Head-to-Head Studies Show Truvada Prevents HIV Even When Taken ‘As Needed’

Written by Heather Kathryn Ross | Published on February 24, 2015

 

Results of the PROUD and IPERGAY trials show that taking Truvada before and after sex makes gay and bisexual men 86 percent less likely to contract HIV.

Two studies testing whether the drug Truvada (emtricitabine and tenofovir disoproxil fumarate) can prevent HIV infections in a real-world setting made their prime-time debuts this week at the Conference on Retroviruses and Opportunistic Infections in Seattle, Washington.
Both were a resounding success, boasting an 86 percent reduction in new HIV infections among volunteers using Truvada.
Truvada is an HIV medication FDA-approved to prevent the spread of HIV when it’s used as pre-exposure prophylaxis, or PrEP.
But the really big news is that researchers got the same results whether the men involved took Truvada once a day (as it’s typically prescribed) or “as needed” before and after risky sex.
Related News: How Can We Get People to Really Use PrEP? »
The first trial, called IPERGAY, included 400 men who have high-risk sex with other men in France and Canada. Volunteers were randomly assigned to take Truvada or placebo pills.
The men took two pills between two and 24 hours before sex, and a third and fourth pill 24 and 48 hours later. Because the men reported having sex frequently, they took Truvada an average of four days a week “as needed.”
There were two new HIV infections among men taking Truvada, and 14 new infections among those taking the placebo pills. Men in the trial taking Truvada lowered their risk of HIV infection by 86 percent.

The second trial, called PROUD, recruited 545 gay and bisexual men in the United Kingdom who admitted to having had recent unprotected sex. Half were assigned to begin taking Truvada every day right away, while half were assigned to receive Truvada after one year.

Find Out: Though Rare, It’s Possible to Develop Drug-Resistant HIV While on PrEP »
In the group that started Truvada right away, three men contracted HIV. However, in the group that delayed Truvada, there were 19 new HIV infections. That's a risk reduction of 86 percent for the first group.
“These results are extremely exciting and show PrEP [pre-exposure prophylaxis] is highly effective at preventing HIV infection in the real world,” said Sheena McCormack, a professor of clinical epidemiology at University College London and chief investigator of the PROUD study. “These results show there is a need for PrEP, and offer hope of reversing the epidemic among men who have sex with men.”
Experts hope these results will remove some of the stigma surrounding Truvada and encourage more men to talk to their doctors about using PrEP.
They caution that these results can’t be expanded to include opposite-sex couples, since the risk of infection during sex is different based on the type of sex partners have. 

Women Fooled By Untested Hormones From Compounding Pharmacies

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According to a new study, an estimated 28 million to 39 million prescriptions are filled each year for hormone-replacement therapies made by compounding pharmacies. But two large Internet surveys reveal that a staggering 86% of women don’t understand that products sold by compounding pharmacies are not approved by the U.S. Food & Drug Administration.

This is a disturbing but not entirely surprising revelation. Compounding pharmacies have made a rollicking business catering to women in menopause who are seeking relief from symptoms such as hot flashes and insomnia. These pharmacies manufacture their own versions of hormones such as estrogen and progesterone, and then market them as “bioidentical” or “natural” products based on the fact that they are derived from botanical sources like soy and they mirror the hormones that women’s bodies make naturally.

The study, published online in Menopause, the journal of The North American Menopause Society (NAMS), compiled results from two surveys of 3,000 women. When asked “Do you believe that bioidentical hormone therapies compounded at a specialty pharmacy are FDA approved?” only 14% of the women correctly said “no,” according to NAMS. Of the rest, 10% said “yes” and the rest didn’t know.

What this large contingent of misinformed women may not understand is that products made by compounding pharmacies do not have to adhere to the same manufacturing quality requirements and strict oversight that FDA-approved products face. The dangers of that became all too clear in 2013, when contaminated steroid products made by a compounding pharmacy in Massachusetts sickened more than 740 people, 64 of whom died.

