Wednesday, May 29, 2024

HIV Treatment and Hepatitis C Treatment

 


Looking Ahead: The Future of Generic HIV Treatments

The development and increased accessibility of generic medications like Biktarvy are transforming the landscape of HIV treatment. Here’s what the future may hold for generic HIV treatments:

Increasing Availability As patents on newer HIV drugs expire, more generics will enter the market. This will likely lead to even lower prices and greater accessibility. The trend toward generics is expected to continue, broadening options for patients and healthcare providers.

Advancements in Treatment Research and development do not stop with the creation of a generic drug. On the contrary, the availability of generic biktarvy exists generic biktarvy exists often spurs innovation as pharmaceutical companies strive to improve efficacy and reduce side effects. Future generics may offer improved formulations that could be easier to administer and more effective.

Global Impact The broader availability of affordable generics will have a profound impact on global health, particularly in low- and middle-income countries. Increasing access to effective HIV treatment is crucial for controlling and eventually eliminating the disease as a public health threat.

Policy and Advocacy As the generic drug market grows, there will likely be increased advocacy efforts to ensure that these drugs are included in national and international health policies. Advocates will work to remove barriers to access and ensure that all patients, regardless of location or income, can benefit from these life-saving treatments.

Technological Integration Emerging technologies, such as telemedicine and mobile health applications, will play a significant role in the distribution and monitoring of HIV treatments. These technologies can help manage prescriptions, track adherence, and provide support, making treatment more accessible and effective.

In conclusion, the future of HIV treatment looks promising with the continued adoption and development of generic drugs. These medications provide a sustainable path forward, offering hope and healing to millions affected by HIV worldwide.



Wednesday, December 18, 2019

Reduce Drug Addiction, Reduce HIV and Hepatitis C

 Reduce Drug Addiction, Reduce HIV and Hepatitis C

SooToday has gotten the adhering to letter from viewers Peter Chow in continuation of his comments on a post released Saturday about an ideas at a Downtown Association meeting that blue lights be mounted in a brand-new downtown plaza to discourage drug addict:

In 1990 Portugal was in the hold of heroin addiction. An estimated 1 per cent of the population-- bankers, students, socialites-- were hooked on heroin and Portugal had the highest possible price of HIV infection in the entire European Union. The government's feedback was one that Americans identify: it introduced significantly rough policies led by the criminal justice system, while conservative movie critics demonized drug users. By 1999, half individuals behind bars were there for drug-related reasons. Nothing was functioning.

Richard Nixon launched the Battle on Medicines in 1971. Ever since, the battle was estimated to have actually cost over a trillion bucks, over $80 billion a year. The result was 10 or 20 yr. jail sentences for belongings of a gram of marijuana. The US has less than 5 per cent of the globe's population, but 25 percent of the world's prison population. 1 per cent of the United States populace is in jail. Over half of inmates in federal prisons are there for drug-related offenses. Prisons jammed with small medicine culprits indicate more fierce crime transgressors on the street. An out of proportion percentage of inmates are black or Hispanic - 32% white, 37% black, 22 per cent Hispanic. The Battle on Medications is overtly racist - white elites grunting drug are offered forgiving punishment, while underclass blacks using split drug end up behind bars for 30 years.

The $80 billion invested each year on corrections is often mentioned as the price of imprisonment, but this figure significantly ignores truth price by disregarding crucial social prices. A new research, "The Economic Worry of Incarceration in the UNITED STATE" designates financial expenses to incarcerated individuals, family members, children as well as communities, which amounts to an annual worry of $1.2 trillion bucks, or 6 percent of the GDP. The costs are birthed by households, children and area participants that have actually dedicated no criminal activity. Generations of black children mature with no dads.

The War on Medications was planned to reduce drug use, decrease drug-related criminal offense, decrease drug-related illness and overdose fatalities, and interrupt as well as take apart organized criminal ventures. It has actually been an amazing failing, not just inefficient yet counterproductive, both domestically as well as abroad. The residential War on Drugs has added to a boost in medicine overdoses as well as promoted and also maintained the creation of powerful drug cartels. Internationally, it not just stops working in its very own right but additionally proactively threatens the objectives of the World war on Horror. The War on Drugs has actually turned Mexico into a war zone. Over 70,000 Americans died from medication overdose in 2017, more than the consolidated totals of the battles in Vietnam, Iraq and Afghanistan.

In 2001, Portugal took an extreme action. It became the initial country in the world to decriminalize the consumption of all medicines. Medication trafficking remained a criminal activity, however possession of percentages for personal usage was decriminalized. Drug dependency was being dealt with as a clinical concern as opposed to a criminal trouble.

Anybody caught with less than a 10-day supply of any type of medicine-- consisting of cannabis as well as heroin as well as drug-- is usually sent out to a local compensation, containing a medical professional, lawyer and also social worker, where they learn more about therapy and offered clinical solutions. No difference is made in between "difficult" or "soft" medicines, or whether usage happens secretive or public. What matters is whether the partnership to medicines is healthy and balanced or not.

Illegal drug usage by teenagers decreased, the rate of HIV infections as well as Hepatitis C amongst drug users dropped, as well as deaths related to heroin as well as opiates decreased greatly. The variety of drug-related fatalities went down from 131 in 2001 to 20 in 2008. Since 2012, Portugal's medication casualty was 3 per million, five times less than the European average as well as 2 per cent, one-fiftieth of that of the United States. Its rate of HIV infection has actually dropped from 104.2 brand-new instances per million, the highest in Europe in 2000, to 4.2 cases per million in 2015. Substance abuse has decreased one of the most amongst the 15- to 24-year-old population, those most at risk of launching substance abuse. Getting rid of the threat of criminal charges-- and along with it, a good deal of preconception-- has made it easier for individuals to seek treatment. The number of people in medication treatment enhanced by over 60 percent - decriminalizing drug use actually leads to extra drug addict intending to give up medications.

Other countries are following Portugal in medicine liberalization, including Norway, Ireland, the Czech Republic, Croatia, the Netherlands, Mexico, Columbia, Uruguay, Argentina, Costa Rica, Ecuador as well as Honduras.

In addition to these programs, lots of countries currently enable managed drug usage centers, where drug addict can eat medications in safer conditions with the help of trained staff. Such centers have been running in Europe because 1986, when the initial was opened in Switzerland. Others have actually because been established in several other countries, consisting of France, Germany, Spain, and Greece, while the city of Vancouver in Canada opened up The United States and Canada's initial overseen medication shot site in 2003.

