viernes, 12 de febrero de 2016

Oral HPV16 Infection Precedes Head and Neck Cancer - National Cancer Institute

Oral HPV16 Infection Precedes Head and Neck Cancer - National Cancer Institute

National Cancer Institute



National Cancer Institute

Prospective Study Links HPV Detection in the Mouth to Head and Neck Cancer

February 12, 2016 by NCI Staff
Three images of a patient with an HPV-positive oropharyngeal tumor (large arrow) that has spread to a nearby lymph node (small arrow).
Credit: Oncology/UBM Medica www.theoncologyjournal.com
In a new study, researchers have confirmed that infection with human papillomavirus (HPV) 16 precedes the development of head and neck cancer. Previous studies have established an association between HPV-16 infection and oropharyngeal cancer, a type of head and neck cancer. The new study is the first to do so using samples collected from patients prior to their cancer diagnosis.
The study also reported, for the first time, an association between head and neck cancer risk and infection with HPV types other than HPV 16.
Ilir Agalliu, M.D., Sc.D., and Robert D. Burk, M.D., of Albert Einstein College of Medicine in New York and their colleagues reported the results of this prospective study January 21 in JAMA Oncology.
Infection in the oral cavity with cancer-causing types of HPV, especially HPV 16, is a risk factor for some types of head and neck cancer, particularly oropharyngeal cancers. In the United States, the incidence of oropharyngeal cancers caused by HPV infection has been increasing, while the incidence of oropharyngeal cancers related to other causes has been falling.
To conduct the study, the researchers analyzed data on oral HPV infection and risk of head and neck cancer in two large national prospective studies: the American Cancer Society Cancer Prevention Study II Nutrition Cohort and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.
At the start of each cohort study, all participants were cancer-free and provided a mouthwash sample to researchers. After an average of nearly 4 years of follow up, a total of 132 participants had been diagnosed with head and neck cancer.
Mouthwash samples (containing oral cells) from the participants who developed head and neck cancer and from 396 healthy matched control individuals were analyzed for the presence of HPV DNA. After adjusting for smoking history and alcohol consumption, the researchers estimated that individuals with HPV 16 in their mouthwash samples had substantially greater odds of developing oropharyngeal cancer than participants with no detectable HPV 16 in their mouthwash samples.
“The results of this study provide, for the first time, clear evidence that detection of HPV 16 DNA in the oral cavity precedes the diagnosis of oropharyngeal cancers and confers a substantial risk for these cancers,” said Dr. Agalliu.
Previous studies had found that, in addition to containing HPV types of the alpha genus (which includes mucosal HPV types such as HPV 16 and other cancer-causing HPV types), the mouth contains a broad range of other HPV types. So the researchers also investigated whether any of these were associated with head and neck cancer. They found that the presence in the mouth of several beta- and gamma-HPVs was also associated with the development of head and neck cancer.
“These findings inform our thinking about the etiology of oropharyngeal cancer—specifically, oral HPV preceding its diagnosis. However, it would be premature to consider the detection of oral HPV as a screening test,” said study coauthor Aimée R. Kreimer, Ph.D., of NCI’s Division of Cancer Epidemiology and Genetics.
“We also need to better understand the role of other risk factors—namely, cigarette smoking and alcohol consumption—and how they interact with oral HPVs in head and neck cancers,” Dr. Burk added.

FDA Approves Eribulin Mesylate for Advanced Liposarcoma - National Cancer Institute

FDA Approves Eribulin Mesylate for Advanced Liposarcoma - National Cancer Institute



National Cancer Institute



02/11/2016


The Food and Drug Administration (FDA) approved eribulin mesylate (Halaven®) on January 28 for some patients with liposarcoma. The approval is for patients whose cancers are advanced (metastatic) or cannot be removed by surgery (unresectable) and are no longer responding to anthracycline-based chemotherapy. “The approval offers a therapeutic option for a disease with minimal treatment options,” said Chris Heery, M.D., director of the Clinical Trials Group in NCI’s Center for Cancer Research.




