May 31, 2013
WHO | Yellow fever in Ethiopia
Friday, May 31, 2013
Thursday, May 30, 2013
Survey of Participants from Landmark GRACE Trial Provides Patients’ Perspectives from an HIV Clinical Study
Johnson & Johnson News Release:
Survey of Participants from Landmark GRACE Trial Provides Patients’ Perspectives from an HIV Clinical Study
Most Survey Participants Would Recommend Joining a Study to Others
TITUSVILLE, N.J., May 30, 2013 – A survey of a segment of clinical trial participants from the GRACE (Gender, Race And Clinical Experience) trial, the largest-ever study of treatment-experienced adult women with HIV to examine gender differences in response to HIV therapy, found that after taking part in the study, 96 percent of survey responders would recommend participation in a clinical trial to others. The results of the participant survey were published in the June 2013 issue of AIDS Patient Care and STDs.The GRACE participant survey assessed the characteristics of patients, and reported on their experiences with and opinions about that study. The results from 151 patients showed that access to treatment and support from study site staff were important factors in enrollment and completion of the GRACE trial. Janssen Therapeutics, Division of Janssen Products, LP, conducted the GRACE trial and the participant survey.
The GRACE study was a Phase 3b trial that evaluated sex- and race-based differences in outcomes associated with PREZISTA® (darunavir)/ritonavir-based therapy in 429 treatment-experienced HIV-infected adults. The study included 65 sites throughout the United States, Puerto Rico and Canada. By using specific recruitment and retention strategies, the trial achieved enrollment of 67 percent women (and 33 percent men), successfully demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.
Survey respondents (n=151) reported that the best part of the GRACE study was access to treatment (41 percent), with most becoming more focused on their health (82 percent) and continuing treatment after the trial (87 percent). Additionally, 47 percent of survey participants cited support from study staff as the most important factor in completing the trial, describing the “professional, supportive, comforting, nonjudgmental, confidential, [and] caring” staff as willing to take extra time to help the participants. Survey respondents also reported feeling more confident about themselves and their future as a result of participating in the GRACE study. Negative experiences as reported by the participants included too many blood draws (26 percent), travel to the study site (13 percent) and the opinion that medicines were hard to take (12 percent). Factors associated with nonadherence, study discontinuation and poor virologic response cited by respondents included being the primary caregiver for children, unemployment, and difficulties with transportation, respectively.
“As researchers, we spend much time analyzing the data points pulled from a clinical trial. The results of the GRACE participant survey provide us with the unique opportunity to view the clinical trial experience through the eyes of a patient,” sai d Kathleen Squires, MD, Director, Division of Infectious Diseases, Thomas Jefferson University, who was a primary investigator in the GRACE study and is the lead author for the patient survey manuscript. “The survey has the potential to help shape how future studies are conducted, as it further addresses some of those barriers that may prevent individuals from participating in clinical research. We now can begin to understand how to better anticipate the barriers and help patients in overcoming them.”
Access to HIV medications was often cited as an important reason for participating in the GRACE trial. Respondents also reported that participation in GRACE increased their awareness of the importance of medication adherence—something that is of the utmost importance in U.S. healthcare, and a particular issue among those on treatment for HIV/AIDS[1].
“When GRACE was completed, the study investigators and HIV community encouraged Janssen to conduct a survey of participants. The positive patient feedback on their experience participating in the study speaks to the design and the care provided by the sites,” said Bryan Baugh, M.D., Medical Director at Janssen Therapeutics. “We want to commend everyone who helped us develop the study and the investigators who helped to make being in the study a positive experience for many participants.”
GRACE Participant Survey: Design and ResultsThe present study was a non-interventional, multicenter, cross-sectional survey completed by former participants of the GRACE trial, including those who did and did not complete the trial. Of the 57 GRACE sites located in the United States and Puerto Rico that enrolled patients, 22 chose to participate in the survey study, which was conducted between June 2010 and June 2011. The primary objective of the survey was to examine GRACE participants’ characteristics (beyond data obtained during the study), and their experiences with and opinions about participating in the study. The secondary objective was to explore statistically the associations between survey responses and adherence to study medications, study discontinuation and virologic response. Patients completed a 40-question multiple-choice and open-ended survey in a single visit.
Respondents reported that the best part of the GRACE experience was access to treatment (41 percent), being part of something bigger (18 percent) and feeling better (17 percent). Seventy-six percent felt that the GRACE trial made them feel differently about their health/HIV care, and most (82 percent) became more focused on their health, with 87 percent of respondents continuing treatment after GRACE. In all, 68 percent would be interested in sharing their GRACE experience and 96 percent would recommend participation in a clinical trial to others.
