Those at risk urged to get screened for Hepatitis C

  • Saturday, 28 Jul 2018

KUALA LUMPUR: Asnah Hamdan suspected something was wrong when she had bruises all over her body during a blood transfusion following the loss of her second child more than 35 years ago.

The 66-year-old former Malaysian Railways employee from Perak said during a routine medical check 10 years later, her doctor casually said: “Asnah, your blood has something.”

But he did not suggest any follow-up.

Asnah said she never had any symptoms. “I didn’t feel sick at all.”

While she was not afraid when informed, her husband of over 50 years had a hard time accepting her diagnosis because his late cousin only knew of her Hepatitis C status towards the end of her life.

But Asnah reassured her husband that the doctors would keep a watchful eye on her and that he need not worry.

“He wants to know why I’ve not been given any medication. It gives him great pain,” she said.

A person may be infected with Hepatitis C for 20 to 30 years before developing symptoms. Left untreated, it can cause liver cirrhosis or liver cancer. Today, there is a cure for Hepatitis C with only three months of treatment.

Dr Muhammad Radzi Abu Hassan, a consultant physician and gastroenterologist at Hospital Sultanah Bahiyah in Alor Setar, urged those at risk, especially people who injected drugs and shared needles and those who had blood transfusions before 1990, to get tested.

“You can get cured,” he assured.

The good news is, Asnah’s husband need not worry anymore – Asnah will begin treatment in August as free treatment in government hospitals has been made available since March.

World Health Organisation Representative to Malaysia, Brunei Darussalam and Singapore Dr Lo Ying-Ru called for increasing access to Hepatitis C testing and treatment. She urged people in high-risk groups to step forward to be tested as there is now a cure.

While congratulating the government for increasing the number of hospitals for treatment, Dr Lo said they should come up with a comprehensive national action plan on viral hepatitis which covered all aspects such as prevention, diagnosis and treatment.

Related stories:

MTAAG+ group seeks better treatment for patients

Wait over for Hep C screening



Wait over for Hep C screening

The cure: FIND HCV country project manager Sem XiaoHui showing the rapid diagnostic test kit for Hepatitis C at the Drugs for Neglected Diseases initiative office in Brickfields, Kuala Lumpur.

The cure: FIND HCV country project manager Sem XiaoHui showing the rapid diagnostic test kit for Hepatitis C at the Drugs for Neglected Diseases initiative office in Brickfields, Kuala Lumpur.

KUALA LUMPUR: In another step up for Malaysia on access to Hepatitis C diagnosis and treatment, 50,000 rapid diagnostic test kits will be made available to high-risk patients in selected clinics.

Global health non-profit body Foundation for Innovative New Diagnostics (FIND) – in collaboration with Drugs for Neglected Diseases initiative – will help the Health Ministry to kick-start the screening process in a big way.

Access to Hepatitis C screening and treatment was limited due to high treatment costs coupled with the lack of awareness, symptoms and screening facilities.

Former health minister Datuk Seri Dr S. Subramaniam announced in March that around 2,000 patients would be treated in public hospitals after the Government gained access to a generic version of the medication sofosbuvir through compulsory licencing (CL).

FIND HCV country project manager Sem XiaoHui said it would provide technical assistance to the ministry and demonstrate the easy-to-use rapid diagnostic test (RDT).

The 50,000 RDT kits would be distributed to 25 selected health clinics within 12 months from mid-September, she said.

“It requires only a finger prick. The RDT is fast and can produce highly accurate results in five to 20 minutes,” she said.

Currently, confirmation tests are available only in state and referral hospitals and patients may need to wait up to a month for the results because these are only tested in laboratories and are labour-intensive, she said.

Sem said the ministry’s first edition HCV guidelines introduced on Oct 17 had put RDTs as a recommended diagnostic test.

The RDT selected was based on the World Health Organisation’s (WHO) recommendation, she said.

On July 23, Drugs for Neglected Diseases initiative (DNDi) said in a statement that it would partner with FIND to generate evidence that would support policy change and the scale up of HCV diagnosis and treatment.

The work will be carried out with the ministry.

It is part of a larger FIND project, known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), and is supported by Unitaid, a global health initiative working with partners to end the world’s epidemics.

