Amazing: Good News On Ebola Vaccines

Two Experimental Ebola Vaccines Show Potential

Two experimental Ebola vaccines showed promise in a clinical trial, researchers report.
The vaccines triggered an immune response and were well-tolerated among people in the phase 2 trial conducted in Liberia, one of the West African nations hit hard by the 2014 Ebola outbreak.
The trial was sponsored by the U.S. National Institute of Allergy and Infectious Diseases.

Researchers had planned to continue testing the vaccines in a broader phase 3 trial with 28,000 people, but that was abandoned because the decline in new Ebola cases made the larger study impossible.
The phase 2 trial tested the cAd3-EBOZ vaccine, which uses a chimpanzee-derived cold virus to deliver Ebola virus genetic material. The trial also tested the rVSV-ZEBOV vaccine, which uses the vesicular stomatitis virus -- related to the rabies virus -- to carry Ebola genetic material.

The trial included 1,500 people aged 18 and older with no reported history of Ebola disease, and was conducted in early 2015. Participants, divided into groups of 500 people, received either one of the two vaccines or a saline injection.

One month after getting the vaccines, measurable Ebola antibodies were detected in 87 percent of the people who received the cAd3-EBOZ vaccine and in 94 percent of the 500 people who received the rVSV-ZEBOV vaccine, the researchers said.

The findings were presented Tuesday by co-principal investigator Fatorma Bolay, director of the Liberian Institute for Biomedical Research, at the Conference on Retroviruses and Opportunistic Infections in Boston.

More information
The U.S. Centers for Disease Control and Prevention has more about Ebola.

Low Vitamin D levels May Lead To Severe Prostate Cancer - See study

Low Vitamin D Levels May Signal More Aggressive Prostate Cancer

Prostate cancer may be more aggressive in men who are deficient in vitamin D, new research suggests.

A study of nearly 200 men having their prostate removed found those with low vitamin D levels were more likely to have rapidly growing tumors than those with normal levels of the "sunshine" vitamin.
"If men with vitamin D deficiency are more likely to have [more advanced disease] at the time of prostate surgery, then perhaps men should be tested for this when they are diagnosed with prostate cancer and subsequently supplemented with vitamin D if they are deficient," said researcher Dr. Adam Murphy. He is an assistant professor of urology at Northwestern University in Chicago.
However, another expert isn't ready to go that far.

This study can't prove that vitamin D deficiency causes aggressive prostate cancer, only that the two are associated, said Dr. Anthony D'Amico, chief of radiation oncology at Brigham and Women's Hospital in Boston.

But D'Amico thinks the results are important enough to spur further study into the possible connection between vitamin D and prostate cancer. "It's a hypothesis that's worth testing," he said.
For now, though, D'Amico doesn't think enough evidence exists to recommend vitamin D supplements to prevent prostate cancer or make it less aggressive.
Murphy said he has been exploring the link between prostate cancer and vitamin D for some time. He said racial distinctions were noted in this study, too, with black men having more aggressive tumors and lower vitamin D levels than white men.
These findings suggest that one reason black men have higher odds of developing -- and dying of -- prostate cancer is because of their "higher propensity for having vitamin D deficiency from the sun-blocking effects of melanin and perhaps dietary intake differences," Murphy said. The study could not prove this, however.
The human body gets vitamin D from certain foods. These include fortified products (such as milk, orange juice and cereal), and certain fish (such as salmon), according to the U.S. National Institutes of Health. The body also makes the vitamin when the skin is exposed to sunlight. Dark-skinned people have more melanin, which prevents burning.

Murphy said men with dark skin, low vitamin D intake or low sun exposure should be tested for vitamin D deficiency when diagnosed with prostate cancer or elevated PSA (prostate specific antigen), which is associated with the cancer. He believes supplementation is warranted for those with low vitamin D levels.

The study included 190 men having prostate surgery. The researchers found that nearly 46 percent of the men had aggressive cancer, and these men had vitamin D levels about 16 percent lower than men with slower-growing tumors.
After accounting for age, PSA levels and abnormal rectal exams, Murphy and his colleagues found that vitamin D levels below 30 nanograms per milliliter (ng/mL) of blood were linked to higher odds of aggressive prostate cancer.
The report was published online recently in the Journal of Clinical Oncology.

More information
For more about prostate cancer, visit the American Cancer Society.

Study Shows: Lazy Weekends May Boost Body Fat.

Playing couch potato on the weekends may be even worse for your weight than working at a desk all week, new research suggests.
Exercise scientists reported that even a 20-minute reduction in sedentary time on Saturdays and Sundays added up to a loss of more than 2 pounds and 1.6 percent of body fat after a year. But the same association was not seen with sedentary time during the weekdays.
"We know that, on average, people consume less or eat healthier diets on weekdays," explained study author Clemens Drenowatz, an assistant professor of exercise science at University of South Carolina in Columbia, S.C.

"So, they may be able to get by with less activity on weekdays because their diet makes up for it. On weekends, they're eating more, which requires more activity or less sedentary behavior to offset," Drenowatz said.