The incident prompted the passage of federal legislation giving the FDA more authority—but not complete control—over compounding pharmacies. The Drug Quality and Security Act offers compounders two choices: they can either register as “outsourcing facilities” with the FDA and become subject to quality control rules similar to those governing large drug manufacturers, or they can sidestep that restriction on the condition that they only compound individual prescriptions for one patient at a time. (No mass producing or mass marketing allowed, in other words.)

That may help lower the contamination risk, but compounded drugs often have other shortcomings. Testing of 12 compounded hormones by More magazine found that levels of some hormones were often lower or higher than what was prescribed. In 11 of the samples, progesterone levels were too low. That’s dangerous: progesterone protects the lining of the uterus, which in turn lowers the risk of endometrial cancer in women taking estrogen for hormone replacement.

http://www.forbes.com/sites/arleneweintraub/2015/02/20/women-fooled-by-untested-hormones-from-compounding-pharmacies/

MUMPS

Mumps is a viral infection that primarily affects the parotid glands — one of three pairs of saliva-producing (salivary) glands, situated below and in front of your ears. If you or your child contracts mumps, it can cause swelling in one or both parotid glands.

Mumps was common in the many parts of the world until mumps vaccination became routine in some advanced countries. Since then, the number of cases has dropped dramatically, so your odds of getting mumps are low in such countries such as USA. Complications of mumps, such as hearing loss, are potentially serious, but rare.

There's no specific treatment for mumps. Mumps outbreaks still occur in many advanced countries including the United States, and mumps is still common in many parts of the world, so getting a vaccination to prevent mumps remains important.

When to see a doctor

If you suspect that you or your child has mumps, see your doctor. Let your doctor's office know before you go in that you suspect mumps so that you won't have to wait so long in the waiting room, possibly infecting others. Mumps has become an uncommon illness, so it's possible that the signs and symptoms are caused by another condition. Swollen salivary glands and a fever could be an indication of inflamed tonsils (tonsillitis) or a blocked salivary gland.
Other viruses can infect the parotid glands, causing a mumps-like illness.

Cure Achy Joints Naturally

Dr. Blaylock’s weekly Tips

One in every three American adults suffers from arthritis. It’s one of the countries leading health problems and is the leading cause of disability in Americans over the age of fifteen. Although numerous pharmaceuticals are prescribed to ease the pain of arthritis, supplements, including plant extracts and vitamins, can reduce inflammation and free radicals within the joints.

Smart drug Modafinil may help those lacking creativity but does not help intelligent people improve results, study claims

By Victoria Ward

Smart drugs can boost the performance of those who are lacking in creativity but do not help those who are academically bright, a study has found.

A survey suggested that one in five students have taken so-called “wake-up drug” Modafinil to boost their ability to study and improve their chances of exam success.

The study, published in the journal Plos One, involved 64 people, half of whom were given a placebo.

Dr Ahmed Dahir Mohamed, from the University of Nottingham, found that by taking the drug, those who were not creative were able to improve their performance in problem solving.

But healthy people functioning at the optimum level found their performance impaired.

Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Nature (11/12, Hayden) explores the ethical concerns surrounding testing for experimental Ebola treatments. According to Nature, two trials taking place in Guinea and Liberia will announce this week whether or not some trial participants will receive a placebo during the testing for ZMapp, a treatment for Ebola. On November 11, NIH held a conference of researchers to consider US clinical trials, while on the same day in Geneva, Switzerland, the WHO held a similar meeting. The WHO concluded that because “standard of care” available in Africa is insufficient to keep patients alive, no control should be used. With plasma trials, controls can be selected among those patients for whom no serum match is available. Clifford Lane, deputy director for clinical research and special projects at NIAID said about the trials, “The idea that there’s no need for randomized, controlled trials presupposes that the drugs have zero side effects, that they are efficacious, and that there’s no substantial variability from patient to patient,” adding, “I don’t think any of that is true.”

