Sky High: Hep C Medication Pricing and the Indian Generic Market

People are left bankrupt, families are left homeless, and many would be scratching for loose change at the end of the ordeal. Why is Hep C medication so expensive? This has been a question for many, even doctors who want to treat patients and have accessible and affordable treatments for their patients are unable to do so due to regulatory issues. 

Most importantly overcoming patent licences and regulations of different countries has been a nightmare for many trying to gain access to affordable medication. It is a known fact that Gilead the prime manufacturers of Hep C medication has signed license agreements with more than 11 Indian generic medicine manufacturers to market generic versions for low and middle income countries. However there are too many restrictions that come into play with various regulatory authorities keeping a tight scrutiny on the availability of these medications due to its associated cost.

Existing prices by Gilead for its products in the Indian generic market range anywhere from $1200-$1900 depending on the length of the treatment. Certain genericversions of the medication are said to be higher than their manufacturing cost. A study conducted by Hill et al. in 2013 indicates that the actual costs of manufacturing these drugs is relatively low, at an estimated $101 per 12 week treatment course, and with the generic competition from the Indian market the marketed prices for these drugs are said to be lower.

It is worthwhile to give patients expensive new drugs that can cure their hepatitis C much earlier than some insurers are now willing to pay for them, according to a UC San Francisco study that models the effects of treating the disease early versus late in its development.

Researchers said they were surprised by the findings, since the drugs can cost up to $100,000 for a full course of treatment. But when they factored in the long-term medical cost of delaying treatment for hepatitis C, they found the savings, in combination with improvements in the quality of patients’ lives, were enough under current standards to justify using them even at early stages of liver fibrosis. Researchers said the drugs were therefore cost effective.

Cost effectiveness is a measure of broad social benefit that health economists use to make decisions about whether medical treatments are warranted. The researchers said the balance was tipped in favor of the drugs because the hepatitisC virus can cause so much damage. Hepatitis C is one of the leading causes of liver cancer, liver transplants and liver-related death, yet the drugs can prevent much of that with an early cure. Moreover, even if costly hepatitis C treatments are delayed, they eventually will be given to many patients once the infection causes enough damage to their livers.

About 3.2 million people have hepatitis C in the United States. The vast majority were infected by blood transfusions before testing of blood donors became available in 1992. Today, most people get infected from injecting drugs.

Left unchecked, hepatitis C causes varying degrees of liver fibrosis in a majority of those infected, and causes cirrhosis in 20 to 30 percent. This damage is classified in five stages of increasing severity, from zero to four. Using sofosbuvir-ledipasvir, which is sold as Harvoni, and is one several new drugs for hepatitis C, researchers compared the costs of treating patients at all stages of fibrosis, zero through four, with the cost of waiting until stages three or four, which is when some patients are usually treated.

They found that, at current drug prices, treating half of those who are currently infected and are aware of their status but have not yet been treated would cost about $53 billion over five years, while treating these patients only at stages three and four would cost $30 billion. Since many of those patients are likely to be given the drugs at later stages of their disease, much of this cost is likely unavoidable, even if it gets delayed. But treating people early would at least avoid the costs of treating the damage from long-term infection. Researchers estimated the lifetime health care savings from treating all stages of liver fibrosis, compared to treating just three and four, at $3.3 billion.

India has been the perfect generic market for cheap and quality drugs. All the Indian manufacturing units have a license to manufacture these drugs directly from Gilead. These drugs are also said to be of very high quality and effective on patients who have already received the generic treatment. Generic versions depends upon successfully overcoming patent barriers, demonstrating equivalence to the originator compound, and obtaining regulatory approval in a timely manner in each developing country. Each Indian pharmaceutical manufacturer follow these strict guidelines and procedures ensuring quality outputs.

India is going to be a major player in the treatment for Hep C. With Gilead's license to its companies, it has a wide geographic coverage to more than 120 low income countries.

In India, for example, the same Harvoni that costs $94,500 in the US costs only about $1000. How is this possible?

Whensofosbuvir pills were registered in the US, Gilead Sciences, the company which produces them, started to spread it's market to Europe and beyond. However, India didn't acknowledge the innovation concerning the sofosbuvir molecule (because it is a little modified version of other existing antiviral molecules) and didn't grant the originator patent right - which meant that Gilead could not market it as an original medicine and priced it well above what would be considered sensible and humane.

