Showing posts with label HCV generics. Show all posts
Showing posts with label HCV generics. Show all posts

Wednesday, May 23, 2018

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
May 23, 2018
Sydney Lupkin, Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

This article was reprinted from with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Wednesday, March 7, 2018

Generic Hepatitis C Drugs Begin to Emerge

Recommended Reading
J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]
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Secialty Pharmacy Times
Generic Hepatitis C Drugs Begin to Emerge
Laurie Toich
Associate Editor Publish Date: Wednesday, March 07, 2018
The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Tuesday, January 30, 2018

Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.

J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]

Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.
Gupta S1, Rout G1, Patel AH2, Mahanta M1, Kalra N1, Sahu P1, Sethia R1, Agarwal A1, Ranjan G1, Kedia S1, Acharya SK1, Nayak B1, Shalimar1.

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Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. 490 patients (mean age: 38.9±12.7years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases, and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n=372, 75.9%) followed by genotype 1 (n=97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%) respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n=175), daclatasvir alone (n=149), ribavirin and peginterferon (n=80), ledipasvir alone (n=43), daclatasvir and ribavirin (n=37), and ledipasvir and ribavirin (n=6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment-naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58) respectively, P=0.005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 weeks or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real life clinical scenario.

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Wednesday, November 29, 2017

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt

Alimentary Pharmacology and Therapeutics - November 29, 2017

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt
H. Omar, W. El Akel, T. Elbaz, M. El Kassas, K. Elsaeed, H. El Shazly, M. Said, M. Yousif, A. A. Gomaa, A. Nasr, M. AbdAllah, M. Korany, S. A. Ismail, M. K. Shaker, W. Doss, G. Esmat, I. Waked, Y. El Shazly

Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

Tuesday, October 31, 2017

MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag

MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag
Report from Médecins Sans Frontières

Tuesday, October 31, 2017 — Dramatic price drops should allow countries to provide treatment for millions of people

Reading Material: Not Even Close: This issue brief provides information on currently available HCV diagnostics and treatments, including pricing and registration information from manufacturers of DAAs

Geneva/Sao Paolo, 31 October 2017—On the eve of the World Hepatitis Summit in Sao Paolo, the international medical humanitarian organization Médecins Sans Frontières (MSF) today announced that it had secured deals for generic hepatitis C medicines for as low as US$1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir.

In the US, pharmaceutical corporation Gilead launched sofosbuvir at $1,000 per pill in 2013, and Bristol-Myers Squibb (BMS) launched daclatasvir at $750 per pill in 2015, leading to the original price tag of $147,000 for a person’s 12-week combination treatment course. The corporations have also been charging exorbitant prices in many developing countries, paralyzing the launch of national treatment programs and causing treatment rationing in many countries around the world.

“What good is a breakthrough medicine that people cannot afford?” asked Jessica Burry, Pharmacist for MSF’s Access Campaign. “Pharmaceutical corporations price hepatitis C medicines far out of reach for people paying out of pocket around the world, and also for many governments struggling to provide treatment in the public sectors; but the prices for generic versions keep coming down. Governments must use every tool in their toolbox to fight for access to lower-priced generics so they can scale up treatment for the millions of people who need it; they should follow the lead of countries like Malaysia and issue compulsory licenses when patents block people’s access to this life-saving treatment.”

In 2015, MSF started procuring sofosbuvir and daclatasvir from Gilead and BMS through their ‘access programs’ at a price of $1,400 to $1,800 per 12-week treatment. Today, MSF pays a fraction of that, at $120, sourced from quality-assured generic manufacturers.

An estimated 71 million people have chronic hepatitis C infection worldwide, 72 per cent of whom live in low- and middle-income countries. Direct-acting antiviral medicines (DAAs) represent a treatment breakthrough for people with hepatitis C, with cure rates of up to 95%, and with far fewer side effects than previous treatments. Yet access to DAAs has remained limited because pharmaceutical corporations charge unaffordable prices, leading many countries to reserve treatment only for people with the most advanced stages of the disease. By the end of 2016, three years after sofosbuvir was launched, only an estimated 2.1 million people globally had been treated with the medicines, leaving 69 million people still without access.

These high prices have also put a major strain on health systems in wealthy countries, in particular those enacting universal health care. Treatment is being rationed in countries such as Australia, Canada, Italy and the US, in addition to developing countries, and is a stark reminder of the early days of HIV treatment.

