hepatitis C treatment with generics in India

Hepatitis C treatment in India for less than $1000

Hepatitis C Treatment Costs Less Than $1000

With Indian Generics, Full Hepatitis C Treatment Course Costs Less Than Just One Brand-Name Pill in the US. But Does It Work?

For the last three months the rumors about cheap generic drugs for hepatitis C treatment are spreading all over the net. The forums and blogs explode with the comments promoting Indian generics in all possible ways: we hear about Australian doctors shipping hepatitis C drugs from India and about the programs that you can enroll in to get the generics delivered to your door. Some blogs who had previously gained the reputation of proven HCV advocates suddenly get attacked by Gilead for the attempt of smuggling Ledisof from India, and all of a sudden there are more “online pharmacies” than the stars in the sky.

With all this controversial info, it is very difficult to know what to believe. Common sense tells us that a complete hepatitis C treatment course, even with generics, can’t cost under $1000 – especially when in the US the same drug comes at $1000 a pill. In this post we tried to compile the information about the Indian companies producing the generics. We also collected several myths about generic drugs and researched as much as possible about them, trying to unveil the truth.hepatitis C treatment with generics in India

Why would Gilead allow someone else to produce hepatitis C treatment for 1% of the price?

To respond to criticism from HCV advocates and numerous NGO’s about Gilead’s aggressive pricing strategy, the Big Pharma signed voluntarily license agreements with several generic manufacturers in India. An empathy for poor people of developing world or a smart strategic decision – whatever it was, this Big Pharma’s move had some serious consequences that we discussed here.

Who is producing generic hepatitis C treatment?

The licensing agreements signed in India allow generic manufacturers to make and sell copies of the expensive drug at lower prices. Among the most reputed drug-makers producing affordable generics for hepatitis C treatment are Mylan, Natco Pharma, Zydus and Hetero.

What’s all the fuss about?

According to WHO’s latest estimations, over 170 million people are diagnosed with hepatitis C worldwide. The total number of hep-C-positive people is even higher, because due to the discreet nature of the disease many patients are not diagnosed until a much later stage. Hepatitis C kills about 350,000 people a year.
The drugs in question, sofosbuvir (sold under a brand name Sovaldi®), and a combination of sofosbuvir and ledipasvir (brand name Harvoni ®) are the hepatitis C latest-generation direct-action antivirals, and are currently considered as the most effective therapy for hepatitis C. The steep price of the medication makes the branded formula virtually inaccessible to the majority of the patients.

Mylan: affordable generics and specialty pharmaceuticals manufacturer

Mylan, despite rumors, is not an Indian company, even if it holds a controlling interest in India-based pharmaceutical ingredients producer. Mylan N.V. is registered in the Netherlands and has the headquarters in the UK. Through its acquisitions (Matrix Laboratories Limited and Merck KGaS), Mylan became a second-largest generic and specialty pharmaceuticals company in the world.
For instance, in the US alone the company has five different locations. In India and China Mylan operates nine API and intermediate manufacturing facilities. Mylan name is well known in Europe, but only few know that Arcana Arzneimittel GmbH, Generics Pharma Hellas, Gerard Laboratories, Qualimed, Somerset Pharmaceuticals, Agila Specialties and Docpharma are actually Mylan companies as well.
With its numerous subsidiaries, over 30,000 employees, and a presence in 150 countries, Mylan has a global manufacturing output of more than 45 billion doses.

Among Mylan’s products for hepatitis C treatment are MyHep® (sofosbuvir 400 mg), MyHep-LVIR® (sofosbuvir 400 mg and ledipasvir 90 mg) and MyDacla® (daclatasvir 60 mg).

Hetero:  hepatitis C treatment, antivirals and cancer drugs

Hetero Drugs Limited is an Indian pharmaceutical company founded in 1993 in Hyderabad by Dr. B. Partha Saradhi Reddy Phd., a scientist and chemistry expert. Nowadays, with over 15,000 employees, revenues over a billion and the marketing presence in over 100 countries, Hetero Drugs is one of the major players of pharmaceutical industry. The company is famous for its presence on generledifos sofosbuvir ledipasvir generics for hepatitis Cic drugs market, but also for its antiviral and cancer drugs. Just yesterday, Hetero announced the launch of new colorectal cancer drug.
Hetero Drugs has also a strong presence in API market and its manufacturing plants have FDA and WHO approvals. It is also a parent company of Hetero group that includes Hetero Labs, Hetero Research Foundation, Symed Labs Limited, Cirex Laboratories, Genx Laboratories, Camber Pharma, and many others.

Hetero’s sofosbuvir is sold under a brand name Sofovir®. The company was also the first one in India to receive a DCGI approval to start the production of hepatitis C treatment for genotypes 1 and 4, distributed under the brand name Ledifos®.