It said patients confirmed having active HCV (viremia) would be treated as part of an ongoing DNDi clinical trial – co-sponsored by the ministry – using a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir.

Patients could also be treated at selected government hospitals through the national HCV programme using generic versions of sofosbuvir/daclatasvir.

Sem said the efforts – decentralising testing and services and making these accessible at the clinic level – were aimed at achieving WHO’s viral hepatitis elimination goals, which was to get 90% of the population screened and diagnosed and 80% treated by 2030.

Sem said less than 20% of the general global population were aware of their Hepatitis C status.

DNDi South-East Asia clinical project manager S. Sasikala said of the 50,000 people screened, 1,200 were expected to require treatment and be absorbed by DNDI and the ministry’s clinical trials in five district/state hospitals.

She said high-risk populations such as those injecting drugs, care providers, those in homosexual relationships, HIV patients, sex workers, those had received blood transfusion before 1992 and family members of infected patients should get tested for HCV.

“The Institute for Medical Research has evaluated the kit and it has very good sensitivity and specificity,” said Health director-general Datuk Dr Noor Hisham Abdullah.

Asked if Malaysia could eliminate Hepatitis C through its public health approach after the CL, he said it was on track on achieving this by 2030.

Although the ministry said it would provide a limited 2,000 treatments this year, Dr Noor Hisham said this capacity would be increased in stages.

Patients had to register with 21 hospitals which provide the treatment, he added.

Related stories:

MTAAG+ group seeks better treatment for patients

Those at risk urged to get screened for Hepatitis C


Health Ministry inks MoU to help diagnose Hepatitis C among vulnerable populations

Health Minister Dzulkefly Ahmad delivers his speech before the signing of the MoU between Clinical Research Malaysia and the Foundation for Innovative New Diagnostics in Putrajaya August 6, 2018. — Picture by Azinuddin Ghazali
Health Minister Dzulkefly Ahmad delivers his speech before the signing of the MoU between Clinical Research Malaysia and the Foundation for Innovative New Diagnostics in Putrajaya August 6, 2018. — Picture by Azinuddin Ghazali

KUALA LUMPUR, Aug 6 — The Ministry of Health (MOH), via Cancer Research Malaysia (CRM) today inked a Memorandum of Understanding (MoU) with the diagnostic firm to help identify and treat Hepatitis C patients in vulnerable, hard to reach populations.

Health Minister Dzulkefly Ahmad, who witnessed the ceremony, today said that the larger concern regarding the disease in Malaysia is the amount of undiagnosed cases.

As such, the Foundation for Innovative New Diagnostics (FIND) will demonstrate the conduct of Rapid Diagnostic Tests (RDTs) in several government health clinics, and link them to care.

“Treatment is now available in 21 government hospitals. The clinical trial (diagnostics) will be in 25 health clinics,” Dr Dzulkefly said following the signing.

One care option is to link the patients with Drugs for Neglected Diseases Initiative (DNDi), which conducts clinical trials co-sponsored by MOH.

There are around 500,000 Hepatitis C patients in Malaysia.

MTAAG+ group seeks better treatment for patients

PETALING JAYA: With many Hepatitis C patients still not getting the latest highly effective treatment, an NGO has urged the Government to increase access to treatment for those at risk.

Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) director Edward Low said a patient had informed the group that he was offered the drug PEG-Interferon for treatment, which was obsolete in advanced countries.

“We are concerned that the treatment for co-infection groups, especially People Living with HIV (PLHIV), has been delayed,” he said in conjunction with World Hepatitis Day 2018 today..

Due to the delay in treatment, Low said a patient died last month as her liver had turned cancerous.

Low also pointed out that those on Highly Active Anti-Retrovirus Therapy (HAART) needed stronger dosage – daclatasvir 90mg.


He said PLHIV had not started the treatment in government hospitals as the 30mg daclatasvir tablet, which is supposed to be added to the 60mg dosage to increase its potency, was not available, adding that doctors did not allow a 60mg tablet to be cut into half.

Low said they had to wait until November for the 30mg pill to arrive.

He said it was best for patients to be treated as early as possible to avoid complications later, and urged those at high risk of having Hepatitis C to get screened.

“We believe that in scaling up screening and with better treatment, we will be able to eliminate Hepatitis by 2030,” he said.