“Almost two decades ago, MSF and others worked hard to get access to generics and bring down prices for HIV medicines,” said Mickael Le Paih of MSF in Cambodia, where MSF treats people living with hepatitis C. “History is repeating itself with hepatitis C—the medicines we need are again too expensive, but we are finding ways to make treatment affordable so that our patients can be cured.”

MSF treats people with hepatitis C in 11 countries. Since 2015, MSF has provided DAA treatment to nearly 5,000 people with hepatitis C. Of those who have completed treatment to date, the overall cure rate – measured by ‘sustained viral response’ – is 94.9 per cent.

Reading Material: Not Even Close: This issue brief provides information on currently available HCV diagnostics and treatments, including pricing and registration information from manufacturers of DAAs

Sunday, October 22, 2017

The Liver Meeting® - HCV direct acting antivirals: Generics shown to be bioequivalent to originator brands

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Follow "Henry E. Chang" on Twitter to review clinical research and updates from The Liver Meeting® 2017; online via an easy to view sharing platform.

Of Interest - Forging a Path to HCV Elimination

Bioequivalent pharmacokinetics for generic and originator HCV direct acting antivirals
Andrew M. Hill1, Loai Tahat2, Mohammed Khalil Mohammed3, Sanjay Nath4, Rabab Fayez Tayyem3, James A. Freeman5, Ismahane Benbitour7, Sherine Helmy


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The Liver Meeting® 2017

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Saturday, October 14, 2017

NPR-Ed Silverman, Dr. William Carey Discuss: New Pan-genotypic HCV Drugs: Cost & Cure

Wellness Wednesday: Hepatitis C, Plastic Surgery Safety

Oct 11, 2017
Program available online at WOSU Radio, hosted by Ann Fisher.

In case you missed it, last week on the morning edition of NPR News, Ed Silverman, senior writer and Pharmalot columnist, STAT News, and Dr. William Carey, senior hepatologist in the Department of Gastroenterology, Cleveland Clinic, sat down to discuss cost and cure rates of the newly approved drugs used to treat all HCV genotypes.

Estimated 180,000 people with HCV go untreated
Gilead, AbbVie and Merck - Cost, price competition, treatment duration, and HCV cure rates
Disease progression
HCV Generics

The interview is about 15 minutes long, starting point is at 15.35, or fifteen minutes into the program.

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Of Interest - On This Blog
Hepatitis C Timeline
First recorded references to hepatitis epidemics, to the 1989 discovery of the hepatitis C virus, as well as HCV discontinued agents, ending with the FDA approved treatments used today.

Saturday, October 7, 2017

High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C

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The following full-text article is available in PDF, shared on Twitter by @HenryEChang

Journal of Virus Eradication 
High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C
Andrew Hill, Giten Khwairakpam, James Wang, Sergey Golovin, Julia Dragunova, Rachel Smith, Vicky Houghton-Price, Roxanna Korologou-Linden, Sanjay Nath, Anna Savage, Greg Jefferys

Background: High prices of direct acting antivirals (DAAs) for hepatitis C virus (HCV) can lead to restrictions on access to treatment in high- and middle-income countries. An increasing number of people in these regions are treating their HCV infection with generic drugs produced in India, China, Bangladesh or Egypt. This analysis assessed the efficacy of generic imported DAAs. Methods: Patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via three buyers’ clubs. The choice of DAAs and the length of treatment were determined on baseline RNA levels, HCV genotype and stage of fibrosis. Patient HCV RNA levels were evaluated pre-treatment, during treatment, at end of treatment (EOT) and then for sustained virological response (SVR) at 4, 12, and 24 weeks, normally by a treating clinician. Results: Overall 616 patients submitted results: 199 from an Australian buyers’ club, 205 from a South-east Asian buyers’ clubs, and 212 from an Eastern European buyers’ club. Of the 616 patients treated, 276 received SOF/LDV (35 with ribavirin [RBV]) and 340 received SOF/DCV (61 with RBV). At baseline, 61% were male, 52 % had HCV genotype 1 and 11% had liver cirrhosis. The mean age was 44.3 years and the mean baseline HCV RNA was 6.9 log10 IU/mL. A rapid virological response (RVR) was observed in 314/375 (84%) of the patients treated. Based on currently available data, the percentage of patients with HCV RNA below the lower limit of quantification (LLoQ) was 99% (234/237) at EOT, 99% (299/303) at SVR4 and 99% (247/250) at SVR12. Conclusions: In this analysis, treatment with imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment, and SVR12 in 99% of patients evaluated to date. Mass treatment with generic DAAs is a feasible and economical alternative route of accessing curative DAAs, where the high prices for branded alternatives prevent access to treatment.

