Stage set for access to Hepatitis C treatment

KUALA LUMPUR: Twenty months after sofosbuvir, the generic Hepatitis C drug was brought into Malaysia through compulsory licensing, only some 4,500 patients have been treated, says the Health Ministry. It admitted that this initial stage of setting the stage for screening and treatment had been saddled with many challenges.

But a lot of the issues have been resolved and the number of patients to be screened and treated are expected to increase exponentially next year.

The process of getting laboratory support, coordinating with hospitals for patients to be treated and procurement that did not meet specifications were among the challenges they had faced, said the ministry’s National Head of Gastroenterology and Hepatology Datuk Dr Muhammad Radzi Abu Hassan.

“We have rectified the problems and we expect the number of patients screened and treated will increase markedly next year, ” he said in a dialogue between civil society organisations and the ministry in a multi-stakeholder forum on Hepatitis C here recently.

Besides the logistics issues, Dr Muhammad Radzi said that at the initial stage, there were fewer patients treated because many of them had liver cirrhosis and were treated in hospitals, which required more of the allocated medication.

But with the efforts to decentralise Hepatitis C screening and treatment this year, more were expected to be diagnosed and treated next year, he added.

“We will have screening and treatment in selected health clinics in every state beginning next year.”

Dr Muhammad Radzi said that with the decentralisation, the ministry would also provide clinics with rapid test kits for better access to screening. The rapid test is to test for Hepatitis C antibodies.

If tested positive, the patient would need another test to confirm if treatment is needed.

In total, he said the ministry and the Foundation for Innovative New Diagnostics (FIND), funded by Unitaid, had screened more than 50,000 high-risk people this year.

FIND, in collaboration with the ministry, had tested out and introduced the Hepatitis C rapid diagnostic test in one health clinic in December last year and in 25 health clinics starting March.

The programme had screened 15,148 patients and 2,031 patients were tested positive for Hepatitis C while 11,523 patients were screened during the ministry’s World Hepatitis Day one-week campaign in July and 220 patients were tested positive, said FIND HCV country project manager Sem Xiao Hui.

For the other cases (of the 50,000) while the rapid test was being studied, health clinics had taken blood samples and sent them to the hospitals or public health laboratories for testing.

In 2017, Universiti Malaya consultant hepatologist Prof Dr Rosmawati Mohamed said that more than 500,000 Malaysians aged between 15 and 60 were estimated to be infected with Hepatitis C, but 74% or 386,000 had active or persistent infection which required treatment.

In July 2017, The Star carried a front page story highlighting the plight of Malaysians who suffered from Hepatitis C as only a fraction could afford the medication that can cost up to RM300,000 for the full course of treatment.

Subsequently, the Cabinet gave approval to issue a government-use licence to enable the import of generic versions of the Hepatitis C drug sofosbuvir.

 

TAGS / KEYWORDS:Hepatitis C Drug , Health Ministry ,

Read more at https://www.thestar.com.my/news/nation/2019/11/13/stage-set-for-access-to-hepatitis-c-treatment

Activist Guide to Hepatitis C Virus Diagnostic

We’re pleased to share the Activist Guide and training curriculum if you could share in your networks or on social media (TAG will have some tweets/FB posts that can be re-tweeted).
Happy Halloween! What’s scarier than government inaction and Pharma greed that prevents people from getting tested and accessing affordable hep C treatment?…NEW Activist Guide and training curriculum helps activists learn how to take back our diagnostics!
 

New Resource on Hepatitis C Diagnostics for Treatment Advocates

October 31, 2019 — We’ve just released a new Activist Guide to Hepatitis C Virus Diagnostics!

The purpose of the Activist Guide to Hepatitis C Virus (HCV) Diagnostics is to provide information for you and your community. The Activist Guide aims to provide a deeper focus on diagnosis with updated information about the steps and different technologies involved in diagnosing a person with hepatitis C. It outlines major barriers to accessing testing technologies and services, which are similar to affordable access to the cure.

It builds on TAG’s Training Manual for Treatment Advocates: Hepatitis C Virus and Coinfection with HIV, which you can refer to for more detailed information about prevention, latest treatments, and care for hepatitis C and HIV coinfection.

The information here is written by and for people who aren’t medical specialists. TAG is comprised of treatment activists who learned about HCV because it was a problem for people in our communities. We designed the Activist Guide to increase advocates’ knowledge about available HCV tests, to discuss barriers to testing, and to assist in strategizing campaigns and action steps to overcome them.

This Activist Guide is organized into six sections. There are discussion points and action steps at the end of each section, and we hope both of these start conversations about finding solutions together.

We’ve also created a training curriculum to adapt and use the content of the Activist Guide in community education workshops. Full details about the Activist Guide, training curriculum, and the downloadable PDFs are available here on the TAG website.

If you have any comments or suggestions for future hepatitis C-related materials, please email Bryn Gay.

Contact Us: Treatment Action Group, 90 Broad Street, Suite 2503, New York, New York 10004, 212-253-7922. communications@treatmentactiongroup.org. TAG fights for life-saving medications for people living with, and at risk for, HIV, TB, and HCV. Please consider supporting this work by making a donation today.

