THIS IS HEPATITIS-KNOW IT-CONFRONT IT BY THE ASSOCIATION OF PEOPLE LIVING WITH HIV-PAKSITAN

The Association of People Living with HIV (APLHIV) is a nationwide network of people living with and affected by HIV and associated key populations. The APLHIV was founded in 2006 and was commissioned formally in 2008, with its Federal Secretariat located at Islamabad. The APLHIV was established in response to the absence of an appropriate platform to voice and address the human rights issues of PLHIV and other marginalized people and to provide them a quality of life with dignity. The APLHIV also provides an effective and vibrant venue to a wide range of national and international organizations with diverse goals to get together to exchange and share HIV related resources and to engage in partnerships to enhance the quality, coverage and impact of their efforts to combat HIV epidemic and address the issues associated with HIV & AIDS. The APLHIV collaborates with existing national structures, regional partners, community based organizations, local NGOs and international non-governmental organizations [INGOs]. All the activities are taken with a focus on facilitating the HIV community and other key populations to have an easy, affordable and sustainable access to treatment, care and support services.

Pakistan is currently facing an epidemic of viral hepatitis in the country with rapid spread of both Hepatitis B and C in the community. Pakistan Medical and Research Council conducted a national prevalence survey 1in the country to ascertain the prevalence of Hepatitis B and C in the country in 2007. Of 47043 persons screened, the HBsAg prevalence came as 2.4% (95% confidence interval of 2.3-2.6) and anti HCV 4.9% (95% confidence interval of 4,7-5.1), making an aggregate of 7.4% thus showing HBV & HCV exposure in about 12`million population. HBV provincial prevalence showed HBV figures of 2.5%,2.4%,1.3% and 4.3% in Sindh, Punjab, NWFP and Balochistan respectively, while figures for HCV were 5%,6.7%.1.1% and 1.5% in Sindh, Punjab, NWFP and Balochistan respectively.

Among the affected population certain risk groups have much higher concentration such as people who use drugs [PWIDs]. The infectivity of Hep –C is much higher than HIV, leading to very high prevalence of Hepatitis in People Living with HIV especially PWIDs. Co-

Infection is complicated to manage and difficult to treat. The treatment is highly expensive, which is almost un affordable for the co-infected PLHIVs. The available treatment includes “Interferon”, “pegylated Interferon” and “Ribavirin”. The side effects are very common and severe, thus forcing many patients to quit the treatment. With introduction of new medicines to treat Hepatitis C such as Sofosbuvir (Sovaldi) the cure rate has drastically improved but the very high cost of this medicine is simply prohibitive for its widespread use in PWIDs.

Because of very high disease burden of Hepatitis in the country, Pakistan launched the first Hepatitis Control Program in the country in 2005 (Prime Minister Program for control of Hepatitis in Pakistan). Under this program emphasis was laid on both prevention and treatment of Hepatitis B and C patients in the country. After Devolution all provinces are now running their own provincial hepatitis control programs.

Although treatment services are available in the provinces but availability of these services is limited and with no information available to HIV community on how to access these services. There is minimal coordination between Hepatitis programs and National/ Provincial AIDS Control programs.

Treatment of Hepatitis B and C is critical in PWIDs because the course of infection of Hepatitis is much accelerated in PLHIV co-infected with Hepatitis leading to very high rates of liver cirrhosis and hepatic carcinoma. Therefore in order to reduce hepatitis C related morbidity and mortality and to ensure that the investment on ARV is not wasted. It is worth mentioning here, that the Hep-C is treatable and curable disease. The rapid development of new highly effective interferon-free treatments for hepatitis C will significantly change the landscape of hepatitis C treatment around the globe. Gaining rapid access to newly developed and proven treatment, sofosbuvir (an oral nucleotide analog polymerase inhibitor) [Gilead – Sovaldi] will be vital to minimize the longer-term side effects which will lead to reduce the Hep-C burden.

However this treatment needs to be made easily available and its price needs to be cut down to affordable levels. Commercial import and addressing legal issues for its production at country level will assist in achieving the targets. This will be only possible by having a National level Hep-C prevention and treatment strategy in the country. Currently in Pakistan to have access to new treatment involves a lengthy procedure involving Drug Regulatory Authority and Ministry of national Health Services, Regulation & Coordination for getting a no objection certificate, which may not be possible for PLHIV, thus making the new treatment inaccessible to common people. On other hand high prices and advance payments are yet other issues making this treatment inaccessible for common people which are violation of human rights.

