FULL USE OF TRIPS FLEXIBILITIES CRITICAL TO ENSURING ACCESS TO MEDICINES AND FULFILLING COMMITMENTS ON UHC

People Living with HIV and Marginalized Communities must be at the centre of all Universal Health Coverage (UHC) related policies, programmes and Discussions

Bangkok, 12 December 2019 – On the International day on Universal Health Coverage (UHC), Asia Pacific Network of People Living with HIV (APN+) calls on all governments in the Asia pacific region to make full use of all flexibilities provided in the WTO TRIPS Agreement to increase access to affordable medicines. APN+ also urge governments to reform patent laws to include these flexibilities and reject TRIPS-Plus provisions in Free Trade Agreements that will delay in accessing cheaper medicines. 

“UHC commitments require our governments to ensure access to essential medicines,” said Shiba Phurailatpam, Regional Coordinator of APN+. “Many of the medicines on the WHO’s Essential Medicines List for HIV, TB and Hepatitis C are patented in many of the countries in the Asia-Pacific region. Using flexibilities in the TRIPS agreement to ensure access to safe, effective and affordable generic medicines will contribute immensely in achieving UHC and funds being used for expensive patented medicines can be used to improve other health care related service. The use of TRIPS flexibilities has been clearly recognized in the Political Declaration signed by all our governments at the UN High Level Meeting on UHC in September 2019,” he added. 

Today, the cost of patented medicines takes up a large chunk of the healthcare budget in many countries and guarantees the profit of big multi national pharmaceutical companies at the cost of lives of millions of people in the developing countries. The pricing, patenting and licensing policies of multi national pharmaceutical companies are resulting in fractured access in Asia-Pacific countries. 

“For the Asia-Pacific region, this is of utmost importance as we contribute large chunk of HIV, HCV, TB epidemic to the global burden, and middle income countries in our region are routinely excluded from price discounts and licensing deals,” said Edward Low of Positive Malaysian Treatment Access and Advocacy Group (MTAAG+). “In Malaysia for instance we have used compulsory licensing to ensure access to affordable Sofosbuvir (HCV drug) in 2017 which has been critical to the rollout of HCV treatment in our hospitals and to help in the research being conducted by DNDI on a new treatment for HCV. The effectiveness of this approach has saved many lives and we call on our government to extend the compulsory license and continue using TRIPS flexibilities to improve our health care programmes,” he said. 

“Countries in the Asia-Pacific region have been global leaders in the use of TRIPS flexibilities,” added Loon Gangte of the Delhi Network of Positive People (DNP+). “In India we have successfully challenged many patent applications on essential medicines ensuring generic availability of these medicines at lower prices. We call on all countries 

in the region to adopt stricter patent criteria to prevent ever-greening patents on medicines and for the use of compulsory licensing to improve availability and affordability. Improved availability and far lower prices of medicines can be achieved through proper, unrestricted generic competition leading to a sustainable price for all kinds of therapy,” he said. 

“Thailand has been a tremendous example for the region in using TRIPS flexibilities to support its Universal Coverage (UC) programme,” said Chalermsak Kittitrakul of AIDS Access Foundation. “Our government issued compulsory licenses on medicines for treating HIV, heart disease and cancer between 2006 and 2008 making savings of millions of dollars for the UC programme that were then used to introduce additional programmes and treatments in our healthcare programme. The use of TRIPS flexibilities is essential to the sustainability of any UHC programme,” he said. 

However, there is also great concern that many countries in the region are negotiating Free Trade Agreements (FTA) that will undermine the ability of the governments in the region to use TRIPS flexibilities. “In Vietnam the FTA with the European Union (EU) has introduced TRIPS-plus measures and we are extremely concerned that these will undermine access to affordable medicines in our country,” said Do Dang Dong of Vietnam Network of People Living with HIV (VNP+). “The Regional Comprehensive Economic Partnership Agreement (RCEP) also has TRIPS-plus demands made by Japan and South Korea. We call on the ASEAN governments to release the text of the RCEP negotiations and reject all TRIPS-plus provisions in the text,” he added. 

“As the regional network of People Living with HIV working for and by people who are most marginalized we urge our governments to put people living with HIV, people with TB, people with hepatitis C and marginalized groups like people who use drugs, sex workers and the LGBTQI communities at the centre of all UHC related policies, programmes and discussions,” added Shiba Phurailatpam of APN+. “The experience with the successful scale up of HIV prevention and treatment programmes has demonstrated that people living with HIV and marginalized communities have the most important expertise in the design and rollout of health programmes and in the use of TRIPS flexibilities to ensure access to medicines for all. Our participation and involvement will contribute in bringing our region one step closer to achieving UHC for all,” he said. 

