News Article | April 20, 2017
ILC 2017: Eight studies being presented at The International Liver Congress™ 2017 demonstrate contrasting evidence on the potential link between direct-acting antiviral treatment for hepatitis C and liver cancer According to data from eight studies being presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, there remains continued debate on whether patients are at risk of developing liver cancer after achieving sustained virologic response (SVR) with a direct-acting antiviral (DAA) regimen for Hepatitis C virus (HCV). Investigators will present the results of their studies that show both sides of the argument - DAA therapy is associated with a higher risk of liver cancer compared with interferon-based therapy, versus there is no difference in liver cancer risk following cure with either therapy. Whilst remarkable progress has been made in the development of successful antiviral therapies for HCV infection, some recent studies suggest that curing patients does not eliminate the risk of developing liver cancer. There also appears to be an unexpectedly high rate of liver cancer (also known as hepatocellular carcinoma [HCC]) recurrence in patients who previously had their tumour treated successfully and had received DAAs.1 This claim was further supported by a Spanish study led by Dr Maria Reig and Dr Mariño, Hospital Clinic Barcelona, Spain in which patients with HCV and HCC who had previously been cured of HCC received DAA therapy. After a median 12.4 month follow-up, following treatment with DAAs, the rate of HCC coming back (recurrence) was 31.2% (24/77) and of those who received HCC treatment at recurrence, 30% (6/20) of patients presented progression in the immediate 6-month follow-up. This is an update of the study that will be published in the May 2017 issue of Seminars in Liver Disease, and is available here: https:/ . "Our study offers further support to previous findings that there is an unexpected high recurrence rate of hepatocellular carcinoma associated with DAAs, and that this association may result in a more aggressive pattern of recurrence and faster tumour progression," said Dr Maria Reig, Barcelona Clinic Liver Cancer Group, Hospital Clinic Barcelona, Spain, and lead author of the study. "These data indicate that there needs to be further research conducted in this area, clarifying the mechanism for the association between liver cancer recurrence and DAA therapy." Identifying those patients at risk of liver cancer is essential, a task that Dr Etienne Audureau, Public Health, Henri Mondor University Hospital, Créteil, France, and colleagues attempted to achieve by developing a prognostic tool for HCC. They found that in patients with severe scarring of the liver due to HCV (compensated cirrhosis), failure to achieve SVR was the most influential factor in predicting liver cancer. In addition, risk factors for liver cancer differ according to SVR status. The investigators recommend that in patients with compensated cirrhosis, eradication of HCV should be achieved before liver function is impaired and people who have achieved SVR should be monitored for liver cancer after 50 years of age. The mechanisms behind the development of liver cancer following HCV cure are not yet understood. One group of investigators led by Prof Thomas Baumert, Inserm Institute for Viral and Liver Diseases, University of Strasbourg, France, aimed to investigate if HCV infections produce epigenetic and transcriptional changes that persist after the infection is cured, and whether these epigenetic changes drive liver disease and HCC following cure. They found that the epigenetic and transcriptional changes are only partially reversed by DAAs and persist after HCV cure, suggesting that these changes are a driver for liver cancer that develops after HCV infection has been cured. The investigators concluded that these findings open a new perspective to develop novel biomarkers to identify patients at high risk of HCC and provide an opportunity to develop urgently needed strategies for HCC prevention. On the other side of the debate, a systematic review, meta-analyses, and meta-regression study, by Prof Gregory Dore and Dr Reem Waziry from The Kirby Institute, UNSW Sydney, and colleagues, found no evidence for higher risk of HCC occurrence or recurrence following DAA treatment, compared with interferon-based HCV therapy. A total of 41 studies, including 26 on HCC occurrence and 15 on HCC recurrence (in total, n=13,875 patients) were included. In studies assessing HCC occurrence, average