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4. Population Pharmacokinetics of the Antimalarial Amodiaquine: a Pooled Analysis To Optimize Dosing

Author

Ali, Ali Mohamed, Penny, Melissa, Smith, Thomas, Workman, Lesley, Sasi, Philip, Adjei, George O, Aweeka, Francesca, Kiechel, Jean-René, Jullien, Vincent, Rijken, Marcus, Mcgready, Rose, Mwesigwa, Julia, Kristensen, Kim, Stepniewska, Kasia, Tarning, Joel, Barnes, Karen, Denti, Paolo, Massougbodji, Achille, Gansané, Adama, Adeothy, Adicat, Aubouy, Agnès, Ouedraogo, Alphonse, Annerberg, Anna, Bruneel, Arnaud, Phyo, Aung Pyae, Win, Aye Kyi, Benakis, A., Goka, Bamenla, Gourmel, Bernard, Ogutu, Bernhards, Schramm, Birgit, McGee, Bryan, Morgan, Caroline, Obonyo, Charles, Mazinda, Charles, Parzy, D., Ashley, Elizabeth, Baudin, Elisabeth, Juma, Elizabeth, Comte, Eric, Ouedraogo, Esperance, Nosten, François, Sugnaux, F., Cottrell, Gilles, Dorsey, Grant, Carn, Gwenaelle, Kossou, Hortense, Amedome, Hyacinthe, Kalyango, Joan, Faucher, Jean-François, Jones, Joel, Simpson, Julie, Doritchamou, Justin, Kurtzhals, J., Pinoges, Loretxu, Hoegberg, Lotte, BERTAUX, L., Malaika, L. Tshilolo Muepu, Bergstrand, Martin, Alifrangis, Michael, Branger, Michel, Cot, Michel, Cammas, Mireille, Kamya, Moses, Day, Nicholas, White, Nicholas, Taudon, N., Rodrigues, Onike, Chotsiri, Palang, Valeh, Parastou, Houzé, Pascal, Deloron, Philippe, Guérin, Philippe, Rosenthal, Philip, Hsi, Poe, German, Polina, Singhasivanon, Pratap, Smith, Richard, Lwango, R., Sirima, Sodiomon, Parikh, Sunil, Alegre, S. Sese, Clark, Tamara, Sundaygar, Timothy, Drysdale, Troy, Taylor, Walter, Sinou, V., Zolia, Yah, Swiss Tropical and Public Health Institute [Basel], University of Basel (Unibas), Ifakara Health Institute, University of Cape Town, Muhimbili University of Health and Allied Sciences, University of Ghana, University of California, Drugs for Neglected Diseases Initiative, Service de Pharmacologie, Hôpital Européen George Pompidou, Université Paris Descartes, Paris, France, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Mahidol University [Bangkok], University of Oxford [Oxford], London School of Hygiene & Tropical Medicine [Fajara, The Gambia], University of Antwerp (UA), Development DMPK-PKPD, Novo Nordisk, Copenhagen, Denmark, Univ Copenhagen, Fac Hlth & Med Sci, Novo Nordisk Fdn, Dis Syst Biol,Ctr Prot Res, Copenhagen, Denmark, and Partenaires INRAE-Partenaires INRAE

Subjects
pediatrics, dose optimization, malaria, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, NONMEM
Abstract