Journal of Virus Eradication
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On This Blog
The controversy over expensive new drugs for hepatitis C
Link to current research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Friday, September 22, 2017

TAG Applauds Malaysian Government's Decision to Make Generic form of Life-Saving Hep C Cure

TAG Applauds Malaysian Government's Decision to Make Generic form of Life-Saving Hep C Cure
September 20, 2017, New York, NY—The Government of Malaysia reaffirmed its commitment to affordable access to hepatitis C treatment by issuing a compulsory license on sofosbuvir (Sovaldi). TAG lauds this landmark decision for enabling the entry of generic competition, which will effectively reduce prices.

Malaysian civil society organizations, including Third World Network, Malaysian AIDS Council, and Positive Malaysian Treatment Access and Advocacy Group, have tirelessly pushed for expanded access to direct-acting antivirals (DAAs) in the public health sector. Last month, Gilead announced Malaysia’s inclusion in a voluntary license (along with Belarus, Thailand, and Ukraine) to permit generic DAA imports from India. Civil society groups urged the government to move ahead with issuing a compulsory license to guarantee high quality generics from an Egyptian manufacturer, which did not fall under the voluntary license.

Compulsory licenses allow a generic company or government institution to manufacture a patented medicine for the “supply of the domestic market” without the consent of the patent holder. However, using these policy flexibilities, enshrined in the global TRIPS Agreement, comes at a risk. Countries, particularly in the global South, may face political pressure or trade repercussions from governments and companies for employing these policy tools. Malaysia’s compulsory license prevents a monopoly control on sofosbuvir, while also paying a royalty to remunerate Gilead. This move helps to reconcile an imbalance between the intellectual property system and protecting public health.

Around half a million people are living with HCV in Malaysia yet DAAs have been priced well out of reach for most patients—a 12-week course of treatment costs up to US$12,000 [MYR 50,000], or nearly half the average annual household income. Healthcare costs and medical bills amount to 35% of Malaysians’ income.

“There’s no justification for Gilead’s exorbitant pricing in a middle-income country like Malaysia: Sofosbuvir can be produced for less than US$100 per average treatment course at volume. Once again, Gilead treats this essential medicine as a luxury good, squeezing maximum revenue from the few who can afford it rather than pricing for universal access,” said Annette Gaudino of Treatment Action Group.

“Patients around the world can no longer be held hostage at Big Pharma’s drug prices. Malaysia has set an example for other countries to fully use policy flexibilities, such as compulsory licenses, when companies like Gilead obstruct expedient delivery of affordable life-saving medicines,” said Bryn Gay of Treatment Action Group. “This decision reinforces people’s fundamental rights to health, the benefits of scientific progress, and access to medicines.”

People living with HCV will now have more treatment options. Sofosbuvir is one of the most widely prescribed DAAs worldwide, and is over 90% effective in curing chronic HCV infection across all genotypes when combined with other antiviral medications. Clinical trials are underway in Malaysia—a collaborative partnership between the Ministry of Health, Drugs for Neglected Diseases initiative, and Pharco Pharmaceuticals—to investigate the potentially new pangenotypic combination, sofosbuvir and ravidasvir.

Thursday, July 27, 2017

Hepatitis drugs more affordable but disease still deadly: WHO

Hepatitis drugs more affordable but disease still deadly: WHO
GENEVA (Reuters) - Prices of drugs to cure hepatitis C and to treat hepatitis B are dropping dramatically, offering affordability and hope to 325 million people living with the viral liver disease that can be fatal, the World Health Organisation (WHO) said on Thursday. A generic antiviral drug for hepatitis C, which can be cured in three months, was placed this week on WHO's list of pre-qualified medicines.
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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Wednesday, July 26, 2017

Hepatitis C - Mylan Receives WHO Prequalification for Generic Sovaldi®

Mylan Receives WHO Prequalification for Generic Sovaldi®

First Generic Prequalification for Sofosbuvir Tablets

HERTFORDSHIRE, England and PITTSBURGH, July 26, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) of its application for Sofosbuvir Tablets, 400 mg, a generic version of Gilead Sciences' Sovaldi®. Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.

Mylan's Sofosbuvir Tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program. With WHO PQ approval, international donors and purchasers, such as UNITAID and U.N. agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy.

"This marks another important step in Mylan's leadership to help fight infectious diseases around the world," commented Mylan President Rajiv Malik. "It also furthers our mission of increasing access to high quality, affordable medicines to patients, healthcare practitioners, governments and other stakeholders to help treat hepatitis C."