Some of the worst parts of the GRACE experience as reported by respondents were too many blood draws (26 percent), travel to the study site (13 percent), and the opinion that medicines were hard to take (12 percent). Although 88 percent reported having completed the GRACE trial, only 74 percent actually did so. Support from site study staff (47 percent) was noted as the most important factor in completing the study. Other common success factors were feeling better or healthier (16 percent), receiving support from family/friends (15 percent) and having access to medications (13 percent). Of the 12 percent who reported not completing the study, the most cited reason for discontinuation was intolerable side effects/not liking how they felt (50 percent).
The majority (71 percent) reported that GRACE was their first HIV study and that they learned about the study from the staff at their clinic (82 percent). Most (79 percent) felt that receiving other medications in addition to the main study drug, darunavir, was very important in their decision to participate in the GRACE study. The majority (76 percent) participated in GRACE at their primary HIV care location and 77 percent did not have any difficulty arranging transportation to the study site. Nearly all (99 percent) participants reported being comfortable or very comfortable with the study site, indicating that the site was very flexible with scheduling visits (93 percent).
The results of the survey were published in an article in the June 2013 issue of AIDS Patient Care and STDs (Volume 27, Number 6), and can be accessed here: http://online.liebertpub.com/doi/full/10.1089/apc.2013.0015
About the GRACE StudyGRACE was a multi-center (65 sites), open-label Phase 3b trial that compared the efficacy, safety, and tolerability of the protease inhibitor PREZISTA (600 mg) boosted with a low dose of ritonavir (100 mg) twice a day, in combination with an investigator-selected optimized background regimen for 48 weeks in men (n=142) and women (n=287).
The study was designed to enroll a high proportion of North American, treatment-experienced women that was reflective of the distribution and demographics of women with HIV in the United States. Trial sites were selected to correspond with the geographic distribution of women with HIV, with the majority of sites located in the Northeastern (16 sites) and Southeastern (29 sites) United States. Study sites were initially required to enroll three women before enrolling a man, and thereafter, each site was required to maintain at least 70 percent female enrollment. Men could only be enrolled if their addition did not compromise the 70 percent female quota.
Additional analyses were conducted as part of the GRACE study, including a sub-study examining efficacy and safety differences in response to race, as well as an immunology sub-study.
Study details and results were presented at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) and published in September 2010 in Annals of Internal Medicine.
About PREZISTA®PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
The GRACE study was a Phase 3b trial that evaluated sex- and race-based differences in outcomes associated with PREZISTA® (darunavir)/ritonavir-based therapy in 429 treatment-experienced HIV-infected adults. The study included 65 sites throughout the United States, Puerto Rico and Canada. By using specific recruitment and retention strategies, the trial achieved enrollment of 67 percent women (and 33 percent men), successfully demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.
Survey respondents (n=151) reported that the best part of the GRACE study was access to treatment (41 percent), with most becoming more focused on their health (82 percent) and continuing treatment after the trial (87 percent). Additionally, 47 percent of survey participants cited support from study staff as the most important factor in completing the trial, describing the “professional, supportive, comforting, nonjudgmental, confidential, [and] caring” staff as willing to take extra time to help the participants. Survey respondents also reported feeling more confident about themselves and their future as a result of participating in the GRACE study. Negative experiences as reported by the participants included too many blood draws (26 percent), travel to the study site (13 percent) and the opinion that medicines were hard to take (12 percent). Factors associated with nonadherence, study discontinuation and poor virologic response cited by respondents included being the primary caregiver for children, unemployment, and difficulties with transportation, respectively.
“As researchers, we spend much time analyzing the data points pulled from a clinical trial. The results of the GRACE participant survey provide us with the unique opportunity to view the clinical trial experience through the eyes of a patient,” sai d Kathleen Squires, MD, Director, Division of Infectious Diseases, Thomas Jefferson University, who was a primary investigator in the GRACE study and is the lead author for the patient survey manuscript. “The survey has the potential to help shape how future studies are conducted, as it further addresses some of those barriers that may prevent individuals from participating in clinical research. We now can begin to understand how to better anticipate the barriers and help patients in overcoming them.”
Access to HIV medications was often cited as an important reason for participating in the GRACE trial. Respondents also reported that participation in GRACE increased their awareness of the importance of medication adherence—something that is of the utmost importance in U.S. healthcare, and a particular issue among those on treatment for HIV/AIDS[1].