Letter To DG, Ministry Of Health

Date : 19th June, 2019

YBhg. Datuk Dr. Noor Hisham Bin Abdullah
Director General
Ministry of Health Malaysia
Level 12, Block E7 Kompleks E,
Pusat Pentadbiran Kerajaan Persekutuan
62590 Putrajaya, Malaysia

E-mail : anhisham@moh.gov.my

Tel : 603 8883 2545

YBhg Datuk Dr,

RE: Civil Society Organizations Recommendations Towards Meeting The WHO 2030 HCV Elimination Targets.

Several civil society members attended the recently concluded 4th National Hepatitis Conference and we would like to congratulate Ministry of Health, especially Hospital Ampang for organizing a very successful national discussion. We would also like to express our gratitude to Datuk Dr Mohammad Radzi Abu Hassan, Head of Gastroenterology Services, MOH and Dr Anita Suleiman, Head of HIV/STI/Hep C Sector, MOH for having a roundtable meeting with the civil society representatives during the conference to discuss about the future hepatitis management for the country.

During the discussion, it was mentioned that the Ministry of Health has formulated a National Viral Hepatitis Strategy Plan, pending for approval. At the time of formulating the strategy plan, it is unclear whether civil society and patient groups have been involved in the process. Thus, we the representatives of hepatitis C advocacy organizations, hepatitis patients and individuals would like to express our recommendations based on the WHO Global Strategy:

1. To have active structured engagement and dialogue with relevant stakeholders such as ministry of health, service providers, patients and civil society where discussions on the challenges and high impact interventions can take place.

2. Scale up testing among high-risk groups. We applaud the ministry’s move to collaborate with FIND to formulate a simplified diagnostic algorithm. Besides providing the HCV rapid test kit at the 25 family medicine specialist clinics, the testing could be further expanded at 728 needle and syringe exchange programme (NSEP) outreach points1,incarcerated and prisons setting throughout Malaysia to target the missed opportunities among the high-risk groups.

3. Increase capacity of outreach workers by training them to perform HCV
rapid test. This move is essential as it integrates and links the HCV
services with other health services such as family medicine specialist
clinics and methadone clinics that will increase savings, reach and
efficiency.

4. Decentralisation of HCV services to overcome the limited capacity of
hepatologists as HCV diagnostics 2 and treatment regimes can be
administered and monitored with less organisational support at the
family medicine specialist clinics and methadone clinics. This will
reduce the number of loss to follow up cases and shorter waiting period
for patients.

5. Eliminate the model of warehousing HCV patients (holding off patients
from treatment). The upcoming HCV guideline should focus on
equitable access for all regardless of the severity of disease as it
increases savings, efficiency and the HCV patients’ overall quality of
life. It will also accelerates the country’s progress towards achieving
WHO’s targets by 2030.

6. Ministry of Health to register more generic direct acting antivirals
(DAAs) without compromising safety, efficacy and quality of the
products because they offer a great opportunity for substantial savings
and increase the number of treatment.

The opportunity to eliminate hepatitis is one, which we cannot let pass us by
since the government’s strong commitment in WHO to eliminate hepatitis by
2030. We would like to call upon Ministry of Health to have fully invested
National Viral Hepatitis Strategy Plan for Hepatitis C, to lend your support to
these recommendations and establish a dedicated channel at Ministry of
Health for continuous engagement with community groups.

Thank you.

1 Boo SL. Malaysia is ‘world leader’ in battling HIV spread with needles, says UK Report. Malay Mail [Internet]. 2015
Feb 17 [cited Apr 5 2019]. Available from: http://www.themalaymailonline.com/malaysia/article/malaysia-is-worldleader-
in-battling-hiv-spread-with-needles-says-uk-report

2 Status paper on availability & accessibility of diagnosis and follow up with MoH to remediate to the issues
highlighted in the paper. https://drive.google.com/file/d/1OQa83TDIGb4_39dFDlkt6oq_vbTcDL92/view

Cc Dr Anita Sulaiman
Ketua
Sektor HIV/STI/Hep C
Bahagian Kawalan Penyakit
Kementerian Kesihatan Malaysia
Aras 4, Blok E10, Kompleks E
Pusat Pentadbiran Kerajaan Persekutuan
62590 Putrajaya, Malaysia

YBhg. Dato’ Dr Muhamad Radzi Abu Hassan
Consultant Gastroenterologist & Hepatologist
Hospital Sultanah Bahiyah
KM 6, Jalan Langgar
05460 Alor Setar, Kedah