Evidence reveals these sites can save lives, reduce public disorder connected with medications, and lead to a drop in the behaviors linked to HIV and also hepatitis C transmission. Yet in the UNITED STATES, they remain controversial-- regardless of numerous significant cities, including Seattle, San Francisco and also Philly, considering strategies to open monitored injection sites. Lawful unpredictability becomes part of the problem: the federal government is opposed to the opening of such facilities, and also state and also regional lawmakers have clashed over them.

It is clear that, on the ground in Portugal, healthcare employees feel much better outfitted to help addicts, frequently with a moving commitment, people mainly forgotten by the remainder of culture. What America and also Canada and also other countries can gain from Portugal is to treat people with even more dignity. Countries like Portugal and also Norway reveal that, without spending huge sums, governments can provide drug users the tools to place their lives back on course, while at the same time mitigating the results of drug addiction. But to do so, it will need to stop treating them like criminals.

-- Peter Chow

Tuesday, December 17, 2019

My Story: Trying to Get Treated for Hepatitis C

My Story: Trying to Get Treated for Hepatitis C

I have been trying to get my hepatitis C treatment from India for the past several months.  Its been a very difficult time for me.  I got the run around from many Indian pharmacies online through India Mart.  I even sent money to one of them because the price was really good, about $300.  Then I waited and waited, nothing happened.  I didn't know what to do.  I kept asking those folks where are my meds, they said its on its way.  I just waited and waited, nothing happened.  Now, by this time its been over 4 weeks and nothing has happened since I sent the money to the company from India Mart.  I feel bad and angry because I got scammed, or atleast I feel like I got scammed. 

I was telling a friend about this, he said he will look in to it.  He asked his wife, Pam, to call around and find out which is the best pharmacy to order hepatitis C meds.  Pam also talked about Greg Jefferies and Dr. Freeman, and how they cut corners to get meds to patients.  Pam mentioned that most if not all the meds they source for hep C patients in the US or Europe is all 4th standard active pharmaceutical ingredients.  What that means is that the generic Harvoni, generic Sovaldi, generic Epclusa, generic Daklinza and generic Mavyret are of the lowest quality product that they themselves make in a small dirty kitchen lab in India.  I was floored when I heard this.

Then I wondered what standard of hep c meds will I get if I ordered from India.  Pam, talked to her colleagues who all work in Big Pharma, said there are excellent high quality manufacturers and you can't go by the brand name.  The reason being is that they know that foreigners are buying these meds and they skimp on the quality.  The truth is if an Indian buys the hep c meds, the quality is ISO 9001 certified and audited by FDA. 

The Indian government does not want to take chance on their pharmaceutical industry because 95% of the generic of hep C meds, its supplied to the US market. Then I wonder, how do I get my hands on my generic Harvoni from India. 

Pam kept searching and talking to people, then she heard about an American doctor at Mayo Clinic that works with a non profit that helps Americans get hepatitis C treatment from India.  The road leads back to India.

She finds out who this non profit is and to her surprise its setup by Americans and Indian Americans.  Immediately she calls the number she got online and glad to hear and American mans' voice, Chris. After talking to Chris for a half hour, Pam orders my meds and within 10 days, I got my meds.

I owe Pam so much thanks and appreciation for all the work she has done. 

Now, I am in my 8 week of treatment and really I feel great, no side effects.  At first, it was a bit hard, not that much, just a strange battle sensation in my body was going on for about  a week.  After that, I just felt getting better and better.

I wish you the best of luck in getting treated for your hepatitis C.  Believe me, you can get the meds too and get cured.

John Wenthrop

Manatee Pushes Syringe Exchange Program Despite Setbacks


 Manatee Pushes Syringe Exchange Program Despite Setbacks

Manatee Area Commissioners have actually voted to apply a syringe exchange program for drug users as well as the region is poised to come to be just the 3rd in Florida to do it.

Manatee Region has actually had one of the most awful medication issues in the state over the last few years, the numbers surprising, the services couple of.

For example, there were 601 overdoses as well as 61 overdose-related deaths in between Jan. 1 as well as Nov. 5. That's a great deal, no question too many. Yet there are other by-products of the issue and perhaps you have actually seen one at a playground by your residence.

They are called unclean needles.


On Tuesday the Manatee Region Payment did something crucial that went somewhat undetected, and the action they took might not just minimize overdoses yet assist the neighborhood in its entirety.


It's called the Contagious Illness Removal Act. Gov. Ron DeSantis signed it into legislation on June 27, and it authorizes county payments to apply a program where drug users can trade unclean needles for new ones. Though the program's suggestion has remained in location throughout the world for years, the United States has been slower to act, Florida in particular. Manatee Area is poised to become only the 3rd region in the state to execute it. Dade has actually been doing it for three years, as well as the results have been urging.

With substance abuse comes filthy needles and also with filthy needles come a slew of issues, amongst them transmittable diseases. In 2017-- statistically a headache in Manatee Region for substance abuse-- there were 457 cases of Hepatitis C reported and also 38 cases of HIV. Clean needles can have helped in reducing those numbers, conserving taxpayers cash at the same time.

The program, according to figures, gives a typical roi of $7.58 for every single dollar. And as part of the regulation, state, region or local funds can not be made use of, just funds via grants or private donations, meaning the government is denying needles for addict. Manatee County still needs to locate a company happy to money it, and a facility to operate it from.

Critics state all this does is promote substance abuse, that it does nothing to prevent it, however there are various other advantages. An individual registered in the program can obtain individual time with a health care service provider at the exchange, receive references for treatment programs and obtain immunized against contagious conditions. As opposed to going after an addict-- which is essentially chasing a ghost-- they come to you as well as perhaps they obtain clean. Several research studies from significant cities have shown this technique works.

Still not persuaded this not does anything but promote more substance abuse? Then check out it from the other side. The law enforcement side, the actual people attempting to clear areas of medicines.

Research studies have shown nearly 30 percent of police policemans obtain supported needles in the line of duty, more than ever get fired. Regarding 27 percent get stuck twice or more. Consider it: Would certainly you intend to pat down a lawbreaker who "forgets ″ he has contaminated needles in his pocket?

There are still obstacles before this begins. A company willing to fund the program has yet to be located, for instance, yet the region commissioners ought to be commended for taking the very first step

Hepatitis B is Getting a Push in Research

 Hepatitis B is Getting a Push in Research

Illness and viruses can establish resistance to various treatments and also it's because of that Aligos Therapeutics is developing 3 different treatments for liver disease B with some grants from NIH.