“When GRACE was completed, the study investigators and HIV community encouraged Janssen to conduct a survey of participants. The positive patient feedback on their experience participating in the study speaks to the design and the care provided by the sites,” said Bryan Baugh, M.D., Medical Director at Janssen Therapeutics. “We want to commend everyone who helped us develop the study and the investigators who helped to make being in the study a positive experience for many participants.”
GRACE Participant Survey: Design and ResultsThe present study was a non-interventional, multicenter, cross-sectional survey completed by former participants of the GRACE trial, including those who did and did not complete the trial. Of the 57 GRACE sites located in the United States and Puerto Rico that enrolled patients, 22 chose to participate in the survey study, which was conducted between June 2010 and June 2011. The primary objective of the survey was to examine GRACE participants’ characteristics (beyond data obtained during the study), and their experiences with and opinions about participating in the study. The secondary objective was to explore statistically the associations between survey responses and adherence to study medications, study discontinuation and virologic response. Patients completed a 40-question multiple-choice and open-ended survey in a single visit.
Respondents reported that the best part of the GRACE experience was access to treatment (41 percent), being part of something bigger (18 percent) and feeling better (17 percent). Seventy-six percent felt that the GRACE trial made them feel differently about their health/HIV care, and most (82 percent) became more focused on their health, with 87 percent of respondents continuing treatment after GRACE. In all, 68 percent would be interested in sharing their GRACE experience and 96 percent would recommend participation in a clinical trial to others.
Some of the worst parts of the GRACE experience as reported by respondents were too many blood draws (26 percent), travel to the study site (13 percent), and the opinion that medicines were hard to take (12 percent). Although 88 percent reported having completed the GRACE trial, only 74 percent actually did so. Support from site study staff (47 percent) was noted as the most important factor in completing the study. Other common success factors were feeling better or healthier (16 percent), receiving support from family/friends (15 percent) and having access to medications (13 percent). Of the 12 percent who reported not completing the study, the most cited reason for discontinuation was intolerable side effects/not liking how they felt (50 percent).
The majority (71 percent) reported that GRACE was their first HIV study and that they learned about the study from the staff at their clinic (82 percent). Most (79 percent) felt that receiving other medications in addition to the main study drug, darunavir, was very important in their decision to participate in the GRACE study. The majority (76 percent) participated in GRACE at their primary HIV care location and 77 percent did not have any difficulty arranging transportation to the study site. Nearly all (99 percent) participants reported being comfortable or very comfortable with the study site, indicating that the site was very flexible with scheduling visits (93 percent).
The results of the survey were published in an article in the June 2013 issue of AIDS Patient Care and STDs (Volume 27, Number 6), and can be accessed here: http://online.liebertpub.com/doi/full/10.1089/apc.2013.0015
About the GRACE StudyGRACE was a multi-center (65 sites), open-label Phase 3b trial that compared the efficacy, safety, and tolerability of the protease inhibitor PREZISTA (600 mg) boosted with a low dose of ritonavir (100 mg) twice a day, in combination with an investigator-selected optimized background regimen for 48 weeks in men (n=142) and women (n=287).
The study was designed to enroll a high proportion of North American, treatment-experienced women that was reflective of the distribution and demographics of women with HIV in the United States. Trial sites were selected to correspond with the geographic distribution of women with HIV, with the majority of sites located in the Northeastern (16 sites) and Southeastern (29 sites) United States. Study sites were initially required to enroll three women before enrolling a man, and thereafter, each site was required to maintain at least 70 percent female enrollment. Men could only be enrolled if their addition did not compromise the 70 percent female quota.
Additional analyses were conducted as part of the GRACE study, including a sub-study examining efficacy and safety differences in response to race, as well as an immunology sub-study.
Study details and results were presented at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) and published in September 2010 in Annals of Internal Medicine.
About PREZISTA®PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
- The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines
- It is important that you remain under the care of your healthcare professional during treatment with PREZISTA®
PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA®.
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA®?
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA®?
- PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
- PREZISTA® may cause liver problems. Some people taking PREZISTA®, together with Norvir® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA®. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
- Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
- PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild
Who should not take PREZISTA®?
- Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John's wort (Hypericum perforatum), lovastatin (Mevacor®, Altoprev®, Advicor®), simvastatin (Zocor®, Simcor®, Vytorin®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™)
- Before taking PREZISTA®, tell your healthcare professional if you are taking sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys®, Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA®?
- Before taking PREZISTA®, tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
- Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
- The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you
- Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA®?
- High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
- Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA®. The cause and long-term health effects of these conditions are not known at this time
- Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
- The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare professional
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please see full Prescribing Information for more details, available at http://PREZISTA.com/sites/default/files/pdf/us_package_insert.pdfAbout Janssen TherapeuticsAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.