In order not to lose profits in huge markets such as India and China, Gilead Sciences gave licences to Indian pharmaceutical companies to create generic version of Harvoni and Sovaldi and market them to Indian population. Gilead would still get their royalties but because the manufacturing process for sofosbuvir pills is not overly expensive, the average price per sofosbuvir pill in India is about $10. In the US it is $1000. And this makes all the difference to Hepatitis C patients in desperate need of sofosbuvir to get well. This is where Soul of Healing comes into its organizational endeavors. 

Every patient should be careful while buying medication from the generic market here in India which is extensively large with many individual contractors involved. Some are pure scam and the product may not be what it is advertised to be. It may be mere gimmick to make some quick bucks.

Soul of Healing alerts and advises its prospective patients against such contractors. We through our subsidiary Sunny Pharma are in touch with Gilead licensed distributors and procure medication directly from them. We assure of its authenticity and we have already helped 1000's of patients and we hope to reach out to more as time comes.

Courtesy: Med Help, UCSF Media

Crucial Information On Hepatitis C: “Stuff you cannot miss”

A new study shows that those carrying the Hep C virus cannot separate fact from fiction when it comes to information about the disease.

It is known to the world as the “silent virus”, and till date there are numerous people who are living with the virus but are unaware of its possession. This virus dangerous in its final outcomes spreads from blood to blood contact and at its end damages the liver leading to chronic illness and eventually death. We cannot deny that there are futuristic strides in this field and recent developments of oral medication have been remarkable to kill the virus and provide a fresh new lease for life.

Governments all over the world have been providing programs to provide accessibility for these medications although pricing and affordability still seems to be a major concern. The oral medications are expensive and most cannot afford the full dose without external aid. Hep C is widely prevalent in our society, and those dealing with it and awaiting treatment can face enormous difficulties. Recently developed oral medications are the only way out of this menace.

According to Nicola Perry, Chairperson of the Hepatitis C Partnership, everyone with the virus should be encouraged to have a fibroscan – a free, quick and painless way to check their liver health. Of course bottom line unlike any other foundation or health care provider our message too is the same, that no one should die from this disease when there is an available cure. There are many things that should be taken into consideration regarding Hep C and general awareness of this disease is important not only for patients but for healthcare providers and people working to eradicate this disease.

We have outlined several facts regarding Hepatitis C, and this information is extremely important for patients to understand the nature of the disease as well as utilizing information during the road to recovery.

Hep C virus was identified 27 years age in 1989. It is a contagious liver disease and it ranges from mild illness lasting a few weeks, to a serious lifelong illness leading to inflammation of the liver and causing the immune system to attack healthy liver cells.

The numbers may be higher, but globally there are more than 130 million people that have Hep C and more than seven hundred thousand people die worldwide from liver related ailments.

Homeless people and people who are habitual drug users are at a higher risk of infection. Hep C can be 30 times more infectious than HIV. The virus is spread by contact with infected blood. One of the biggest risks comes from using / sharing needles or contaminated equipment for snorting or smoking drugs. Compared to HIV and Hep B, it is much likely to be spread through sexual contact, household contact or by mother to child transmission.

Transfusion-related infection is now rare since the introduction in the 1990s of routine screening of blood for hepatitis C antibodies.

HepatitisC is not spread by sharing eating utensils, food or drinks, or from shaking or holding hands with someone who is infected, but the virus can survive in dried blood on everyday surfaces at room temperature for up to four days. (It can survive longer in a confined environment such as inside a syringe.)

You can lessen your risk of getting the virus by avoiding sharing needles and injecting or snorting drugs, avoiding sharing razors, toothbrushes, nail clippers, or other personal care items that may have come into contact with infected blood, and avoiding using tattoo or piercing equipment that's been used on someone else.

HepatitisC is often referred to as the "silent virus". It commonly has no or very few symptoms, both in the acute (first six months) and early chronic stages. The acute stage of infection therefore tends to go unnoticed.

Chronic infection occurs in 70-80pc of adults acutely infected. Some non-specific symptoms of chronic disease may include ongoing flu-like symptoms, joint pains, abdominal pain, loss of appetite, changed bowel habits, mood swings and insomnia. Complications of chronic hepatitis C include cirrhosis, liver failure and liver cancer.