The study findings are scheduled to be presented Wednesday at an American Heart Association meeting in Phoenix. Studies presented at scientific conferences typically have not been peer-reviewed or published, and results are considered preliminary.

Much research in recent years has established an association between sedentary behavior -- which includes time sitting watching television or using computers -- with poor health outcomes, such as heart disease, diabetes, obesity and some cancers, according to the American College of Sports Medicine.
In a group of 332 adults aged 20 to 35, Drenowatz and his colleagues measured the time participants were sedentary by using a device that measured inactivity over a 10-day period. Participants also reported their own sedentary behaviors separately for weekdays and the weekend.

In addition, the study participants' body weight and body fat measurements were taken every three months over a one-year period.

"From what we saw, the overall sedentary time wasn't different on weekdays versus weekends," Drenowatz said. "A lot of people had sedentary occupations, like office jobs, and they didn't really make up for that on the weekends either. This suggests diet is the reason, though obviously more research needs to be done."

Two clinicians from Christiana Care Health System in Wilmington, Del., weighed in on the findings. They suggested that healthy workplace behaviors -- such as light lunches and midday walks -- may help balance out the negative effects of sitting at a desk all day.

Many people "don't really have the option of being that inactive on weekdays," said Dr. Omar Khan, medical director for community health at Christiana Care. "Weekends are a whole different matter. There's a big opportunity to be healthy -- or, as many of us tend to be, fairly unhealthy. With a two-day chunk of potentially being a couch potato, anything we do in that space can be fairly significant."
Karen Anthony, senior program manager for community health at Christiana Care, suggested that moving around for an extra 20 minutes on the weekends -- which seemed to spur measurable weight loss in study participants -- could lead to even more activity.

"Twenty minutes is a fraction of your weekend," she said. "It doesn't take a whole lot of extra movement to see that result."

Drenowatz said it's important to distinguish between exercising and merely reducing sedentary time, which means less sitting.

"I'm not telling people they need to go out and exercise -- that's a separate issue -- but just to reduce their sedentary time. It may be just standing up and walking around a bit ... can help," Drenowatz suggested.

He and Khan also noted that a loss of 1.6 percent of body fat over one year simply by moving 20 minutes more on the weekends may have a positive impact on the risks for developing heart disease.
"A lot of people get caught up with body weight, but from a health perspective, body fat and where it's located actually has a bigger impact on cardiovascular disease over the long term," Drenowatz said.

More information
The American College of Sports Medicine offers tips on reducing sedentary behaviors.

See The Link Between Emotional Abuse and Migraine

Emotional Abuse During Childhood Linked to Adult Migraine Risk

Adults who suffered emotional abuse as children may have an increased risk of migraines, but such a link wasn't seen with physical or sexual abuse, researchers are reporting.
"Emotional abuse showed the strongest link to increased risk of migraine," study author Dr. Gretchen Tietjen, from the University of Toledo in Ohio, said in an American Academy of Neurology news release. "Childhood abuse can have long-lasting effects on health and well-being."
But while the study showed an association between childhood emotional abuse and migraine, it did not prove cause and effect, Tietjen noted.

Of the nearly 14,500 young adults in the study, approximately 14 percent had been diagnosed with migraines. About 47 percent said they were emotionally abused during childhood, 18 percent said they were physically abused and 5 percent said they were sexually abused.
Sixty-one percent of those with migraines said they were abused as children, compared with 49 percent of those without migraines. After accounting for age, income, race and sex, the researchers concluded that adults with a history of childhood abuse were 55 percent more likely to have migraines than those who weren't abused.

Further analysis showed that those who were emotionally abused as children were 52 percent more likely to have migraines than those who weren't abused. However, adults who suffered physical or sexual abuse during childhood did not have a significantly higher risk for migraines than those who weren't abused.

For the study, physical abuse was defined as being punched, kicked or thrown around. Sexual abuse
included forced sexual touching or sexual relations, the researchers said.

The link between emotional abuse during childhood and increased migraine risk later in life remained after the researchers took into account depression and anxiety. In that analysis, adults who suffered emotional abuse as children were 32 percent more likely to have migraines than those who weren't abused.

"More research is needed to better understand this relationship between childhood abuse and migraine. This is also something doctors may want to consider when they treat people with migraine," Tietjen said.

The findings are to be presented in April at the American Academy of Neurology's annual meeting, in Vancouver, Canada. Research presented at meetings is considered preliminary until published in a peer-reviewed journal.

More information
The American Academy of Family Physicians has more about migraines.

Are You Aware That Ovarian Cancer Is More Than One Disease?

Ovarian Cancer Is More Than One Disease: Report

Ovarian cancer isn't a single disease, but rather a number of different malignancies involving the ovaries, an expert U.S. panel says.
Evidence suggests that many ovarian cancers begin in other tissues, such as the fallopian tubes, and eventually spread to the ovaries. In other cases, cancers arise from cells not considered to be part of the ovaries, a report from the U.S. National Academies of Sciences, Engineering, and Medicine said. The report was mandated by Congress.