Aligos Therapeutics Chief Executive Officer Lawrence Blatt told BioSpace that the different properties in development address different elements of the infection. Having mix treatments is something of a need with a virus like hepatitis B, he stated. The relevance of mix treatments was something medication programmers learned when checking out treatments for HIV. Blatt said monotherapies confirmed mostly inefficient and also the infection developed resistances versus the drugs.

"Only when we had three-way therapies did we see the reactions we're seeing today," Blatt said.

And that's what Blatt as well as the Aligos team wishes to see in HBV. The 3 properties are designed to collaborate to provide a hoped-for best feedback. For HBV, Aligos is creating a capsid setting up modulator (WEBCAM), a little particle allosteric prevention, an S-antigen Transport-inhibiting oligonucleotides Polymer (QUIT), which has an unknown device of action and an antisense oligonucleotides, which bind to corresponding messenger RNAs (mRNAs) and cause their deterioration through the enzyme Ribonuclease H. In combination, Blatt said the possessions have actually shown "collaborating knockdown" in preclinical research studies and also the business is really hoping that will certainly "bode well" when the products go into the clinic in 2020. Situation in point, with the WEB CAM possession, Blatt stated Aligos had shown the highest strength of any type of CAMERA currently in the clinic.

Considering the firm's future development plans in HBV, Blatt claimed the strategy is to relocate the 3 assets right into the facility for monotherapy study in 2020 and afterwards begin mix researches. His hope with the internal established treatments is to find a program that will certainly "accomplish a continual useful remedy in HBV." The planned timeline is for the QUIT possession to enter the clinic in the 2nd quarter of 2020, the WEB CAM property to enter in the third quarter as well as the ASO property by the end of the 4th quarter.

Liver disease B is a liver infection brought on by the liver disease B infection. Symptoms and signs of hepatitis B include stomach discomfort, high temperature, joint discomfort, anorexia nervosa, nausea, weakness as well as tiredness, as well as a yellowing of the skin. If the infection becomes persistent, implying it lasts for longer than 6 months, it can cause liver failing, liver cancer cells or cirrhosis of the liver. Numerous companies are working on therapies for persistent liver disease B. Gilead Sciences, which created drugs that provided an useful cure for liver disease C, is establishing Vemlidy for chronic liver disease B. Roche and also Dicerna teamed up to develop an RNA interference (RNAi) treatment for chronic HBV. Previously this year, Janssen Pharmaceuticals flaunted information from a recurring Phase I/II professional research study of JNJ-3989, an RNAi property in HBV. Janssen's item targets the liver disease RNA specifically as well as quits it from making surface antigens. GlaxoSmithKline accredited an Ionis-developed therapy for people with persistent liver disease B infection (CHB) infection following positive Phase II outcomes.

Along with liver disease B, Aligos is also establishing a treatment for nonalcoholic steatohepatitis (NASH). At the Liver Satisfying in South San Francisco last month, the company presented data highlighting the preclinical efficiency of its thyroid hormonal agent receptor beta (THR-β) agonist for NASH. The possession, ALG-055009, lowered cholesterol in an obvious as well as sustained style after a solitary dose as well as demonstrated exceptional bioavailability when carried out by mouth, the business claimed. Like the HBV possessions, Aligos is intending on taking the NASH item into the center soon. Nevertheless, unlike the HBV assets, Blatt said the company will likely look at locating a development companion for ALG-055009. Blatt claimed the firm is in talks with some business, but, as might be expected, Blatt did not reveal what business Aligos is in talks with for a partnership offer. In the NASH area, there are various players, particularly provided the truth that there are no as-of-yet approved therapies for the disease. Gilead is operating in the area. The Foster City, Calif.-based firm has selonsertib, firsocostat and also cilfexor in various mixes to deal with NASH in several professional trials. Various other business, such as Genentech, Curis, Viking Therapies, Intercept Pharma as well as even more are also dealing with the disease.

NASH is estimated to influence more than 16 million individuals in the U.S. alone. If neglected, NASH clients encounter significant repercussions, including end-stage liver condition, liver cancer cells as well as the need for liver transplant. Present treatment requirements for NASH are way of life adjustments, including diet regimen, weight reduction and workout. GlobalData speculated the NASH market will hit $18.3 billion by 2026.

Sunday, February 5, 2017

Harvonipriceinindia.com Sovaldipriceinindia.com is taken down by Gilead Sciences and up running at careexim.org and sunnypharma.org

Our websites for the past few years has been taken down by Gilead Sciences.  The behemoth manufacturer of Harvoni, Sovaldi and Epclusa, stated that we were using their trademark names to market generics. 

Our attorney in our defense retorted that the said names, Harvoni, Sovaldi and Epclusa are known around the world for life saving medicine.  Its like saying I want a Coke but the shopkeeper doesn't have a Coke but they give you Pepsi.  Its a generic term that is used so common and never questioned that you want a soft drink. 

Needless to say after a month of litigation with the ICANN body and Gilead Sciences attorneys that we were forced to release the ownership of two of our domains, and sovaldipriceinindia.com. 

We learned a valuable lesson.  We have fully dedicated all of our resources to our 1 year old site http://www.sunnypharma.org as our primary site for all folks looking for generic hepatitis C treatments.  Gilead Sciences gave the license to Indian manufacturers to produce the generic versions of Harvoni, Sovaldi and Epclusa.  As previously we have made these treatments available at a fraction of the cost to most people around the world.  We will continue to do so.  Our mission is no patient left behind.   


One other very important development happened during this process.  Our organization was slandered and falsely denegrated for not being the real deal.  This was published in hepmag.com by Greg Jefferys.  Our organization had to plead with Greg to rescind all statements of malice towards our friendly non profit, SoulofHealing.org in the US and the NGO, SunnyPharma.org in India.  Greg claimed in his articles that our friend, non profit is not recognized by the US federal government.  Which is 100% false.  On the SoulofHealing.org website, it clearly gives the EIN, Employee Identification Number, with a link to the IRS.gov, which is the Internal Revenue Services website of the US government. 

For those of you not from the US, IRS is the tax collecting arm of the US government.  It has the highest standards of who and what non profit organization receives the gold standard of US federal tax exemption.  SoulofHealing.org went through the 2 year rigorous process of proving to the US federal government that the services that they provide is and legally and rightfully tax exempt.

Greg Jefferys a Phd pursuant of journalism, conveniently overlooked this very important fact before throwing mud on SoulofHealing.org.  He not only threw mud o SoulofHealing.org, he threw mud on SunnyPharma.org for not providing legitimate treatment.  This saddened us to the core that a public figure like Greg Jefferys would write an article about our organization and our friend SoulofHealing.org.  Our reply to Greg was please contact our patient referrals, our doctors and our nurses who have successfuly gone through our program with flying colors. 