Please see full Prescribing Information for more details, available at http://PREZISTA.com/sites/default/files/pdf/us_package_insert.pdfAbout Janssen TherapeuticsAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.
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Wednesday, May 29, 2013
GSK strengthens vaccines business with acquisition of Okairos
GSK News Release:
GSK strengthens vaccines business with acquisition of Okairos
- GSK to further expand its vaccines platform technology expertise through strategic acquisition
Issued: Wednesday 29 May 2013, London UK
GlaxoSmithKline (GSK) today announced that it has acquired Okairos AG (Okairos), a specialist developer of vaccine platform technologies for €250 million (approximately £215 million/$325 million) in cash.
Swiss-based Okairos, a private company, has developed a novel vaccine platform technology which is expected to play an important role in GSK’s development of new prophylactic vaccines (designed to prevent infection) as well as new classes of therapeutic vaccines (designed to treat infection or disease). Okairos’ technology complements GSK’s existing vaccine technology and expertise and will enable GSK to continue its work developing the next generation of vaccines. The deal also includes a small number of early stage assets.
The acquisition reinforces GSK’s commitment to investment in innovative science. GSK’s vaccines business sits alongside pharmaceuticals and consumer healthcare as part of a balanced business and product portfolio capable of delivering sustainable sales growth.
Christophe Weber, President, GSK Vaccines said: “This is a fantastic opportunity for patients and our research organisation as it is expected to contribute to the development efforts for an exciting new generation of vaccines, building on the excellent science and expertise of both companies.”
Riccardo Cortese, Chief Executive Officer and founder, Okairos, said: "I am extremely pleased with this agreement, which will enable GSK to build on the hard work we have put into developing our vaccines and platforms to the stage that they are at today. With its considerable resources and know-how, I am confident that GSK is best-placed to maximise this opportunity to potentially transform the vaccines landscape.”
Under the terms of the transaction, GSK will take full ownership of the company and thus assume ownership of early stage assets for diseases such as respiratory syncytial virus (RSV), hepatitis C virus (HCV), malaria, tuberculosis, ebola and HIV, supplementing the company’s existing vaccines pipeline. GSK and the Okairos management team are committed to an innovative collaboration and will work together over the next few months to develop ways of working that will maintain the autonomy, spirit and agility of this unique small biotech firm which will be strengthened by the support and advantages that GSK can provide.
Okairos was supported by investments from the following life science venture capital firms: BioMedInvest, the Boehringer Ingelheim Venture Fund, LSP, Novartis Venture Funds and Versant Ventures.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Okairos - is a non-listed clinical-stage biopharmaceutical company, developing genetic vaccines for major infectious diseases - including malaria, hepatitis C, HIV, respiratory syncytial virus and cancer - using a novel proprietary technology. The company is also pursuing therapeutic vaccines to treat cancer. For more information, visit www.okairos.com
Platform technology:
Okairos’ platform technology is based on novel viral vectors (mechanisms which deliver genetic material into cells) that are designed to help stimulate immune responses, (in particular T-cells) and aim to protect against and treat infectious diseases and cancer.. The potential of this technology has been tested in clinical studies in which over 700 subjects have been vaccinated, including Phase II programmes in hepatitis C and malaria.
Okairos’ platform technology is based on novel viral vectors (mechanisms which deliver genetic material into cells) that are designed to help stimulate immune responses, (in particular T-cells) and aim to protect against and treat infectious diseases and cancer.. The potential of this technology has been tested in clinical studies in which over 700 subjects have been vaccinated, including Phase II programmes in hepatitis C and malaria.
Tuesday, May 28, 2013
European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection
Press Release:
FOSTER CITY, Calif. --(BUSINESS WIRE)--May. 28, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg), a single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. This approval allows for the marketing of Stribild in all 27 countries of the European Union .
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California , Gilead has operations in North America , Europe and Asia Pacific .
European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection
“Single tablet regimens make it easier for HIV patients to take their treatment consistently every day, which may improve their health outcomes,” said Jürgen Rockstroh, MD, Professor of Medicine, University of Bonn , Germany and a lead investigator for one of the Stribild pivotal studies. “Stribild is a highly effective and well tolerated HIV treatment regimen, and is an important addition to the growing arsenal of simplified therapies in Europe.”
This approval is supported by 48-week data from two pivotal Phase 3 studies in which Stribild met its primary objective of non-inferiority compared to Atripla®(efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada®(emtricitabine/tenofovir disoproxil (as fumarate)) (Study 103).