International audience; Amodiaquine plus artesunate is the recommended antimalarial treatment in many countries where malaria is endemic. However, pediatric doses are largely based on a linear extrapolation from adult doses. We pooled data from previously published studies on the pharmacokinetics of amodiaquine, to optimize the dose across all age groups. Adults and children with uncomplicated malaria received daily weight-based doses of amodiaquine or artesunate-amodiaquine over 3 days. Plasma concentration-time profiles for both the parent drug and the metabolite were characterized using nonlinear mixed-effects modeling. Amodiaquine pharmacokinetics were adequately described by a two-compartment disposition model, with first-order elimination leading to the formation of desethylamodiaquine, which was best described by a three-compartment disposition model. Body size and age were the main covariates affecting amodiaquine clearance. After adjusting for the effect of weight, clearance rates for amodiaquine and desethylamodiaquine reached 50% of adult maturation at 2.8 months (95% confidence interval [CI], 1.5 to 3.7 months) and 3.9 months (95% CI, 2.6 to 5.3 months) after birth, assuming that the baby was born at term. Bioavailability was 22.4% (95% CI, 15.6 to 31.9%) lower at the start of treatment than during convalescence, which suggests a malaria disease effect. Neither the drug formulation nor the hemoglobin concentration had an effect on any pharmacokinetic parameters. Results from simulations showed that current manufacturer dosing recommendations resulted in low desethylamodiaquine exposure in patients weighing 8 kg, 15 to 17 kg, 33 to 35 kg, and >62 kg compared to that in a typical 50-kg patient. We propose possible optimized dosing regimens to achieve similar drug exposures among all age groups, which require further validation.

Published
2018
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5. Hepatitis C virus prevalence and genetic diversity among pregnant women in Gabon, central Africa

Author

Mahé Antoine, Brun-Vézinet Francoise, Branger Michel, Njouom Richard, Makuwa Maria, Ndong-Atome Guy-Roger, Rousset Dominique, and Kazanji Mirdad

Subjects
Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Hepatitis C virus (HCV) infection is a major global public health problem in both developed and developing countries. The prevalence and genetic diversity of HCV in pregnant women in Gabon, central Africa, is not known. We therefore evaluated the prevalence and the circulating genotypes of HCV in a large population cohort of pregnant women. Methods Blood samples (947) were collected from pregnant women in the five main cities of the country. The prevalence was evaluated by two ELISA tests, and the circulating genotypes were characterized by sequencing and phylogenetic analysis. Results Twenty pregnant women (2.1%) were infected with HCV. The seroprevalence differed significantly by region (p = 0.004) and increased significantly with age (p = 0.05), being 1.3% at 14–20 years, 1.1% at 21–25 years, 1.9% at 26–30 years, 4.1% at 31–35 years and 6.0% at > 35 years. Sequencing in the 5'-UTR and NS5B regions showed that the circulating strains belonged to genotypes 4 (4e and 4c). Conclusion We found that the HCV seroprevalence in pregnant women in Gabon is almost as high as that in other African countries and increases with age. Furthermore, only genotype 4 (4e and 4c) was found. More extensive studies aiming to evaluate the prevalence and heterogeneity of HCV genotypes circulating in the general population of the country are needed.

Published
2008
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7. Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia

Author

Schramm, Birgit, primary, Valeh, Parastou, additional, Baudin, Elisabeth, additional, Mazinda, Charles S, additional, Smith, Richard, additional, Pinoges, Loretxu, additional, Sundaygar, Timothy, additional, Zolia, Yah M, additional, Jones, Joel J, additional, Comte, Eric, additional, Bruneel, Arnaud, additional, Branger, Michel, additional, Jullien, Vincent, additional, Carn, Gwenaelle, additional, Kiechel, Jean-René, additional, Ashley, Elizabeth A, additional, and Guérin, Philippe J, additional

Published
2013
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8. Epidemiological, virological and clinical characteristics of HBV infection in 223 HIV co-infected patients: a French multi-centre collaborative study

Author

Thibault, Vincent, primary, Gaudy-Graffin, Catherine, additional, Colson, Philippe, additional, Gozlan, Joël, additional, Schnepf, Nathalie, additional, Trimoulet, Pascale, additional, Pallier, Coralie, additional, Saune, Karine, additional, Branger, Michel, additional, Coste, Marianne, additional, and Thoraval, Francoise Roudot, additional

Published
2013
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9. Quasispecies Analysis andIn VitroSusceptibility of HBV Strains Isolated from HIV–HBV-Coinfected Patients with Delayed Response to Tenofovir