National Cancer Institute



FDA Approves Eribulin Mesylate for Advanced Liposarcoma



February 11, 2016 by NCI Staff
By inhibiting the formation of microtublules (green), eribulin disrupts mitosis, a type of cell division, in tumor cells.
Credit: Wikimedia Commons / Afunguy
The Food and Drug Administration (FDA) approved eribulin mesylate (Halaven®) on January 28 for some patients with liposarcoma. The approval is for patients whose cancers are advanced (metastatic) or cannot be removed by surgery (unresectable) and are no longer responding to anthracycline-based chemotherapy.
“The approval offers a therapeutic option for a disease with minimal treatment options,” said Chris Heery, M.D., director of the Clinical Trials Group in NCI’s Center for Cancer Research.
The drug’s approval was based on the findings in a subgroup of 143 patients with advanced liposarcoma who were participating in a randomized phase III clinical trial of eribulin mesylate. Patients in the trial (which also included patients with another type of sarcoma, leiomyosarcoma) were randomly assigned to receive eribulin mesylate or the chemotherapy drug dacarbazine until their disease progressed or until they were no longer able to tolerate the side effects of treatment.
The median overall survival for patients with liposarcoma treated with eribulin mesylate was 15.6 months, compared with 8.4 months for those who received dacarbazine.
In the trial, treatment-related side effects were more common in patients who received eribulin mesylate, including neutropenia and peripheral neuropathy. High-grade side effects were also more frequent, but manageable, in the eribulin-treated patients.
“The approval of an agent that improves overall survival offers a backbone of therapy for the future upon which we can hope for greater improvements in this difficult-to-treat disease,” said Dr. Heery.
In October 2015, the FDA approved another drug, trabectedin (Yondelis®), for patients with advanced liposarcoma and leiomyosarcoma. It’s not clear yet “what the best order of these agents will be for liposarcoma,” Dr. Heery said, “but it is exciting to have two treatment options for patients with this difficult disease.”

Drug Information Update- FDA approves new drug for treatment of chronic hepatitis C genotypes 1 and 4

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response or SVR), suggesting a participant’s infection had been cured.

The overall SVR rates ranged from 94-97 percent in genotype 1-infected subjects and from 97-100 percent in genotype 4-infected subjects across trials for the approved treatment regimens. In order to maximize SVR rates for patients, the product label provides recommendations regarding length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and their virus. It is recommended that healthcare professionals screen genotype 1a-infected patients for certain viral genetic variations prior to starting treatment with Zepatier to determine dosage regimen and duration.
The most common side effects of Zepatier without ribavirin were fatigue, headache and nausea. The most common side effects of Zepatier with ribavirin were anemia and headache.
Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight. Liver-related blood tests should be performed prior to starting therapy and at certain times during treatment. Zepatier should not be given to patients with moderate or severe liver impairment.
For more information, please visit: Zepatier.

Bilingual Twitter Chat and #ILoveMyHeart Campaign with Salud Today

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Get in on the action!

The OMH #IloveMyHeart Campaign, with our partners Salud Today (@SaludToday) and the Association of Black Cardiologists (@ABCardio1), is still going strong! We encourage you to participate by taking a picture with a poster board showing us how you keep your heart healthy. Share your photos on Facebook or Twitter with the #ILoveMyHeart hashtag and the @FDAOMH Twitter handle. 

In honor of American Heart Month this February, we are hosting a bilingual Twitter chat with Salud Today  (@SaludToday) onTuesday, February 16th from 1 p.m. – 2 p.m., EST. We'll chat about risk factors for heart disease and provide tips to lead a heart healthy lifestyle. We hope you can join us and provide insights on this important topic.

I love my heart campaign group photo of OMH staff

Headlines: Confidentiality Rule Open for Public Comment

Headlines: Confidentiality Rule Open for Public Comment

SAMHSA Headlines



Confidentiality of Alcohol and Drug Abuse Patient Records: Proposed Revisions Open for Public Comment

HHS has published proposed revisions to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations—42 CFR Part 2. This proposal was prompted by the need to update and modernize the regulations. The goal of the proposed changes is to ensure that patients with substance use disorders have the ability to participate in, and benefit from, new integrated health care models without fear of putting themselves at risk of adverse consequences.

