Missing the Target: Access to Treatment for People Living with HIV - Latvia
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27.03.2010

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Research process and methodology

 

Research for this report was conducted between November 2009 and January 2010. It consisted of an extensive literature and policy documentation review; a review of letters from PLHIV; and in-depth interviews with a total of 18 people. They included HIV/AIDS program managers; health care workers and service providers; representatives from the Ministry of Health (MoH), Ministry of Justice, international organizations, and NGOs working in the HIV advocacy field; and eight PLHIV.

 

1. Overview of country situation regarding HIV treatment access

 

The first HIV-positive person in Latvia was not registered until 1987, when the country was part of the Soviet Union. The number of HIV cases was relatively low over the next decade, with most transmissions attributed to sexual contact (the majority of them among MSM). In 1997, however, HIV started spreading rapidly among IDUs, a community in which it reached epidemic levels within a couple of years.

The number of registered known new infections reached a high of 807 in 2001; of those individuals, more than 80 percent were IDUs. Since then the registered number of new infections has decreased annually. The most recent data (for the year 2009) shows the lowest number— 2752—of new HIV registered cases in one calendar year since 1999. The share of new infections attributed to injecting drug use has declined in recent years, but observers do not agree on whether this means the epidemic is no longer concentrated in that population. A WHO mission report from 2009 concluded that the Latvian HIV epidemic remains concentrated among IDUs and their sex partners, but some Latvian specialists consider the epidemic to have become more generalized.

HIV and AIDS rates in Latvia are among the highest in the European Union (EU). The HIV incidence rate in Latvia in 2008 was nearly three times higher than in the EU overall: 157.6 per million population compared with 60.6 per million. By the end of 2009, a total of 4,614 HIV cases had been registered in the country since 1987. Around 60 percent of the total are among former or current IDUs.

About two-thirds (3,082) of the 4,614 people officially registered as having HIV are also registered with the Latvian Infectology Centre (LIC). This means that about one-third of all Latvians who have tested positive for HIV have not sought out treatment at the only facility in the country that provides specialized care for HIV infection.

Many of the individuals who are registered at the LIC are co-infected with other serious infections. Most notably, nearly two-thirds (1,888) of registered patients have also tested positive for hepatitis C, a virus that is common among IDUs. Smaller but still significant levels of co-infection have been recorded in regards to hepatitis B (250 patients) and TB (72).  

Diagnostic tests such as CD4 and viral load are free of charge for patients in Latvia. 

 

Universal access

Government officials have not specified universal access targets. The National HIV/AIDS Strategy does state that all in need (100 percent) should receive HIV treatment, including ART, treatment for OIs, and social services for those on treatment. Yet neither that plan nor other relevant policy documents actually indicate how “those in need” is defined.

Estimates vary widely in the absence of specific definitions. According to representatives from one NGO the number of persons currently in need of ART who are not receiving it is at least 130. They add that ideally, assuming the clinical threshold for ART initiation were raised above its current CD4 level of 200 cells/ ml, the number of persons who could be eligible for treatment and would benefit from it might be between 1,000 and 1,500. As one noted:

For a small country such as Latvia, at least one-third of people living with HIV should start receiving treatment when their CD4 counts drop below 500. Clinical research studies suggest better outcomes, including a decreased likelihood of developing resistance to drugs, if treatment is started at an earlier stage.

According to the some treatment specialists, meanwhile, there are around 800 people who need treatment. If true, that would mean that, as one said, “ART is received by roughly one-half of persons who need it”.

 

2. Sources of HIV treatment delivery and other related issues

 

Currently there is only one facility in Latvia, the LIC, that provides a comprehensive suite of services free of charge for HIV-positive people—including provision of ART, HIV-specific diagnostic tests, treatment for OIs and social support. In 2007, a total of 328 patients were on ART through the LIC; by January 2010, that number had risen to 439 individuals (including 26 children). Of that total, 189 (43 percent) were IDUs and 301 (69 percent) were male. The data on IDUs suggests that members of this vulnerable population are far less likely to be on ART. They comprise about two-thirds of all people who have ever tested positive for HIV, yet their share of PLHIV on ART is much lower.

Of the 439 PLHIV receiving ART through the LIC, a total of 35 PLHIV were receiving it in prisons (as of the end of December 2009). At the time data for this report was being collected, 20 HIV-positive pregnant women were receiving ART as part of an effort to prevent vertical transmission.

In Latvia, ARVs used in treatment are primarily originator brands and no generic medicines are being used. In January 2010, a total of 75 ART regimens were potentially available in Latvia.13 The most commonly used first-line treatment regimen was efavirenz (EFV) in combination with lamivudine (3TC) and zidovudine (AZT), which was prescribed to 203 patients as of 1 January 2010. In total, first-line treatment regimens were prescribed to 312 patients, or 71 percent of all people on ART.