WTO Trade Policy Review: Malaysia explains its compulsory license for Hep C drug

On 14 February 2018 and 16 February 2018, the World Trade Organization (WTO) conducted a Trade Policy Review (TPR) of Malaysia. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The TPRM takes place in the “Trade Policy Review Body which is actually the WTO General Council — comprising the WTO’s full membership — operating under special rules and procedures”. (Source: WTO, Trade Policy Reviews: Brief Introduction). The Chair of the Malaysia TPR was H.E. Ambassador Juan Carlos González (Colombia); the discussant was H.E. Ambassador Claudio de la Puente (Peru). Malaysia’s delegation was led by Mr. J. Jayasiri, Secretary General of the Ministry of International Trade and Industry (MITI).

On Thursday, 26 April 2018, two months after the Trade Policy Review of Malaysia was held, the WTO secretariat released the addendum to the minutes of the meeting which “contains the advance written questions and additional questions by WTO Members, and replies provided by Malaysia.” (Source: WT/TPR/M/366/Add.1). Of particular interest are the perspicacious questions posed by Brazil and Ukraine in relation to Malaysia’s September 2017 issuance of a compulsory license on sofosbuvir, a medication used for the treatment of hepatitis C.

In their written questions, Brazil and Ukraine referred to the WTO secretariat report prepared in advance of the Trade Policy Review of Malaysia (WT/TPR/S/366); the report published in December 2017 states:

3.174.Compulsory licensing provisions are applied to patents, layout designs of integrated circuits, and copyrights and related rights. There have been no changes to provisions on compulsory licensing, and no compulsory licences have been granted since 2014.

KEI contacted the WTO secretariat to clarify its assertion in its TPR report for Malaysia that “no compulsory licences have been granted since 2014”; the WTO secretariat responded that the text of this particular paragraph was prepared in the summer of 2017 prior to Malaysia’s issuance of a compulsory license in September 2017.

Brazil’s written questions and Malaysia’s answers are reproduced below.

3.3.8 Intellectual Property Rights
Page 75 (Para 3.174)

According to paragraph 3.174, no compulsory licences have been granted in Malaysia since 2014. However, there reports in the media stating that in September, 2017, the Malaysian government approved the use of Rights of Government under Patent Act 1983 (Act 291) for the patented invention of Sofosbuvir, a hepatitis C medicine. In that regard, please answer:


Can you confirm this information? If confirmed, was the decision based on the Doha Declaration on the TRIPS Agreement and Public Health (…“the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all” and it is reaffirmed “the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose”)?

Answer: The implementation of the compulsory licence under the Rights of Government is based on the existing provision of Patents Act 1983 and in accordance with the Doha Declaration on the TRIPS Agreement.

9.How many additional hepatitis C patients are expected to receive treatment after the approval of the use of Rights of Government?

Answer: Based on a report in 2010, it is estimated that 453,700 Malaysians were infected with viral Hepatitis C with 2,000 newly diagnosed patients per year. The treatment plan is being finalized since the Sofosbuvir tablets are yet to be available. It is expected that 1,500 Hepatitis C patients will receive treatment in 2018, as compared to only 500 patients who were treated with other Hepatitis C drugs before the approval of the use of Rights of Government.

10.Were there any challenges encountered by the Government of Malaysia in implementing the use of Rights of Government for Sofosbuvir?

Answer: The implementation is still at an initial stage.

11.Does the Government of Malaysia intend to use the system provided for by Article 31bis of the TRIPS Agreement, which entered into force on 23 January, 2017?

Answer: The decision on this issue is based on the current provision of the Patents Act 1983 and the TRIPS Agreement.

Ukraine’s written questions and Malaysia’s answers are reproduced below.

3.3.7 Intellectual property rights Overview

    • Pages 74 -75
    (paragraphs 3.171, 3.174) According to the Report “Malaysia ratified the Protocol Amending the TRIPS Agreement on Public Health in December 2015. … There have been no changes to provisions on compulsory licensing, and no compulsory licences have been granted since 2014.”

It is also mentioned in Para 2.7 (page 23) of the Report that “Treaties or international legal instruments (including WTO agreements) are not implemented automatically; appropriate national legislation is required to give the treaty force of law domestically.”


