This report was prepared as part of the project ‘Access to Hepatitis C treatment in Russia: situation assessment and recommendations for action’ funded by Open Society Foundations.
Authors: Stela Bivol, Anya Sarang
Although the incidence of hepatitis C virus (HCV) in Russia is extremely high, posing one of the biggest threats to the national public health, access to treatment of hepatitis C in the country remains limited. On the one hand, the government acknowledges hepatitis C as a socially significant disease and commits to providing free treatment for those in need, but on the other hand, treatment programs receive minimal funding at the federal and local levels, and the country does not even attempt to lobby for reduced prices for medications. In the absence of a special governmental treatment program, patients have to pay for their treatment, although not many people can actually afford a full course that significantly exceeds an average salary.
Despite the urgency of the problem, Russia has yet to conduct a systematic research that would assess hepatitis C prevalence, treatment needs, availability of medications, legal provisions and the level of access to HCV treatment. Such research is needed if the country wants to harmonize its approaches to achieve exponential growth of access to hepatitis C treatment and optimize its advocacy priorities.
The aim of this research is to describe processes around access to HCV treatment in the Russian Federation.
Research methods: review of scientific papers, collection of epidemiology data, in-depth interviews held in three regional centers (Yekaterinburg, Barnaul, Togliatti) and at the federal level with patients who started and/or finished hepatitis C treatment (n=21), as well as with doctors who prescribe and manage treatment (n=5) and experts (n=4).
At least 5 million people in Russia are infected with hepatitis C (approximately 4.4% of the whole adult population), of which, according to various estimates, 1–2 million people urgently need treatment. Despite the lack of official statistics on HCV prevalence and treatment needs in the population, one can estimate approximate proportions of the problem based on available data. According to the Central Scientific Research Institute of Epidemiology, Russia is home to 5 million people who live with hepatitis C. Even following the most conservative estimates, a total of people who tested positive to hepatitis C antibodies in the country is over 1.5 million. Similar figures (1.1–2 mln people) are reported by the Federal Service for Protection of Consumer Rights and Personal Wellbeing. According to international sources, 20–40% of people with hepatitis C may develop cirrhosis or cancer of the liver, and these patients should be treated in the first place. Already now, 1–2 million people out of the 5 million affected need to start treatment as soon as possible, while others should be treated as their disease progresses. Apart from high HCV prevalence, the spread of chronic hepatitis C is another concern, with figures as high as 40.2 per 100,000 reported for 2010 (a three-fold increase compared to 1999), prevailing in people under 40 years of age.
Hepatitis C in Russia mostly affects people who inject drugs (PWID), among which, according to the most conservative estimates, as much as 1.3 million people are infected. Sentinel surveillance data show extreme HCV prevalence rates among PWID, in some cities ranging from 45% to 90% (mid-range estimate – 69%). According to UN Reference Group, estimates of the number of IDUs living with HCV in Russia range from 985,500 to 1,770,250 (2008), with a mid-range estimate of about 1.3 mln (2011).
According to the Central Scientific Research Institute of Epidemiology, up to 30–40% of Russian patients are infected with hepatitis C genotypes 2 and 3, which better respond to treatment with pegylated interferon and ribavirin. About 50% are infected with genotype 1b. Genotype determines treatment effectiveness and its outcomes. Patients with genotype 2 and 3 are prescribed 24-week courses of treatment, while genotype 1b requires a 48-week course.
According to international guidelines, treatment should be provided to all HCV-infected people with detectable virus activity. To identify clinical indicators and address them properly and in due time, all patients should be offered preliminary examination: an IFA test (to detect HCV antibodies), a clinical blood analysis (total bilirubin, ALAT, AspAT, total protein, amylase, blood urea nitrogen, glucose, etc.), an ultrasound investigation, RNA tests (qualitative and quantitative), HCV genotype test, puncture biopsy and elastography of the liver.
Russia doesn’t have an integrated registry of patients in need of hepatitis C treatment. Until now, full clinical examination has not been offered to patients registered in infectious clinics, regardless of the region. As a result, treatment needs have not been assessed on the basis of clinical indications. Russia’s system of epidemiological monitoring and surveillance is underdeveloped, which makes it near impossible to realistically evaluate the total number of chronic hepatitis C (CHCV) cases and treatment needs in this respect. Until 2011, Russia’s system of monitoring was segmentary and failed to incorporate the whole of laboratory data, so it was difficult to give adequate national estimates related to treatment needs for more than a million of registered HCV patients. To improve the situation, a special Reference Center was created in 2011, tasked with functions of HCV diagnostics, prevention, provision of technical support to the regions in the sphere of disease control, and a situation analysis held on the basis of an integrated computerized patient registry (in several regions this project is still at a pilot stage).