Author

Lada, Olivier, primary, Gervais, Anne, additional, Branger, Michel, additional, Peytavin, Gilles, additional, Roquebert, Benedicte, additional, Collin, Gilles, additional, Fraqueiro, Gil, additional, Moucari, Rami, additional, Leclerc, Laurence, additional, Martinot-Peignoux, Michelle, additional, Matheron, Sophie, additional, and Marcellin, Patrick, additional

Published
2012
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10. Recombination of hepatitis B virus DNA in patients with HIV

Author

Fallot, Guillaume, primary, Halgand, Boris, additional, Garnier, Elisabeth, additional, Branger, Michel, additional, Gervais, Anne, additional, Roque-Afonso, Anne-Marie, additional, Thiers, Valérie, additional, Billaud, Eric, additional, Matheron, Sophie, additional, Samuel, Didier, additional, and Féray, Cyrille, additional

Published
2011
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11. Long-term outcome of primary non-responders to tenofovir therapy in HIV/HBV-co-infected patients: impact of HBV genotype G

Author

Lada, Olivier, primary, Gervais, Anne, additional, Branger, Michel, additional, Peytavin, Gilles, additional, Roquebert, Benedicte, additional, Collin, Gilles, additional, Fraqueiro, Gil, additional, Moucari, Rami, additional, Hamet, Gwen, additional, Martinot-Peignoux, Michelle, additional, Matheron, Sophie, additional, and Marcellin, Patrick, additional

Published
2011
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12. Interpretation of Real-Time PCR Results for Hepatitis C Virus RNA When Viral Load Is Below Quantification Limits

Author

Laperche, Syria, primary, Bouchardeau, Françoise, additional, André-Garnier, Elisabeth, additional, Thibault, Vincent, additional, Roque-Afonso, Anne-Marie, additional, Trimoulet, Pascale, additional, Colimon, Ronald, additional, Duverlie, Gilles, additional, Leguillou-Guillemette, Hélène, additional, Lunel, Françoise, additional, Bouvier-Alias, Magali, additional, Pawlotsky, Jean-Michel, additional, Henquell, Cécile, additional, Schvoerer, Evelyne, additional, Stoll-Keller, Françoise, additional, Chaix, Marie-Laure, additional, Branger, Michel, additional, Gaudy-Graffin, Catherine, additional, Rosenberg, Arielle R., additional, Pozzetto, Bruno, additional, Vallet, Sophie, additional, Baazia, Yazid, additional, Izopet, Jacques, additional, and Lefrère, Jean-Jacques, additional

Published
2011
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13. Hepatitis C Virus Infection May Lead to Slower Emergence of P. falciparum in Blood

Author

Ouwe-Missi-Oukem-Boyer, Odile, primary, Touré Ndouo, Fousseyni S., additional, Ollomo, Benjamin, additional, Mezui-Me-Ndong, Jérome, additional, Noulin, Florian, additional, Lachard, Isabelle, additional, Ndong-Atome, Guy-Roger, additional, Makuwa, Maria, additional, Roques, Pierre, additional, Branger, Michel, additional, Preux, Pierre-Marie, additional, Mazier, Dominique, additional, and Bisser, Sylvie, additional

Published
2011
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15. Multicenter Trials Need To Use the Same Assay for Hepatitis C Virus Viral Load Determination

Author

Laperche, Syria, primary, Bouchardeau, Françoise, additional, Thibault, Vincent, additional, Pozzetto, Bruno, additional, Vallet, Sophie, additional, Rosenberg, Arielle R., additional, Roque-Afonso, Anne-Marie, additional, Gassin, Michèle, additional, Stoll-Keller, Françoise, additional, Trimoulet, Pascale, additional, Gault, Elyanne, additional, Chanzy, Bruno, additional, Mercier, Bernard, additional, Branger, Michel, additional, Pawlotsky, Jean-Michel, additional, Henquell, Cécile, additional, Lunel, Françoise, additional, Gaudy-Graffin, Catherine, additional, Alain, Sophie, additional, Chaix, Marie-Laure, additional, Duverlie, Gilles, additional, Izopet, Jacques, additional, and Lefrère, Jean-Jacques, additional