follow up was shorter and average age was higher in DAA studies compared to interferon studies; incidence was lower with longer follow-up and younger age. In studies assessing HCC recurrence, average follow up was also shorter. Ultimately, in the meta-regression analysis, no evidence in favour of a differential HCC occurrence or recurrence was found between DAA and interferon regimens, after adjusting for study follow-up and age. "Recent studies have reported contradicting evidence on risk of hepatocellular carcinoma following direct-acting antiviral therapy; our aim was to bring some clarity to this," said Prof Gregory Dore, Kirby Institute and lead author of the study. "These data show the higher incidence of HCC observed following DAA therapy can be explained by the shorter duration of follow-up and older age of participants, rather than the DAA treatment regimen." A Scottish study, led by Dr Hamish Innes, School of Health and Life Sciences, Glasgow Caledonian University, Scotland, found that the risk of liver cancer following SVR was not associated with the use of DAAs, but baseline risk factors. Furthermore, risk of HCC development was similar in patients taking interferon-free regimens versus interferon-containing regimens, following a multivariate adjustment (IRR: 0.96, p=0.929) and no significant differences in HCC risk were found when treatment regimen was defined in terms of DAA containing regimens versus DAA free regimens. These data indicate that rather than the treatment regimens themselves, it is the baseline risk factors that determine risk of hepatocellular carcinoma. Another interesting study in Japanese patients with HCV genotype 1 infection, found a reduced incidence of liver cancer following achievement of SVR after 12 weeks of therapy with an interferon-free regimen (ledipasvir plus sofosbuvir) to a similar degree as that obtained with an interferon-containing regimen (simeprevir with peginterferon plus ribavirin). This study, which was conducted by Dr Masaaki Korenaga, Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan, and colleagues, also found that unexpected development of liver cancer following SVR in patients without previous liver cancer could potentially be predicted by imaging procedures (computer tomography or enhanced magnetic resonance imaging). Similarly, a Chinese study led by Dr George Lau, from the Beijing 302-Hong Kong Humanity and Health Hepatitis C Diagnosis and Treatment Centre, in Beijing, China, found no increase in the incidence of liver cancer in patients who achieved SVR12 with DAA compared to peginterferon plus ribavirin. A Sicilian study conducted by Dr Vincenza Calvaruso, University of Palermo, Palermo, Italy, and colleagues, demonstrated that patients who achieved SVR with DAAs had a similar risk of developing liver cancer when compared to historical controls of patients with compensated cirrhosis who achieved SVR after interferon-based therapy. In addition, those who achieved SVR with DAAs had a lower risk of developing liver cancer than those patients whose HCV infection was not cured. "The original observations made by researchers from the Barcelona Clinic Liver Cancer Group have sparked a huge number of studies aimed at verifying the potential association between DAA treatment and increased HCC recurrence after cure," said Prof Francesco Negro, Divisions of Gastroenterology and Hepatology of Clinical Pathology, University Hospital of Geneva, and EASL Governing Board Member. "At this stage, there is no reason to alter treatment guidelines until the issue is definitively clarified. We cannot exclude, however, that we may have to revise post-SVR surveillance in some specific patient subgroups." This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2017 will take place from April 19 - 23, at the RAI Amsterdam, Amsterdam, The Netherlands. About The European Association for the Study of the Liver (EASL) Since its foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy. Contact For more information, please contact the ILC Press Office at: Session title: Parallel session: Liver tumours: from patient stratification to management Time, date, and location of session: 16:00 - 18:00, Thursday 20 April, Elicium 2 Abstract: No evidence for higher risk of hepatocellular carcinoma occurrence or recurrence following direct-acting antiviral HCV therapy: A systematic review, meta-analyses, and meta-regression (PS160), 16:00 - 16:15 Gregory Dore, Australia Session title: Parallel session: HCV: post SVR management and complications Time, date, and