Worldwide, there are more than 70 million people living with chronic hepatitis C, which results in nearly 400,000 related deaths every year. (1) The WHO estimates that antiviral medication can cure more than 95% of chronic hepatitis C cases. (2)

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at

(1, 2)

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Friday, July 21, 2017

WHO prequalifies first generic hepatitis C medicine and first HIV self-test

In the lead-up to Paris AIDS conference, WHO prequalifies first generic hepatitis C medicine and first HIV self-test

Hepatitis C

WHO today prequalified the first generic version of sofosbuvir, a critical medicine for the treatment of hepatitis C. The development could expand access to treatment by increasing the number of quality-assured generic medicines on the market. Sofosbuvir, 400 mg tablet, is manufactured by Mylan Laboratories Ltd., India.

“This is a break-through medicine with a 95% cure,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products at WHO. “The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.”

WHO prequalification means the product can now be procured by the United Nations and financing agencies such as UNITAID, which has recently introduced hepatitis C in the portfolio of diseases it covers. Countries such as Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Kenya, Zambia, Ethiopia, Pakistan and Egypt are already procuring generic versions of sofosbuvir. The fact that WHO has prequalified one of those generics will give them extra guarantee of the product’s quality, safety and efficacy.

“Direct acting antiviral medicines such as sofosbuvir are highly effective for treating and curing chronic hepatitis C infection. But, at best, 1 out of 10 people in need had access to these medicines in 2015,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Prequalification of the hepatitis C medicine for the first-time is therefore exciting news, ahead of World Hepatitis Day next week.”

The average price of the required three-month treatment course of Mylan’s sofosbuvir is around US$ 260, a small fraction of the medicine’s market entry price in late 2013, and of the price set in the majority of high-income countries. The medicine remains highly expensive in many countries, but licensing agreements between Gilead Sciences, who developed sofosbuvir, and a number of generic manufacturers have made it possible for low-income and some middle-income countries to provide the medicine at more affordable prices.

HIV self-test
WHO today prequalified the first HIV self-test in a move to increase HIV diagnosis and treatment. The product, OraQuick ® HIV Self-Test (manufactured by OraSure Technologies Inc.) uses oral fluid as a specimen and provides results in as little as twenty minutes.

“The prequalification of this product means that countries with poor laboratory infrastructure will be able to safely increase testing capacity, thereby facilitating treatment of people living with HIV,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products, WHO.

The move also marks a significant step in allowing countries to implement WHO guidelines, released in 2016, recommending HIV self-testing as a complementary approach to reach those who remain undiagnosed due to fear of stigma and discrimination.

“Over the past year, the number of countries incorporating HIV self-testing into their policies has increased from 16 to 40. This is impressive progress,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Having quality-assured self-tests is essential to enable countries to implement more rapidly. It is a positive step towards making innovative HIV self-testing accessible to all those who would benefit from it.”

In 2016, an estimated 30% of all people living with HIV remained unaware of their HIV status, many from higher risk populations who are either less likely to approach a health facility or are unable to do so.

“As the first HIV self-testing product to obtain WHO prequalification, this is a major step that will help give governments the confidence they need to adopt and scale up use of self-testing,” said Philippe Duneton, Deputy Executive Director of Unitaid.

There is currently great interest from the international community in deploying tests intended for HIV self-testing, with numerous countries having developed national guidelines and plans for implementation. Support for procurement and deployment of these tests has been pledged by most major international financing and procurement agencies, including a specific agreement on affordable pricing for 50 lower-middle income countries in Africa and Asia between the manufacturer and the Bill and Melinda Gates Foundation, a funder of WHO Prequalification.

Thursday, July 20, 2017

Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Saudi J Gastroenterol [serial online] 2017 [cited 2017 Jul 20];23:263-4. Available from:

Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Said A Al-Busafi1, Heba Omar2

It is with great interest that we read the Saudi Association for the Study of Liver diseases and Transplantation (SASLT) position statement [1] and guidelines [2] on direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV) infection. The position statement and the guidelines, which were clearly influenced by the limited availability of highly priced DAAs, recommend that HCV treatment should be prioritized to patients at higher risk for developing HCV-related complications.