Signed by,

Organizations:
1. Crisis Home
2. Beyond Borders
3. Pengasih Malaysia
4. Persatuan Kebajikan Komuniti Ikhlas Malaysia
5. Persatuan Cahaya Harapan Negeri Kedah/Perlis
6. Persatuan Insaf Murni Malaysia
7. Pertubuhan Islah Movement
8. Perantaraan Pesakit Kelantan (Sahabat)
9. Pertubuhan Kebajikan Intan Zon Kehidupan
10. Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
11. SEED Malaysia
12. Treatment Action Group. N.Y.
.
Individuals:
1. Adzrin Mumin
2. Ahmad Kamar Pilos Abd Jalil
3. Azuan Az
4. Badrul Haffiz Yob
5. Dr Nason Tan Day Seng
6. Henry Koh
7. Haryati Jonet
8. Jaafar Daud.
9. Kartini Salmah
10. Kwan Wing Kien
11. Manis Chen
12. Md Rusli Md Ali
13. Md Khairu Che Imran
14. Mohd Afiq Mohd Khairi
15. Mohd Amirul Ikram
16. Mohd Azaha Hamid
17. Mohd Hafiz Abd Rahman
18. Mohd Rashid Hashim
19. Muhammad Aiman Mohd Nor
20. Norfaizal Mhd Asokomaran
21. Razali Ayub
22. Rosli
23. Sulastri Ariffin
24. Suzana Ahmad
25. Syariana Jane Kassim
26. Tan Wan Leong
27. Wan Kamariah Daud
28. Zainudin Amin

For further info contact Mr Edward Low

Address:
E-33A-02, 3 Two Square, No.2, Jalan 19/1, Petaling Jaya, Selangor.
Tel & Fax: 03-7931 2066
Email: mtaagplus@gmail.com

Letter to Mayor Changsha, Hunan, China

Date : 22nd Aug 2019

Mr. HU Zhongxiong
Mayor
Changsha City
Hunan Province
People’s Republic of China

Dear Mr. HU,

We write to share our urgent concerns about the human rights of three prominent anti-discrimination activists who have been detained by Changsha Municipal state security agents and facing possible state subversion charges. Cheng Yuan, Liu Yongze and Xiao Wu of Changsha Funeng have done important work to end discrimination against people living with HIV and people with hepatitis, and to advance the right to health and rights of persons with disabilities in China. As the supervisor of Changsha Municipal State Security Bureau, you should ensure they uphold the legal rights of these three activists.

Cheng Yuan has led over a decade of ground-breaking impact litigation on health rights — first at Tianxiagong, and later as co-founder of Changsha Funeng. Two of his landmark cases, in 2013 and 2016, won damages for teachers who lost their jobs due to their HIV status. Cheng Yuan has also led work on hepatitis B discrimination litigation, advocated forcefully for the rights of persons with disabilities and for an end to China’s One Child Policy, and worked to promote freedom of information and rule of law.

On Monday, 22 July, Cheng and two colleagues, Liu Yongze and Xiao Wu, disappeared. Cheng Yuan’s wife, Shi Minglei, has nothing to do with his NGO, but she has been placed under residential surveillance under suspicion of subverting state power. Cheng Yuan’s brother has also been questioned by police because of his vocal concerns about the case. So far, their lawyers have not been able to meet with any of the three activists.

As a UN member state, China committed to the 2030 Agenda for Sustainable Development in 2015, and in doing so committed to ending HIV by 2030, to combating hepatitis, to promoting peaceful and inclusive societies for sustainable development, and to achieving “zero discrimination” against people living with HIV. To achieve this, UNAIDS recommends countries finance and support HIV-related legal services to reduce stigma and discrimination, and the Global Fund has committed to scaling up this work in numerous countries — it is exactly the kind of work in which Changsha Funeng has expertise.

China has ratified the International Covenant on Economic, Social and Cultural Rights, which upholds the right to health, as well as the Convention Against Torture, and has committed to many other human rights standards. China has signed but not ratified the International Covenant on Civil and Political Rights.

China must not only uphold, but set a positive example to the world of promoting UN commitments to end HIV and end discrimination, as well as international human rights law. The Changsha Three live and work in Changsha. We urge the mayor of Changsha to commend Changsha Three instead of detaining them, and we urge you to directly address the harassment by Changsha state security police of Cheng Yuan’s family members.

Sincerely,

Edward Low
Director
Positive Malaysian Treatment Access & Advocacy Group

Ubat – Sofosbuvir/Daclatasvir

Matlamat rawatan virus hepatis C (HCV) adalah penyembuhan (apabila tiada lagi HCV dalam sistem darah seseorang pada minggu ke 12 selepas rawatan tamat).
Apa itu sofosbuvir/daclatasvir? Sofosbuvir/daclatasvir adalah satu kombinasi dos tetap bagi dua ubat melawan HCV (sofosbuvir dan daclatasvir).

Nama dagang bagi sofosbuvir ialah Sovaldi; nama dagang bagi daclatasvir ialah Daklinza.Kombinasi kedua-dua ubat mungkin juga dijual dengan nama Darvoni atau Sovodak. Pertubuhan Kesihatan Sedunia (WHO) telah meluluskan ubat-ubatan ini bagi mereka yang mempunyai semua jenis genotip hepatitis C (1 – 6) yang berumur 18 tahun dan ke atas.