1. National prevalence of Hepatitis C and Hepatitis B in Pakistan is 4.9% and 2.4% respectively.
2. Over 12 million people are infected by Hep-C in the country.
3. The epidemic is generalized with concentration in key Populations
4. The highest prevalence rate is in PWIDs.
5. HIV/HCV Co-Infection is found to be over 95% in HIV Community with PWID background.
6. The treatment is highly expensive and almost unaffordable by the PLHIV.
7. The existing treatment of Interferon has severe side effects.
8. Long procedures need to be adopted to have access to new treatment.
9. High prices of both existing and new treatments are almost unaffordable by the PLHIVs/PWIDS.
10. No coordination mechanism exists among HIV and Hepatitis programs
11. Information about the availability of Hep-C treatment is nonexistent.
12. Hep-C is treatable and curable disease.
13. Co-infection is difficult to manage and complicated to treat.

Hepatitis C is a blood borne virus. No validated/updated National surveillance data estimates are available. The APLHIV with the support of APN+ and other partners took an initiative to undertake a mapping exercise to see HIV/HCV Co-Infection among PLHIV with PWID background. The mapping exercise resulted in more than 95% of co-infection. The treatment costs for both existing and new medication are highly expensive and with limited access. The considerable side effect profile of current treatment regimens is mostly attributed to the use of interferon administered as weekly injections, which act as a barrier to treatment uptake. The USFDA approved sofosbuvir (Gilead – Sovaldi) in Dec 2013, which is taken in combination with ribavirin represents the first ever all oral, interferon-free hepatitis C treatment. This medicine is now available on much reduced prices in Pakistan through private sector, but still un affordable by majority of the people in need.

The Government must initiate processes to ensure ready, easy and affordable access to new treatments for hepatitis C by committing to fast-tracking new hepatitis C treatments through government approval processes.

To achieve impacts with such an improved treatment of hepatitis C, it is important to strengthen existing health system that could ensure an efficient system of treatment, support services and treatment follow-up especially with PWIDs. With almost 95% prevalence of HCV in PLHIV with PWID background, this will be particularly important to ensure access to treatment for hepatitis C to this population. This will require collaborative work to inform, prepare and resource the health and community care system including; treatment awareness programs; specific models of care tailored for population groups; development of clinical protocols; integration of HIV/HCV treatment in HIV Treatment Centers, health professional training, links to community based services for complementary information and support and effective involvement of community based organizations in referral mechanism.

To reverse a growing burden of HCV/HIV Co-Infection, rising new infection and rising death toll from hepatitis C, new hepatitis C treatments must be made available to the patients in general and to the PLHIV community in particular. Otherwise the investment being made in provision of ARVs may reverse. The APLHIV-Pakistan believes that the Government should:

Most of new infections occur among PWID, yet access to sterile injection equipment and other HCV prevention tools is alarmingly inadequate, awareness lacking and treatment highly expensive. This failure allows the epidemic to continue spreading especially in PWID community. This community, co-infected with two deadly infections lives a life which is almost below or near to poverty line, having minimum access to affordable diagnostics, care, and treatment.

Pegylated interferon (PEG-IFN), the backbone of HCV treatment, is priced out of reach and new medications are even more expensive and subjected to lengthy procedures. The PWIDs are subjected to double stigma thus making the access to diagnoses and treatment much harder. Therefore, the APLHIV, a representative body of HIV Community and Key population and our advocates, call on the governments to act with urgency to ensure easy and affordable access to new HCV treatment; this is possible!

The APLHIV also urge the government to take necessary steps for integration of HIV/HCV Co-Infection treatment within the HIV Treatment centers to ensure easy access to treatment and to facilitate the management of co-infection.

In Pakistan conventional interferon + Rivavirin combination therapy is considered to be the 1st line treatment since 1998. Mostly patients and their families pay for the treatment. Six months treatment costs about 700 USD to 4000 USD depending on the combination. The duration of treatment ranges from 24 to 48 weeks but with severe side effects and drug interaction. Due to high prices, access to current HCV treatment is virtually nonexistent for most people living with HIV/HCV Co-Infection. This cost is unmanageable when approximately 45% PLHIV are found to be unemployed and those who are employed have an average income of Rs.8000/per month, thus, making the treatment for PLHIV inaccessible. The manufacturing of current treatment is being undertaken by only one (1) company which is one of the major causes of high prices. Manufacturing and supply sources are needed to create competition that will lead to reduce the prices. . In Egypt, for example, a locally manufactured alternative pegylated interferon, Reiferon Retard, has been available since 2004. Market competition has supported a six fold reduction in the price. This is the lowest price in the world, and demonstrates that substantial price reductions are possible if there is competition.

The new treatment is yet to be introduced commercially in Pakistan and its price is even higher than of current treatment available. Approximately 300,000 Rs per patient are required and to be paid in advance, which leaves the poor patients cruelly out of any chances to be treated.