SAMHSA Appoints Kimberly A. Johnson, Ph.D., as Director of SAMHSA's Center for Substance Abuse Treatment (CSAT)

In her new role, Dr. Johnson will be responsible for the leadership, management, and operation of CSAT's more than $2 billion budget and significant portfolio grants and contracts to states, tribes, territories, communities, and nonprofit organizations.

Up to $1.2 Million Available for Strategic Prevention Framework – Partnerships for Success Grants

The purpose of this grant program is to address two of the nation's top substance abuse prevention priorities: (1) underage drinking among persons aged 12 to 20; and (2) prescription drug misuse among persons aged 12 to 25.

Up to Nearly $16.3 Million Available for Grants To Expand Substance Abuse Treatment Capacity in Adult Treatment Drug Courts and Adult Tribal Healing to Wellness Courts

The purpose of this program is to expand and/or enhance substance use disorder treatment services in existing adult problem-solving courts and Adult Tribal Healing to Wellness Courts, which use the treatment drug court model to provide alcohol and drug treatment (including recovery support services, screening, assessment, case management, and program coordination) to defendants/offenders.

Up to $1.5 Million Available in Cooperative Agreements To Benefit Homeless Individuals

The purpose of this program is to enhance and/or expand the infrastructure and mental health and substance use treatment services of states and territories, local governments, and other domestic public and private nonprofit entities, federally recognized American Indian/Alaska Native tribes and tribal organizations, urban Indian organizations, public or private universities and colleges, and community and faith-based organizations.

National Behavioral Health Barometer, 2015

SAMHSA's most recent National Behavioral Health Barometer report highlights many trends in Americans' behavioral health. The 2015 Barometer findings cover key behavioral health care issues affecting American communities including the prevalence rates of youth and adult substance use, serious mental illness, suicidal thoughts, and people seeking treatment for these disorders.

Parity of Mental Health and Substance Use Benefits With Other Benefits: Using Your Employer-Sponsored Health Plan To Cover Services


This publication examines what the Mental Health Parity and Addiction Equity Act means for people with employer-sponsored health plans who need treatment for substance abuse or mental illness; it discusses key elements of health care legislation particularly as it relates to filing a claim, denial of a claim, and the appeals process.

Opioid Overdose Prevention Toolkit – Updated 2016

This publication equips health care providers, communities, and local governments with material to develop practices and policies to help prevent opioid-related overdoses and deaths. Now includes information on the first nasal spray version of naloxone hydrochloride approved by the U.S. Food and Drug Administration.

February 10–March 16, 2016

Webinar: SAMHSA's Electronic Health Records Boot Camp Series

Register for this six-part series designed to help behavioral health leaders increase their understanding of electronic health records (EHRs) and prepare to implement EHR systems within their organizations. Participants will learn about the benefits of EHRs and have the opportunity to get their questions answered and concerns addressed alongside other substance use and mental health treatment leaders.
February 17, 2016

Exploring the American Indian Life Skills Development Curriculum for Suicide Prevention

Join SAMHSA's Tribal Training and Technical Assistance Center in this discussion on the American Indian Life Skills Development Curriculum, a course for Native high school and middle school students designed to reduce suicidal thinking and behavior.
February 29, 2016

Emerging Compliance Hotspots for Certified Community Behavioral Health Clinics (CCBHC): Care Coordination With Collaborating Organizations

Register to learn about the relationships that CCBHCs will forge in their communities with Designated Collaborating Organizations (DCOs) and other providers. Presenters will discuss the types of CCBHC services that may be provided by DCOs, as well as the types of contractual arrangements that CCBHCs will need to pursue with DCOs to ensure clinical and financial responsibility.
Mental Health First Aid

Mental Health First Aid

Learn the five steps in Mental Health First Aid—a mental health literacy program in which anyone can learn the signs and symptoms of mental health crisis and how to help.