location of session: 16:00 - 18:00, Thursday 20 April, Hall 5 Abstracts presented in order of appearance in press release: Tumour recurrence after Interferon-free treatment for hepatitis C in patients with previously treated hepatocellular carcinoma discloses a more aggressive pattern and faster tumour growth (PS031), 16:00 - 16:15 Maria Reig, Spain Identifying residual risk of hepatocellular carcinoma following hepatitis C virus eradication in compensated cirrhosis: decision-tree and random forest models developed in the French multicenter prospective ANRS CO12 CirVir cohort (PS034), 16:45 - 17:00 Etienne Audureau, France Hepatitis C virus-induced epigenetic and transcriptional changes persist post cure (PS033), 16:30 - 16:45 Thomas Baumert, France Among cirrhotic patients with a hepatitis C sustained viral response, the risk of de-novo hepatocellular carcinoma relates to baseline factors and not the use of direct acting antivirals: results from a nationwide cohort (PS035), 17:00 - 17:15 Hamish Innes, United Kingdom Sustained virologic response by ledipasvir/sofosbuvir reduces the incidence of hepatocellular carcinoma in Japanese patients with HCV genotype 1 infection. - Comparison with Simeprevir with peginterferon plus ribavirin (PS036), 17:15 - 17:30 Masaaki Korenaga, Japan No increase in the occurrence rate of hepatocellular carcinoma in Chinese treated by direct-acting antivirals compared to Interferon after eradication of hepatitis c virus: A long-term follow-up (PS037), 17:30 - 17:45 George Lau, China Occurrence of hepatocellular carcinoma in patients with hepatitis C virus related liver disease treated with direct-acting antivirals (PS038), 17:45 - 18:00 Vincenza Calvaruso, Italy Gregory Dore: Advisory board member and receives honorarium from Gilead, Merck, Abbvie, Bristol-Myers Squibb, Janssen, has received research grant funding from Gilead, Merck, Abbvie, Bristol-Myers Squibb, Janssen, and travel sponsorship from Gilead, Merck, Abbvie, and Bristol-Myers Squibb Vincenza Calvaruso: Advisory Board for AbbVie, BMS, Gilead Sciences and Intercept. Grant and research support for MSD 1 Reig M et al. Unexpected early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy; a note of caution. J Hepatol. 2016;65:719-726.
News Article | August 1, 2017
Results from Clinical Trial with FIT Biotech's HIV Vaccine Candidate Presented at the International AIDS Society (IAS) Conference in Paris FIT Biotech Oy ("Company") announced today that a scientific poster on a Vaccine Research Institute (VRI) clinical trial results involving the Company's HIV vaccine candidate, GTU-MultiHIV B, was presented at the 9TH IAS Conference on HIV Science in Paris, France. The title of the poster is: Immunogenicity and safety of 4 prime-boost combinations of HIV vaccine candidates (MVA HIV-B; LIPO-5; GTU-MultiHIV B) in healthy volunteers - Inserm-ANRS VRI01 phase I/II randomized trial. The lead author is Dr. J.-D. Lelièvre of the VRI, Inserm, University Paris-Créteil, France. The clinical trial in the scientific poster was conducted through the VRI program (Inserm-ANRS) and enrolled HIV-negative subjects. It tested four different prime-boost regimens. The major findings are: "We are making progress towards a functional cure for HIV, and having the support of the HIV community is key for succeeding in this", commented Santeri Kiviluoto, Chief Scientific Officer. FIT Biotech is a part of a major research consortium EHVA that develops new vaccines against HIV. The project is funded by the EU Horizon 2020 framework programme. FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy. The Vaccine Research Institute (VRI), Laboratory of excellence, was established by the French National Agency for Research on AIDS and viral hepatitis (ANRS - France Recherche Nord & Sud Sida-HIV Hépatites) and the University of Paris-Est Créteil (UPEC) to conduct research to accelerate the development of effective vaccines against HIV/AIDS (Human Immunodeficiency Virus / Acquired ImmunoDeficiency Syndrome), HCV (Hepatitis C Virus) and emerging infectious diseases. VRI's structure strengthens the links between basic and translational research, patient associations and the socio-economic world. VRI stems from the existing ANRS vaccine research program and includes research teams with multidisciplinary expertise, a network of national and international eminent scientists, a network of clinical centers, core facilities, and industry and charitable partners. It is based at the Henri Mondor hospital, Créteil, France. The Labex VRI is supported by the "Investissements d'Avenir" program managed by the ANR under reference ANR-10-LABX-77-01 http://vaccine-research-institute.fr/en Press contact: Mireille CENTLIVRE E-mail: email@example.com Tel: +33 (0) 1 49 81 39 07 ANRS (French National Agency for Research on AIDS and viral hepatitis - France Recherche Nord & Sud Sida-HIV Hépatites) is the leading organization for research on the HIV/AIDS and hepatitis epidemics in France, and a leader in the fight against these diseases in developing countries. In 2012, ANRS became an autonomous agency within Inserm. ANRS objectives are to acquire and increase new knowledge in order to improve the prevention of HIV/AIDS and HCV and to care for people infected. ANRS brings together research scientists from all disciplines and doctors belonging to research organizations (Inserm, CNRS, Institut Pasteur, IRD), universities and hospitals all over France. The Agency's vaccine research program is managed by VRI (Vaccine Research Institute). http://www.anrs.fr/
News Article | May 29, 2017
ANRS 12286 MOBIDIP(1), a clinical trial running in parallel in three countries in sub-Saharan Africa (Cameroon, Burkina Faso, and Senegal), shows that dual therapy with lamivudine and a boosted protease inhibitor is effective as second-line treatment in patients infected by HIV with multiple mutations. Such treatment de-escalation will reduce costs, side effects, and the need for virological monitoring of patients. The results of this study, led by Laura Ciaffi (TransHIVMI; Inserm-IRD-Université de Montpellier) and Sinata Koulla-Shiro (ANRS site -Cameroon), is published in The Lancet HIV on May 28, 2017. Second-line treatments of HIV infection recommended by the WHO for resource-limited countries are highly effective. However, there is currently no reliable way of de-escalating these treatments, while maintaining an undetectable viral load. Two strategies may provide a solution. The first is monotherapy with a boosted protease inhibitor (BPI), which in several trials has already yielded encouraging results, albeit with a risk of increased viral load. Such an increase constitutes a risk in resource-limited countries because patients there do not have access to regular virological monitoring, which can identify treatment failure. The second strategy is to combine a BPI with lamivudine, which is inexpensive, well tolerated, often used first line, and effective. This combination, however, has never been evaluated in patients infected by HIV with mutations that confer drug resistance, notably to lamivudine (M184V). ANRS 12286 MOBIDIP is the first trial to compare these two treatment de-escalation strategies in resource-limited countries, in patients with viremia controlled by second-line treatment. ANRS 12286 MOBIDIP: assessing the efficacy of a new therapeutic strategy ANRS 12286 MOBIDIP was led from 2014 and 2016 by Laura Ciaffi of TransHIVMI (joint Inserm-IRD-Université de Montpellier research unit, directed by Eric Delaporte of IRD/Université de Montpellier) and Sinata Koulla-Shiro (ANRS site -- Cameroon) and her colleagues in 3 countries of sub-Saharan Africa (Cameroon, Burkina Faso, and Senegal). The study's 265 patients(2) had an initial viral load below 200 copies/mL, and were followed up for 96 weeks. The main purpose of ANRS 12286 MOBIDIP was to compare the failure rates of the two therapeutic strategies: monotherapy and dual therapy. Half the study patients received BPI treatment and the other half were given BPI plus lamivudine. After 48 weeks of treatment, monotherapy was interrupted and the patients resumed triple drug therapy. The patients on dual therapy continued their treatment till week 96. The rate of treatment failure, defined as a viral load above 500 copies/mL, was 3% (4/132 patients) for dual therapy and 24.8% for monotherapy (33/133 patients). CD4 cell count increased greatly in the patients on dual therapy (65 versus 12 cells/mm3), indicating increased immune defense. Overall, both treatments were well tolerated by the patients. ANRS 12 286 MOBIDIP has provided the first evidence of the efficacy of de-escalated second-line therapy, which is less costly and better tolerated than triple-drug therapy in patients infected by HIV with multiple mutations. This dual therapy combining BPI and lamivudine could be appropriate in resource-limited countries with economic and virological monitoring constraints. Moreover, the use of lamivudine, which is already used in first-line treatment, could avoid the switch to another class of drugs, which could be prescribed later if necessary.