The main source of funding is the Priority National ‘Health’ Program that offers HCV treatment for people living with HIV. Currently, no federal program exists in Russia that would cover clinical examination and diagnostics needed to prescribe treatment to all patients who need it. The main source of funding for hepatitis C treatment of the Priority National ‘Health’ Program that involves several activities in the field of diagnosis, prevention and treatment of viral hepatitis B and C, but only for people living with HIV. In 2008–2012 Russia allocated 8.4 billion rubles to purchase pegylated interferon, linear interferon and ribavirin, which provided for 18,881 48-week treatment courses with pegylated interferon. In 2012, HCV treatment program was downsized, which led to reduced amounts of procured medications and a 30% decrease in treatment coverage (ITPCru, 2012). Indicators for HCV treatment availability beyond 2012 have not been set, as the national program has yet to be updated, and no short- or long-term plans in this respect are currently available.
The Priority National ‘Health’ Program provides treatment to less than 10% of PLHIV who need treatment for Hepatitis C. Even though people living with HIV is a priority group for this national project, HCV treatment coverage remains extremely low. According to quantitative data published at research websites (as federal-level data is not available), from 2008 to 2011 only 5% of patients with HIV/
HCV co-infection received treatment in Togliatti, and 8% – in Altay region and Yekaterinburg.
Injecting drug users are excluded from treatment programs. Low treatment coverage of patients with HIV/HCV co-infection is related to the fact that people who use injecting drugs are often refused treatment. In all the surveyed regions, internal regulations prohibited AIDS Centers from enrolling people with drug dependency into treatment programs. This is common practice in Russia, although such an approach is not based on any scientific evidence. As a result, treatment is not provided to those patients who need it most. When dealing with people who use drugs, doctors usually offer them hepatoprotectors or advise to stay off drugs for 6 or 12 months. But in the absence of effective drug treatment programs, up-to-date rehabilitation centers and support mechanisms, this requirement is not feasible for most PWID in Russia.
Legal ban on methadone and buprenorphine substitution therapy programs leads to exclusion of people who use drugs from treatment programs. All over the world, opioid substitution treatment programs involve people with drug addiction in hepatitis C treatment programs and help encourage adherence to treatment. In Russia, OST programs are officially prohibited. As a result, doctors fail to prescribe antiviral treatment to CHCV patients who use drugs, on the grounds that they won’t be able to follow their treatment regime.
High cost is the main barrier to expansion of CHCV treatment. Pegylated interferon is in general a very expensive medication due to oligopoly of two original brand drugs. Yet, several countries (such as Egypt and Brazil) successfully lobbied ten-fold reductions in prices, while others introduced compulsory licensing to produce biosimilar medications (India and Vietnam). In Russia, HCV treatment drugs are purchased at high cost, and the government does little to advocate for reductions. According to the federal procurement documents for 2012, the price for a standard 48-week treatment course varied from 292,402 rubles (9,366 USD) to 419,199 rubles (13,427 USD).
Health facilities in Russia are not ready for expanded hepatitis C treatment. Within the Priority National ‘Health’ Program, people living with HIV/HCV are usually treated by AIDS Centers, although in some cases patients are referred to local polyclinics. Regional activities aimed at strengthening and maintaining human resource capacities are basically non-existent, which results in the health system failing to address HCV treatment burden even in the context of minimal access to treatment. Infectious diseases specialists often lack adequate training to manage HCV patients: when piloted, PNP did not involve staff enhancement, and additional training was offered only to small proportion of medical specialists. Besides that, the system fails to determine officially at which level hepatitis C treatment should be provided. HCV treatment in some regions is considered a highly specialized medical intervention owned by in-patient hepatology facilities, whereas in other regions HCV care is an outpatient service provided by local polyclinics.
Medication control is a complex and bureaucratic procedure, therefore many doctors refuse to deal with HCV treatment. Medical staff have to fill in numerous forms that are part of the medication control procedure, and some hepatology centers have refused to provide treatment to avoid these complications. Moreover, medications are usually stored at AIDS Centers, and not in pharmacies, to be distributed by doctors personally. On the grounds of medication storage conditions and rules against unauthorized use, some facilities require that patients receive their weekly injections in the clinic, which is inconvenient and even problematic for some of them.
Doctors fail to inform patients about the recent HCV treatment methods, which results in low treatment uptake. Few people living with hepatitis C know about availability of up-to-date antiviral treatment. Post-test counseling for patients with HCV is usually a mere statement of diagnosis. Most respondents haven’t heard about any treatment options from their doctors. In most cases, doctors only prescribe hepatoprotectors, the use of which is not scientifically grounded and financially burdensome.