Two tests are used to diagnose hepatitis C. An antibody test is used to determine whether someone has ever been exposed to the virus. Up to 20pc of people clear the virus from their bodies naturally - 'spontaneous clearance'. If an antibody test is positive, a second test will check if the virus is still present. A further PCR (polymerase chain reaction) test determines whether the patient is currently infected by detecting the presence of the genetic material of the virus.

Certain factors can speed up the disease's progression, such as alcohol intake, co-infection with HIV or hepatitis B, superinfection with hepatitis A and older age at infection. A healthy lifestyle and a good diet can have a positive impact on liver health. Recommendations for managing hepatitis C infection include cutting out alcohol, drugs and smoking, having a healthy diet, exercising regularly, avoiding unnecessary medication and getting vaccinated against both hepatitis A and B.

There are six genotypes of the hepatitis C virus and they respond differently to treatment. It is also possible for a person to be infected with more than one genotype. A fibroscan can check for liver scarring within minutes without the need for an invasive and painful liver biopsy. The fibroscan uses ultrasound technology to figure out whether or not a patient has fibrosis, or scarring of the liver, and if they do, how much. In Ireland, patients with a "fibro-score" of 8.5 or more meet the criteria for new treatments available for hepatitis C.

Patients with hepatitis C can be cured. Until recently, treatment was based on therapy with interferon and ribavirin and required weekly injections for 48 weeks. This cured roughly half of treated patients, but caused adverse reactions.

The recent development of multiple direct-acting antivirals (DAAs) by GileadSciences Inc are more effective, safer and better-tolerated than the older therapies, and can cure most patients in about 12 weeks. Relapse or reinfection is still possible, so patients are advised to stay in contact with their doctor. Oral medications depending on genotype are available in different combinations and go by the name Harvoni and Sovaldi. These highly effective medications have been developed by Gilead Sciences.

Disclaimer: Soul of Healing is a Nonprofit based in the US, its subsidiary Sunny Pharma in Bangalore provides generic alternatives for Hep C treatment. For more information you can visit harvonipriceinindia or contact us.

Courtesy: The Independent News and Hep C Info. 

 

Oral Medications available for the treatment of Hep C

We will only discuss about the recent developments in treating Hepatitis C. We hope by now you have overcome the stigma behind this virus and contemplate getting rid of it and living a normal healthy life.

Remember that the most important factor in determining your right treatment is to get tested for a genotype. 

The generic market in India opened to 120 low and middle income countries in January releasing the generic version of Harvoni licensed by Gilead. The other treatments available are Sovaldi, Ribavirin and Daklinza.

These recently developed oral medications have been clinically tested, and have shown remarkable results in patients successfully being cured.

We will give you an outline of basic information of each one of these meds used for treating Hep C.  

Gilead recently developed Epclusa and has received FDA approval. The generic version under the license of Gilead is set to come out in the markets in India. They will be available to 120 low and middle income countries.

Another important medication developed by Gilead and approved by the FDA recently is being awaited and clinically tested. Epclusa is an addition to the existing line of medications available for Hep C treatment.

All medications have been developed by Gilead Inc and under its license are 10+ Indian pharmaceutical companies manufacturing the generic version.

Generic Harvoni:

Harvoni is a prescription medicine used with or without Ribavirin to treat chronic Hep c for genotype: 1, 4, 5 or 6 infection.

It contains the prescription medicines Ledipasvir 90mg and Sofosbuvir 400mg. It is not known if Harvoni is safe and effective in children under 18 years of age.

You should consult your health care provider or your physician before taking this medication. Before taking Harvoni tell your physician if you have liver problems other than Hep C infection, have had a liver transplant, have severe kidney problems or you are on dialysis, have HIV infection, have any other medical condition, are pregnant. It is not known if Harvoni will harm your unborn baby.

Talk to your physician or your health care provider in detail regarding the medications you are currently taking including prescription and over the counter medicines, vitamins and herbal supplements. Harvoni and other medicines may affect each other. This can cause you to have too much or not enough Harvoni or other medicines in your body. This may affect the way Harvoni or your other medicines work or may lead to side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.