News Article | May 29, 2017
ANRS 12286 MOBIDIP(1), a clinical trial running in parallel in three countries in sub-Saharan Africa (Cameroon, Burkina Faso, and Senegal), shows that dual therapy with lamivudine and a boosted protease inhibitor is effective as second-line treatment in patients infected by HIV with multiple mutations. Such treatment de-escalation will reduce costs, side effects, and the need for virological monitoring of patients. The results of this study, led by Laura Ciaffi (TransHIVMI; Inserm-IRD-Université de Montpellier) and Sinata Koulla-Shiro (ANRS site -Cameroon), is published in The Lancet HIV on May 28, 2017. Second-line treatments of HIV infection recommended by the WHO for resource-limited countries are highly effective. However, there is currently no reliable way of de-escalating these treatments, while maintaining an undetectable viral load. Two strategies may provide a solution. The first is monotherapy with a boosted protease inhibitor (BPI), which in several trials has already yielded encouraging results, albeit with a risk of increased viral load. Such an increase constitutes a risk in resource-limited countries because patients there do not have access to regular virological monitoring, which can identify treatment failure. The second strategy is to combine a BPI with lamivudine, which is inexpensive, well tolerated, often used first line, and effective. This combination, however, has never been evaluated in patients infected by HIV with mutations that confer drug resistance, notably to lamivudine (M184V). ANRS 12286 MOBIDIP is the first trial to compare these two treatment de-escalation strategies in resource-limited countries, in patients with viremia controlled by second-line treatment. ANRS 12286 MOBIDIP: assessing the efficacy of a new therapeutic strategy ANRS 12286 MOBIDIP was led from 2014 and 2016 by Laura Ciaffi of TransHIVMI (joint Inserm-IRD-Université de Montpellier research unit, directed by Eric Delaporte of IRD/Université de Montpellier) and Sinata Koulla-Shiro (ANRS site - Cameroon) and her colleagues in 3 countries of sub-Saharan Africa (Cameroon, Burkina Faso, and Senegal). The study's 265 patients(2) had an initial viral load below 200 copies/mL, and were followed up for 96 weeks. The main purpose of ANRS 12286 MOBIDIP was to compare the failure rates of the two therapeutic strategies: monotherapy and dual therapy. Half the study patients received BPI treatment and the other half were given BPI plus lamivudine. After 48 weeks of treatment, monotherapy was interrupted and the patients resumed triple drug therapy. The patients on dual therapy continued their treatment till week 96. The rate of treatment failure, defined as a viral load above 500 copies/mL, was 3% (4/132 patients) for dual therapy and 24.8% for monotherapy (33/133 patients). CD4 cell count increased greatly in the patients on dual therapy (65 versus 12 cells/mm3), indicating increased immune defense. Overall, both treatments were well tolerated by the patients. ANRS 12 286 MOBIDIP has provided the first evidence of the efficacy of de-escalated second-line therapy, which is less costly and better tolerated than triple-drug therapy in patients infected by HIV with multiple mutations. This dual therapy combining BPI and lamivudine could be appropriate in resource-limited countries with economic and virological monitoring constraints. Moreover, the use of lamivudine, which is already used in first-line treatment, could avoid the switch to another class of drugs, which could be prescribed later if necessary. (1) Evaluation of a maintenance strategy using protease inhibitor with or without lamivudine in patients in Africa (Yaoundé, Bobo-Dioulasso, Dakar) with a viral load controlled by second-line antiretroviral therapy (2) These patients were from ANRS 12169 2LADY (comparative trial of second-line triple drug therapies). Boosted protease inhibitor monotherapy versus boosted protease inhibitor plus lamivudine dual therapy as second line maintenance treatment in HIV-1 infected patients in Sub Saharan Africa (ANRS12 286/MOBIDIP): a randomized, controlled, open-label superiority trial. Laura Ciaffi1, Sinata Koulla-Shiro2, Adrien Sawadogo3, Cheik Tidiane Ndour4, Sabrina Eymard-Duvernay1, Pretty Rosereine Mbouyap2, Liliane Ayangma5, Jacques Zoungrana3, Ndeye Fatou Ngom Gueye6, Mohamadou Diallo4, Suzanne Izard1, Guillaume Bado3, Coumba Toure Kane7, Avelin Aghokeng1,8, Martine Peeters1, Pierre Marie Girard9, Vincent Le Moing1, Jacques Reynes1, Eric Delaporte1 for the MOBIDIP Study Group. The Lancet HIV, 28 may 2017. 1IRD UMI 233 - INSERM U1175 - Montpellier University, Montpellier France, 2ANRS Research Centre Cameroon, Central Hospital, Yaoundé Cameroon, 3Day Care Center, University Hospital Souro Sanou, Bobo Dioulasso Burkina Faso, 4Research and Training Center (CRCF), Fann University Hospital, Dakar Senegal, 5Ambulatory Treatment Center, Military Hospital, Yaounde Cameroon, 6Day Care Center, Fann University Hospital, Dakar Senegal, 7CHU A Le Dantec Laboratoire de Bactériologie-Virologie Dakar, Sénégal 8Virology laboratory IMPM-IRD Centre de Recherche sur les Maladies Emergentes, Yaounde Cameroon, 9Department of Infectious and Tropical Diseases, Saint-Antoine Hospital, AP-HP INSERM UMR S 1136, Paris France
Raffi F.,University of Nantes |
Babiker A.G.,University College London |
Richert L.,French Institute of Health and Medical Research |
Molina J.-M.,University Paris Diderot |
And 15 more authors.