10. In view of the entry into force of the Protocol Amending the TRIPS Agreement (on 23 January 2017), could Malaysia kindly inform on national implementing measures providing for special compulsory licences and its scope (for export or import of medicines)?

Answer: Malaysia has submitted the acceptance of the Protocol Amending the TRIPS Agreement in December 2015. Hence, Malaysia is amending the Patents Act 1983 to include the provision of the Article 31bis of TRIPS Agreement.

11.What competent authorities are responsible for initiation and making decision relating to the grant of compulsory licences to address public health problems according to Malaysian legislation?

Answer: Initiation to invoke compulsory licensing due to public health concern is under the jurisdiction of Ministry of Health(MOH). Granting of compulsory licensing comes under the Ministry of Domestic Trade, Co-operatives and Consumerism (MDTCC) which is the competent authority as provided under the Patents Act 1983.

12.Who may apply for the grant of the compulsory licence to use the patented invention concerning medicines and how is the process of cooperation between applicants and responsible authorities organized?

Answer: Any person can apply for compulsory licenses under Patent Acts 1983. The process of cooperation between applicants and responsible authorities is provided under Part X (Compulsory Licences) Section 49 to 54 of Patents Acts 1983. The procedures are provided under Regulation 38 to 42 of Patent Regulations.

13.Are there any pre-grant conditions and requirements on remuneration to the patent holder?

14.If so,could Malaysia, please, also describe the relevant legislative provision concerning pre-grant conditions and remuneration?

Answer: Details regarding compulsory licenses are provided under Section 49 to 54 of Patents Acts 1983. With regard to compulsory licenses under Rights of Government, it is provided under Section 84 of Patents Act 1983.

15.Considering Press Statement of Minister of Health of Malaysia of 20 September 2017 (available at:, could Malaysia, please, clarify the state of play of the implementation of the decision to initiate the Rights of Government to exploit the patented invention of Sofosbuvir?

Answer: MDTCC and MOH are working closely on the implementation of the decision to initiate the Rights of Government. Malaysia is currently finalizing the procurement of generic Sofosbuvir tablets.

16.Has Malaysia examined the possibility of using the system, set out by the Protocol Amending the TRIPS Agreement, while making above mentioned decision?

Answer: The decision on this issue is based on the current provision of the Patents Act 1983.

NGOs laud ministry’s efforts as a win for public health

  • Tuesday, 20 Mar 2018

PETALING JAYA: NGOs are happy that patients can now be cured of Hepatitis C after the Government issued a compulsory licence to gain access to the effective drug.

Third World Network (TWN) programmes director Chee Yoke Ling said it welcomed this long-awaited day when Malaysians who needed affordable Hepatitis C treatment could finally be cured.

She said the great efforts of the Health Ministry over several years had achieved a victory for public health.

“Malaysia is now able to buy generic sofosbuvir at one of the lowest prices in the world.

TWN also urged the authorities to expand the availability of treatment to university hospitals under the Education Ministry.

Drugs for Neglected Diseases initiative (DNDi) South-East Asia regional office head Jean-Michel Piedagnel said no other country in the world went as far in providing life-saving Hepatitis C treatment to all.

“It shows that public political leadership is essential in promoting access to healthcare. Proud to be part of the team,” he said.

DNDi is an international non-profit drug research and development organisation, of which the Health Ministry is a founding member.

Malaysian Medical Association president Dr Ravindran R. Naidu said the free Hepatitis C treatment was a step in the right direction.

“However, at present, treatment is only in government hospitals and the patients have to be carefully selected,” he said, adding that the free treatment would initially be available only in 18 government hospitals nationwide.

Positive Malaysian Treatment and Advocacy Group director Edward Low also agreed that the move to make Hepatitis C treatment free was a good start.

“We hope this treatment programme is able to expand to the primary healthcare centres like district clinics because the oral medicines are easy to monitor by trained physicians,” said Low when contacted.


Rawatan Hepatitis C percuma di 18 hospital kerajaan

MENTERI Kesihatan, Datuk Seri Dr S Subramaniam berbual dengan seorang pesakit pada lawatan rasmi di Hospital Selayang hari ini. Turut hadir Ketua Pengarah Kesihatan, Datuk Dr Noor Hisham Abdullah. – Foto Aizuddin Saad

SELAYANG : Seramai 2,000 pesakit kronik Hepatitis C bakal menikmati rawatan antiviral secara percuma di 18 hospital kerajaan seluruh negara.