 

 

Zydus Cadila: among top 10 U.S. generic companies

Cadila Healthcare is an innovative, global pharmaceutical company headquartered at Ahmedabad, in Western India. The company is the fifth largest pharmaceutical company in India and has nine nine pharmaceutical production facilities. Significant manufacturer of antivirals for hepatitis C treatment and generic drugs in general , Cadila also produces a wide range of diagnostics products, as well as herbal, skin care and other OTC products.
The U.S. division of Cadila Healthcare called Zydus Pharmaceuticals Inc. is located in Pennington, NJ. For the past 10 years annually Zydus was recognized as one of the fastest growing pharmaceutical companies in the U.S. The company is also in the top 10 U.S. generic companies by the total number of prescriptions dispensed.
Zydus Cadila manufactures over 50% of their active pharmaceutical ingredients (API), and even produces their own bottles. The company claims that this allows them to maintain the excellent supply record, in line with their focus on providing outstanding customer service and high-quality, affordable generics.

affordable generics hepatitis C India

SoviHep ®, a Zydus’s brand of sofosbuvir, is marketed by the the specialty division of the group, Zydus Heptiza.

Natco: the fastest growing pharmaceutical company?

Natco Pharma Limited was incorporated in Hyderabad, India, 35 years ago. Starting operations as a single unit with only 20 employees, today the company has over 3,200 employees spread between five manufacturing facilities. Constantly ranked among the fastest-growing pharmaceutical companies in India, Natco is also recognized for its innovation in Pharmaceutical R&D.

Starting from 2015, Natco produces a full range of products for hepatitis C treatment, including HEPCINAT® (sofosbuvir), HEPCINAT-LP® (sofosbuvir – ledipasvir) and NATDAC® (daclatasvir).

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Five most common hepatitis C questions

Five most common hepatitis C questions

Hepatitis C questions that you always wanted – but never dared – to ask

hepatitis C questions

Posing a hepatitis C question to a doctor is the best way to learn, but if it’s your friend or a family member who is suffering from hepatitis, you might not have an occasion to talk to a doctor. We figured out the answers to some hepatitis C questions for you, so that you won’t feel dumb or poorly informed if the conversation starts. (If you are reading this page, it probably means that hepatitis C is not an empty word for you – and THE conversation will start sooner or later).

Hepatitis C question #1: Is it contagious?

This is one of the most common hepatitis C questions.

Yes, it is contagious. But mostly only through blood.

HCV is transmitted primarily through large or repeated percutaneous exposures to infectious blood. Center for Disease Control and Prevention

In other words, you need to be exposed to contaminated blood through a cut in the skin in order to catch the virus. Such “exposure” includes:

  • Injection drug use (the most common way of transmission in the US today),
  • Needlestick injuries (in the labs or hospitals, for example),
  • Surgeries, dentist intervention, blood transfusions or organs transplants (mostly before 1992, when the routine screening was introduced in the US and majority of the developed countries).

Sometimes, much more infrequently, hepatitis C can also be transmitted by:

  • An HCV-infected mother giving birth to a child,
  • Sharing blood-contaminated personal items (razors, toothbrushes, nail clippers),
  • Having sex with HCV-infected person (especially men having sex with men, and especially in co-infection with HIV),
  • Other invasive procedures that were not done according to sanitary regulations (piercings, tattoos, injections in the context of hepatitis C outbreaks).

However, these later transmission ways are very inefficient means of transmission, meaning that the contamination chances are very low. The chances increase in case of repeated risky behavior – such as constant sharing the razor with infected person.

Hepatitis C virus can survive outside of human body (inside the syringe or on the razor, for instance) for several weeks!

Hepatitis C is much less contagious than hepatitis B; luckily, a vaccine exists for hepatitis B. Also, the risk of transmitting hepatitis C increases with the viral load – a number of copies of the virus in the infected person’s blood – especially when it comes to mother-child contamination during labor.

Hepatitis C question #2: Is there a hepatitis C vaccine?

This is another very common hepatitis C question. The answer is no, there is no vaccine against hepatitis C. The main problem is that the virus undergoes the transformations in the human body, so the human immune system doesn’t react to the virus straight away as it would with some other diseases. For the same reason, people who had hepatitis C and then were cured – either clearing the virus spontaneously or by following a hepatitis C treatment – are not immune and can catch the virus again if they are exposed to it.

Research into the development of a vaccine is ongoing, but nothing really promising yet.

It is highly recommended that people infected with hepatitis C get vaccinated against hepatitis B, because the harm caused to the liver from both simultaneous infections is increased.

Hepatitis C question #3: Can I give it to my family and friends?

Technically the answer is yes, but this does not happen very often. In the most cases when it happens it is through blood exposure with an infected friend or family member.

If you dispose of sanitary napkins correctly, cover the bleeding sores and don’t share razors, toothbrushes, nail clippers – or needles and syringes – with friends, it is highly unlikely that they get a virus from you.