“We look forward to making Stribild available to HIV-treating physicians and their patients throughout the European Union as quickly as possible,” said John C. Martin , PhD, Chairman and Chief Executive Officer, Gilead Sciences .
Stribild is also approved in the United States , Canada , Australia , South Korea , Japan and Turkey .
Stribild is the third single tablet HIV regimen developed by Gilead to become available in Europe . The first, Atripla, was approved in the European Union in 2007 and is marketed by Gilead in partnership with Bristol-Myers Squibb and Merck & Co. The second, Eviplera®▼ (emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate) 245 mg)), is marketed by Gilead and Janssen R&D Ireland and received European marketing authorization in November 2011 .
About Stribild
Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil (as fumarate) 245 mg.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005 . Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan , where JT retains rights.
Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
Marketing applications for elvitegravir and cobicistat as standalone agents are currently under review in the European Union . In the United States , on April 29, 2013 , Gilead announced it had received Complete Response Letters from the U.S. Food and Drug Administration (FDA ) on its New Drug Applications for elvitegravir and cobicistat as standalone agents. The company is working to address the questions raised in FDA’s letters as quickly as possible.
Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established.
EU Important Product Information About Stribild
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues. Lactic acidosis has a high mortality and patients at increased risk should be followed closely.
Stribild should not be taken with any of the following due to the potential for serious and/or life-threatening events or loss of virologic response and possible resistance to Stribild:
- alpha 1-adrenoreceptor antagonists: alfuzosin
- antiarrhythmics: amiodarone, quinidine
- anticonvulsants: carbamazepine, phenobarbital, phenytoin
- antimycobacterials: rifampicin
- ergot derivatives: dihydroergotamine, ergometrine, ergotamine
- gastrointestinal motility agents: cisapride
- herbal products: St. John’s wort (Hypericum perforatum)
- HMG Co-A reductase inhibitors: lovastatin, simvastatin
- neuroleptics: pimozide
- PDE-5 inhibitors: sildenafil for treatment of pulmonary arterial hypertension
- sedatives/hypnotics: orally administered midazolam, triazolam
As a fixed combination, Stribild should not be administered concomitantly with other medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of hepatitis B virus infection.
Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion. Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (as fumarate).
Patients who have previously discontinued treatment with tenofovir disoproxil (as fumarate) due to renal toxicity should not be treated with Stribild.
Patients should have creatinine clearance calculated and urine glucose and urine protein determined prior to initiating Stribild therapy.
Stribild should not be initiated in patients with creatinine clearance below 70 mL/min. It is recommended that Stribild is not initiated in patients with creatinine clearance < 90 mL/min unless, after review of the available treatment options, it is considered that Stribild is the preferred treatment for the individual patient.
Creatinine clearance, serum phosphate, urine glucose and urine protein should be monitored every four weeks during the first year and then every three months. More frequent monitoring of renal function should be considered in patients at risk for renal impairment.
Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance. Patients who experience a confirmed increase in serum creatinine of greater than 26.5 μmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety.
Renal function should be re-evaluated within one week if serum phosphate is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance decreases to < 70 mL/min during Stribild therapy.
If creatinine clearance is confirmed as < 50 mL/min or serum phosphate decreases to < 0.32 mmol/L (1.0 mg/dL) then Stribild should be discontinued.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil (as fumarate) and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil (as fumarate) without cobicistat.
Stribild should be avoided with concurrent or recent use of a nephrotoxic medicinal product due to the increased risk of renal adverse reactions (with the tenofovir disoproxil (as fumarate) component of Stribild).
Bone abnormalities (infrequently leading to fractures) may be associated with proximal renal tubulopathy and appropriate consultation should be obtained if suspected.
Stribild has not been studied in patients with severe hepatic impairment (CPT Score C).
Discontinuation of Stribild therapy in patients co-infected with HIV and hepatitis B virus (HBV) may be associated with severe acute exacerbations of hepatitis. Patients co-infected with HIV and HBV who discontinue Stribild should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of hepatitis B therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post treatment exacerbation of hepatitis may lead to hepatic decompensation.
Immune Reactivation Syndrome has been reported in patients treated with combination therapy, including the components of Stribild.
Combination therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown.
About Gilead Sciences
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians in Europe may not see advantages of Stribild over other HIV therapies and may therefore be reluctant to prescribe the product. In addition, pending marketing applications for elvitegravir and cobicistat as standalone agents in the United States and Europe may not be approved or approvals may be delayed, including due to Gilead’s inability to address the questions raised in FDA’s complete response letters. Further, any marketing approvals, if granted, may have significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 , as filed with the U.S. Securities and Exchange Commission . All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
EU Summary of Product Characteristics for Atripla, Eviplera, Stribild and Truvada are available at
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
Eviplera, Stribild and Truvada are registered trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark ofBristol-Myers Squibb & Gilead Sciences, LLC .