Take Harvoni exactly as your healthcare provider tells you to take it. Do not change your dose unless healthcare provider tells you to.

Do not stop talking Harvoni without first talking with your healthcare provider. Take 1 Harvoni tablet one time each day and at the same time each day. Take Harvoni with or without food. It is also important that you do not skip doses of Harvoni during treatment. If you take too much Harvoni call your healthcare provider or go to the nearest hospital emergency room right away.

Generic Sovaldi:

Sovaldi is another oral medication to treat Hep C for genotype 1, 2, 3 or 4. Sovaldi contains 400mg Sovosbuvir and is taken once daily with our without food. It should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of Hep C. There are various recommended combinations,

Genotype 1 or 4 Sovaldi/ Peg Inferon Alfa/ Ribavirin 12 Weeks

Genotype 2      Sovaldi/ Ribavirin                               12 Weeks

Genotype 3      Sovaldi/ Ribavirin                               24 Weeks

Sovaldi in combination with Ribavirin for 24 weeks can be considered for patients with genotype 1 infection who are interferon ineligible.

Should be used in combination of Ribvarin for treatment of HCV in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first.

Sovaldi dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.

The most common adverse events observed with Sovaldi in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sovaldi in combination with peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia and anemia.

If the other agents used in combination of Sovaldi are permanently discontinued, Sovaldi should also be discontinued.

Generic Epclusa

Epclusa is a fixed-dose combination of Sofosbuvir 400mg and Velpatasvir 100mg.

It is taken orally once daily with our without food. It is the first of its kind in the history of available 

Hep C medication treating pan genotypes 1, 2, 3, 4, 5, or 6. Patients without cirrhosis are recommended Epclusa for 12 weeks and Patients wit decompensated cirrhosis are recommended Epclusa plus Ribavirin for 12 weeks. A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.

The most common adverse reactions (incidence greater than or equal to 10%) observed were headache and fatigue for 12 week treatment. The most common adverse reactions ( incidence greater than or equal to 10%, all grades) observed with treatment with Epclusa and Ribavirin for 12 weeks in patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia and diarrhea.

Each Epclusa tablet is pink, diamond-shaped, film-coated, and debossed with "GSI" on one side and "7916" on the other side.

Epclusa will be available soon in the coming months in the Indian market.

Disclaimer: The medical information is taken from Gilead’s patient information. These are available online and we highly recommend you to consult them. For final judgment always consult your health care provider or physician.  

Quit Treating Hep C as a “Social Stigma”

Having Hep C can be painful. It takes a toll on your physical and mental health, it pressurizes you financially because you need your life saving medication, and it disturbs your life cycle.

There are millions of Americans who are living with Hep c virus. This virus is life damaging leading to organ failure and ultimately death. Although in the current scenario it is treatable like any other disease with anti viral oral medication.

People afflicted with Hep C treat it like a stigma which they shouldn’t because it affects quality of life, be it home, office or the community one lives in. The reality is harsh and people do have difficulties in confronting the situation.

Stigma is associated with those who were past drug users and who contracted the virus through injecting needles. While there are many who have Hep C due to drug use this is only one of the many ways you can get the virus. Most of the people who have Hep C may not have used drugs at all. Commonly people presume that those with Hep C may have been past drug users and that may not be the case for all.   

The way to get out of this stigma is to be brave enough to face the fact that yes I have the virus but ultimately if I work towards it and get the right treatment I will be back leading a normal life. Realism, optimism and positivism are crucial factors when you are going through this difficult phase of your life.

Be realistic accept the fact that you have the virus and you have to do something about it. Optimism, because the disease has a treatment, and positivism to look forward to overcoming and getting rid of the virus and looking towards the future to live a life of your choosing while at it there is still a lot more that can be achieved.

The stigma of having hep c has varied reasons which mainly point towards a person’s individual life choice. Although this virus is not easily transmitted fear is still the number one factor which goes on to take a psychological burden. If we can deal with fear then we have solved 50% of our illness paving way for mental and physical recovery. This should be initiated along with healthy dietary and sanitary habits.