Hepatitis C is not transmitted by sharing food and kitchen utensils, such as glasses and spoons. It is also not transmitted by hugging, kissing, sneezing, coughing or shaking hands.

If you discover that you have hepatitis C, it is not really necessary for all your family to get tested – unless there were some specific risks. However, if you think that you might have had hepatitis C while being pregnant, it is highly recommended that your child gets tested.

Hepatitis C question #4: What about my sexual partners?

Scientific studies show that even though sexual transmission is technically possible, the chances are very low. HCV transmission has not been demonstrated in heterosexual couples monitored over time, according to CDC. It means that condom use in stable monogamous relationship between a man and a woman is not required.

We talk about stable relationship, because to convey the study, the couple has to be monitored over the time – and therefore, there can only be scientific evidence for the stable couples. Again, we talk about monogamous relationship, because if either of the partners in the study had other partners, he or she could have caught the HCV from them – so again, carrying out the study and getting valid results would be impossible in this case.

Obviously, when it comes to spontaneous intercourse with a random partner, people infected with hepatitis C should protect their partners – and themselves, for this matter – from hepatitis C, hepatitis B, HIV and other diseases by wearing a condom. It is especially important to wear a condom when it comes to the intercourse between HCV-infected men, and especially if they are co-infected with HIV. The risk of sexual transmission for this case is much higher.

Hepatitis C question #5: What are the symptoms of HCV?

In many cases the chronic hepatitis C infection goes without symptoms, and this is why so often it remains unnoticed. Over the time the infection leads to mild to severe liver disease, including liver cirrhosis and cancer.

The lack of symptoms in the early stage of chronic disease is the reason why many people are identified as HCV-positive during routine blood test (when their liver enzyme levels such as ALT, AST are elevated) or during blood donation.

Nevertheless, chronic hepatitis infection is always preceded by the acute one, which in some cases is easier to spot. If a person is to develop hepatitis C symptoms, he or she will usually have them between 4 and 12 weeks following the exposure.

Bonus question: Who should be tested for HCV infection?

The testing is recommended for anyone who has increased risk of having hepatitis C. This includes:

  • People born before 1965,
  • People who received blood transfusions, organ transplants or clotting factor concentrates, especially before 90’s,
  • Injection drug users, even if they only used it once, and even if it was long time ago,
  • Patients who had long-term hemodialysis treatment,
  • People with known HCV exposure, such as nurses involved into needlestick incident while working with HCV-positive blood,
  • People who show the symptoms of liver disease, such as jaundice or abnormal liver enzymes test,
  • Children born to HCV-positive mothers.

In the latter case, to avoid a false positive test triggered by mother’s antibodies the child shouldn’t be tested until the age of 18 months.

Unlike hepatitis B, hepatitis C is less contagious and the transmission chance during the labor is low. Also, there are no vaccine and no preventive measures that could be taken to avoid this transmission. So, despite what is commonly believed – and this is another commonly asked hepatitis C question – routine HCV testing of pregnant women is not necessary (unless they are in one of the high-risk groups mentioned above).

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New treatment for hepatitis C from India

New treatment for hepatitis C from India

Generic sofosbuvir and ledipasvir – used in a combination as a new treatment for hepatitis C – will cost 1/90 of their US price

Despite its amazing efficiency, little side effects and short treatment course, the new direct-action antiviral, sofosbuvir (used together with ribavirin, daclatasvir or ledipasvir as a new treatment for hepatitis C), is only prescribed to a tiny fraction of patients. And no wonder! At $1,000 per pill, it is the drug that the majority of the developed world simply can’t afford.

Gilead, the owner of sofosbuvir patent in the US, has been widely criticized for its outrageous pricing strategy. In India, however, their approach is very different. In September 2014, Big Pharma signed voluntarily licensing agreements with seven Indian generic drug manufacturers. According to these agreements, generic version of sofosbuvir can now be produced for sale in India and 90 other developing and middle-income countries – with a much more modest price tag.

new treatment for hepatitis C produced in India

The licensees are free to set their own price. While Gilead planned to sell original Sovaldi™ in India for $900, generic manufacturers will probably sell it for even less. Even at this discounted price the drug still won’t be affordable to Indians, the critics say, pointing out that GDP per capita in India is only $1480.

India GDP and Sovaldi price
Based on Wikipedia data. Currency: Indian Rupees.

The manufacturing costs of 12-weeks sofosbuvir treatment are less than $150, according to expert estimation.

While the new hepatitis C drug remains too expensive for Americans in the US, for Europeans in Europe and for Indians in India, Indian generics will be perfectly affordable for Western population. Even keeping in mind the travel costs, hep C-related medical tourism in India is likely to flourish.

Some already propose innovative – and often daring – solutions to import new treatment for hepatitis C to their home country (read here).

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