The introduction of the curative DAAs to the global market caused worldwide celebration because it is expected to save millions of lives and control if not eliminate one of the major infectious disease worldwide.[3] Unfortunately, for the majority of HCV patients, these costly medications are not readily available, accessible, or affordable even for those in the developed countries.[3] This is likely going to affect many countries in their ability to minimize the burden of this disease.[4]

On the other hand, generic DAAs (sofosbuvir, ledipasvir, and daclatasvir) are being produced in India and other countries with permission of the concerned pharmaceutical agencies and priced less than 1% of their current actual price in USA and Europe. The evidence for the clinical safety and efficacy of these generics is compelling including the recent interim results from international REDEMPTION trial presented by Freeman et al.[5] The results of this trial, which was supported by the European Association for the Study of the Liver (EASL), are important in indicating that generic DAAs are highly effective and safe comparable to those reported in clinical trials of branded DAAs. Another abstract presented by Hill et al. at the same meeting showed that the active pharmaceutical ingredient for the combination of sofosbuvir and daclatasvir was approximately $200 for 12 weeks' course of treatment per patient.[6]

Oman, with an estimated HCV prevalence of 1%, is one such country where access to those important agents is also limited.[7] This has led many of our patients to self-import these drugs from India giving them hope instead of waiting for years to be treated from this debilitating disease.

At the Sultan Qaboos University Hospital, using the EASL 2016 guidelines,[8] we have treated 58 HCV patients [28% genotype 3, 26% cirrhotic with 40% of them decompensated, and 3% severe chronic kidney disease (CKD)] with generic DAAs including (sofosbuvir, ledipasvir, and daclatasvir). Sustained virological response was achieved in 57 patients (98%), the remaining one patient with severe CKD discontinued treatment due to worsening renal function. All patients with decompensated cirrhosis were delisted from transplantation.

Therefore, healthcare leaders and policy makers at the national and international level should adopt strategies to ensure that these DAAs are made available and are accessible and affordable for all in need.
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Alghamdi AS, Alqutub A, Abaalkhail F, Sanai FM, Alghamdi H, Altraif I, et al. SASLT position statement on the direct-acting antiviral agents for the treatment of hepatitis C virus infection. Saudi J Gastroenterol 2015;21:60-3.
[PUBMED]  [Full text]  
Alghamdi AS, Alghamdi M, Sanai FM, Alghamdi H, Aba-Alkhail F, Alswat K, et al. SASLT Guidelines: Update in Treatment of Hepatitis C Virus Infection. Saudi J Gastroenterol 2016;22(Suppl 2):S25-S57.
Freeman JA, Hill A. The use of generic medications for hepatitis C. Liver Int 2016;36:929-32.
Edwards DJ, Coppens DG, Prasad TL, Rook LA, Iyer JK. Access to hepatitis C medicine. Bull World Health Organ 2015;93:799-805.
Freeman J, Sallie R, Kennedy A, Hieu PT, Jeffreys G, Hill AM. High sustained virological response rates using generic Direct Acting Antiviral treatment for Hepatitis C, imported into Australia. J Hepatol 2016;2:S209.
Hill A, Gotham D, Fortunak J. Significant Reductions in Costs of Generic Production of Sofosbuvir and Daclatasvir for Hepatitis C Treatment in Low- and Middle-Income Countries. J Hepatol 2016;2:S209.
Alnaqdy A, Alfahdi A, Alkobaisi M, Kaminski GZ. Prevalence of autoantibodies in patients with hepatitis C virus infection in Oman. Ann Saudi Med 2003;23:127-31.
European Association of the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol 2017;66:153-94.  

Sunday, May 28, 2017

It Takes A Village - Hepatitis C in Cambodia & Generic DAAs In India

 It Takes A Village - Hepatitis C in Cambodia & Generic DAAs In India
The good news? New hepatitis C drugs have an average of over a 90% cure rate. The bad news? Unfortunately treatment is not available to everyone.

The Bad And Better News
In the United States cost and restrictions to HCV therapy remain a barrier, according to a national review of Medicaid restrictions for HCV medications, access to treatment has improved since 2014, but still is restricted in many Medicaid programs, read the full report published over at Healio. Globally, access is improving, however in 2015 only a small number of patients undergoing HCV treatment received newer drugs; "While the cumulative number of persons treated for HCV reached 5.5 million in 2015, only about half a million of these persons had received the newer, more effective and better tolerated class of drugs called direct-acting antivirals (DAAs). There were more new HCV infections than patients who were started on treatment in 2015." according to WHO's Global hepatitis report, 2017. In other news, March of this year WHO prequalified the generic active pharmaceutical ingredient of sofosbuvir.

Of Interest
May 29
Importance of Getting Tested for Hepatitis C
Source - Health Professional Radio
Segment overview: Dr. Douglas Dietrich and former Hepatitis C patient, Bob Rice, discuss the importance of getting tested for Hepatitis C.  