Bagaimana sofosbuvir dan daclatasvir diambil? Sofosbuvir dan daclatasvir diambil sekali sehari, sebelum atau selepas makan, selama 12 minggu. Rejimen rawatan bebas Ribavarin adalah digalakkan bagi bagi pesakit yang belum pernah
dirawat sebelum ini. Mereka yang mempunyai sirosis (kekerasan organ hati) terkompensasi (sirosis tanpa simptom penyakit hati), mungkin perlu melalui rejimen rawatan lebih lama atau dengan mengambil ubat, ribavarin, jika mereka belum pernah dirawat sebelum ini. Walau bagaimanapun, tempoh optimal penggunaan sofosbuvir dan daclatasvir bagi pesakit dengan sirosis belum lagi ditetapkan. Keberkesanan rawatan bergantung kepada sama ada seseorang mempunyai sirosis, genotip virus mereka, dan sejarah rawatan HCV mereka yang lalu.
Jangkamasa Rawatan yang dicadangkan WHO dan Kadar Penyembuhan dalam Percubaan
Klinikal1,2,*,**

Genotip 1 dan 2, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu**: 93%
Genotip 3, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu**: 79-82%
24 minggu: 90%
Genotip 4, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu: 98%
Genotip 5, tiada sirosis + sirosis terkompensasi2
12 minggu: 100% 12 minggu: 100%
Genotip 6, tiada sirosis2 + sirosis terkompensasi2
12 minggu: 98% 12 minggu**: 90%

1. Lihat juga Treatment Action Group. Ribavarin Fact Sheet. 2015 December. Boleh didapati di:http://www.treatmentactiongroup.org/hcv/ factsheets/ribavirin (Diakses pada 1 Februari 2019).

2. Iwamoto M, Sonderup MW, Sann K et al. Real-world effectiveness and safety of Daclatasvir/Sofosbuvir with or without Ribavirin among genotype 5 and 6 Hepatitis C Virus patients. Poster session presented at: the 68th Annual Meeting ofAmerican Association for the Study of Liver Diseases; 2017 October 20-24; Washington, D.C.

*Kadar penyembuhan dalam percubaan klinikal adalah lebih tinggi berbanding dalam populasi umum kerana pesakit dalam percubaan selalunya lebih sihat dan menerima lebih pantauan dan sokongan **Hanya disyorkan di negara-negara yang distribusi genotipnya diketahui dan prevalens bagi genotip 3 adalah <5%.

Apa yang paling penting boleh dilakukan oleh seseorang untuk sembuh adalah mengambil ubat-ubatan HCV anda – apa yang dipanggil pematuhan. Ini akan mengurangkan risiko virus untuk membina rintangan terhadap rawatan.
Apa itu rintangan ubat? Setiap hari, HCV membiak menjadi berbilion salinan dirinya. Sebahagian salinan tidak sama dengan virus asal. Ia mungkin berubah-ubah (dipanggil mutasi) yang boleh menyebabkan ubat hepatitis C berhenti berfungsi.

Jika pesakit tertinggal dos rawatan, HCV berpeluang untung membiak–dan sebahagian salinan mungkin dapat menentang rawatan HCV. Sebahagian orang mempunyai rintangan terhadap ubat walaupun mereka tidak pernah mendapat rawatan hepatitis C, tetapi ramai yang tetap dapat disembuhkan. Kebanyakan mereka yang tidak sembuh mempunyai rintangan terhadap satu atau banyak ubat HCV yang diambil. Rintangan terhadap ubat-ubatan hepatitis C boleh hilang dalam beberapa bulan, tetapi ia juga boleh bertahan bertahun-tahun dan mungkin dapat menghadkan peluang-peluang rawatan semula.

Sofosbuvir/daclatasvir dan umur, gender, dan bangsa/etnisiti: Dalam percubaan klinikal, kadar penyembuhan tidak berbeza mengikut umur (lebih 65 tahun versus bawah 65 tahun), gender, atau bangsa. Kesan-kesan sampingan sofosbuvir/daclatasvir: Berbincanglah dengan doktor anda tentang kesan-kesan sampingan yang mungkin ada dan bagaimana ia boleh diuruskan. Dalam percubaan-percubaan klinikal sofosbuvir/daclatasvir, kesan-kesan sampingan yang paling biasa ialah pening kepala, keletihan, dan loya, selalunya ringan.

Dapatkah sofosbuvir/daclatasvir berfungsi dengan ubat-ubatan HIV? Sofosbuvir/daclatasvir boleh digunakan dengan ubat-ubatan HIV tertentu, tetapi dosnya mungkin perlu diselaraskan daripada dos dewasa 60 mg/hari yang
standard. Berbincanglah dengan doktor anda sebelum mengambil sofosbuvir/daclatasvir mengenai tindakbalas ubat yang mungkin ada.
Sofosbuvir/daclatasvir dan ubat-ubatan lain: Sofosbuvir/daclatasvir boleh digunakan bersama ubat-ubatan pengganti opiate (e.g., buprenorphine atau methadone) tanpa perlu penyelaran dos. Menggabungkan ubat-ubatan
dapat meningkatkan atau mengurangkan tahap ubat (dipanggil interaksi ubat-ubatan). Peningkatan tahap ubat mungkin akan mengakibatkan kesan sampingan menjadi lebih teruk, sementara pengurangan tahap ubat mungkin akan menyebabkan ubat kurang berfungsi, memberi risiko rintangan atau tidak dapat sembuh daripada sakit hepatitis C.