Published
2007
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16. Expertise of French Laboratories in Detection, Genotyping, and Quantification of Hepatitis C Virus RNA in Serum

Author

Lefrère, Jean-Jacques, primary, Roudot-Thoraval, Françoise, additional, Lunel, Françoise, additional, Alain, Sophie, additional, Chaix, Marie-Laure, additional, Dussaix, Elisabeth, additional, Gassin, Michèle, additional, Izopet, Jacques, additional, Pawlotsky, Jean-Michel, additional, Payan, Christopher, additional, Stoll-Keller, Françoise, additional, Thibault, Vincent, additional, Trabaud, Mary-Anne, additional, Bettinger, Dominique, additional, Bogard, Marc, additional, Branger, Michel, additional, Buffet-Janvresse, Claudine, additional, Charrois, Anne, additional, Defer, Christine, additional, Laffont, Catherine, additional, Lerable, Joëlle, additional, Levayer, Thierry, additional, Martinot-Peignoux, Michèle, additional, Mercier, Bernard, additional, and Rosenberg, Arielle R., additional

Published
2004
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19. Hepatitis C virus genotypes in French blood donors

Author

Gournay, Jér??me, primary, Marcellin, Patrick, additional, Martinot-Peignoux, Michèle, additional, Gabriel, Franck, additional, Erlinger, Serge, additional, Benhamou, Jean-Pierre, additional, Degott, Claude, additional, Courtois, Françoise, additional, Branger, Michel, additional, and Wild, Anne Marie, additional

Published
1995
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22. Long-term outcome of primary non-responders to tenofovir therapy in HIV/ HBV-co-infected patients: impact of HBV genotype G.

Author

Lada, Olivier, Gervais, Anne, Branger, Michel, Peytavin, Gilles, Roquebert, Benedicte, Collin, Gilles, Fraqueiro, Gil, Moucari, Rami, Hamet, Gwen, Martinot-Peignoux, Michelle, Matheron, Sophie, and Marcellin, Patrick

Subjects
HIV-positive persons, TENOFOVIR, LAMIVUDINE, DRUG efficacy, EMTRICITABINE
Abstract

Aim To evaluate the early virological response ( EVR) to combined tenofovir-lamivudine or emtricitabine regimen in HBV/ HIV-co-infected patients and the long-term efficacy of tenofovir. Methods In this retrospective monocentric study, among the 166 HIV/ HBV-co-infected patients regularly followed from 2003 to 2008 at Bichat Claude Bernard Hospital, 61 patients had received, either de novo combination therapy with tenofovir and lamivudine or emtricitabine (group I, n = 15) or add-on tenofovir to lamivudine therapy (group II, n = 46). The HBV polymerase region was sequenced and analysed for all patients with available samples. Results All 15 group I patients achieved EVR vs 32 (82%) of group II patients ( P = 0.15). Seven adherent group II patients met criteria for primary non-response, but achieved delayed response ( DR) to therapy. In these seven patients, when compared with the 39 group II patients, there was a trend to longer duration of lamivudine pre-treatment and to higher rate of lamivudine-resistant mutants; and HBV genotype-G proportion was higher ( P = 0.026). No virological breakthrough occurred after a median of 46 months follow up. Conclusion In these HBV/ HIV-co-infected patients, first-line HBV therapy with tenofovir and emtricitabine or lamivudine was associated with EVR. However, DR to tenofovir was observed in 15% of patients who added tenofovir to lamivudine therapy, of whom four of seven (57%) had genotype G- HBV infection. No resistance was evidenced after 46 months of therapy even in patients with DR to tenofovir. At last, a good renal safety profile of TDF was observed after a median follow-up of 4 years of therapy. [ABSTRACT FROM AUTHOR]

Published
2012
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24. Quasispecies Analysis and In VitroSusceptibility of HBV Strains Isolated from HIV–HBV-Coinfected Patients with Delayed Response to Tenofovir

Author

Lada, Olivier, Gervais, Anne, Branger, Michel, Peytavin, Gilles, Roquebert, Benedicte, Collin, Gilles, Fraqueiro, Gil, Moucari, Rami, Leclerc, Laurence, Martinot-Peignoux, Michelle, Matheron, Sophie, and Marcellin, Patrick