Guests: Dr. Douglas Dieterich and Bob Rice
Presenter: Neal Howard
Guest Bio: Dr. Douglas Dieterich is currently Professor of Medicine in the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai and also Director of The Institute for Liver Medicine at Mount Sinai Health System , New York, NY. Dr. Dieterich graduated from Yale University in New Haven, CT and received his Doctorate of Medicine from New York University of Medicine in NY.  He became Clinical Assistant Professor of medicine and then a Clinical Professor of Medicine, both at the New York University.  He remains as an Adjunct Clinical Professor of Medicine at New York University School of Medicine.

Bob Rice is a former hepatitis C patient who, after undergoing multiple rounds of treatment and a liver transplant, has been cured of his disease. He also works as a HepC/HIV educator at Hope House in Boston, MA.

It Takes A Village
Across the globe dedicated men and women make a huge impact in the lives of people battling HCV. Today we hear from just a small handful of these people, bloggers, who take us along on their inspirational journey helping patients access life saving treatment and care.

Theresa Chan, is a physician treating hepatitis C patients at MSF's clinic in Cambodia and Greg Jefferys, a well known advocate travels to India bringing awareness to affordable generic versions of hepatitis C direct acting antivirals. 

Theresa Chan

Médecins Sans Frontières/ Doctors Without Borders (MSF)
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation. We offer assistance to people based on need, irrespective of race, religion, gender or political affiliation. Our actions are guided by medical ethics and the principles of neutrality and impartiality.

Blog Updates
May 23
Theresa Chan
Hepatitis can be caused by different viruses. But what happens when a patient is infected with more than one? Theresa blogs from Cambodia...

May 18
Theresa Chan
Fighting Hepatitis in Cambodia: The Rock and the Hard Place
Midway through my first week in the hepatitis C clinic, a patient was urgently triaged for an MD evaluation. He arrived on foot, but only with the support of his son and his daughter.
There was an unfocused quality to his gaze and the whites of his eyes were yellow.
“How long has he been sick?” I asked his daughter, because he couldn’t answer me himself. He just blinked at me and nodded, with his eyes averted as if he were listening intently to his own, opaque thoughts....

May 25
Hepatitis C in Cambodia
Doctors Without Borders / MSF-USA
"The majority of our patients are pretty poor, so this is a hardship for them to have to come all the way to Phnom Pehn to get treated for hepatitis C, but they are doing it," said Dr. Theresa Chan. Doctors Without Borders/Médecins Sans Frontières (MSF) has been delivering treatment to patients with hepatitis C in Phnom Penh since October 2016. Due to the overwhelming needs, and this being the only free screening and treatment available in the city, MSF has been prioritizing those with the greatest risk of developing severe and fatal forms of the disease. Many more people need these drugs, and the exorbitant price charged for them must be addressed.

Recommended Reading
Blogs, photos and stories from the front line of MSF's emergency medical work

Greg Jefferys

Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

May 23

In The News - Greg Jefferys
What started as “medical tourism” to India turned into a social mission for him as he became the go-to person for patients who wanted cheaper Hep C drugs. Before he knew it, Jefferys had created a buyers club, helping patients buy generic versions of Sofosbuvir. In his personal blog, Jefferys documents the entire process of accessing the generic version to generating a prescription from doctors, to reaching out to a trusted supplier in India to buy the drugs in great detail...

Blog Updates
May 15
The Shoot
By Greg Jefferys
The primary purpose of my visit to India this year was twofold, to meet up with my associates here and to attempt to increase global awareness of Indian generic DAAs as a viable and affordable treatment option for people around the world who are infected with Hepatitis C.

This morning, before I went out wandering in the Chor Bazaar I had a meeting with a journalist from the Economic Times of India, a national Indian newspaper.

This journalist’s specialty is pharmaceuticals and we discussed why it is that, even though Indian and Bangladesh generic treatments for Hep C are readily available, effective and (relatively) cheap, so few people with Hep C in the West know this and so few medical professionals make their patients aware of this option.

By Greg Jefferys
Today I am flying from Singapore to Mumbai on my second trip to India in two years. But it is a very different journey to the one I undertook in April 2015. This time I am not a sick and desperate man travelling to India infected with Hepatitis C to try to buy generic Sovaldi, which was my only hope for survival.

This time I am cured of Hep C and am flying to India as part of a team effort to try to increase global awareness of the effectiveness and affordability of Indian generics for the treatment of Hepatitis C.
Part One -  India: Day One
Part Two - India: Day Two

Related Articles On This Blog
HCV generics

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums

Friday, May 26, 2017

Push for generic drugs in India

Push for generic drugs in India
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control....