The Lancet | Year: 2014
Background Standard first-line antiretroviral therapy for HIV-1 infection includes two nucleoside or nucleotide reverse transcriptase inhibitors (NtRTIs), but these drugs have limitations. We assessed the 96 week efficacy and safety of an NtRTI-sparing regimen. Methods Between August, 2010, and September, 2011, we enrolled treatment-naive adults into this randomised, open-label, non-inferiority trial in treatment-naive adults in 15 European countries. The composite primary outcome was change to randomised treatment before week 32 because of insufficient virological response, no virological response by week 32, HIV-1 RNA concentration 50 copies per mL or higher at any time after week 32; death from any cause; any new or recurrent AIDS event; or any serious non-AIDS event. Patients were randomised in a 1:1 ratio to receive oral treatment with 400 mg raltegravir twice daily plus 800 mg darunavir and 100 mg ritonavir once daily (NtRTI-sparing regimen) or tenofovir-emtricitabine in a 245 mg and 200 mg fixed-dose combination once daily, plus 800 mg darunavir and 100 mg ritonavir once daily (standard regimen). This trial was registered with ClinicalTrials.gov, number NCT01066962. Findings Of 805 patients enrolled, 401 received the NtRTI-sparing regimen and 404 the standard regimen, with median follow-up of 123 weeks (IQR 112-133). Treatment failure was seen in 77 (19%) in the NtRTI-sparing group and 61 (15%) in the standard group. Kaplan-Meier estimated proportions of treatment failure by week 96 were 17·8% and 13·8%, respectively (difference 4·0%, 95% CI -0·8 to 8·8). The frequency of serious or treatment-modifying adverse events were similar (10·2 vs 8·3 per 100 person-years and 3·9 vs 4·2 per 100 person-years, respectively). Interpretation Our NtRTI-sparing regimen was non-inferior to standard treatment and represents a treatment option for patients with CD4 cell counts higher than 200 cells per μL. Funding European Union Sixth Framework Programme, Inserm-ANRS, Gilead Sciences, Janssen Pharmaceuticals, Merck Laboratories. © 2014 Elsevier Ltd.
PubMed | Hopitaux Universitaires, Bordeaux University Hospital Center, ANRS, French Institute of Health and Medical Research and 6 more.
Type: Journal Article | Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America | Year: 2015
Human immunodeficiency virus (HIV) infection is associated with a high risk of classical Hodgkins lymphoma (cHL) in the combined antiretroviral therapy (cART) era.We analyzed the characteristics and outcome of HIV-associated cHL diagnosed in the modern cART era. The French ANRS-CO16 Lymphovir cohort enrolled 159 HIV-positive patients with lymphoma, including 68 (43%) with cHL. HIV-HL patients were compared with a series of non-HV-infected patients consecutively diagnosed with HL.Most patients (76%) had Ann-Arbor stages III-IV and 96% of patients were treated with ABVD. At diagnosis, median CD4 T-cell count was 387/L and 94% of patients were treated with cART. All patients received cART after diagnosis. Five patients died from early progression (n = 2), sepsis (1) or after relapse (2). Two additional patients relapsed during follow-up. Two-year overall and progression free survivals (PFS) were 94% [95% CI, 89%, 100%] and 89% [82%, 97%], respectively. The only factor associated with progression or death was age with a relative risk of 8.1 [1.0; 67.0] above 45 years. The PFS of Lymphovir patients appeared similar to PFS of HIV-negative patients, 86% [82%, 90%], but patients with HIV infection displayed higher risk features than HIV-negative patients.Although high-risk features still predominate in HIV-HL, the prognosis of these patients, treated with cART and mainly ABVD, has markedly improved in the modern cART era and is now similar to non-HIV-infected patients.