        NPR (11/11, Harris) reports in its “Goats and Soda” blog that the meeting in Geneva will also consider how to design the trials to best meet ethical considerations and patient health. The WHO’s Martin Friede cautioned that placebo trials are met with skepticism in West Africa and notes other designs that can meet rigorous scientific challenges, saying, “This can be done through historical records, it can be through comparing what’s being done in other sites.” Friede added, “What we do not want are trials that are conducted where, at the end of the study, we are unable to say whether the drug is safe or not or whether the drug is effective or not.”

        OSU Scientist Develops Promising Ebola Treatment. The Oregonian (11/11, Terry) reports that a scientist at Oregon State University has developed a potential Ebola treatment. Patrick Iversen, the head scientist on the project, said initial trials were very promising, and that “If the epidemic lasts, I’m pretty sure we will use the drug (in Africa).” Sarepta Therapeutics, the firm behind this treatment, was in attendance at the NIH meeting on Tuesday. Sarepta has 20 courses of treatment available now and in two-three months, could have ten times that amount on hand.

Study: Experimental Hep C Treatment May Cure 97

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Study: Experimental Hep C Treatment May Cure 97% Of Liver Transplant Patients.

Bloomberg News (11/11, Chen) reports that in a “mid-stage study of 34 patients, 33 [97%] were cured of the virus after 24 weeks of treatment” using AbbVie Inc. (ABBV)’s hepatitis C treatment, an “experimental cocktail of ombitasvir, ritonavir, dasabuvir, ABT-450, and ribavirin, an antiviral drug used to supplement hepatitis C treatments.” The study, published today in the New England Journal of Medicine, involved patients “who had received a liver transplant.”

        Reuters (11/11, Penumudi) reported that in a study involving genotype 4 hepatitis C patients, the treatment was effective 100% of the time.

        Gilead: Hepatitis C Combination Treatment Cures 96-97% Of Cirrhosis Patients. Reuters (11/12, Pierson) reports that Gilead Sciences Inc. announced that its new combination hepatitis C drug Harvoni (ledipasvir/sofosbuvir), which was approved by the US FDA last month, cured 96-97% of cirrhosis patients with the genotype 1 of the virus who had failed to benefit from other treatments. In one subset of the 155 patients involved in the study, the patients took Harvoni alone for 24 weeks and were cured at a rate of 97%. In a group of patients who received Harvoni plus ribavirin for 12 weeks, the cure rate was 96%.

Facebook CEO Joins the Fight Against Ebola

Hear him:
I want to make sure Facebook does its part to help fight Ebola. So today, we’re announcing three things:

-We’re providing internet connectivity in Guinea, Liberia and Sierra Leone to help medical and aid workers track cases and coordinate their response.

-We’re sharing information on Facebook, in partnership with UNICEF, to help people in the affected and nearby countries prevent, detect and treat Ebola.

-We’ll soon be highlighting the work of some of the non-profits leading the fight on the ground, and giving everyone on Facebook the ability to donate directly.

Stopping Ebola is an important global challenge, and together we can make a difference. This video outlines our efforts. https://www.facebook.com/groups/696383700406188/864553410255882/?ref=notif&notif_t=like

Ebola Therapies In The Works.

According to Bloomberg News (11/4, Skerritt), Tekmira Pharmaceutical Corp.’s stock prices are the highest among makers of Ebola therapies. According to an October 21 statement from the company, the treatment is specific to Guinea’s Ebola strain and will “rapidly and accurately match the evolving genetic sequences” of the disease. In September, the FDA approved this treatment for confirmed Ebola patients. Bloomberg profiles other promising Ebola drugs, including their companies’ stock values.

        Bloomberg News (11/4, Bennett) reports that the board of GAVI, an organization of governments and the Bill & Melinda Gates Foundation that supplies vaccines to developing countries, will meet next month to decide which of the promising Ebola vaccines to support. GlaxoSmithKline’s vaccine is a contender for that support. The vaccine works to prevent Ebola in animals, but human trial results expected in December will reveal the drug’s true efficacy.

        The New York Times (11/5, Pollack, Subscription Publication) reports that studies for an Ebola quick-test are also underway. Rapid tests would be useful in West Africa, where lab results often take days, in airport screenings, and in hospitals amid the dawning flu season. The WHO and the FDA both support development of a rapid test.