While the Indian government is strongly backing generic drugs, a report from an international research team has found that the use of the generic versions of direct-acting antiviral (DAA) drugs that are available in India to treat hepatitis C virus (HCV) infection are not only cost effective, but actually save lifetime costs for treating infected patients in India....

The report states that the upfront costs of DAA are offset by the avoidance of costs incurred to treat late-stage disease....
Continue reading....

Related Articles On This Blog
HCV generics

Wednesday, May 24, 2017

Indonesian buyers club helps people obtain generic hepatitis C treatment

Indonesian buyers club helps people obtain generic hepatitis C treatment

Liz Highleyman
Published: 24 May 2017
A community-led buyers club in Indonesia has helped more than 100 people get generic direct-acting antiviral (DAA) drugs to treat hepatitis C and is seeing a high cure rate, according to a presentation at the 25th International Harm Reduction Conference (HR17) last week in Montréal.

An estimated 3 million people in Indonesia are living with hepatitis C virus (HCV), according to Sindi Putri of the Indonesia AIDS Coalition (IAC). The number of people who inject drugs is estimated at nearly 106,000, of whom 77% are thought to have hepatitis C. Co-infection with HIV and HCV is common in this population.
Continue Reading

NAM aidsmap
Conference news: HR17
The 25th International Harm Reduction Conference (HR17) was held in Montréal, Canada from 14-17 May.

Related Articles On This Blog
HCV generics

Indian generic version of Sofosbuvir - China captures 12 smugglers

China captures 12 smugglers of Indian pharmaceuticals
Source: Xinhua| 2017-05-24 18:48:38|Editor: ying
CHANGCHUN, May 24 (Xinhua) -- Chinese police have detained 12 people for smuggling and selling Indian-made treatments for hepatitis C and cancer, authorities said Wednesday.

Customs in Changchun, the capital city of China's Jilin Province, obtained information in November 2016 that five online stores may have smuggled Indian-made medications and sold them in China at a high price, according to Xu Zhaosha of Changchun customs
Continue reading....

Of Interest
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Tuesday, May 23, 2017

Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with HCV genotype 1b

In the Journals
Generic ledipasvir-sofosbuvir achieved SVR12 in HCV genotype 1b

May 23, 2017
Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with hepatitis C genotype 1b, according to a recently published study.

“Genotype 1 is the most common in China, as it accounts for 58.4% of all HCV-infected persons, principally genotype 1b,” the researchers wrote. “As an eliminator of HCV and a leader of direct-acting antiviral agents (DAAs), sofosbuvir has revolutionized the treatment of [chronic hepatitis C] since 2013. However, brand name DAAs are unaffordable. Fortunately, Gilead Sciences ... approved generic ledipasvir-sofosbuvir with a very low price in many neighboring countries of China, and patients can go to these countries to purchase the drug and for treatment.”
Continue reading....

Of Interest
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Monday, May 22, 2017

Gilead warns against Hep C drugs from buyers clubs, says patients may be at risk

Gilead warns against Hep C drugs from buyers clubs, says patients may be at risk
Vikas Dandekar
California-headquartered Gilead Sciences has warned against the use of generic versions of its blockbuster Hepatitis C drugs procured by patients directly through “buyers clubs.” A disruptive phenomenon, dozens of buyers clubs have mushroomed in recent years that enable supply of generic lifesaving medicines to thousands of patients afflicted with the fatal liver ailment....

In its latest May 9 regulatory filings in Form 10K at the US Securities Exchange Commission, Gilead said it is aware of the existence of various “buyers clubs” around the world, adding that through personal importation of such medicines, patients may be at risk of taking unapproved medications which may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances....

James Freeman, Founder at FixHepC, a buyers club based in Australia, countered the claims made by Gilead about the safety issues. Freeman agreed that supply chain integrity is vital in ensuring patients received correct medicines....
Continue reading...

May 22, 2017 03:56 PM IST | Source:

Of Interest - Updated
May 23 2017 : The Economic Times (Bangalore)
Two Aussies Cheerlead for Indian Hep C Generic Drugs
Divya Rajagopal
Mumbai:  INDIAN BUYERS CLUB A survivor and a doctor provide patients affordable alternatives of newly discovered drugs with high cure rates
Remember Ron the rodeo cowboy from the Oscar-winning film Dallas Buyers Club?
The biopic portrayed the story of Ron Woodroof, an AIDS patient in the mid-1980s who signed up for an experimental AIDS treatment movement. He smuggled unapproved drugs into Texas for treating his symptoms and distributed them to fellow patients at a time when the disease was highly stigmatised. There's now an Australian parallel, of sorts, with an Indian twist.