Sofosbuvir/daclatasvir tidak patut diambil oleh mereka yang mengambil ubat-ubatan rentak jantung amiodarone kerana kombinasi sofosbuvir dengan amiodarone dapat mengakibatkan masalah jantung yang boleh mengancam nyawa. Jangan ambil suplemen herba St. John’s wort dengan sofosbuvir/daclatasvir dan beritahu doktor anda jika anda mengambil ubat untuk kholesterol atau ubat-ubatan bagi kanser, sawan, jangkitan bakteria, atau pedih ulu hati/refluks asid.

Berbincanglah dengan doktor anda sebelum memulakan atau menghentikan sebarang ubat-ubatan, suplemen,atau ubat-ubatan herba.Sofosbuvir/Daclatasvir dan Rawatan-rawatan HIV (Antiretroviral)Penghalang protease HIV (HIV protease inhibitors)
Atazanavir/ritonavir atau atazanavir/cobicistat Reyataz)

Kurangkan daclatasvir kepada 30 mg.

Penghalang integrase HIV (HIV integrase inhibitors)
Kombinasi dos tetap elvitegravir, cobicistat,
emtricitabine, dan tenofovir DF (Stribild)

Kurangkan daclatasvir kepada 30 mg.

Penghalang transkriptase berbalik bukan analog nukleosida HIV (HIV non-nucleoside reverse transcriptase
inhibitors)
Efavirenz (Sustiva, Atripla) Tambah daclatasvir kepada 90 mg.
Etravirine atau nevirapine (Intelence, Viramune)

Tidak disyorkan dengan penggunaan
sofosbuvir/daclatasvir.

Tenofovir DF (Viread, Truvada, Atripla, Complera,
Stribild) Tidak perlu penyelarasan dos. Tiada isu yang diketahui

dengan TDF dan daclatasvir.

Penyimpanan sofosbuvir/daclatasvir: Simpan sofosbuvir dan daclatasvir pada suhu bilik (di bawah 30°C [86°F]). Sofosbuvir/daclatasvir bagi pesakit buah pinggang: Sofosbuvir/daclatasvir tidak disyorkan bagi pesakit dengan kerosakan buah pinggang yang teruk (kegagalan buah pinggang Gred 4 dan 5).

Sofosbuvir/daclatasvir bagi pesakit dengan sirosis: Garis panduan rawatan HCV mencadangkan pesakit hati yang parah (Child-Pugh Kelas B atau C) untuk dirawat oleh pakar. Penggunaan sofosbuvir/daclatasvir telah terbukti secara amnya adalah selamat bagi mereka dengan sirosis (terkompensasi dan dekompensasi), tetapi
tempoh rawatan mungkin perlu diselaraskan dengan genotip hepatitis C. Sebagai tambahan, ribavirin mungkin perlu ditambah dalam rejimen rawatan.

Sofosbuvir/daclatasvir semasa hamil atau menyusukan anak dan bagi kanak-kanak: Tidak diketahui sama ada sofosbuvir/ daclatasvir dapat membahayakan bayi yang belum lahir atau menyusukan anak. Jika anda sedang hamil atau menyusukan anak, atau merancang untuk salah satunya, berbincanglah dengan doktor anda tentang risiko dan kelebihan rawatan HCV. Dalam kajian haiwan berkaitan kehamilan tikus dan arnab, dos sofosbuvir/daclatasvir yang amat tinggi menyebabkan kecacatan kelahiran, keguguran, dan kematian ibu. Pada dos yang lebih rendah, tiada bahaya dapat dilihat.

Sofosbuvir/daclatasvir ketika ini sedang diuji bagi kanak-kanak berumur kurang daripada 18 tahun, tetapi belum lagi disyorkan bagi kumpulan umur ini.

Helaian fakta ini adalah terkini pada bulan Mei 2019. Dinasihatkan untuk sentiasa semak maklumat yang terkini.

Strengthening Advocacy for Hepatitis C Diagnostics: Malaysia Workshop Summary Report

1-3 March 2019, Penang, Malaysia

Positive Malaysian Treatment Access and Advocacy Group (MTAAG+), with partners Treatment Action Group and the Foundation for Innovative New Diagnostics, convened the first advocacy workshop on hepatitis C virus (HCV) diagnostics. The workshop presented the latest developments in HCV treatment and diagnostics and prepared community members to participate and raise advocacy concerns at the 4th National Hepatitis Conference (held later on 7-8 March in Kuala Lumpur). A total of 41 participants attended, including family medicine providers and other specialists, technical resource people, and community leaders working with or representing people living with HIV and/or HCV (PLHIV and/or PLHCV), people who use drugs, men who have sex with men, transgender people, incarcerated people, and sex workers.

Workshop goals:

  • Strengthen treatment, harm reduction, and other healthcare advocates’ capacity and technical knowledge on HCV diagnostics
  • Foster advocates’ leadership skills and prepare their meaningful community engagement in high-level national decision-making processes associated with timely regulatory approval, guidance development, and scale up of diagnostic technologies.

In addition, the workshop aimed for participants to exchange experiences from different districts and clinical settings, while ensuring the presence of medical expertise and breaking down the silos between medical professionals, advocates, and community members in order to build a coalescent yet diverse and active coalition.