Menteri Kesihatan, Datuk Seri Dr S Subramaniam, berkata ada 23,000 pesakit Hepatitis C yang sudah berdaftar dengan kementerian untuk mendapatkan rawatan itu.

Katanya, rawatan yang dimulakan sejak dua minggu lalu disasar dapat memberi manfaat kepada seramai lebih 400,000 pesakit Hepatitis C di seluruh negara mengikut anggaran Pertubuhan Kesihatan Sedunia (WHO), dengan sebilangan besar masyarakat belum tahu mereka menghidap penyakit itu.

“Rawatan berkenaan adalah pencapaian terbaik negara kerana menjadi negara pertama dunia menggunakan compulsory licence (CL) untuk rawatan hepatitis C.

“Ubat generik ini memberi makna besar kepada negara dan pesakit kerana ia boleh membunuh virus, pada masa sama menghalang ia daripada menjangkiti orang lain,” katanya.

Beliau berkata demikian pada Majlis Inisiasi Ubatan Direct Acting Antiviral (DAA) untuk rawatan Hepatitis C di Hospital Selayang di sini hari ini.

Yang turut hadir Ketua Pengarah Kesihatan, Datuk Dr Noor Hisham Abdullah; Pengarah Biro Kawalan Farmaseutikal Kebangsaan, Bahagian Perkhidmatan Farmasi Kementerian Kesihatan, Dr Salmah Bahri dan Pengarah Hospital Selayang, Dr Siti Zaleha Mohd Salleh.

Beliau turut meluangkan masa melakukan lawatan ke wad Hepatologi di situ.

Katanya, hepatitis C atau penyakit berkaitan hati adalah adalah antara isu kesihatan awam yang besar.

Pesakit yang tidak dirawat berpotensi untuk mengidap penyakit lain berkaitan hati, termasuk kemungkinan mendapat barah hati.

Ia boleh berjangkit menerusi transfusi darah.

Dr Subramaniam, berkata DAA yang diimport dari Mesir dianggap sebagai kos efektif malah diyakini berupaya menyembuhkan penyakit hingga 95 peratus.

“Dulu untuk seorang pesakit kita menanggung kos hingga RM50,000 untuk 12 kali rawatan seorang, tetapi dengan ubat ini, kita berupaya mengurangkan hingga RM1,000 saja untuk seorang pesakit,” katanya.

Dalam usaha menangani Hepatitis C, Kementerian giat menjalankan pemeriksaan darah bagi mengenal pasti individu dijangkiti supaya mereka mendapat rawatan sewajarnya.

Sementara itu mengulas mengenai insiden kebakaran di Hospital Kuala Lumpur (HKL) baru-baru ini, beliau berkata pihaknya sedang menunggu laporan forensik bomba.

Katanya, dalam langkah keselamatan, pihaknya turut melakukan audit pada semua hospital yang berusia lebih 20 tahun sejak tahun lalu.

“Kita turut memperkasakan kakitangan mengenai aspek keselamatan termasuk kebakaran dan ia dijalankan secara berterusan.

“Antara langkah kita selalu tekankan kepada kakitangan, ialah memadamkan sumber oksigen dan hentikan bekalan elektrik bagi mengelakkan risiko lebih teruk daripada berlaku,” katanya.

Kebakaran berlaku Sabtu lalu didakwa disebabkan oleh litar pintas dan merebak dengan cepat kerana stor tempat berlaku kebakaran, turut digunakan untuk menyimpan banyak peralatan perubatan daripada plastik.

Putting lives above profits for Hepatitis C treatment

A HIGHLY effective drug which can cure Hepatitis C hit the market in 2013 but five years later, over 70 million people around the world are still not getting the needed treatment.

In Malaysia, that was initially the fate of an estimated 400,000 pa­­tients for this disease, amid intense debates whe­ther the cheaper generic version of drugs should be made available to more people.

One major reason for the untreated millions of people was the prohibitive price.

When the direct acting anti-viral medicine (DAA) sofosbuvir was first introduced in the United States, it cost US$84,000 (RM324,000) for a full 12-week treatment course.