Atripla is a registered trademark of
For more information on Gilead Sciences , please visit the company’s website atwww.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Monday, May 27, 2013
Salmonella uses protective switch during infection
Pacific Northwest National Laboratory News Release:
Salmonella uses protective switch during infection
May 27, 2013
- Mary Beckman, PNNL, (509) 375-3688
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The food poisoning bacteria Salmonella is also known as Salmonella enterica enterica, serovar Typhimurium.
Photo courtesy of Centers for Disease Control and Prevention.
RICHLAND, Wash. – For the first time, researchers have found a particular kind of molecular switch in the food poisoning bacteriaSalmonella Typhimurium under infection-like conditions. This switch, using a process called S-thiolation, appears to be used by the bacteria to respond to changes in the environment during infection and might protect it from harm, researchers report this week online in the Proceedings of the National Academy of Sciences Early Edition.
S-thiolation protects proteins from irreversible chemical changes when a cell is stressed. The newly discovered switch might regulate when or how proteins work while offering protection, providing researchers insight into Salmonella infection.
"We continue to recognize just how clever this bug is in adapting to its environment," said systems biologist Josh Adkins of the Department of Energy's Pacific Northwest National Laboratory. "During infection it lives in hostile environments, and so it can use multiple approaches to adjust its functions."
Whole Ensemble
Salmonella Typhimurium causes food poisoning in people and can be fatal in the elderly or very young. Recent technological advances in the field known as proteomics are allowing researchers to explore how proteins, the workhorses of the cell, allow the bacteria to infect and cause illness. Most technologies that examine a cell's ensemble of proteins do so by chopping the proteins up. Adkins, lead author Charles Ansong and other colleagues wanted to look at whole proteins, which provides more information such as how proteins are regulated.
Cells regulate how proteins work in several ways. One of the most common adds molecular pieces that serve as gas pedals on proteins, turning them up or down in a grand orchestrated way. Proteomics methods that chop up proteins allow a researcher to determine that a particular protein was present, but not if it was actually functioning. Those methods also destroy evidence about how hard the gas pedal was pressed.
To identify which proteins were likely turned on or off during Salmonella infection, the team grew the bacteria either with rich food that satisfied all their nutritional needs or with nutrient-poor food that mimicked the kind of stressful environment the microbes find themselves in while infecting someone.
Then the researchers took samples of the bacteria and identified the proteins inside. They used a method called top-down proteomics, a technological advancement that allows researchers to look at wide swaths of whole proteins instead of just a few at a time. The team identified 563 unique proteins. This number is comparable to fungus and human studies but almost three times as many as in other bacterial studies using top-down proteomics.
They also determined if the proteins had molecular modifications on them. These can cap an end of a protein or dot the protein's length. Because different modifications can be mixed and matched on one protein, they ended up with a total of 1,665 different forms of the 563 unique proteins.
"This study shows how well top-down proteomics works, especially to get at regulatory information," said co-author Ljiljana Pasa-Tolic, who led top-down proteomics development with mass spectroscopist Si Wu at EMSL, DOE's Environmental Molecular Sciences Laboratory on the PNNL campus.
Gluts Versus Cysts
Of particular interest to the team were S-thiolation modifications. These modifications cover and protect a protein's sulfur atoms, which tend to snag each other like velcro and cause misshapen proteins. The modifications come in two flavors: a bulky glutathione and a compact cysteine. While glutathione modifications are pretty well studied, only four studies reveal cysteine modifications, and only two of those are in bacteria.
A total of 25 proteins sported glutathiones and another 18 wore cysteines. But nine of these stood out: The glutathiones and the cysteines attached to the same exact spot on the nine proteins. Not at the same time — the team found that Salmonella used glutathiones at these sites when they were fat and happy, growing with rich food. When grown under stressful conditions with nutritionally poor food, the Salmonella swapped their glutathiones for cysteines.
In addition, switching S-thiolation modifications appeared to be a talent unique to Salmonella. The team checked other bacteria such as Escherichia coli, a common gut bacteria, and Yersinia pestis, which causes plague, to see if other species used this S-thiolation switch on their proteins. They didn't, suggesting that Salmonella had come up with this tactic during its own evolution.