With all this said and done, Greg Jefferys did remove the defaming articles, however without an apology.  Our plea was if you are contesting the genuiness of our organization please verify what we state.  If you do not verify and continue to slander our organizations the hepatitis C communities around the world will suffer.  The bottom line is patients are in need of treatment.  We beg you not to distort our genuine service to help those with hepatitis C at large.  It was a great feeling when Greg conceded to our motion.  We want to say thank you Greg for realizing what we are doing is real and forthright.

http://www.sunnypharma.info

China to Receive Generic Harvoni, Sovaldi, Epclusa and Daklinza Delivered by Courier, Guaranteed

Trying to send generic hepatitis C treatments like Harvoni, Sovaldi, Epclusa and Daklinza to China easy or difficult? 

Well several months ago, we had patients from China asking for treatment.  All the couriers we requested information from said it is difficult to send treatment to China.  It seems that an import/export permit is required to receive treatment.  For God's sake are you serious!!

What's the next step?  We contacted our international courier services again and requested it be shipped to Hong Kong.  Smiles all around, no restrictions whatsoever, smooth sailing.  So we sent out several regimens of generic Harvoni, Sovaldi and Daklinza.  At that time Epclusa was not available.  All of our patients' contacts in Hong Kong received their treatment without any issues. 

We would like to interrupt this message and sing in halls of worship halelujah for 30 seconds.   

Now in 2017, we're told all treatment headed to China can be send without any import and export certificates held by the receiver.  Well, we don't know if this is good to be true just yet.  We will experiment and see if our patient actually gets the treatment in their hands. 

We always recommend that all of our patients from China to receive their treatments in Hong Kong.  Its tried and tested and it has worked with out fail.  So, please take the time and effort to find a responsible person to receive the treatment in the more friendly Hong Kong. 

If you by chance of a proper method or procedure to receive treatment in mainland China, please share with https://www.sunnypharma.info.  You can also email us at hcvmeds@gmail.com.  We're also available at our US telephone number 1-858-952-1077, 24 hours a day 7 days a week.

We look forward to any assistance or knowledge you can share with our staff and our organization.  In the mean time, do whatever it takes to make sure you get the generic versions of Harvoni, Sovaldi, Epclusa and Daklinza. 

Jerry Still hasn't started his Hepatitis C Treatment: Generic Harvoni from Sunnypharma.org

A few days ago we received a call from our BBQ restaurant owners in South Carolina.  The elder brother, distraught and frightened that his younger brother still had not started his generic Harvoni treatment. 

Our most compassionate advocate, Birat Krishna Thapa, was againt mortified with this news.  Birat is the type of advocate that goes through walls to make sure our patients get their treatment, start and complete the treatment successfully.  Then follows up 6 months later to make sure the hepatitis C virus is still undetectable.

Just a few months ago Birat was promised by the younger brother he would start treatment after the holidays have come and gone.  Now we receive a call from the elder brother stating that one of their restaurants maybe shutdown due to the irresponsibility of the younger.  Restaurants can come and go but people cannot.  Younger brother's lifestyle of drinking, smoking and womanizing will not help in fighting the HCV infection. 

Birat's number one concern is that the generic Harvoni that we sent them has an expiration date.  Why throw money down the drain?  Why be infected with hepatitis C when you can cure yourself with the treatment in your hands?  Why risk infection to your family and friends around you?  Why? Why? Why?  Its only going to take 84 days of treatment then you're scott free. 

The cost of generic Harvoni is $1495 for 12 weeks 84 tablets.  It dirt cheap compared to $95,000.  We're thinking maybe the cost is negligible and is not a cause for alarm with a looming expiry date.  We don't know.  We want to throw our hands up in despair.

However, Birat will never.  He's like a bloodhound that has a scent and is determined to make sure his patients are treated and live a normal healthy life.  We will keep you updated on what's happening in South Carolina.

.....To be continued...

 http://www.sunnypharma.info

James Finds Hepatitis C Treatment: Generic Harvoni for $1495 12 weeks, 84 tablets

What in God's name is going on with our country?  The reason I ask is, I am a patriot, a war veteran and an accountant at a large insurance company in California. 

I served our country because that is what my ancestors before me have done to give my family and I our freedom.  It is the highest honor personally for me as an American.  My accounting degree from USC is secondary to my service.

While serving in the Iraq war I was injured and found out later I was infected with hepatitis C.  The VA hospitals provided great care but not the treatment.  My GI doc said we are not allowed to give you the treatment just yet because your liver is overall healthy.  Its true, I don't drink or smoke.  I eat healthy and exercise regularly.  I agreed to wait until I cleared to receive treatment. 

Just want to let you know this was before the VA agreed to provide treatment to all veterans. 

Our doctor recommended that my entire family get tested for hepatitis C.  My wife and our two children.  The children were negative for HCV but my wife wasn't.  My darling wife panicked and became horrified.  We had TRICARE.  Which is great unless you have a condition that requires very expensive treatment. 

My wife consulted with numerous doctors regarding treatment for both of us.  They all said there is nothing we can do.  A nurse friend of my wife said I had hepatitis C but I was cured in a few weeks.  Her insurance also denied her.  She went through to get her generic Harvoni.  She asked the company to make sure they provide references, which they did.  Physicians, nurses and a few University hospitals and clinics from around the country.  She was impressed.  She dug in to the company more and found out they're a partner of an American non profit.  The whole organization was setup to serve mostly Americans that cannot get many different types of treatment that is out of reach for most patients. 

We want the world to know that my wife and I are now cured of hepatitis C.  We had no viral load after 6 weeks, but our GI said to complete the course.  We tested again after 6 months and again no viral load detected.  We want to thank Dr. Warren McCray of SoulofHealing.org and Sunnypharma.info's Melissa McKnight, Birat Thapa, Jennifer Haton and other support staff for providing a venue to get treatment.

Jenny's Story to Get Hepatitis C Treatment for Her Husband Frank

My husband has a fibroscan of 2 the doctors tell him he's not eligible for treatment until his liver is in worst condition.  Primarily because the treatment is so costly and is reserved only for fatally ill patients.  This is not good news for our family. 

So, what did I do?  I wrote to our state representatives and our senators to ask for help in regarding treatment.  Their offices responded swiftly with prescription assistance programs that can possibly help my husband get the necessary treatment.  I want to mention before contacting our elected leaders in the state and senate, I reached out to our insurance company.  We have Blue Cross Blue Shield and they've been good to us for over 25 years and now they've disappointed us by letting us down on the most important of health issues. 