Ahead of Print -Phylogeny of Zika Virus in Western Hemisphere, 2015 - Volume 22, Number 5—May 2016 - Emerging Infectious Disease journal - CDC

Ahead of Print -Phylogeny of Zika Virus in Western Hemisphere, 2015 - Volume 22, Number 5—May 2016 - Emerging Infectious Disease journal - CDC



ZIKA

Volume 22, Number 5—May 2016

Letter

Phylogeny of Zika Virus in Western Hemisphere, 2015

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To the Editor: Zika virus (ZIKV) belongs to the genus Flavivirus, family Flaviviridae, and is transmitted by Aedesspp. mosquitoes. Clinical signs and symptoms of human infection with ZIKV include fever, headache, malaise, maculopapular rash, and conjunctivitis.
ZIKV was first isolated in 1947 from the blood of a febrile sentinel rhesus monkey during a study of yellow fever in the Zika Forest of Uganda (1). During the next 20 years, ZIKV isolates were obtained primarily from East and West Africa during arbovirus surveillance studies in the absence of epidemics. During those 20 years, cases of ZIKV infection were detected sporadically; however, given the clinical similarity of ZIKV and dengue virus infections and the extensive cross-reactivity of ZIKV antibodies with dengue viruses, it is possible that ZIKV was associated with epidemics that were incorrectly attributed to dengue viruses. Beginning in 2007, substantial ZIKV outbreaks were reported first in Yap Island (Federated States of Micronesia), then in French Polynesia, and then in other Pacific Islands (24).
Genetic studies have revealed that ZIKV has evolved into 3 distinct genotypes: West African (Nigerian cluster), East African (MR766 prototype cluster), and Asian. It has been postulated that the virus originated in East Africa and then spread into both West Africa and Asia ≈50–100 years ago (5). In early 2015, cases of ZIKV infection were detected in Rio Grande State, northern Brazil, and limited sequence analyses revealed that the virus was most closely related to a 2013 ZIKV from French Polynesia, within the Asian clade (6).
Thumbnail of Phylogenetic tree of Zika virus isolates identified from Guatemala and Puerto Rico in December 2015 (indicated in boldface) compared with reference isolates obtained from GenBank. The isolates from Guatemala and Puerto Rico grouped with other Asian genotype viruses. The tree was derived by neighbor-joining methods (bootstrapped 1,000 times) using complete-genome sequences. Location, year identified, and GenBank strain identification for the viruses used in tree construction are show
Figure. Phylogenetic tree of Zika virus isolates identified from Guatemala and Puerto Rico in December 2015 (indicated in boldface) compared with reference isolates obtained from GenBank. The isolates from Guatemala and Puerto...
In December 2015, the Centers for Disease Control and Prevention Arbovirus Diagnostic Laboratory detected ZIKV in serum specimens collected from persons in Guatemala and Puerto Rico. The complete nucleotide sequence of ZIKV was derived directly from 3 of these serum specimens by using next-generation sequencing on the Ion Torrent (Thermo Fisher Scientific, Waltham, MA, USA) platform. The raw sequence reads were analyzed and assembled by using the CLC bio Genomics Workbench (CLC bio, Waltham, MA, USA) and Lasergene NextGen (DNAStar, Madison, WI, USA). The complete genome sequences were aligned by using ClustalW (http://www.megasoftware.net/) with all available full-length ZIKV sequences from GenBank representing the 3 genotypes. Nearly identical phylogenetic trees were generated by using several methods (minimum-evolution, maximum-likelihood, neighbor-joining), and a neighbor-joining tree was generated and analyzed with 1,000 replicates for bootstrap testing (Figure). GenBank accession numbers for ZIKV sequences presented in this article are KU501215 (Puerto Rico PRVABC59), KU501216 (Guatemala 8375), and KU501217 (Guatemala 103344).
In agreement with the initial sequencing of samples from Brazil conducted by Zanluca et al. (6), the 3 newly sequenced ZIKVs from Guatemala and Puerto Rico are all within the Asian genotype and most closely related to strains recently isolated from Brazil (2015) and French Polynesia (2013). The tree topology confirms previous findings and indicates that Asian genotype viruses have been gradually evolving and spreading geographically throughout Asia and the Pacific Islands since at least 1966; the tree suggests that the Malaysia 1966 ZIKV is representative of an ancestral genotype (7). The percent nucleotide identity among all the Western Hemisphere ZIKVs is >99%, and as a group, these Western Hemisphere viruses are ≈89% identical (96% aa) to viruses of the East African and West African genotypes.
As reported by Musso et al. (8), the phylogeny and movement of ZIKV and chikungunya virus are strikingly similar. Each virus is grouped into 3 genotypes of very similar geographic distribution: East Africa, West Africa, and Asia. For both viruses, it also seems that viruses from East Africa moved into Asia ≈50–100 years ago and evolved into a unique Asian genotype (9,10). In addition, the similarity with respect to the recent movement of these viruses from Asia into the Pacific Islands and then into the New World (9) is noteworthy. It seems that similar ecologic and/or human social factors might be responsible for the movement of chikungunya virus and ZIKV into the New World at approximately the same time. Further studies might elucidate the exact mechanism of this transcontinental movement, leading to effective prevention strategies.
Robert S. LanciottiComments to Author , Amy J. Lambert, Mark Holodniy, Sonia Saavedra, and Leticia del Carmen Castillo Signor
Author affiliations: Centers for Disease Control and Prevention, Fort Collins, Colorado, USA (R.S. Lanciotti, A.J. Lambert)Department of Veterans Affairs, Palo Alto, California, USA (M. Holodniy)VA Caribbean Health Care System, San Juan, Puerto Rico, USA (S. Saavedra)Laboratorio Nacional de Salud Guatemala, Villa Nueva, Guatemala (L. del Carmen Castillo Signor)