The researchers speculate that Salmonella might use the smaller cysteine under stressed conditions as an energy saving device. Additional research will reveal what control functions the modifications are actually performing on the proteins, as well as explore how global this method of control is within the microbe.
This work was supported by the National Institute of Allergy and Infectious Disease through interagency agreement Y1-AI-8494-01 and the National Institute for General Medical Sciences.
Reference: Charles Ansong, Si Wu, Da Meng, Xiaowen Liu, Heather Brewer, Brooke L. Deatherage Kaiser, Ernesto S. Nakayasu, John R. Cort, Pavel A. Pevzner, Richard D. Smith, Fred Heffron, Joshua N. Adkins and Ljiljana Paša-Tolic. Top-down proteomics reveals a unique protein S-thiolation switch in Salmonella Typhimurium in response to infection-like conditions, Proc Natl Acad Sci U S A, Early Edition online the week of May 27, 2013, DOI 10.1073/pnas.1221210110.
Thursday, May 23, 2013
Novel coronavirus infection - update (Middle East respiratory syndrome- coronavirus)
World Health Organization News Release:
Global Alert and Response (GAR)
Global Alert and Response (GAR)
Novel coronavirus infection - update (Middle East respiratory syndrome- coronavirus)
23 MAY 2013 - The Ministry of Health in Saudi Arabia has notified WHO of an additional laboratory-confirmed case of infection with the Middle East respiratory syndrome coronavirus (MERS-CoV).
The fatal case was reported from Al-Qaseem region in the Central part of the country and is not related to the cluster of cases reported from Al-Ahsa region in the Eastern part of the country. The patient was a 63-year-old man with an underlying medical condition who was admitted to a hospital with acute respiratory distress on 15 May 2013 and died on 20 May 2013. Investigation into contacts of this case is ongoing.
The Saudi authorities are also continuing the investigation into the outbreak that began in a health care facility since the beginning of April 2013 in Al-Ahsa. To date, a total of 22 patients including 10 deaths have been reported from the outbreak.
Globally, from September 2012 to date, WHO has been informed of a total of 44 laboratory-confirmed cases of infection with MERS-CoV, including 22 deaths.
WHO has received reports of laboratory-confirmed cases from the following countries in the Middle East: Jordan, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). France, Germany, Tunisia and the United Kingdom also reported laboratory-confirmed cases; they were either transferred for care of the disease or returned from Middle East and subsequently became ill. In France, Tunisia and the United Kingdom, there has been limited local transmission among close contacts who had not been to the Middle East but had been in close contact with the laboratory-confirmed or probable cases.
Based on the current situation and available information, WHO encourages all Member States to continue their surveillance for severe acute respiratory infections (SARI) and to carefully review any unusual patterns.
Health care providers are advised to maintain vigilance. Recent travellers returning from the Middle East who develop SARI should be tested for MERS-CoV as advised in the current surveillance recommendations. Specimens from patients’ lower respiratory tracts should be obtained for diagnosis where possible. Clinicians are reminded that MERS-CoV infection should be considered even with atypical signs and symptoms, such as diarrhoea, in patients who are immunocompromised.
Health care facilities are reminded of the importance of systematic implementation of infection prevention and control (IPC). Health care facilities that provide care for patients suspected or confirmed with MERS-CoV infection should take appropriate measures to decrease the risk of transmission of the virus to other patients, health care workers and visitors.
All Member States are reminded to promptly assess and notify WHO of any new case of infection with MERS-CoV, along with information about potential exposures that may have resulted in infection and a description of the clinical course. Investigation into the source of exposure should promptly be initiated to identify the mode of exposure, so that further transmission of the virus can be prevented.
WHO does not advise special screening at points of entry with regard to this event nor does it currently recommend the application of any travel or trade restrictions.
WHO continues to closely monitor the situation.
Note: To provide uniformity and facilitate communication about the disease, the Coronavirus Study Group of the International Committee on Taxonomy of Viruses has decided to call the new virus Middle East respiratory syndrome coronavirus (MERS-CoV). Reference: De Groot RJ, et al. Middle East Respiratory Syndrome Coronavirus (MERS-CoV): Announcement of the Coronavirus Study Group. J Virol. Published ahead of print 15 May 2013. doi:10.1128/JVI.01244-13.
Wednesday, May 22, 2013
Novel coronavirus infection - update
World Health Organization News Release:
Novel coronavirus infection - update
22 MAY 2013 - The Ministry of Health in Tunisia has notified WHO of two laboratory-confirmed cases and a probable case of infection with the novel coronavirus (nCoV).