News Article | November 10, 2016
Industry veteran adds biotech innovation depth to Finn Partners' global reach and EU expertise in pharma and patient advocacy NEW YORK and PARIS, Nov. 10, 2016 /PRNewswire/ -- Finn Partners announced today the appointment of Mina Volovitch as Head of its Paris office and senior partner in the agency's Global Health Practice. Volovitch will be based in Paris and report to Chantal Bowman-Boyles, managing partner, leading Finn Partners Europe and Gil Bashe, managing partner, Global Health. Volovitch's more than 20 years' experience in health communications includes work with the globe's leading names in medicine and public health including bioMérieux, Bristol Myers-Squibb, Lilly, Novartis, Roche, Sanofi Pasteur, Transgene, the French Cancer Society, the National League Against Cancer (largest French patient group), the ANRS (National Agency for Research on Aids), the Mérieux Foundation and IAVI. "Our European offices are adding more and more health work encompassing biotechnology, patient advocacy and health technology assignments. Mina's dual-role as head of our Paris office and senior member of the global health practice demonstrates how our agency values and growth attract exceptional talent," said Bowman-Boyles. "Mina is among the great health communicators with knowledge and experience engaging some of the most influential players in medical innovation, patient advocacy and public health across Europe," said Bashe. "Her collaborative approach is already strengthening the service and insight Finn Partners offers health clients around the globe. Just as importantly, she lives the Finn Partners value of making a difference in the world through her professional and volunteer efforts." Volovitch began her career at Merck working in marketing, eventually becoming director of communications at MSD Paris. Following Merck, Volovitch joined the Mérieux Institute (the vaccine innovator that is today Sanofi Pasteur), where she served as director of communications. In 1987, she created Mynecom, a specialist healthcare communications agency. Her professional experience includes running national and global professional- and patient-communications programs; handling issues in pharmaceuticals and health products; and expertise across AIDS, biotech, cardiology, immunology, infectious disease, medical devices, oncology and vaccines. She is also a member of the National League Against Cancer communications working group. "I am energized and proud to join Finn Partners during this exciting time of growth for its global health practice and Paris office," said Volovitch. "I share the agency's commitment to make a difference in the world, and the icing on the cake is building upon professional relationships with colleagues with whom I've worked in the past. Quite simply, I have deep trust and respect for Finn Partners management team in building one of the world's fastest growing PR and marketing communications agencies," she added. About Finn Partners, Inc. Finn Partners was launched in late 2011 to realize Peter Finn's vision to create a leading communications agency dedicated to shaping a bold new future in which innovation and partnership are strong brand drivers. Finn Partners specializes in the full spectrum of marketing and public relations services, including digital and social media. Practice areas include arts, consumer, CSR and social impact, education, financial services, health, technology and travel & lifestyle. Since its inception four years ago, Finn Partners has received six agency awards that are indicators of client and cultural leadership: "Best Midsize Agency" in 2015, "Best Agency to Work For" in 2013 and "Best New Agency" in 2012 from the Holmes Report and "Midsize PR Firm of the Year" in 2015 and "Top Places to Work in PR" in 2013 from PR News. Headquartered in New York City, the company has approximately 550 employees, with offices in Chicago, Detroit, Fort Lauderdale, Jerusalem, London, Los Angeles, Munich, Nashville, Paris, Portland, San Francisco and Washington D.C., and offers international capabilities through its own global network and PROI Worldwide. Find us at www.finnpartners.com and follow us on Twitter @finnpartners.