References

  1. Dick GWKitchen SFHaddow AJZika virus isolations and serological specificity. Trans R Soc Trop Med Hyg1952;46:50920 . DOIPubMed
  2. Lanciotti RSKosoy OLLaven JJVelez JOLambert AJJohnson AJGenetic and serologic properties of Zika virus associated with an epidemic, Yap State, Micronesia, 2007. Emerg Infect Dis2008;14:12329DOIPubMed
  3. Cao-Lormeau VMRoche CTeissier ARobin EBerry ALMallet HPZika virus, French Polynesia, South Pacific, 2013. Emerg Infect Dis.2014;20:10856DOIPubMed
  4. Musso DNilles EJCao-Lormeau VMRapid spread of emerging Zika virus in the Pacific area. Clin Microbiol Infect2014;20:O5956.DOIPubMed
  5. Faye OFreire CCIamarino AFaye Ode Oliveira JVDiallo MMolecular evolution of Zika virus during its emergence in the 20th century. PLoS Negl Trop Dis2014;8:e2636 . DOIPubMed
  6. Zanluca Cde Melo VCMosimann ALDos Santos GIDos Santos CNLuz KFirst report of autochthonous transmission of Zika virus in Brazil. Mem Inst Oswaldo Cruz2015;110:56972DOIPubMed
  7. Haddow ADSchuh AJYasuda CYKasper MRHeang VHuy RGenetic characterization of Zika virus strains: geographic expansion of the Asian lineage. PLoS Negl Trop Dis2012;6:e1477DOIPubMed
  8. Musso DCao-Lormeau VMGubler DJZika virus: following the path of dengue and chikungunya? Lancet2015;386:2434DOIPubMed
  9. Volk SMChen RTsetsarkin KAAdams APGarcia TISall AAGenome-scale phylogenetic analyses of chikungunya virus reveal independent emergences of recent epidemics and various evolutionary rates. J Virol2010;84:6497504DOIPubMed
  10. Lanciotti RSLambert AJPhylogenetic analysis of chikungunya virus strains circulating in the Western Hemisphere. Am J Trop Med Hyg2016In press.

Figure

Suggested citation for this article: Lanciotti RS, Lambert AJ, Holodniy M, Saavedra S, del Carmen Castillo Signor L. Phylogeny of Zika virus in Western Hemisphere, 2015 [letter]. Emerg Infect Dis. 2016 May [date cited]. http://dx.doi.org/10.3201/eid2205.160065


DOI: 10.3201/eid2205.160065