Australian Greg Jefferys, 62, is the unlikely protagonist of this story . Himself a Hepatitis C survivor, Jefferys has become a Ron for several who suffer from the potentially fatal viral infection. And just like Ron, who didn't back off in the face of resistance from US regulators, Jefferys' crusade has been equally relentless.
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Wednesday, May 17, 2017

Costs for generic hepatitis C drugs available in India would be paid back in 5 to 10 years

Published: May 17, 2017

Full Text Article
Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India
Treatment with generic DAAs available in India will improve patient outcomes, provide a good value for money within 2 years, and be ultimately cost-saving. Therefore, in this and similar settings, HCV treatment should be a priority from a public health as well an economic perspective.

Media Coverage Of This Article:

Costs for generic hepatitis C drugs available in India would be paid back in 5 to 10 years
May 17, 2017
Use of the generic versions of directly-acting antiviral (DAA) drugs that are available in India to treat hepatitis C virus (HCV) infection is not only cost effective but actually saves lifetime costs for treating infected patients in that country. A report from an international research team appears in the open-access journal PLOS ONE and describes finding that the upfront costs of DAA are offset by the avoidance of costs incurred to treat late-stage disease.

"More than 9 million people are infected with HCV in India, and more than 70 million worldwide," says Jagpreet Chhatwal, PhD, of the Institute for Technology Assessment at Massachusetts General Hospital (MGH), senior and corresponding author of the paper. "These persons are at risk of developing serious conditions such as cirrhosis and liver cancer, which can be fatal. However, only a fraction of them have been treated with these drugs so far."

First introduced in 2011, DAAs such as sofosbuvir (Sovaldi) and ledipasvir (which is combined with sofosbuvir in Harvoni) have proven to be remarkably successful in the battle against HCV infection, with cure rates exceeding 95 percent. In developed countries, treatment with DAAs is very expensive—reaching nearly $65,000 in the U.S.—although it meets standards for cost effectiveness. In those countries the advent of these drugs has drastically changed the landscape of HCV infection. But other countries have lagged behind in their use.

Through agreements with the pharmaceutical companies that developed these drugs, generic drug manufacturers in India are now able to produce versions that cost as little as $300 for the entire duration of treatment. But the absence of data on the cost effectiveness of these drugs in that country and low budgets for HCV treatment have meant that only a small proportion of people needing these drugs have received them.

The research team—including investigators from Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow, India, and the World Health Organization - used a mathematical model to compare the outcomes of DAA treatment with those of no DAA treatment based on profiles of 30 hypothetical patients with characteristics typical of Indian patients with HCV infection. Factors incorporated into the model included the natural history of HCV disease, the costs of DAA administration, the costs of treating the adverse outcomes of HCV disease, and quality of life of individuals infected with HCV.

The model indicated that, compared with no DAA treatment, use of the generic drugs in HCV-infected Indian patients would increase life expectancy by more than eight years while reducing lifetime health care costs by more than $1,300 per person. Payback for the upfront costs of DAA drugs would be achieved in an overall average of less than 10 years - under 5 years for patients at advanced stages of HCV disease and almost 12 years if treatment begins at earlier stages. Even though there was wide variation in the factors—such as patient age, disease stage, and viral genotype - input to the model, results always indicated that generic DAA treatment reduced lifetime costs.

"Our hypothesis was that treatment would be cost saving, given the low drug costs in India. However, we were pleasantly surprised to find that the full payback was achieved so soon after treatment," says Chhatwal, who is an assistant professor of Radiology at Harvard Medical School. "Our finding that treatment pays back its initial costs makes a very strong statement - that investment in HCV screening and treatment should be a priority for public health agencies in India and other countries where generic DAAs are available. It could also be argued that generic DAAs should be made available in other low- and middle-income countries where HCV infection is common and budgets for treatment limited."

Lead author Rakesh Aggarwal, MD, DM, of the Department of Gastroenterology at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), a WHO Collaborating Center on Viral Hepatitis, says, "This is a win-win situation for the low- and low-middle-income countries where the generic DAAs can be sold. If these countries spend money on HCV treatment today, they will recoup it in the form of reduced health care expenditure within less than one decade. There is hardly any other health care intervention with such good return. Our results should show political leaders in those countries that they have a wonderful opportunity to make a difference for their constituents."

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