The authors noted there are "surprising gaps" in knowledge about ovarian cancer. They called for additional research to learn more about the causes and improve prevention, early detection, treatment and management of the disease.
"While progress has been made in ovarian cancer research over the past few decades, much remains to be learned," Jerome Strauss III, chair of the report committee, said in an academy news release. Strauss is also executive vice president for medical affairs and dean of Virginia Commonwealth University School of Medicine, in Richmond.
"The more that is understood about the basic biology of various types of ovarian cancers, such as where they originate in the body, the more rapidly we can move toward advances in prevention, screening, early detection, diagnosis, treatment and supportive care," he explained.
Each year, more than 21,000 women in the United States are diagnosed with ovarian cancer, the researchers said. And, more than 14,000 women die from the disease each year, they added. The
five-year survival rate is less than 50 percent, the researchers noted.

Early ovarian cancer doesn't have any distinctive symptoms. There's also no effective screening test for ovarian cancer. About two-thirds of these patients are diagnosed in the late states of the disease, when the cancer has already spread to other parts of the body, the report authors said.

The report also found that the quality of care for ovarian cancer patients varied widely across the nation. Several groups have developed standard-of-care guidelines, but less than half of ovarian cancer patients receive that recommended care, the research revealed.
The report found two main predictors of a better outcome for women with ovarian cancer. One was being treated by a gynecologic oncologist. The other was receiving treatment at a hospital that handles a large number of such cases. However, many patients don't have access to such care, the report authors said.

To reduce disparities in care, they recommended that doctors and scientists look for ways to ensure consistent use of the current suggested standards of care.
The report also said that better methods of identifying women at high risk for ovarian cancer could improve prevention and early detection. For example, there are strong links between ovarian cancer and a family history of the disease, specific inherited genetic mutations such BRCA1 and BRCA2, and certain hereditary cancer syndromes, the authors noted.

More information
The U.S. Office on Women's Health has more on ovarian cancer.

Some Misconceptions About Acne

There are still plenty of negative and mistaken beliefs about people with acne, a new study finds.
Researchers showed photos of acne and several common skin conditions to study participants and asked them their views about each condition. More than 62 percent said they were upset by the photos of acne. And more than 80 percent said they felt pity toward people with acne, the research revealed.
Of even greater concern, more than two-thirds said they would be ashamed if they had acne and would find someone with acne unattractive. Forty-one percent said they would be uncomfortable being seen in public with someone with acne, and more than 44 percent said they would be uncomfortable touching a person with acne, the findings showed.

Many of the study participants had common misconceptions about acne. Fifty-five percent mistakenly believed acne was caused by poor hygiene. Half thought acne was infectious, and 37.5 percent thought the skin condition could be linked to dietary choices.

"I was surprised by these results. Since so many people have experienced acne, I thought they would have more empathy for patients with this condition," study author Dr. Alexa Boer Kimball said in an American Academy of Dermatology news release. Kimball is the director of the clinical unit for research trials and outcomes in skin, and a professor of dermatology at Harvard Medical School in Boston.

"Clearly there are a lot of misconceptions out there. People are making incorrect assumptions about acne, and it's affecting their opinion of patients with this condition," Kimball said.
"Acne is a medical condition, so you shouldn't hesitate to seek medical attention for it," she said. There are number of effective treatments available from your dermatologist, she added.

The findings were presented at the American Academy of Dermatology's annual meeting in Washington, D.C. Findings presented at meetings are generally viewed as preliminary until they've been published in a peer-reviewed journal.

Acne is the most common skin condition in the United States and affects up to 50 million Americans every year.

"Acne is a very visible condition, and it affects many patients during adolescence, when they're especially vulnerable. When acne persists into adulthood, so can its effects on self-esteem, which may create difficulty for patients in work and social situations," Kimball said.
Misconceptions about the condition can also affect how people with acne manage it, Kimball explained.

"If you think acne is related to hygiene, you may start scrubbing your face aggressively in an effort to cleanse your skin, and this may make the condition worse. Or, if you think acne is related to what you eat, you may decide to cut certain foods out of your diet, but there is little scientific evidence to support many of those strategies," Kimball said.

More information
The American Academy of Family Physicians has more on acne.

See New regimen FDA Approved for the Treatment of HIV-1 Infection

FDA Approves Odefsey

 

FDA Approves Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the Treatment of HIV-1 Infection
 Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV.

Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

The approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.

The Odefsey approval is part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, Gilead is responsible for the manufacturing, registration, distribution and commercialization of the product in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union, and expanded in 2014 to include Odefsey.
Odefsey does not cure HIV infection or AIDS.

Patient Assistance Programs

Gilead’s U.S. Advancing Access® program provides assistance to appropriate patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Odefsey.
The program offers information and assistance for patients, including:

• Access to agents who can provide information related to coverage and insurance-related questions. The Advancing Access Copay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.
• The Advancing Access Patient Assistance Program and Truvada® Medication Assistance Program, which will provide Gilead medications at no charge for eligible patients with no other insurance options.
• Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Odefsey for patients who receive medications through these programs.

About Gilead

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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 may not see the benefits of prescribing Odefsey. 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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.

Source: Gilead Sciences, Inc.