Anderson J.L.,University of Melbourne |
Fromentin R.,Vaccine and Gene Therapy Institute Florida |
Corbelli G.M.,European AIDS Treatment Group |
Ostergaard L.,Aarhus University Hospital |
AIDS Research and Human Retroviruses | Year: 2015
Biomedical research has led to profound advances in the treatment of HIV infection. Combination antiretroviral therapy (ART) now provides the means to readily control viral infection, and people living with HIV who receive timely and effective ART can expect to benefit from a life expectancy comparable to uninfected individuals. Nevertheless, despite effective treatment, ART does not fully restore the immune system and importantly HIV persists indefinitely in latent reservoirs, resulting in the need for life-long treatment. The challenges and limits of life-long treatment have spurred significant scientific interest and global investment into research towards an HIV cure. The International AIDS Society (IAS) 2014 Towards an HIV cure symposium brought together researchers and community to discuss the most recent advances in our understanding of latency and HIV reservoirs, and the clinical approaches towards an HIV cure under current investigation. This report summarizes and reviews some of the major findings discussed during the symposium. © Mary Ann Liebert, Inc. 2015.
Borand L.,Institute Pasteur in Cambodia |
Laureillard D.,ANRS |
Madec Y.,Institute Pasteur Paris |
Chou M.,University of Health Sciences |
And 7 more authors.
Antiviral Therapy | Year: 2013
Background: The optimal dose of efavirenz for HIV-infected patients receiving a tuberculosis regimen including rifampicin remains debated, especially for subjects weighing over 50 kg. To address this issue, we measured plasma efavirenz concentrations from Cambodian adults with tuberculosis enrolled in the CAMELIA randomized trial (ClinicalTrials.gov number, NCT01300481) 6 weeks after the onset of antiretroviral therapy. Methods: Efavirenz concentrations and proportions of patients with concentrations below 1,000 ng/ml were compared across patient body weight below or above 50 kg using a Student's t-test and a χ2 test, respectively. Factors associated with efavirenz concentrations below 1,000 ng/ml were identified by logistic regression analysis. Logistic regression analysis was also performed to check if efavirenz concentrations below 1,000 ng/ml were associated with virological failure. Results: Plasma efavirenz concentrations were higher in the 332 patients who weighed <50 kg compared with the 150 who weighed ≥50 kg (median [IQR] 2,859 [1,787-4,749] and 2,060 [1,425-3,575] ng/ml, respectively; P=0.02). However, the proportion of patients with efavirenz concentrations below 1,000 ng/ml was not different between those weighing less than or more than 50 kg (6% and 10%, respectively; P=0.13) and a body weight above 50 kg was not associated with a higher risk of plasma efavirenz concentrations below 1,000 ng/ml. When plasma efavirenz concentrations below 1,000 ng/ml were present, they were not associated with virological failure. Conclusions: The current WHO guidelines recommending 600 mg efavirenz daily irrespective of patient's body weight remains a safe and effective approach to treating coinfected adults needing simultaneous tuberculosis and HIV therapy. ©2013 International Medical Press.
Journot V.,French Institute of Health and Medical Research |
Perusat-Villetorte S.,French Institute of Health and Medical Research |
Bouyssou C.,French Institute of Health and Medical Research |
Couffin-Cadiergues S.,ANRS |
And 3 more authors.
Clinical Trials | Year: 2013
Background In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participants final enrollment. Purpose We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Methods Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participants name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participants enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Results Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information (54%). The procedure reduced nonconformities by 81% (95% confidence interval (CI): 73%-89%) before enrollment. Nonconforming consent forms dropped from 25% to 0% over the period, indicating a rapid learning effect between trials. Fewer nonconformities were observed for participants screened later in a trial (odds ratio (95% CI): 0.5 (0.3-0.8); p = 0.004), indicating a learning effect within trials. Nonconformities were more common for participants enrolled after screening (2.4 (1.1-5.3); p = 0.03), indicating a stricter scrutiny by form checkers. Limitations Although our study had a pseudo before-and-after design, no major bias was identified. Power and generalizability of our findings were sufficient to support implementation in future trials. © 2013 The Author(s).