The two laboratory confirmed cases are a 34-year-old man and a 35-year-old woman. They are siblings. Both of them had mild respiratory illness and did not require hospitalization. Retrospective investigation into the cases revealed that the probable case, their father, 66 year old, became ill three days after returning from a visit to Qatar and Saudi Arabia on 3 May 2013. He was admitted to a hospital after developing acute respiratory disease. His condition deteriorated and he died on 10 May 2013. He had an underlying health condition. Initial laboratory tests conducted on the probable case tested negative for nCoV.
Further investigation into this outbreak is ongoing and close contacts of the family are being monitored for any unusual signs of illness. These are the first confirmed cases of infection with nCoV in Tunisia.
In Saudi Arabia, a patient earlier reported as part of the ongoing investigation into an outbreak that began in a health care facility since the beginning of April 2013, has died. To date, a total of 22 patients including 10 deaths have been reported from this outbreak in the Eastern part of Saudi Arabia. The government is conducting an ongoing investigation into the outbreak.
Globally, from September 2012 to date, WHO has been informed of a total of 43 laboratory-confirmed cases of infection with nCoV, including 21 deaths. Several countries in the Middle East have been affected. They are Jordan, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). Cases have also been reported by four additional countries: France, Germany, Tunisia and the United Kingdom. All of the cases have had a direct or indirect connection to the Middle East, including two cases with recent travel history from the UAE. In France and the United Kingdom, there has been limited local transmission among close contacts who had not been to the Middle East but had been in contact with a traveler who recently returned from the Middle East.
Based on the current situation and available information, WHO encourages all Member States to continue their surveillance for severe acute respiratory infections (SARI) and to carefully review any unusual patterns.
Health care providers are advised to maintain vigilance. Recent travelers returning from the Middle East who develop SARI should be tested for nCoV as advised in the current surveillance recommendations. Specimens from patients’ lower respiratory tracts should be obtained for diagnosis where possible. Clinicians are reminded that nCoV infection should be considered even with atypical signs and symptoms, such as diarrhoea, particularly in patients who are immunocompromised.
Health care facilities are reminded of the importance of systematic implementation of infection prevention and control (IPC). Health care facilities that provide care for patients with suspected nCoV infection should take appropriate measures to decrease the risk of transmission of the virus to other patients, health care workers and visitors.
All Member States are reminded to promptly assess and notify WHO of any new case of infection with nCoV, along with information about potential exposures that may have resulted in infection and a description of the clinical course. Investigation into the source of exposure should promptly be initiated to identify the mode of exposure, so that further transmission of the virus can be prevented.
WHO does not advise special screening at points of entry with regard to this event nor does it currently recommend the application of any travel or trade restrictions.
WHO continues to closely monitor the situation.
Wild poliovirus in the Horn of Africa
World Health Organization News Release:
Wild poliovirus in the Horn of Africa
22 MAY 2013 - The Horn of Africa is currently experiencing an outbreak of wild poliovirus type 1 (WPV1). A four-month-old girl near Dadaab, Kenya, developed symptoms of acute flaccid paralysis (AFP) on 30 April 2013. Two healthy contacts of the child tested positive for WPV1. They are the first laboratory confirmed cases in Kenya since July 2011. Investigation into this outbreak is ongoing. In addition, a case of WPV1 in Banadir, Somalia was confirmed on 9 May 2013.
In response to the outbreak, the first vaccination campaign, reaching 440 000 children began on 14 May 2013 in Somalia and a second round of vaccination is planned for 26 May 2013 in synchronization with the affected parts of Kenya.
The risk to neighbouring countries is deemed as very high, due to large-scale population movements across the Horn of Africa and persistent immunity gaps in some areas. Dadaab hosts a major refugee camp, housing nearly 500 000 persons from across the Horn of Africa.
An alert for enhanced surveillance for polio has been issued to all countries across the Horn of Africa, highlighting the need to conduct active searches for any suspected cases. All countries are urged to rapidly identify sub-national surveillance gaps and to take measures to fill the gaps.
In 2005, polio spread east across the African continent, and into Yemen and the Horn of Africa, resulting in over 700 cases. Since then, international outbreak responses have been adopted and new monovalent and bivalent oral polio vaccines have been developed, which can significantly reduce the severity and length of polio outbreaks.
Some areas of Somalia (south-central) are also affected by an outbreak due to circulating vaccine-derived poliovirus type 2 (cVDPV2), which has resulted in 18 cases in Somalia since 2009. In 2012, this strain spread to Dadaab, causing three cases.
WHO’s International Travel and Health recommends that all travellers to and from polio-infected areas be fully vaccinated against polio.
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