Last year, The Star reported that Malaysia was not given special pricing for the drug by pharmaceutical companies because it is considered a middle-income country, even though the disease is a major public health threat.

Negotiations with the drug company failed after it gave its last offer at RM50,000 for a 12-week full-course treatment, said Health Mi­­nis­ter Datuk Seri Dr S. Subrama­niam recently.

The Government then defied the odds and became the first in the world to gain access to the generic version of sofosbuvir through compulsory licence (CL), an authorisation that allows access to generic products at a much lower cost while the patent is still underway.

It is part of the flexibility provided under the World Trade Organi­sation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. It brought the cost down to RM1,000 for the full-course treatment in combination with daclatasvir.

This led to the wrath of big pharmaceutical companies which pressured Malaysia to retract its position, saying that the decision discouraged innovation. They even got the US government to intervene.

Meanwhile, in developed countries, governments could only provide a limited number of treatments a year due to the high cost.

In the United States, 18 lawmakers wrote in February to the Department of Health and Human Services to consider issuing CL for expensive Hepatitis C treatments.

They argued that rationing current treatment only to those with advanced forms of the disease is harming public health in the country.

The number of people worldwide who have not been treated is a staggering 71 million, according to the latest World Health Organisation (WHO) 2018 progress report on access to Hepatitis C treatment.

The number of those who initiated DAA-based treatment for Hepa­ti­tis C was negligible, with an increase from about one million in 2015 to 1.5 million in 2016, it said.

This is despite the fact that 95% of people with Hepatitis C can be completely cured within two or three months.

While pharmaceutical companies want their intellectual property rights to be recognised, governments and civil society are asking if astronomical pricing of drugs is justified.

It is important to recognise that it is costly to develop drugs, including the cost of clinical trials. Pharma­ceutical companies also have to answer to shareholders. But how much profit is too much and what is the value of human lives?

Gilead Sciences’ representative said it does not wish to comment for now.

However, the US Senate investigation of Gilead Sciences revealed that Pharmasset had initially considered a price of US$36,000 (RM138,900) for sofosbuvir.

But Gilead Sciences, which had acquired Pharmasset, set the market price at US$84,000 (RM324,000), according to The BMJ journal report.

The report, “Betting on Hepatitis C: How Financial Speculation in Drug Development Influences Access to Medicines” on July 27, 2016, said the price was set “after internal deliberation over multiple factors, including an evaluation of the high prices of previous drugs and how much health systems could bear”.

“The resulting cycle of profit accumulation, speculation, and higher prices deepens the problem of affordable access to medicines,” it said.

It also said that by the first quarter of 2016, Gilead had accumulated over US$35bil in global revenue from Hepatitis C medicines since its launch in December 2013.

The revenue was more than triple the cost of the initial acquisition of Pharmasset and nearly 40 times the cost of Gilead and Pharmasset’s combined reported costs for developing sofosbuvir-based medicines, it said.

It brings into question the purpose of a new discovery or innovation. It is supposed to bring progress and better health to mankind. But what purpose does it serve when millions are unable to afford it?

A lot of rethinking is needed if the world is to achieve better health outcomes with Hepatitis C.

The WHO report urged governments to scale up treatments by procuring the more affordable generic DAAs, which have become available through voluntary licensing or local production.

Drugs for Neglected Diseases initiative (DNDi) South-East Asia regional office head Jean-Michel Piedagnel said pharmaceutical companies should cover their R&D cost and make some profit but they should also base their profit on volume rather than a small market to enable the disease to be tackled from a public health approach.

“When cost is prohibitive, only a limited number of people will be treated and Hepatitis C infection will still be transmitted.

“Malaysia using CL in making drugs affordable and tackling Hepatitis C through public health approach is a game changer.

“The approach could eliminate Hepatitis C,” he said.

Third World Network programmes director Chee Yoke Ling said the misuse of patents includes the issue of “ever greening” – the use of various strategies to file many patents around a medicine which can increase the market mono­­poly beyond the normal term of 20 years for the first patent.

In Malaysia, patients in public hospitals started receiving DAAs treatment last month following the CL move.

The move had also led to Gilead Sciences announcing on Aug 24 to include Malaysia in the Hepatitis C generic licensing agreement with several Indian manufacturers.