I don't understand since hepatitis C is such a communicable disease and is a major health concern for our nation why they're not subsidizing the costs of treatment.  I understand its about the bottom line for the pharmaceutical companies and they have earned it.  For the average middle income family, the treatment should be subsidized further to even $10,000 rather than $95,000. 

Obamacare didn't help us in this situation.  I really hope President Trump will come through on some of his campaign promises and help in the fight to reduce the cost of treatment. 

In the mean time, my doctor referred me to a non profit, Soul of Healing, http://www.soulofhealing.org to see if they can help my husband get access to treatment. 

For all you folks with hepatitis C and your loved ones, you can get through this.  Have faith.

http://www.sunnypharma.info

Thursday, January 12, 2017

Please Jerry Take your Generic Harvoni

 Please Jerry Take your Generic Harvoni


Two months ago Hank came to us to request treatment for his brother Jerry.  They ordered their treatment a week before Thanksgiving 2016.  They received the treatment the following Monday.

A little background about Jerry:


Jerry and his older brother Hank are owners of a famous BBQ joint in a small town in South Carolina.  They have been so successful they opened up another BBQ joint in a neighboring town, doing equally well.  Hank is the more responsible brother of the two.  However, Hank is confined to a wheelchair but is very mobile to manage both restaurants.  He has been concerned about his brother's hepatitis C that was diagnosed more than 25 years ago.  Hank had been on Jerry to get on the treatment and be hepatitis C free ever since Harvoni came out.  Of course Jerry's insurance didn't cover it, even after 4 attempts (sound familiar).  So, Hank did all the leg work locating SoulofHealing.org and went through their Patient Assistance Program setup by pharmaceutical companies.  They were denied there as well.  Hank, nor did Jerry, have $180,000 sitting around for the 24 week treatment of Harvoni.  Hank was referred to SunnyPharma.info to get the subsidized generic version of Harvoni from us.  Which we obliged.

Birat, our patient outreach coordinator calls up Jerry to get an update on how the treatment was going.  To his amazement he found Jerry did not start his treatment at all.  Jerry said he will start soon after Thanksgiving, Christmas and New Years.  Birat called up Jerry on January 4th to find out Jerry still has not started treatment.

Unfortunately, Birat got furious over this and immediately called Jerry's brother Hank to find out what the hell (pardon our French) is going on.

Hank informs Birat, Jerry has not been doing anything other than partying 24/7 with his friends at the local taverns.  Hank sadly expressed his concerns that "I'm in a wheelchair and I can't be chasing my brother around to take his meds when he's out all hours of the night getting drunk and womanizing."  Birat, the most mild mannered HCV advocate completely lost his control.  Melissa, the head honcho, receives a call at 2 am Pacific Standard Time to hear Birat expressing his concern and asking for guidance on how to get Jerry started on his treatment. 


Melissa's Two Cents



Melissa has been around the block a few times, she asked Birat to scare the expletive out of Jerry to take his meds.  Birat called his doctor and informed his staff to immediately call Jerry to start his treatment or he will be hospitalized due to his fibroscan reading.  Unfortunately that tactic did not work. 

Birat racking his brain to figure how can I get my patient to start his treatment before the generic Harvoni expires.  That was is it, the expiration date.  He sternly rings up Jerry and frankly tells him you only have 7 months left before your treatment expires.  If you don't, you will have spent almost $4,000 on treatment that will be flushed down the toilet.  Immediately, Jerry reacted and asked how much time do I have?  Birat, you have less than 4 weeks to start your treatment.

Birat will call up Jerry again in a bout 4 weeks to see if Jerry started his treatment. 

We have consulted 100's of patients  that have hepatitis C and all of them have followed through treatment with a T and come out viral load free.

We will not let Jerry slip through our fingers, we will be on him like white on rice to make sure he follows through.

We don't have any other option other than success for ALL of our patients to be hepatitis C.  Perhaps we're a little tough because we have heard and seen too much over the years and what hepatitis C has done to our families and communities.  We have a golden opportunity to rid the world of this awful disease, lets do it.

For all those of you hesitant to start treatment because of lifestyle changes or worried about side effects, you can do it.  You can get through this, so many around the world have, now its your turn.

Jason Hienley
HCV Advocate
http://www.sunnypharma.info
http://www.soulofhealing.org

University of Arizona Hospitals and Clinics Patient treated with generic Harvoni beat Hepatitis C

We want to give you an update.  Approximately 6 months ago a patient from the University of Arizona hospital and clinics was referred to us for generic Harvoni.  After few weeks of treatment our patient had his blood work done and it was clear.  The treatment recommended was generic Harvoni.  At that time we had provided Resof L by Dr. Reddy's Laboratories brand manufactured by Hetero Drugs (Gilead Sciences official partner).  Then a couple more months go by, the treatment was completed and lab results showed no viral load present.  We were obviously very happy and 95% expected the results.  Our patient's wife informed us they we're not completely out of the woods yet.  Its seems that her husband had been treated in the past but the virus came back.  They were on peg interferon and ribavirin treatment.  The doctor informed them that to do another lab test in 3 months.  Well, our patient's lab tests confirmed no viral load.  We're very happy with the results.  Our patient's wife Jill said that they will do another test in another 6 months.  We're confident that the results will be negative for hepatitis C.

Please email your stories or give us a call about your experiences with treatment with the generic versions of Harvoni, Epclusa, Sovaldi and Daklinza.

Until then we wish you the best of health.

Sincerely,

Melissa McKnight
hcvmeds@gmail.com
sunnypharma.info
soulofhealing.org

Sunday, January 8, 2017

Excellent Response to generic Epclusa from American Patient









We have just received news a few days ago that one of our patients Gwenyth lab results show no viral load detected.  Everyone on the Soul of Healing and Sunny Pharma team we're anxious about how effective the generic Epclusa from Beacon Pharmaceuticals would be.  Even with Dr. Freeman of Tasmania advocating Beacon Pharmaceuticals, as skeptical Americans its hard to believe.

                        Generic Epclusa 12 weeks, 84 tablets $2195 SunnyPharma.info

Well, the good news is Gwenyth has only been on treatment for 2 weeks and the no viral load results are impressive.  Her physician strongly recommends her full course of 12 weeks to complete the treatment once in for all.  This makes sense, its the case of "just in case", we don't want to take chances.  Really, what's another 10 weeks.  Gwenyth, thank you so much for sharing the results and we look forward to hearing from you again in another 10 weeks.