Several strategies and themes emerged to scale up diagnoses, based on the Status Report on Availability and Accessibility of Hepatitis C Diagnosis in Malaysia:

  • Increase awareness among people at risk (key populations) to encourage them to go for testing
  • Increase decentralization of HCV health services outside hospital settings
  • Improve surveillance and collect more comprehensive HCV-specific data
  • Strengthen and escalate advocacy for treatment availability

To take concrete steps to address these strategies, advocates developed action plans and a comprehensive list of recommendations, which were presented to Malaysian health authorities in a civil society dialogue at the National Hepatitis Conference. Overall, the key outcomes of the workshop were a clearer overview of the hepatitis C situation in Malaysia and basic understanding of challenges related to HCV diagnostics and treatment among advocates. Furthermore, there was a renewed sense of solidarity and confidence in being advocates on hepatitis C, with a focus to ensure that there will always be civil society representation and input moving forward in national elimination planning.

Download the report below.


ATTACHED DOCUMENTS

Report HCV Diagnostics Advocacy Workshop_Malaysia

PDF – 5.7 Mb

Status Paper – Availability and Accessibility of Hepatitis C Diagnosis in Malaysia

Status paper on availability & accessibility of diagnosis and follow up with MoH to remediate to the issues highlighted in the paper.

Availability and accessibility of Hepatitis C diagnosis in Malaysia

The Malaysian Government, particularly the Ministry of Health, has shown a strong commitment to hepatitis C (HCV), in particular, with the availability of effective, all oral direct-acting antiviral (DAA) hepatitis C treatment earlier this year. It is estimated that 380,000 Malaysians are living with Hepatitis C, yet a minority or only less than 10 % have been detected. Therefore, a key factor still outstanding is to find the missing thousands of individuals in Malaysia who are currently infected with hepatitis C but not diagnosed. Early detection of those infected is crucial as successful HCV therapy improves liver disease, reduces the risk of death and liver cancer.

The Foundation for Innovative New Diagnostics (FIND) and the Drugs for Neglected Diseases initiative (DNDi) had recently announced their collaboration with the Ministry of Health (MOH), Malaysia to scale up of hepatitis C (HCV) diagnosis and treatment. The initial diagnostic step that will be taken is decentralized HCV screening at MOH health clinics using pre-qualified rapid diagnostic tests:  HCV positive cases will subsequently undergo HCV confirmation to enable them to be linked to HCV treatment as part of a DNDi clinical trial or in government hospitals (https://www.dndi.org/2018/media-centre/press-releases/find-dndi-malaysianmoh-efforts-hepatitisc-screening-treatment/).

The objective of this report is to

  1. assess availability and accessibility of HCV diagnostic tools in Malaysia
  2. identify strategies to improve access to HCV testing and improve linkage to care and therefore, support, strengthen and complement Ministry of Health’s existing efforts to scale up of HCV diagnosis and treatment

Key observations

Figure 1 shows the HCV Care Cascade, not only focusing on the major gap in those diagnosed and aware, but also the possible gaps all along after HCV diagnosis.

HCV screenings

The initial step for HCV diagnosis in all hospitals and health centres where mandatory or opportunistic HCV screening done is testing for the presence of Hepatitis C antibodies using laboratory-based assay. Rapid diagnostic test (RDT) for HCV is currently mainly performed by non-governmental organisations such as Positive Malaysian Treatment Access & Advocacy Group and Hepatitis Free Malaysia/Hepatitis Free Pahang.

HCV Confirmation

As the presence of Hepatitis C antibodies implies either current or past or infection, a confirmation step is crucial as only those with HCV viraemia will be considered for HCV treatment. Confirmation of HCV viraemia can be done using either HCV RNA test or HCV Core Ag as recommended by all major international guidelines on HCV management.

In public hospital setting, HCV confirmatory tests can only be done in very few MOH hospitals in Malaysia (Hospital Kuala Lumpur, Hospital Sungai Buloh, Hospital Selayang, Hospital Sultanah Bahiyah, Hospital Umum Sarawak and Hospital Melaka), University Malaya Medical Centre (UMMC) and University Kebangsaan Malaysia Medical Centre (UKMMC). Currently, HCV confirmatory tests are not yet accessible to primary care physicians.

Until recently, HCV RNA testing is limited to HCV RNA quantitative test, which costs at least three times higher compared to the HCV RNA  qualitative test. WHO and EASL guidelines recommended using either quantitative or quantitative HCV RNA tests as both tests are equally sensitive assays with a lower limit of detection of ≤15 IU/ml.

In the public hospital setting, HCV RNA qualitative testing was only available in UMMC until recently, where its now available at Hospital Kuala Lumpur and Hospital Umum Sarawak. The test is also available in the Institute for Medical Research (IMR).

In hospitals where HIV RNA tests is done, testing for HCV RNA can also be made available on the same platform in Hospital Pulau Pinang and Hospital Raja Perempuan Zainab II, Kota Bharu.

