhibitor backbone. Those known to have >4 protease inhibitor (PI)-associated mutations and/or who had failed >2 PI-containing regimens were excluded. Results: Baseline characteristics were balanced. 30% harboured >= 1 PI-associated mutation (10% harboured :l major mutation). Treatment failure at 48 weeks (primary end point) Occurred in 20% (25 of 127) of the LPV/r arm and in 17% (21 of 121) of the ATV/r arm (difference -2.3%; 95% confidence interval: -12.0 to 8.0; P = 0.0018). Virological failure Occurred in 7% (9 of 127) of the LPV/r arm and in 5% (6 of 121) of the ATV/r arm (difference -2.1%; 95% confidence interval: -8.7% to 4.2%, P < 0.0001 for non-inferiorating). CD4(+) changes from baseline were similar in each arm (approximately 40 cells/mm(3)). Adverse event rate leading to study drug discontinuation was 5% in both arms. Median fasting triglycerides and total cholesterol decreased significantly in the ATV/r arm (-53 and -19 mg/dL, respectively versus -4 and -4 mg/dL in the LPV/r arm; P < 0.001 in both comparisons). Alanine aminotransferase/aspartate aminotransferase hepatic abnormalities were similar in the 2 arms. Conclusions : Switching to ATV/r in virologically Suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].

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