Abstract

Background Among 141 HIV–HBV-coinfected patients treated with tenofovir in our centre, 87% were good-responders to therapy. Seven patients showed a delayed response to tenofovir. The present study was performed to evaluate the quasispecies variability and the in vitrodrug susceptibility to approved antiviral drugs of HBV genomes directly isolated from patients’ sera.Methods After purification of DNA from serum samples, full-length HBV DNA was amplified by PCR, cloned and sequenced. Drug sensitivity of HBV strains isolated from four delayed responders and five good-responders was assessed and compared to a wild-type HBV strain after transfection of the full genome into HepG2 cells.Results Delayed responders, compared with good responders, showed a higher incidence of lamivudine-resistant mutations (71% and 35%, respectively; P=0.021) and a higher proportion of HBV genotype G (57% versus 16%, respectively; P=0.026). Clonal analysis demonstrated a higher variability of HBV quasispecies in delayed reponders than in good responders. In vitroanalysis showed a lower efficacy of adefovir and tenofovir in delayed reponders. Furthermore, HBV genotype G strains showed a mild to weak susceptibility to tenofovir.Conclusions The reason for the slow decline in HBV DNA level observed during therapy in delayed responders is not clear. Delayed responders showed higher quasispecies variability, a higher proportion of HBV genotype G and a mild in vitrodecreased susceptibility to tenofovir and adefovir. A combination of these factors in heavily treatment-experienced HIV-infected patients could explain the lower tenofovir activity. These patients must be closely monitored to prevent prospective emergence of resistance to approved antiviral drugs.

Published
2012
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25. Expertise of French Laboratories in Detection, Genotyping, and Quantification of Hepatitis C Virus RNA in Serum

Author

Lefre`re, Jean-Jacques, Roudot-Thoraval, Franc¸oise, Lunel, Franc¸oise, Alain, Sophie, Chaix, Marie-Laure, Dussaix, Elisabeth, Gassin, Miche`le, Izopet, Jacques, Pawlotsky, Jean-Michel, Payan, Christopher, Stoll-Keller, Franc¸oise, Thibault, Vincent, Trabaud, Mary-Anne, Bettinger, Dominique, Bogard, Marc, Branger, Michel, Buffet-Janvresse, Claudine, Charrois, Anne, Defer, Christine, Laffont, Catherine, Lerable, Joe¨lle, Levayer, Thierry, Martinot-Peignoux, Miche`le, Mercier, Bernard, and Rosenberg, Arielle R.

Abstract

ABSTRACTBefore initiating new large-scale therapeutic trials for hepatitis C virus (HCV)-infected patients, the French Health Authorities for HCV research decided to organize an evaluation of the expertise of laboratories that could be engaged to undertake molecular biology assays in such trials; 21 experienced laboratories participated in this national evaluation of laboratory expertise, which was performed in two successive rounds. The first round evaluated the laboratories for their abilities to detect HCV RNA in serum, determine genotypes, and quantify HCV RNA loads. The results observed by qualitative assays for HCV RNA detection were 100% sensitivity and 100% specificity for all laboratories. The genotyping results were 100% concordant for 9 laboratories and greater than 90% for 10 laboratories. By contrast, large coefficients of variation were observed for quantitative determination of HCV RNA loads, leading to a second round with standardized quantitative assays only. The dispersion of the results was larger by the AMPLICOR HCV Monitor assay than by the branched-DNA assay (mean coefficients of variation, 57.4 and 16.9%, respectively). In the majority of cases, discrepancies between the results of the two tests were found for samples with high viral loads. These results indicate the usefulness of validating, by controlling for expertise, both the reliabilities of laboratories involved in multicenter work and the standardized assays chosen for use in the evaluation of the biological impacts of new therapies.

Published
2004
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26. Hepatitis C Virus (HCV) Viremia in Human Immunodeficiency VirusSeronegative and -Seropositive Patients with Indeterminate HCV Recombinant Immunoblot Assay.