Although HCV core antigen assays is slightly less sensitive than HCV RNA, a WHO commissioned systematic review which included 44 studies, has provided a high level of evidence that HCV core antigen is good alternative to HCV RNA detection and is strongly recommended both by WHO and EASL guidelines for HCV confirmation. Awareness of HCV core antigen as a confirmatory test for HCV is still lacking, although there is increasing access to this test in 7 MOH hospitals (Hospital Kuala Lumpur, Hospital Ampang, Hospital Selayang, Hospital Sultanah Bahiyah,  Hospital Raja Perempuan Zainab, Hospital Sultanah Aminah and Hospital Queen Elizabeth)

Liver disease assessment

The main reason to assess the stage of liver disease is not to miss cirrhosis. Fibroscan is a reliable non-invasive test, but its only available in UMMC and 3 MOH hospitals (Hospital Selayang, Hospital Sultanah Bahiyah, Hospital Raja Perempuan Zainab). Serum biomarkers of fibrosis such as APRI and FIB-4 can be used and have been shown to have a good negative predictive value to rule out cirrhosis.

HCV Genotyping

There is no role for HCV genotyping in the 2018 WHO guidelines as only pangenotypic regimens are recommended. However, as Genotype 3 is the in predominant HCV genotype in Malaysia, accounting for 63% of all HCV in Malaysia, HCV genotyping is still required for cirrhotic patients as the duration of treatment and the need for ribavirin differ according to genotype and treatment experience for certain pangenotypic regimen (eg Daclatasvir/Sofosbuvir)

In the public hospital setting, HCV genotyping is only available in UMMC and Hospital Kuala Lumpur. The test is also available in Institute for Medical Research (IMR).

Assessment of cure and monitoring

HCV RNA test is only required once if used for HCV confirmation and 12 weeks post treatment to assess cure/SVR. For those with cirrhosis, surveillance for HCC is required for life with US +/- AFP measurement, and these are only done at tertiary centres.

If available, HCV RNA quantitative test should be used to assess cure/SVR to save costs.

Strategies to improve access to HCV testing and improve linkage to care

Lack of access to HCV Diagnostic is undoubtedly a major barrier in the HCV care continuum. As recently highlighted, this is fuelled by quasi-monopolies on HCV diagnostics, and the lack of competition has kept prices of reagents at a high price

  • Increase public awareness to identify those at risk of HCV

Engagement with family medicine specialists to facilitate identification of those at high risk for HCV had started since 2014 which have been shown to result in an increase detection and notification of new HCV cases in 2016. These should be strengthened further with the use of rapid diagnostic tests (RDT) for HCV screening of those at high risk of HCV.

In addition, the quest to “Find the Missing Thousands” living with hepatitis C who have not been detected should involve many stakeholders, including NGOs and those living with hepatitis C, to make  testing more accessible and remove barriers for testing amongst them. There is a need to increase public awareness programmes to identify those at risk of HCV and the use of rapid diagnostic tests for HCV screening is recommended in these settings

  • Decentralizing HCV confirmation tests and liver disease assessment

For those tested HCV positive with the initial HCV screening/RDT, reflex HCV confirmatory tests is recommended at the same sitting so these patients are not lost to follow-up.

Nearly 60% of HCV in Malaysia were transmitted amongst people who use drug (PWUD). Mandatory HCV screenings have been conducted in patients with opioid use disorder who are being followed at primary care facilities and medication-assisted treatment (MAT) clinics, with approximately 64% of the 3000 registered patient at government MAT setting annually with slightly higher number of cumulative registered patients at private MAT clinics who are HCV-infected. HCV testing in these settings is limited to anti-HCV test, therefore a large proportion of patients who were tested positive for HCV antibody have not undergone confirmatory HCV testing and liver disease assessment, so these tests should be prioritized at primary care facilities and (MAT) clinics

  • Providing simple HCV diagnostic and treatment algorithm

The recently updated WHO guidelines provides a simple algorithm for HCV diagnosis, treatment and monitoring, which can definitely increase the understanding on the steps needed to achieve HCV cure and monitoring thereafter.

  • Increase access to DAAs and increase treatment sites

Access to generic DAA is only available at 22 MOH hospitals. To reach the goal of HCV elimination by 2030, the government needs to expand HCV diagnosis and treatment services. To achieve this will require moving beyond hospital settings and necessitate the greater involvement of a broad range of health professionals, especially primary-care providers.

  • Efficient procurement and supply management of diagnostics (and DAAs)

Centralised or bulk procurement system or negotiation of cost of HCV diagnostics and DAAs at a national level can translate to more efficiency and lower cost of procurement of reagent and drugs for the government.

The use of using open diagnostic platforms for HCV platforms has been suggested as the way forward to introduce competition and can potentially be very efficient and decrease prices of reagents in the near future. In addition, a nationwide access to generic DAA therapy is urgently needed so that the burden of HCV diagnosis and care management is shared by both the public (including university hospitals) and private sectors.