God bless we wish you all the best.

Melissa McKnight
HCV Advocate
1-858-952-1077
hcvmeds@gmail.com

Saturday, November 12, 2016

SunnyPharma.info is Now Live generics of Sovaldi $695, Harvoni $1495, Daklinza $695 and Epclusa $2195

Dear HCV Communities and Loved Ones,

  We are under increase pressure to stop using certain names within our website domain name.

The giants of pharma are treading on our ability to find affordable treatments and make it available for our patients back home.

We have lost two of our websites and now promote affordable treatment through SunnyPharma.info.  SoulofHelaing.org is the American non profit that we have partnered with to help our community have access to affordable treatment.

Get ready and tell your hepatitis C support groups, they will get treated, we will never deny any of our patients.

We have donated over 400 treatments to hepatitis C patients around the world.  Your support is immeasurable and the lives we have all saved together.

Happy Holidays and a Happy New Year 2017.

Sincerely,

Melissa McKnight
Patient Outreach Coordinator
hcvmeds@gmail.com
1-858-952-1077

Sunday, July 24, 2016

Diabetes Health Center

WebMD News from HealthDay

By Mary Elizabeth Dallas

HealthDay Reporter

TUESDAY, July 19, 2016 (HealthDay News) -- Eating more healthy fats, like nuts, seeds and vegetable oils, while limiting animal fats and refined carbohydrates, can help prevent or control type 2 diabetes, new research suggests.

The large study found these dietary changes can lower blood sugar levels and improve insulin sensitivity.

"The world faces an epidemic of insulin resistance and diabetes. Our findings support preventing and treating these diseases by eating more fat-rich foods like walnuts, sunflower seeds, soybeans, flaxseed, fish and other vegetable oils and spreads, in place of refined grains, starches, sugars and animal fats," said study co-leader Dr. Dariush Mozaffarian. He is dean of the Friedman School of Nutrition Science and Policy at Tufts University in Boston.

                    You Can Receive a FREE Diabetes Test Kit from Tufts University

"This is a positive message for the public. Don't fear healthy fats," Mozaffarian said in a university news release.

Researchers analyzed results of 102 trials including 4,660 adults to evaluate how different types of dietary fat and carbohydrates affected key risk factors for type 2 diabetes.

The analysis, published July 19 in PLOS Medicine, involved studies that provided participants with meals with different amounts of saturated, monounsaturated and polyunsaturated fats and carbohydrates. The researchers assessed how these dietary differences affected measures of metabolic health, including blood sugar and insulin levels, as well insulin sensitivity and production.

Following a diet rich in monounsaturated or polyunsaturated fat instead of meals high in carbohydrates or saturated fat helps improve blood sugar control, the researchers found.

Previous studies have estimated that each 0.1 percent drop in HbA1C -- an indicator of long-term blood sugar control -- could reduce the incidence of type 2 diabetes by 22 percent and heart disease by 6.8 percent, the researchers said.

"Among different fats, the most consistent benefits were seen for increasing polyunsaturated fats, in place of either carbohydrates or saturated fat," said the study's first author, Fumiaki Imamura, of the Medical Research Council Epidemiology Unit at the University of Cambridge in England.

The study authors said their findings should help inform doctors and patients about the effects of diet on metabolic health and the risk for type 2 diabetes.

"Until now, our understanding of how dietary fats and carbohydrates influence glucose, insulin and related risk factors has been based on individual studies with inconsistent findings," Imamura said. "By combining results from more than 100 trials, we provide the strongest evidence to date on how major nutrients alter these risks."
View Article Sources Sources

The Influence of Diabetes Management on Kidney Function

worldwide. It has affected about 285 million patients in 2010 and is expected to reach 439 million by 2030. The globalization of the diabetes epidemic, given its micro- and macrovascular problems, imposes enormous economic burden on patients and healthcare systems in both developed and developing economics. Among the diabetic microvascular diseases, chronic kidney disease (CKD) presents unique challenges. Diabetes is the leading cause of end stage renal disease (ESRD). Chronic kidney disease contributes to the development of cardiovascular disease and therefore increases the risk of death and cardiovascular events. Approximately 40 % of patients with type 2 diabetes have higher urinary albumin excretion consistent with underlying renal disease and 17% of patients with diabetes have CKD. Intensive glycemic control may play a vital role to halt or slow down the advancement of diabetic kidney disease. Anti-hyperglycemic agents in these patients are inadequate due to safety and tolerability concerns. Metformin, sulfonylureas and thiazolidione are connected with an increased incidence of hypoglycemia, weight gain and lactic acidosis in patients with type 2 diabetes and CKD. Patients with type 2 diabetes and CKD do not achieve or maintain adequate glycemic control. The use of metformin in CKD patients is controversial, and is even on FDA black box warnings as causing lactic acidosis, which is rare but potentially fatal. A previous study (ADVANCE) proved that intensive glucose control in type 2 diabetes patients drastically decreased the risk of renal outcomes, including new or worsening nephropathy and ESKD.
The purpose of this study was to find out if long-term intensive glycemic control can lead to ESKD. ADVANCE-surviving patients were recruited for ADVANCE–ON, a post-trial study. HbA1c fasting blood glucose, blood pressure, weight, and serum creatinine of patients were assessed at their first post-trial and then annually. The cause of death for patients who died was recorded. Telephone or home visits are offered to patients who cannot do a follow-up. The study outcome was ESKD, stroke, cardiovascular death, myocardial infarction and hypoglycemia. Cumulative incidence survival curves and Cox proportional hazards models were some of the statistical methods used. The patients end points of the date of death, date of last visit, and date of vital status were noted.
Of the 8,494 patients, 4,283 of them did intensive glycemic treatment while 4,211 underwent the standard glucose control. Of these, 5,131 of them completed their visit. The post-trial follow-up of 5.4 years, gliclazide modified release, metformin, insulin, glitazones and glucosidase inhibitors are used in both intensive and standard glucose with an HbA1c of (0.67%, 95% CI 0.64, 0.70 P<0.001) was observed at the end of randomized therapy. 2.9 years later, the post-trial visit had (0.08% 95% CI -0.07, 0.22 P =0.29). There was a rise in HbA1c in the intensive control group versus the standard group. The HbA1c levels of the two groups converged at the post-trial visit (7.3% vs 7.3%, P=0.29). 27 patients recorded ESKD during in-trial events and 37 of the patients died due to renal causes. 55 patients recorded ESKD during post-trial and 64 died due to renal causes. There was a drastic decrease in the risk of ESKD witnessed in intensive glucose control in trial period. (7 vs 20 events, HR 0.35 95%CI 0.15, 0.83 P=0.02). These values persisted after 9.9 years of follow-up (29 vs 53, HR 0.54 95% CI 0.34, 0.85 P< 0.01). Over the 9.9 years, 194 patients needed to be treated with intensive glucose control to prevent one ESKD event. Also, the number needed to be treated by CKD stage was 109 for CKD stages 1 and 2 and 393 for CKD stage 3 or more.
In conclusion, it was clear that intensive glucose control had no effect on overall cardiovascular death, all-cause mortality, myocardial infarction, or stroke. Also, baseline CKD status had no effect on intensive glucose control on these outcomes. However, control continues to protect against the development of ESKD in type 2 diabetes patients, but the patients with most benefit are those with preserved kidney function. The weakness of this study includes the non-adjudicated renal end points and lack of complete biochemical data for all patients during the post-trial follow-up.
Practice Pearls:
  • CKD is the leading cause of end stage renal disease worldwide and contributes to the development of cardiovascular diseases, thus increasing the risk of death and cardiovascular events.
  • Intensive glycemic control in type 2 diabetes decreased drastically the primary composite outcome of microvascular events mainly as consequence of a reduction in nephropathy.
  • Type 2 diabetes patients who benefit the most are those with preserved kidney function. Intermediate effects in in the group were those with CKD stage 1 and 2 and a lesser effects in CKD stage 3 or greater at baseline.