1. Therefore, the APLHIV calls on the government to take necessary legislative measure to ensure a competition to bring down the interferon prices and facilitate manufacturing of injections at large scale level opening the venues for more pharmaceutical companies for production.
2. The APLHIV also calls on the government to introduce a policy based on “Patent opposition and Compulsory licensing”. Issuing a compulsory license (CL) allows generics producers to produce affordable drugs, despite patents. The use of compulsory licensing is recommended in the WHA’s 2010 resolution on viral hepatitis: “to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights [TRIPs] in order to promote access to specific pharmaceutical products.” LMIC governments that elect to issue CLs must not be threatened or punished—with sanctions or by other means—by governments in upper-income countries.

An estimated number PWID is 104,8042, with over 37% of HIV prevalence among PWIDs. Out of these PLHIV with PWID background over 95% are co-infected by HIV and HCV3. The proportion even goes higher if we do not work out the co-infection, that means PWID are disproportionately affected by hepatitis C and requires an urgent attention of Health policy makers and implementers for massive upscale of harm reduction services across the country. Implementation and scale-up of evidence-based harm reduction programs, particularly NSP and OST have successfully lowered the rate of HIV infections among people who inject drugs around the globe. All the countries in the region are best practicing the OST services including Islamic Republic of Iran and Malaysia. The constitution of Pakistan, ANF act and the Hodood ordinance also allows the use of OST. In addition similar actions should be taken to control HCV, which is 10 times more infectious than HIV. In fact, the vast majority of people living with HIV/HCV co-infection acquire both viruses because they do not have access to sterile injection

equipment. Although antiretroviral therapy has extended the life expectancy of people with HIV/AIDS, they remain vulnerable to liver disease from HCV—in fact, it has become a leading cause of death among HIV-positive people. HIV accelerates HCV disease progression, and more than triples the risk for liver disease and liver failure.

Therefore, the APLHIV demands: –

1. Governments must make it a priority to screen and treat people who inject drugs and people with HIV co-infection on regular bases. This can be best done by integrating HIV/HCV testing and treatment facilities at the HIV treatment centers.
2. Give HCV/HIV Co-Infection, a National priority, in the post-2015 health agenda, and provide adequate resources for a continuum of hepatitis C prevention, treatment, care, and support programs for all who need these services—especially people who inject drugs and who are co-infected.
3. Ensure access to affordable HCV treatment to all and especially to coinfected PLHIVs, who currently lack access, by importing cheaper generics and making a policy based “Patent opposition and compulsory licensing”.
4. Ensure that people who use drugs are not excluded from these lifesaving services including OST and HCV treatment.
5. Meaningfully involve civil society—specifically DUNE, Nai Zindagi and the APLHIV, in the creation of tailored hepatitis C control plans, in the design, implementation, and monitoring of these programs/services.
6. The APLHIV also calls on the CCM and the GFATM to look into the possibility of including HCV management into its fold to ensure maximum benefits of its investment on ART/ARVs.

Reportedly, the new treatment, sofosbuvir (Sovaldi) manufactured by an American company Gilead, has been introduced in Pakistan, though on a very limited scale and on non commercial bases. The Feroze Sons has been authorized by the Government to facilitate the treatment. Under the agreement, a patient has to undergo a lengthy process to have access to this new treatment, which starts with prescription by a physician, no objection certificate by Drug Regulatory Authority, approval by the MNHSR&C and feeding the patient’s details into web portal by Feroze Sons. This process is not only very lengthy but it may lead to compromise the confidentiality of the patient, which may be against fundamental human rights. It must be ensured to respect and protect informed consent, confidentiality and the right to privacy concerning medical testing, treatment or health services rendered.

Therefore, the APLHIV firmly demands:

1. It must be ensured that during this entire process the personal information is not accessible to non health people/organizations.
2. It must be ensured that the consent of the patient is sought before even sharing the data with all the departments involved within the mechanism.
3. It must be ensured to respect and protect informed consent, confidentiality and the right to privacy concerning medical testing, treatment or health services rendered.

As mentioned above, access to new treatment involves a lengthy process, which might hinder the Co-Infected PLHIVs/PWIDs to benefit from the treatment. With 56.3% of HIV+ females and 27.5% of male HIV+ with no formal education at all are not expected to easily understand the lengthy process to seek the treatment. The procedural delays will retard efforts to seek the benefits of new treatment.

Therefore, the APLHIV calls on the Government to:

Ensure that the NGOs, CBOs, involved in provision of services to [including the APLHIV] Co-Infected PLHIV/PWIDs must be engaged in a meaningful manner for provision of care, support and referral services and to ensure the continuum of treatment.