References

  1. McDonald SA, Azzeri A, Shabaruddin FH, Dahlui M, Tan SS, Kamarulzaman A, Mohamed R. Projections of the Healthcare Costs and Disease Burden due to Hepatitis C Infection under Different Treatment Policies in Malaysia, 2018–2040. Appl Health Econ Health Policy. 2018 Aug 25. doi: 10.1007/s40258-018-0425-3
  2. Ho SH, Ng KP, Kaur H, Goh KL. Genotype 3 is the predominant hepatitis C genotype in a multi-ethnic Asian population in Malaysia. Hepatobiliary Pancreat Dis Int. 2015;14(3):281–6. 5
  3. Freiman JMTran TMSchumacher SG, et al. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med.2016 Sep 6;165(5):345-55. doi: 10.7326/M16-0065
  4. World Health Organization. Global health sector strategy on viral hepatitis 2016–2021. 2016.
  5. Fatiha S, et al. Estimated 3-year acquisition cost of direct acting antiviral (DAA) for the treatment of Hepatitis C in Malaysia in 2018 to 2020. APASL 2018 Delhi
  6. Near-Monopolies On HCV Diagnostics Curb Competition, Keep Prices High, Research Finds

http://www.ip-watch.org/2018/10/24/near-monopolies-hcv-diagnostics-curb-competition-keep-prices-high-research-finds/Accessed 25 October 2018.

  1. Ministry of Health Malaysia. Press Statement Minister of Health 20th September 2017 – Implementation of the Rights of Government for Sofosbuvir Tablet to Increase Access for Hepatitis C Treatment in Malaysia. 2017.
  2. World Health Organization. Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection. 2018.
  3. AASLD/IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. September 2017 Retrieved from https://www. hcvguidelines.org/Treatment-Naive. Accessed 4 September 2018.

Appendix 1

Study Profile

Number of interviews: 15

The interview was conducted throughout Malaysia from the period of end of July 2018 to early October 2018, covering non-medical personals and doctors from the government clinics and hospitals.

Below are the summary of our interviewees profile.

Question 1
Non-Medical Personnel 2
FMS 3
Hepatologist 3
Gastro 1
Total 9

 

Question 2
Microbiologist 2
Patologist 4
Non-Medical Personnel 2
Total 8

 

Notes :

The non-medical personals answered both questions one and two thus we recorded their presence in both column on question 1 and question 2.

Appendix 2

HCV Diagnostic Survey, Malaysia – July 2018 – Summary Report

ACCESS TO DIAGNOSTIC TESTING

Question 1. Please note the availability of the following tests and their prices in the public sector.

Add rows as needed.

Test (Diagnosis) Available in public sector? Length of result Total price (per test) Price paid out-of-pocket by patient Length of result  

Venue of lab & name.

HCV Rapid Test Kit X On the spot        
HCV antibody (HCV Ab or anti-HCV) X Ranges from 1 – 3 days to

1 – 2 weeks

RM20 Nil   HKL
HCV core antigen X Ranges from 2 – 3 days to 1 week or more. RM80 Nil    
HCV RNA PCR X 1 – 8 weeks RM400 Nil   Sungei Buloh
HCV Genotype X 4 – 8 weeks       HKL / IMR
Fibroscan X   Depends on opportunities as 3 years ago was immediately     Selayang

 

Main issues captures from all the interviews are listed below :

  1. Budget allocation in government hospital.
  2.  Not maximising use of the existing Gene Expert Machine.
  3. The length of result available is too long.
  4. HCV RNA PCR, HCV Genotype can not be ordered directly from KK and has to be referred to the hospital specialist.
  5. Not aware about the existing Gene Expert Machine available.
  6. Need to refer patients to hospital for confirmation test (HCV RNA PCR).
  7. Budget constrain especially for HCV RNA PCR is very expensive test.
  8. Further (HCV RNA PCR) testings are based on criteria (selective criteria such as patients who are planned for treatment, co-infection cases) at cost constraint.

Recommendations :

  1. More budget allocation as some may not be repeated cases.
  2. Need integration with TB department.
  3. Government subsidize cost for reagent.

 

Usage of Diagnostic   

Manufacturer

Price procured for the machine.

RM

Cost per reagent /cartridge Number of test requested

per day

Number of test was used per day Number of free testing. Number of out source testing.
HCV Rapid Test Kit SD Bioline/ Others            
HCV antibody (HCV Ab or anti-HCV) Abbott     23 – 40 tests

per day

  40 test  
HCV core antigen  

 

          Available at HKL only
HCV RNA PCR

(for TB usage)*

Abbott/Cobas/

Cepheid

(Gene Xpert)

RM34K – RM80K

per unit

RM70 – RM80

per unit

 

> 50 tests/day 50 tests/day   Malaysia Liver Foundation
HCV RNA PCR

(for IMR)

Cobas   RM200 – RM300   10 – 20 tests per week    
HCV Genotype Abbott/Cobas

 

          30 tests and mostly available at HKL only
HCV Genotype

(for IMR)

Cobas   RM300 – RM400   1 – 5 tests per week (New)    
Fibroscan

 

  RM200K – RM700K   10 cartridges 25 cartridges per week All free No.

* Note:  Gene Expert IV – existing 19 units for TB usage in MoH hospitals, and propose 14 units for HIV/HCV usage, and most of them are on reagent rental contract. Prices are based on procurement through reagent rental. This would also depends on workload such as number of tests performed per year basis. Obviously analyser as an asset would offer lower prices.