Can Statins Cause Diabetes?

It’s true. All medications have side effects, and numerous studies have shown that cholesterol-lowering statin drugs are linked to a small increase in the risk of Type 2 diabetes, even as they reduce the risk of heart attacks.

The higher the dose of a statin, the greater the diabetes risk, said Dr. Eric Topol, director of the Scripps Translational Science Institute and chief academic officer at Scripps Health. But many heart doctors, including Dr. Mary Norine Walsh, president-elect of the American College of Cardiology, say concern about diabetes should not deter patients from taking statins “if you fall into the higher risk category” for heart disease.

On the other hand, someone who has never had heart disease and who has high cholesterol but no other risk factors is less likely to derive benefit from a statin drug while still facing the risk of diabetes, Dr. Topol said, adding, “There you have a very tight benefit-to-risk ratio.”

The Food and Drug Administration updated its advisory about statins in 2012 to include warnings about the slightly increased risk of higher blood sugars and Type 2 diabetes, based in part on two large analyses of earlier studies that controlled for diabetes risk factors like being overweight or being older. One found a 9 percent increase in the risk of diabetes among statin users, and the other a 12 percent increase, with a greater risk for those on intensive rather than moderate doses of the drugs.

The 2012 F.D.A. advisory also warns of other side effects of statins, such as muscle injury, rare cases of liver damage and reports of memory loss and confusion.

“You and your physician need to be aware of risks,” said Dr. Walsh, and you may want to be assessed for diabetes. But she said, “It is not a reason not to take a statin if you fall into the higher risk category. The overall benefit of statins for people who need them because of their cardiovascular risk far exceeds the risk of diabetes.”

Do you have a health question? Submit your question to Ask Well.

Related:

Meet the brothers who reversed their father's diabetes



Growing up, Anthony and Ian Whitington’s father, Geoff, was an energetic and committed dad. Having divorced from the boys’ mother when they were 10 and eight respectively, Geoff, then a BT engineer, gave up his weekends to allow the boys to do whatever they fancied – be it sports or day trips.

Like most men, Geoff was always quick with a joke but grew stubborn as a mule in middle age. When he was diagnosed with Type 2 diabetes in 2003 at the age of 51, both he and his sons (by then grown up and moved away) thought little of it.

After all, they were told at the time the disease was 'manageable’ by tidying up Geoff’s diet, prescribing some pills and keeping a keen eye on his blood sugar. He did this, attempting every fad diet available but never quite managing to keep the weight off and never quite seeing that as a problem.
fixing dad
Geoff Whitington with his sons on a family holiday Credit: Christopher Pledger

Over the course of the next decade Geoff’s weight ballooned to 20 stone, exacerbated by excessive snacking during sedentary night shifts in his post-retirement job as a security guard.
"They were asking me to sign a contract that said I’d do everything they told me. I had no idea what I was letting myself in for"Geoff Whitington

By 2013 complications had set in: he contracted Charcot Foot – a progressive and gory destruction of the joint – which, in addition to diabetes-related ulcers on his other foot, meant a grave risk of amputation.

He fell into near-depression, withdrawing from visiting his sons and grandchildren. Consigned to an early death from diabetes, he even took to writing a will.

“He was retracting. He wasn’t the same Geoff, no jokes, no banter,” recalls Anthony, now 38. “Reading up, we found out that people who have a foot amputated are expected to live for about two years beyond that. Something needed to be done.”
geoff whitington
Geoff's foot prior to his sons' interviention Credit: Christopher Pledger

Anthony, a freelance filmmaker, and Ian, 37, a cameraman, hatched a plan to help their father. The pair also decided to make a documentary, Fixing Dad, to chart Geoff’s progress, which airs on BBC Two tonight.

“I thought they were just calling my bluff,” says Geoff, 64. “They were basically asking me to sign a contract that said I’d do everything they told me. I agreed, but I had no idea what I was letting myself in for.”

The brothers researched the disease - which affects more than 3.6 million people in the UK - drew up a three-pronged attack on Geoff’s fitness, nutritional and mental hurdles, and set a daunting target: that the three of them would complete a the 100-mile Prudential RideLondon-Surrey cycling event in July 2014.
Fixing Dad: meet the brothers who reversed their fathers diabetes Play! 03:52

“Dad could barely walk, so running was immediately out, and he wasn’t keen on the body image of swimming, so that left cycling,” Anthony says. “It turned out to be the ideal exercise for him, exerting far less pressure on his feet and easy to get in to.”

They joined him at every turn. On Geoff’s daily cycles, Anthony would either run or ride with him, while Ian filmed. They’d eat together too, measuring their sugar levels after meals. Kebabs and pub lunches were replaced with lean, carbohydrate-free meals.

“The key was taking dad out of his environment, to break his cycle and make him realise what was at stake,” Anthony says. “We organised a group camping trip to Spain, with our bikes, and at the end we sat him down and showed him a load of family photos, of him as a young man and of his grandchildren.”
What is diabetes? In 60 seconds Play! 01:05

In the documentary, Anthony and Ian express guilt at having let their father deteriorate for so long as they focused on their careers, while Geoff appreciates all he could lose by refusing to change his life.