Ignorance is another aspect that has many patients confused, some have even performed poorly in their work space and their entire life seems to be in an unimaginable crisis. To put it straightforward these are constructs of one, and all the problems that seem to create extreme barriers can be removed from within if the individual puts to rest ignorance and embracing knowledge that will lead to making better and wiser decisions. On the outset people are always fearful of illness and death that is basic human nature.

There various ways we can overcome this fear, and to begin with positive attitude along with making the right decision to take you to the path of recovery is very important. Our societies in its conscious ways avoid people who are sick hence making it very difficult. It is important for family members and friends to be supportive in all possible ways under such circumstances.

There are various techniques and methods to keep you positive and healthy. Some of the tips have been listed by Hep C Advocate in their manual.

Be honest and realistic.

Do not base your attitude on thinking things are worse than they are or better than they are.

Make sure you seek the truth, try getting accurate information about Hep C.

Do not think that Hep C is an automatic death sentence it no longer is and it is curable.

Always live in the present, experience your surroundings, eat well and take plenty of rest.

Imagination is a powerful tool, utilize it for your benefit for positivism and optimism, avoid negativity and sadness. Always focus your attention that brings peace, joy , laughter and meaning.

Maintain your perspective for positivism. Accept the fact that you have the virus but there is a cure and you will be cured.

Rid your thoughts of negativity always have substitutes that boost your morale.

You have to try and relax at all times.

Visualize your health as getting better by the day, practice self-transformation techniques. 

Always realize that you can control your life fully and make your decisions for your benefit and a secure future. Get support, be active in support groups, and talk to people about it.

Be helpful towards the society you are living in, step outside of your individuality and reach out to others who are also in need of help. In Minding the Body, Mending the Mind, Joan Borysenko writes, “Adversity is the crucible in which the spirit is forged.” A similar expression is “that which does not kill us, makes us stronger.” Hepatitis C is an invitation to cherish each day, to live fearlessly and fully.

It is the opportunity to wear a new label. ACTING RESPONSIBLY.

You are not legally required to disclose your hepatitis C status. However, there are certain moral responsibilities that come with having a potentially infectious virus. First, do not attempt to donate blood, tissue or organs without complete and honest disclosure about your health. There are certain conditions in which donation is appropriate, such as for research purposes. Hepatitis C-positive organs are used in certain circumstances.

Educate yourself about ways you can reduce your risk of HCV transmission to others. Act from a place of responsibility rather than a place of fear. One final thought for reflection – there is another definition of stigma. In botany, the stigma is the part of a plant where bees deposit pollen. The stigma bears the fragrant sweet solution that attracts bees. It is a place of fertilization. For those with HCV, it may be the place where shame blossoms into hope. It is time to bring hepatitis C out of the closet and into the sunshine.

Your life is based on the choices you make. Your family depends on your presence, being responsible and enduring adversity is a hallmark characteristic for human life. Hep C is not a disease to be afraid of or something to hide because it is like any other disease and there are tons of them in our world. Drug users too have their set of problems, their past may be a nightmare and an addition of the virus can be mentally deteriorating. Constantly keeping negativity with such issues will only hamper the process of recovery, agility, vigilance and strength is required to rid one’s mind of these negative aspects. Always remember at the end of the day there is a cure, Hep c is no longer a disease with limited treatment, it has all available cures and one can enjoy a normal life within 3-6 months of oral treatment. Keep calm, the future is bright.

Symptoms and Causes of Hepatitis C

According to the Center for Disease Control and Prevention 80% of people with Hep C do not have or show symptoms.The inception of symptoms can come at a stage where different types of ailments are noticeable. The symptoms include Fever, Dark Urine, Loss of Appetite, Abdominal pain or discomfort, Joint Pains, and Jaundice. Most people go on to have acute Hep C meaning the virus is there in the body for a period of 6 months or longer, it is common to have the infection for 15 years or longer before being diagnosed.Hep C is also an invisible disease. How does one know whether an individual has hep c or not, in the early stages it is very hard to tell while many do not show symptoms. The inflammation of liver due to the virus can be very serious. Hep c in fact is considered as the most serious of all the hepatitis viruses.

There are more warning signs of the Hep C virus that include nausea or vomiting, pain in  your stomach, muscle pain, abnormalities in urine or bowel movements, and yellowing in your eyes or skin. After exposure to the Hep C virus the symptoms could start anywhere between six or seven weeks.