Treatment demand is limited by high cost of preliminary tests required for the prescription of treatment. As stated in the PNP ‘Health’ guidelines, preliminary clinical examination for future participants of treatment programs should be paid from the regional budgets, but due to severe underfunding most patients have to pay for the testing themselves. The standard package of specific laboratory tests costs from 3500 to 8000 rubles (depending on the test), and another 4000–6000 rubles is required to have elastography of the liver.
Russia does not have clinical protocols for hepatitis C treatment. Although in March 2013 clinical guidelines were approved, absence of official clinical protocols makes it impossible to develop unified patient selection criteria and provide quality treatment. With no federal-level treatment protocols available, the regions develop local regulations, define their own treatment eligibility criteria or refer patients to the local treatment commissions to decide on patient selection.
Patient selection criteria are very subjective, the most common requirement being ‘treatment should be provided only to socially reliable citizens’. The process of patient selection varies from region to region is managed by individual doctors, thus lacking objectivity. AIDS Center specialists often add their own criteria of ‘urgent patients’, according to which patients who have other problems besides CHCV do not get a full clinical examination required for the prescription of comprehensive treatment – for example, addressing also hepatitis B, tuberculosis and other co-infections. Thus, doctors select only among patients ‘worthy of treatment’ who, in their opinion, are capable of adhering to complex medication schemes. The lists of contraindications used by healthcare specialists are not always in agreement with international recommendations.
Instead of reflecting the actual treatment needs, regional requests for certain amounts of therapy kits submitted to PNP ‘Health’ are based on the assumed federal budget and limited capacities of the AIDS Centers. Regional healthcare authorities take various approaches to preparing annual requests for medications as part of the national ‘Health’ program. Some regions report that they divide between medical facilities the quotas set at the federal level, and local doctors then prepare estimates of how many patients would be sent for preliminary examination this year. Other regions are reportedly able to obtain as many medications as they request, and their doctors decide themselves on how many patients they can treat the coming year.
In both cases, therapy lists are based not on the number of tested patients in need of treatment, but on various subjective factors.
Hepatitis C treatment is basically not available to HIV-negative patients. While patients with HIV at least theoretically have a chance to get HCV treatment, the situation for HIV-negative individuals looks quite bleak. Russia does not have a federal program to treat HCV, and although some regions initiate their own treatment programs that address monoinfections, they are able to treat very few patients, whereas the demand is calculated in thousands or even tens of thousands. In the absence of governmental funding, HCV treatment often has to be paid by patients. To treat genotypes 2 and 3, doctors sometimes offer linear interferon to patients who cannot afford pegylated interferon, which is considered sub-standard according to international approaches.
- Develop federal-level clinical protocols for treatment of viral hepatitis C, mandatory for all regions of the Russian Federation.
- Develop and approve a separate federal program for treatment of viral hepatitis C as a socially significant disease, including the provision of therapy, all the necessary pre-examinations, treatment monitoring and medications against side-effects.
- Develop standards of outpatient treatment, including detailed description of the procedure and the levels of service provision, as well as workload standards for doctors and other healthcare specialists.
- Facilitate inclusion of people who use drugs in hepatitis C treatment programs. Reverse regional norms excluding drug users from treatment programs. Provide client management services for people with drug dependency (social and psychological support, self-help groups) to improve adherence to treatment, enhance patient motivation and address other specific needs.
- Legalize methadone/buprenorphine substitution therapy programs in Russia in order to safeguard treatment adherence in patience with opioid dependency.
- Reduce the cost of pegylated interferon procured by the government through implementation of adequate price reduction mechanisms: modifying procurement procedures, negotiating with manufacturers, reducing initial auction prices – or introducing compulsory licensing and local production of medications that have social relevance and the lack of which can be catastrophic for public health.
- Introduce an integrated registry of patients with hepatitis C as a tool to evaluate treatment needs, and register all patients with HCV, irrespective of their social status, risk factors or co-infections.
- Enable training possibilities for the medical staff in order to decentralize treatment provision: from infectious diseases doctors in specialized institutions to infectious diseases doctors within the primary network, including the delivery of medications through pharmacies.
- Scale up demand and raise patient awareness through the provision of quality counseling (including post-test counseling) by specialists and peer educators, as well as through the creation and maintenance of patient schools.
- Expand harm reduction projects (needle and syringe exchange, outreach-programs) to ensure timely diagnosis and involvement of people who use drugs in treatment programs.
- To patient organizations and groups: actively advocate for increased access to treatment, including through strategic litigation and peer education.
Categories: Hepatitis in Russia | Tags: access to treatment, Anya Sarang, ARF, drug users, HCV, hepatitis C, Russia | No comments »