The granting of a sofosbuvir voluntary licence (VL) meant that it will be possible for lower-cost gene­ric versions of the drug to be made available. The price before the VL was US$30,000 (RM128,115) per person.

While WHO has called on countries to step up its fight against He­­patitis C, pharmaceutical companies too need to be more conscionable and introduce a business mo­­del that provides the support needed for nations, instead of purely maximising profit.


Health D-G: New Hepatitis C treatment has 97% cure rate

KUALA LUMPUR: A new affordable Hepatitis C treatment – with Malaysian involvement in clinical trials – has shown a 97% cure rate and is able to treat the most severe form of the disease.

The treatment, which uses the drug ravidasvir in combination with a generic version of sofosbuvir, has been shown to be safe and effective, with extremely high cure rates for patients including hard-to-treat cases, according to interim trial results.

The results were presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.

“As hepatitis C has become a major public health concern in Malaysia, it is crucial to increase access to treatment for the benefit of the nation,” said Health director-general Datuk Dr Noor Hisham Abdullah (pic) in a press release issued by the DNDi on Thursday (April 12).

In September 2017, The Star reported that the Government announced it had issued a “government-use” license on sofosbuvir to allow 400,000 Hepatitis C patients in Malaysia to access generic version of the drug in public hospitals.

Tthe new combination drug announced by DNDi will be able to treat Genotype 3, which is the most severe form of Hepatitis C.


Rawatan kombinasi hepatitis C mampu bayar yang baharu menunjukkan 97% kadar kesembuhan

Paris, 12 April 2018

Hasil keputusan menyokong pendekatan kesihatan awam terhadap hepatitis C

Satu rawatan kombinasi hepatitis C mampu bayar yang melibatkan calon ubat terbaharu, ravidasvir telah dibuktikan selamat dan berkesan, dengan kadar kesembuhan yang sangat tinggi kepada pesakit, termasuk kes-kes yang sukar dirawat. Ini ialah hasil keputusan interim ujian percubaan Fasa II/III STORM-C-1 yang dibentangkan oleh pertubuhan penyelidikan dan pembangunan bukan berasaskan keuntungan iaitu inisiatif bagi Ubat untuk Penyakit Yang Diabaikan (DNDi) di Persidangan Hati Antarabangsa di Paris.

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Healthcare worker examines liver of hepatitis C patient in Thailand

Keputusan menunjukkan bahawa kombinasi sofosbuvir/ravidasvir adalah setanding dengan terapi terbaik untuk hepatitis C yang terdapat hari ini tetapi dijual pada harga mampu bayar dan boleh menjadi pilihan alternatif di negara-negara yang dikecualikan daripada program akses kepada syarikat farmaseutikal,” kata Dr Bernard Pécoul, Pengarah Eksekutif DNDi.

Ujian percubaan menggunakan ubat yang dikeluarkan oleh pengeluar ubat Mesir, Pharco Pharmaceuticals ini telah dijalankan oleh DNDi dan ditaja bersama oleh Kementerian Kesihatan Malaysia, di sepuluh tapak di Malaysia dan Thailand. Perjanjian-perjanjian yang telah ditandatangani pada 2016 dan 2017 membolehkan ujian-ujian percubaan dan peningkatan pesakit di Malaysia memulakan harga sasaran US$300 untuk rawatan selama 12 minggu, hampir 100% pengurangan daripada harga rawatan sedia ada di Malaysia.

Memandangkan hepatitis C telah menjadi salah satu masalah kesihatan awam utama di Malaysia, adalah penting untuk meningkatkan akses kepada rawatan demi manfaat negara,” kata Datuk Dr Noor Hisham Abdullah, Ketua Pengarah Kesihatan, Kementerian Kesihatan Malaysia. Pada September 2017, kerajaan Malaysia telah mengeluarkan lesen “kegunaan kerajaan” ke atas paten-paten sofosbuvir bagi membenarkan 400,000 pesakit hepatitis C di Malaysia mendapat akses kepada rejimen HCV generik di hospital-hospital awam.