Author

Marcellin, Patrick, Martinot-Peignoux, Michèle, Elias, Alida, Branger, Michel, Courtois, Françoise, Level, Régine, Erlinger, Serge, and Benhamou, Jean Pierre

Abstract

Positivity of recombinant immunoblot assay (RIBA) for detection of antibodies to hepatitis C virus (anti-HCY) is usually associated with HCY viremia. The significanceof an indeterminate RIBA result, defined by reactivity to only one HCY antigen, is unclear. Whether anti-human immunodeficiency virus (HIY)-negative or -positive subjects with an indeterminate RIBA have HCY viremia detectable by polymerase chain reaction was investigated. An indeterminate RIBA was found in 48 (15%) of 318 anti-HIY-negative and 38 (23%) of 167 anti-HIY-positive subjects (P < .05). Clinical stage was IY-C-l or IY-C-2 in 82% of those anti-HIY-positives. HCY viremia was found more frequently in anti-HIY-positive (89%) than in anti-HIY-negative subjects (50%) with an indeterminate RIBA (P < ,05). These results suggest an impaired anti-HCY response associated with HIY infection. [ABSTRACT FROM PUBLISHER]

Published
1994
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28. Quasispecies analysis and in vitro susceptibility of HBV strains isolated from HIV-HBV-coinfected patients with delayed response to tenofovir.

Author

Lada O, Gervais A, Branger M, Peytavin G, Roquebert B, Collin G, Fraqueiro G, Moucari R, Leclerc L, Martinot-Peignoux M, Matheron S, and Marcellin P

Subjects
Adenine administration & dosage, Adenine therapeutic use, Adult, Antiviral Agents therapeutic use, Cloning, Molecular, Coinfection, DNA, Viral analysis, Drug Resistance, Viral, Female, Genotype, HIV drug effects, HIV physiology, HIV Infections virology, Hep G2 Cells, Hepatitis B virus drug effects, Hepatitis B, Chronic virology, Humans, Lamivudine therapeutic use, Male, Middle Aged, Mutation, Organophosphonates therapeutic use, Sequence Analysis, DNA, Tenofovir, Transfection, Adenine analogs & derivatives, Antiviral Agents administration & dosage, HIV Infections drug therapy, Hepatitis B virus genetics, Hepatitis B, Chronic drug therapy, Lamivudine administration & dosage, Organophosphonates administration & dosage
Abstract

Background: Among 141 HIV-HBV-coinfected patients treated with tenofovir in our centre, 87% were good-responders to therapy. Seven patients showed a delayed response to tenofovir. The present study was performed to evaluate the quasispecies variability and the in vitro drug susceptibility to approved antiviral drugs of HBV genomes directly isolated from patients' sera., Methods: After purification of DNA from serum samples, full-length HBV DNA was amplified by PCR, cloned and sequenced. Drug sensitivity of HBV strains isolated from four delayed responders and five good-responders was assessed and compared to a wild-type HBV strain after transfection of the full genome into HepG2 cells., Results: Delayed responders, compared with good responders, showed a higher incidence of lamivudine-resistant mutations (71% and 35%, respectively; P=0.021) and a higher proportion of HBV genotype G (57% versus 16%, respectively; P=0.026). Clonal analysis demonstrated a higher variability of HBV quasispecies in delayed reponders than in good responders. In vitro analysis showed a lower efficacy of adefovir and tenofovir in delayed reponders. Furthermore, HBV genotype G strains showed a mild to weak susceptibility to tenofovir., Conclusions: The reason for the slow decline in HBV DNA level observed during therapy in delayed responders is not clear. Delayed responders showed higher quasispecies variability, a higher proportion of HBV genotype G and a mild in vitro decreased susceptibility to tenofovir and adefovir. A combination of these factors in heavily treatment-experienced HIV-infected patients could explain the lower tenofovir activity. These patients must be closely monitored to prevent prospective emergence of resistance to approved antiviral drugs.

Published
2012
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