According to Rupert George, media and campaigns manager at The Hepatitis C Trust, the most common symptom of the virus is feeling unexplainably tired. Other symptoms can also include pains in the upper part of the abdomen, dry eyes, irritable bowel and irritable bladder. But George stresses that the vast majority of people with hepatitis C do not have any noticeable symptoms, which is why it’s often referred to as a “silent disease”. Because of this, he believes it’s more important to know the risk factors for catching the virus so people can think about any times they may have been infected.

“The most common way is injecting and drug use, but people who are in contact with drugs services are much more likely to be tested for hepatitis C than any other group of people, so they’re also most likely to know that they have it,” he tells The Huffington Post UK.People who use steroids and other image or performance enhancing drugs are thought to have levels of hepatitis C nine times higher than the general population. But people living with the virus unknowingly may have contracted the disease through other forms of needle-use.

“I’m aware of someone who contracted it through a botox injection,” he says. “You can get it from a tattoo, you can get it through piercing, you can get it through anything where your skin is being punctured and there’s the potential for blood-to-blood contact.” George says getting a tattoo or receiving medical treatment aboard, where regulations are sometimes less strict, is particularly risky.

“If you go and have a tattoo make sure the tattoo artist uses fresh ink and fresh needles,” he says. “It’s a very robust virus. Even if the artist uses a fresh needle, but then dips the needle in the ink they’ve used to tattoo the previous customer, there’s the potential for somebody to become infected through the ink.”Although the risk of hepatitis C being transmitted via sex is fairly low, there is the potential for it to be passed between partners. In this instance, vaginal sex during menstruation or anal sex with the associated risk of bleeding carry the highest risk of infection. For this reason, men who have sex with men are considered particularly at risk. “There’s also the chance to contract it with people who use tubs of lube during sex,” George adds.

“If you’re using the same lube, that can be something the virus can stay in and it can stay there long enough for someone to become infected via that route.” Finally, anyone who received a blood transfusion before 1991 may be living with the virus without knowing it, as before this time there wasn’t a test available for it. “There are women with hepatitis C who contracted it due to a blood transfusion during childbirth,” George explains.

If any of these risk factors apply to you or you’re just concerned about hepatitis C in general, you can ask your GP for a simple blood test that will reveal if you’ve been infected. There’s no need to panic if you come back with a positive result as in the vast majority of cases, hepatitis C can now be cured.
“Up until about three years ago there was only one treatment available which really wasn’t very nice. It was quite akin to chemotherapy and it didn’t work for quite a lot of people particularly well. It was very long - about 48 weeks,” George explains. “But now there are these new fantastic treatments that can work as quickly as eight weeks and cure 90% of people.”

Most people who receive treatment will receive a combination of two or three medications to fight the virus – known as combination therapy. “It’s in your interested to get tested,” George says. “There is a cure and you can get it sorted for yourself.”Huff Post Blogger Toni Feldstein was diagnosed with hepatitis C in 1985 and says she’s aware of stigma attached to the illness because of the misconception that it’s a “dirty disease”.

But she wants people who have been diagnosed to feel confident in talking about the virus in order to raise awareness. “Don’t be afraid to say it out loud. People will respect your honesty and openness and you will feel more empowered by standing in your truth and integrity. Don’t let it limit you as a human being,” she says.
“Embarrassment, shame and guilt only lead to low self-esteem. There is no shame in having your disease or living with it. If some people have a negative reaction to it, it is their issue, not yours.”For more information about hepatitis C, visit www.soulofhealing.org  or leave us a message and we will get back to you.

Disclaimer: Soul of Healing is a Nonprofit based in the US, its subsidiary Sunny Pharma in Bangalore provides generic alternatives for Hep C treatment. For more information you can visit sunnypharma.org or contactus. 

Courtesy: Huffington Post, Hep C Advocate and Healthline. 

HCV Pictorial Facts

Disclaimer:  Soul of Healing Trust India is associated with Sunny Pharma based in Bangalore. We have a Prescription Assistance Program for Hepatitis C patients who cannot afford treatment or have high insurance premiums. For more information please call us at +1-858-952-1077 or click here. 