As people living with HIV, UHC is of particular concern for our lives and health. The Asia Pacific Network of People living with HIV/AIDS (APN+) calls on Governments to: 

  1. Use to the full extent flexibilities provided in the WTO TRIPS Agreement to increase access to medicines, diagnostics and vaccines.
  2. Reject all TRIPS-plus provisions in trade agreement negotiations and ensure that other provisions related to investment, government procurement, competition etc. do not undermine our access to health services and medicines
  3. Ensure that the enforcement of intellectual property does not create barriers to legitimate trade
  4. Ensure people living with HIV and all marginalized population are involved in all UHC related policies, programmes and discussions. 

APN+ also calls on developed countries to immediately cease putting pressure on developing countries when they use TRIPS flexibilities to improve access to medicines. 

***************** Contact:Mr. Shiba Phurailatpam,shiba@apnplus.org, +66 8660 00738 

myhepcservices

We have recently launched the above site for anyone to locate the nearest government clinic or hospital that provide screening, confirmatory test, diagnostic  and also treatment of Hepatitis C.  Please click to the link to check out https://myhepcservices.com/

Baru-baru ini pihak kami telah melancarkan satu laman untuk kemudahan orang ramai mengenalpasti klinik atau hospital kerajaan yang menawarkan perkhidmatan ujian pengesanan, pengesahan, dignostik dan juga rawatan Hepatatis C. Sila klik pautan berikutan https://myhepcservices.com/

 

Universal Health Coverage Day 2019: Who’s being left behind and why?

Ending AIDS by 2030healthy lives and well-being for all, and the ambitious treatment target of 90-90-90, just three of the key commitments made to ensure that everyone has access to HIV treatment and other essential medicines.

Yet despite global and national commitments, along with scientific advancements, millions of people are being left behind. A lack of access is devastating, both on an individual and societal and moral basis. When the drug to save someone’s life exists, no-one should be dying.

The majority of people living with HIV reside in middle-income countries but this is also often where the treatment gap is the largest.

So why? Why are drugs not reaching everyone who needs them?
What stops universal health coverage being achieved?

Our partners, from middle-income countries around the world, share their perspectives and frustrations about what the barriers are; the consequences; and what needs to change:

“We appreciate the commitment made by governments to Universal Health Coverage but achieving it will be a distant dream as long as the cost of medicines remains unaffordable,” says Shiba Phurailatpam, Regional Coordinator of the Asia Pacific Network of People living with HIV (APN+).

“Health care programs in our region are already struggling with the high cost of patented medicines. Whether we achieve UHC now, soon, or after 100 years will depend on how soon our governments bring in affordable generic medicines,” says Phurailatpam.

Achieve UHC? Tackle price and prejudice

Phurailatpam believes a dual-response is required, one which tackles both price and prejudice.

“Though the commitment to UHC exists in theory, marginalized communities in our region continue to struggle to access health care programs. Bringing UHC one step closer will only happen when people who are highly marginalized are put at the centre of all UHC related policies, programs and discussions.”

“We have a lot to learn from the HIV epidemic. The same drugs which used to be more than 10,000 US dollars per patient per year are now less than $100 because of generic production and competition. If we are serious about achieving UHC then we have got to sort out the issue of patented drugs and their high cost.”

Alma de León, ITPC’s Regional Director for Latin America and the Caribbean, agrees: “If we want to achieve universal coverage, drug patents must be eliminated,” de León says. She takes a hard line: “No more patent registration on life-saving drugs.”

De Leon also believes there is not enough take up of TRIPS flexibilities in order to prevent or challenge unmerited monopolies or other intellectual property barriers, something she is working on with civil society organizations in the region, to build on and change the medicine landscape.

Mykyta Trofymenko, Intellectual Property Counsel at 100% LIFE affirms that unmerited patents is also what’s stretching the health budget to breaking point in Ukraine. 

“Evergreening patents seriously obstruct access to medicines in Ukraine. According to 2017 data, one medicine monopolized by two secondary (evergreening) patents takes up a staggering 40% of the HIV budget and more than 10% of the whole state budget for procuring medicine.”

‘Intellectual property’ can at first seem a daunting topic to people without a technical or legal background, but Aissam Hajji, ITPC-MENA’s Advocacy Officer, explains why it’s essential for all health advocates to engage with this issue: “Experience has shown that action taken by civil society has a direct impact on stimulating competition,” he says. “It’s really important for civil society to understand the impact of monopolies on medicines and the important role they can play. Medicines no longer benefit from a status of ‘public goods’ [as Alma would like to see happen], instead they are mere products to profit from. With an absence of competition, these profits are unrestricted.”

It is clear from our work on access to medicines, that the ambitious health targets set cannot be achieved unless we tackle the patent problem. 

The commitments to UHC are being undermined by intellectual property barriers, especially in middle-income countries which are frequently excluded from pricing deals and licenses due to their income classification. However, this can change. Partners of the Make Medicines Affordable campaign are removing barriers and setting precedents to create long-term change. 

Read more at : http://makemedicinesaffordable.org/en/universal-health-coverage-day-2019-whos-being-left-behind-and-why/

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.