DNDi menjalankan ujian percubaan label terbuka STORM-C-1 untuk menilai keberkesanan, keselamatan, toleran dan farmakokinetik calon ubat ravidasvir yang digabungkan dengan sofosbuvir. 301 pesakit dewasa dengan jangkitan teruk telah dirawat dengan kombinasi ravidasvir/sofosbuvir selama 12 minggu untuk pesakit tanpa sirosis hati dan 24 minggu untuk pesakit dengan sirosis terkompensasi. Selaras dengan piawaian antarabangsa yang menakrifkan kesembuhan bagi rawatan HCV, 12 minggu selepas tamat tempoh rawatan, 97% daripada mereka yang terlibat telah sembuh (95% CI: 94.4-98.6). Kadar kesembuhan adalah sangat tinggi walaupun bagi pesakit yang paling sukar dirawat: pesakit dengan sirosis hati (96% sembuh), pesakit yang menghidap HIV menggunakan rawatan biasa mereka (97%), pesakit yang dijangkiti dengan genotip 3 (97%) termasuk mereka dengan sirosis (96%) dan pesakit yang telah diberikan rawatan HCV sebelum ini (96%). Yang penting, pesakit yang mengalami kombinasi beberapa daripada faktor-faktor risiko ini telah sembuh dan tiada isyarat keselamatan luar jangka telah dikesan.

Figure: STORM-C-1 : SVR12 rates overall and per pre-defined sub groups-Intend to treat analysis
Analisa kadar keseluruhan STORM-C-1 : SVR12 dan bagi setiap kumpulan kecil pra-takrif yang dicadang untuk dirawat

Dari perspektif penyedia rawatan, ini ialah perkembangan yang sangat menarik kerana kita telah lama menantikan satu rawatan yang mudah, mampu bayar dan kuat yang boleh diterima oleh semua kumpulan pesakit termasuk mereka yang hasil rawatannya pada masa ini adalah yang lebih kurang baik, seperti pesakit yang menerima terapi antiretroviral,” kata Pierre Mendiharat, Timbalan Pengarah Operasi untuk Médecins Sans Frontières / Doktor Tanpa Sempadan (MSF). “Ini penting untuk memperluaskan rawatan kepada pesakit dalam kategori paling lemah di negara-negara sedang membangun.” MSF dan DNDi bekerjasama untuk meningkatkan akses kepada penjagaan dan rawatan untuk pesakit-pesakit HCV di negara-negara berpendapatan rendah dan pertengahan yang utama, melalui projek STORM-C yang dibiayai oleh inisiatif Keupayaan Pelaburan Transformasi (TIC) MSF.

Lebih 71 juta orang menghidap hepatitis C di seluruh dunia, sejenis penyakit yang telah menyebabkan 400,000 kematian setiap tahun. Walaupun rawatan yang sangat berkesan telah wujud selama beberapa tahun, kurang daripada tiga juta orang menerima rawatan tersebut, sedangkan lebih ramai orang yang dijangkiti setiap tahun berbanding jumlah yang diberikan rawatan. Pertubuhan Kesihatan Sedunia menyasarkan 80% pesakit yang didiagnosis dengan HCV mendapat rawatan menjelang 2030.

Ravidasvir ialah perencat NS5A oral yang dilesenkan kepada DNDi oleh Presidio Pharmaceuticals. Kebanyakan pesakit yang terlibat dalam ujian percubaan DNDi di Malaysia dan Thailand mempunyai genotip 1 (42% daripada peserta) atau genotip 3 (53%), dengan itu mengesahkan keberkesanan kombinasi tersebut untuk kedua-dua genotip tambahan ini. Ujian-ujian percubaan lanjut dirancang untuk mendokumenkan keberkesanan dan keselamatan kombinasi tersebut kepada pesakit yang dijangkiti dengan genotip HCV yang lain, terutamanya kepada kumpulan-kumpulan yang lemah, bagi memungkinkan pendekatan kesihatan awam kepada rawatan hepatitis C.

Pharco berasa bangga dapat membolehkan pendekatan kesihatan awam kepada rawatan hepatitis C dengan menyediakan rawatan mampu bayar. Kami berharap akan dapat meneruskan kolaborasi ini pada masa hadapan dalam ujian percubaan klinikal tambahan bagi mengesahkan keberkesanan dan keselamatan ravidasvir,” kata Dr. Sherine Helmy, CEO, Pharco.