“The grandchildren were a big thing,” Geoff concedes. “In the past I didn’t really have a close relationship with them at all. The threat of never having that was a huge driving factor.”
"At the end of the film we pose a question: who would you miss most when they’re gone?"Anthony Whitington

The journey wasn’t always easy – various explosive arguments are captured at points where the pressure felt too much – but just nine months after he began the programme, Geoff completed the 100-mile ride through London.

Then, in February last year came the news they’d always wished for. The diabetes had been successfully 'resolved’. Geoff was fixed.
fixing dad documentary
Anthony and Geoff in training Credit: Ian Whitington

“It was amazing. They told us that as long as he stays on this course, he’d have no need for the pills,” Anthony says.

Today Geoff stands at a lithe 13 stone – having lost seven - and says the project has brought the whole family together.

“Marilyn, my wife, has lost three stone coming out on the bike with me. My step-children and Ian and Anthony’s families have caught the bug too. I’m the fittest I’ve ever been and completely addicted.”
geoff whittington
Success: Geoff and Anthony crossing the finish line  Credit: Christopher Pledger

Now employed helping his sons’ film work, and a regular speaker at diabetes conferences around the world, Geoff’s life has been entirely transformed.

“Without a shadow of a doubt,” he says, “my boys saved my life. I wouldn’t be here with the family if it weren’t for what they did.”

Plans are now afoot for a follow-up to Fixing Dad, focusing this time on other diabetes sufferers across Britain.

“At the end of the film we pose a question: who would you miss most when they’re gone?” Anthony says. “Until you’re proven otherwise, diabetes is a condition that’s entirely fixable.”

Fixing Dad will be shown on BBC2

Diabetes Health Center

TUESDAY, July 19, 2016 (HealthDay News) -- Eating more healthy fats, like nuts, seeds and vegetable oils, while limiting animal fats and refined carbohydrates, can help prevent or control type 2 diabetes, new research suggests.

The large study found these dietary changes can lower blood sugar levels and improve insulin sensitivity.

"The world faces an epidemic of insulin resistance and diabetes. Our findings support preventing and treating these diseases by eating more fat-rich foods like walnuts, sunflower seeds, soybeans, flaxseed, fish and other vegetable oils and spreads, in place of refined grains, starches, sugars and animal fats," said study co-leader Dr. Dariush Mozaffarian. He is dean of the Friedman School of Nutrition Science and Policy at Tufts University in Boston.

"This is a positive message for the public. Don't fear healthy fats," Mozaffarian said in a university news release.

Researchers analyzed results of 102 trials including 4,660 adults to evaluate how different types of dietary fat and carbohydrates affected key risk factors for type 2 diabetes.

The analysis, published July 19 in PLOS Medicine, involved studies that provided participants with meals with different amounts of saturated, monounsaturated and polyunsaturated fats and carbohydrates. The researchers assessed how these dietary differences affected measures of metabolic health, including blood sugar and insulin levels, as well insulin sensitivity and production.

Following a diet rich in monounsaturated or polyunsaturated fat instead of meals high in carbohydrates or saturated fat helps improve blood sugar control, the researchers found.

Previous studies have estimated that each 0.1 percent drop in HbA1C -- an indicator of long-term blood sugar control -- could reduce the incidence of type 2 diabetes by 22 percent and heart disease by 6.8 percent, the researchers said.

"Among different fats, the most consistent benefits were seen for increasing polyunsaturated fats, in place of either carbohydrates or saturated fat," said the study's first author, Fumiaki Imamura, of the Medical Research Council Epidemiology Unit at the University of Cambridge in England.

The study authors said their findings should help inform doctors and patients about the effects of diet on metabolic health and the risk for type 2 diabetes.

"Until now, our understanding of how dietary fats and carbohydrates influence glucose, insulin and related risk factors has been based on individual studies with inconsistent findings," Imamura said. "By combining results from more than 100 trials, we provide the strongest evidence to date on how major nutrients alter these risks."

FDA Panel Supports Dexcom CGM For Insulin Dosing in Diabetes

A US Food and Drug Administration (FDA) advisory panel has voted in favor of allowing the Dexcom G5 Mobile continuous glucose monitoring (CGM) system to be used as a replacement for fingerstick glucose monitoring in patients with diabetes.

At a hearing held July 21, 2016, the FDA's clinical chemistry and clinical toxicology advisory panel voted 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits of the proposed new indication would outweigh the risks.

Currently, the Dexcom G5 CGM is indicated for adjunctive use along with self-monitoring of blood glucose (SMBG), done using a fingerstick test, to provide trend information and alert the patient of high and low blood glucose values. If the FDA follows the panel's advice, the new indication would allow patients to skip the premeal fingersticks and instead use the CGM's data to determine their insulin doses, as well as make other lifestyle decisions such as whether to exercise.

The new label would provide instructions for patients on how to use the CGM's data to determine their insulin doses, including how to adjust insulin doses up or down based on the trend arrows that the device displays. The label would also advise when SMBG testing is necessary, including twice daily for calibration, when the CGM fails to provide a reading, or when symptoms don't match the reading.

Despite the overall favorable vote, many panelists expressed discomfort with the meal dosing simulation model data presented by the company — validated with clinical data from just 71 patients with type 1 diabetes — to support the indication, rather than results from actual patients in randomized clinical trials. Panel members advised the company to gather additional post-marketing data.

Patients Already Using Devices in This Way

Most panelists also said that Dexcom would need to provide training beyond simply a pamphlet or video to make sure that patients understand how to properly use the CGM data to determine insulin doses. There was debate, however, regarding the extent to which the company could provide usage information vs how much of the responsibility would fall to healthcare providers, who would also need to be up to speed.

The stronger vote on efficacy reflected the fact that the Dexcom technology has advanced considerably in recent years. The current G5 iteration is nearly as accurate as SMBG, with a mean absolute relative difference of about 9%, compared with 4% to 9% for the various cleared SMBG meters.

Also influencing the vote was the fact that many current Dexcom users are already using the devices off-label to dose insulin (69% according to market survey data presented during the public comment session by DiaTribe founder Kelly Close) and at least now the company would be able to advise patients about this use, which it is currently forbidden to do.

Over 30 people, including endocrinologists and patients, spoke during the public comment session — many with travel expenses paid by Dexcom — nearly all in favor of approval for the dosing indication. Representatives from the American Diabetes Association, Endocrine Society, and American Association of Clinical Endocrinologists also spoke in support of the indication. Continue Reading