Hepatitis C : Introduction

HepatisC infection is caused by the Hepatitis C Virus (HCV). It is an emerging public health threat in a global scale. The Sustainable Development Goals (SDGs) adopted on 25 September 2015 recognize hepatitis as a global health issue to be tackled on an urgent basis.

Hepatitis is now one of the leading causes of death across the world and it is timely that the SDGs have recognized it as a major global health concern for which comprehensive health strategies need to be formulated and implemented and resources mobilized, nationally and internationally as a priority. Prevention of transmission, improving access to testing and treatment services and providing care and support services for those living with Hepatitis should be the focus of national responses to Hepatitis, particularly in high burden countries.

In 2014, HCV-related liver disease was reported to be the primary cause of death in the US. 2 It is also the leading cause of death in people co-infected with HIV. People living with HIV/HCV co-infection are at a greater risk for the progression of liver fibrosis but it is HCV, not HIV that is the cause of a significant number of deaths in co-infected people because while there are combination antiretroviral widely available to treat HIV, HCV testing and treatment remains out of reach for most who need it, even in high-income countries. PLHCV will continue to suffer without access to HCV prevention, testing, and treatment services unless immediate action is taken by policy-makers to address HCV. 1.2 HCV DISEASE PROGRESSION HCV infection may result in acute or chronic infection. Acute HCV infection is defined as the presence of HCV within six months of exposure. In 15–45% of individuals affected with acute infection the virus clears on its own 3 while the remaining proportion i.e. 55–85% 4 will carry HCV for the rest of their lives if not treated, and are considered to have chronic HCV infection. Those testing positive for anti-HCV antibodies must undergo a nucleic acid test (NAT) for HCV RNA to detect the presence of HCV in order to confirm chronic HCV infection. Chronic HCV infection can cause liver cirrhosis, hepatocellular carcinoma (HCC) and liver failure all of which are progressively fatal if affected people do not receive appropriate treatment.

HCV TREATMENT IS WITHIN REACH Fortunately, there now are highly effective, safe, well-tolerated and pan-genotypic treatments in the form of Direct-Acting Antivirals (DAAs) like sofosbuvir, ledipasvir and daclatasvir available in India which can cure most PLHCV. Results from clinical trials of daclatasvir and sofosbuvir demonstrate cure rates of up to 98% in Genotype 1 and 89% in Genotype 3, the two most common genotypes found in India, after 12 weeks of treatment. 5 This is a significant improvement from interferon-based therapies, which offer only 45-70% cure rates 6 besides having worse toxicity and side effects compared to DAAs. Sofosbuvir, a DAA with pan-genotypic properties, is now the backbone of HCV treatment across the world. In India, it is now available at less than half the price of interferon-based therapies. Sofosbuvir fixed-dose combination with Ledipasvir is also available in the market, as is Daclatasvir, another pangenotypic drug, the latest DAA to be approved in India. Sofosbuvir based regimens are likely to cure most PLHCV including the difficult to treat genotypes. With generic versions of these key DAAs being available in the market and the resultant competition, it is very likely that the prices of these medicines will decrease further in the medium to long term, presenting an opportunity to scale-up treatment services for PLHCV.

While Gilead has priced sofosbuvir exorbitantly in developed country markets, for example, in the United States, a three month course of treatment is priced at USD 84,000 (54,60,000 INR), generic versions are available in India at USD 306 i.e. INR 19,900 (approximately) making Indian prices 99% cheaper than the US price for sofosbuvir which is USD 84,000.7 Generic Sofosbuvir and Ledipasvir FDC is priced at around Rs. 25,000 for a month’s treatment while Daclatasvir is available at Rs. 46000 (approximately). Given that India is a leader in production and supply of generic medicines globally and that with more generic entrants into the market the prices are likely to reduce further, Indian generics could be well-placed to supply new DAAs to the developing and developed world at affordable prices. But voluntary licenses that Indian generics have signed with Gilead risk restrict licensees global sales to mostly low-income, low burden countries which might impact decisions of generic companies to supply to many of these countries. In addition, the high cost of diagnostics pose an additional barrier to initiating and scaling-up treatment services.

Soul of Healing with its subsidiary Sunny Pharma based in Bangalore provides for through its PAP generic medication that can treat Hep C. For more information please feel free to visit and contact us.