 

Table 1. Most commonly used first-line ART regimens in Latvia 

	1 March 2009 (number of patients on each)	1 January 2010 (number of patients on each)
EVF+3TC+AZT	139	203
EFV+ABC+3TC	41	54
ABC+3TC+AZT	10	16
EFV+3TC+d4T	11	12
EFV+3TC+ddI	10	7
Other first-line treatment regimens	14	20
Total	225	312

 

Second-line ART as well as first-line treatment is free of charge to patients. As of 1 January 2010, a total of 110 patients were prescribed second-line ARVs. The most commonly used second-line treatment regimens were those involving lopinavir/ritonavir (Kaletra): regimens with that medicine were prescribed to 50 patients, and commonly it was used in combination with 3TC and AZT. (An additional 17 persons were on an individual “salvage” treatment regimens.) 

In Latvia, a total of 25 medicines are being used in ART and provided free of charge by the government. This compares favourably with neighbouring Estonia, for example, where only 13 first- and second-line medicines are available free of charge. In March 2009 LIC had suggested that within the limited health budget the minimum list of first and second-line ARVs, which are provided free of charge for patients, should be set and alternative ARVs (more expensive) could be bought by patients in pharmacy.  On the other hand interviews with NGOs and with doctors reveal that “patients should be treated with the best medicines and doctors should not look into the costs”.

The most recent developments in the field of HIV treatment suggest that as of January 2010 the medicines used in treatment were included in the list of reimbursement medicines. Within the new reimbursement system a price is set as negotiated with pharmaceutical companies and is lower (3rd lowest in EU) than that paid by tendering the medicines in previous years. For example, within the new reimbursement system ART costs have dropped significantly, which are still high as compared with other middle income countries, and the very high number of treatment regimens do not allow for getting better prices.

 

Table 2. Costs of most often used ART treatment regimens in Latvia, LVL per patient per year

	1 March 2009	1 January 2010
EVF+3TC+AZT	3714	3170
EFV+ABC+3TC	4623	3899
ABC+3TC+AZT	4752	4626
EFV+3TC+d4T	4031	3431

 

Under new HIV treatment guidelines, patients can obtain a one-month supply of ARVs at the pharmacy of their choice. (Those who have demonstrated regular adherence can, if their doctors approve, receive a three-month supply each time.) Perhaps more importantly from the standpoint of simplified access to HIV treatment, the system is slowly changing towards a more decentralized approach. This means that although the treatment regimen still can be set only by the medical council at the LIC (consisting of four doctors), medicines can be prescribed by infectious diseases specialists throughout the country once a month. Moreover, negotiations with general practitioners have started so that general practitioners (GPs) can prescribe medicines, a step that would make ART even more accessible across Latvia. 

There are some concerns, however, about whether decentralization will be effective, at least initially. Respondents to this study identified current and potential obstacles, including the following: lack of specialists in many regions of the country outside of Riga, and many GPs’ unwillingness to be involved in HIV treatment.

The first obstacle may in fact be easier to address because it is simply about numbers. The second, though, is more complicated. Many primary care providers are reluctant to treat PLHIV because they have insufficient or limited knowledge about HIV in general or treatment specifically. Some, however, would rather not be involved with PLHIV because of the stigma associated with illicit drug use. Their actions and behaviour raise serious concerns about HIV-related human rights violations.

A final notable point about HIV treatment sources is worth noting. Recent policy changes also allow NGOs to apply for funding for social care for PLHIV from municipal budgets. According to respondents, most NGOs consider this a good idea but are not certain as to how useful it will be. Their uncertainty stems from lack of clarity so far as to whether the available funds would be sufficient for them to hire full- or part-time staff to provide such services on their own.

 

3. Factors influencing access to treatment

 

Numerical limits on ART access. The LIC’s medium-term strategy (2005–2009) placed implicit caps on ART access. It specified that with initial levels of funding (in 2005), the government would be able to support ART provision to a total of 250 individuals—and added that with additional funding, up to 470 people could receive treatment. Advocates consider such prescribed limits to be a major obstacle to efforts to reach real universal access in Latvia. They also believe the limits essentially make it impossible for the government to meet its vow to provide treatment to everyone in need—a vow that was made with no specific indication of numerical limits for any reason whatsoever. 

IDUs’ access to ART. As noted earlier, IDUs’ share of all HIV infections has declined over the past few years. However, the longstanding association of the epidemic with IDUs and their sex partners has led to some controversial policies over the years based on persistent drug use-related stigma and discrimination across society.

For example, until recently active drug use was a contraindication for access to ART through the government health care system. Officially that is no longer true: the new pharmacological HIV treatment recommendations developed and revised in 2009 by the Centre of Health Economics specifically exclude drug use as a factor in deciding whether an individual is eligible for receiving ART. The change in policy has not necessarily changed health care providers’ attitudes and behaviour, however. Many respondents note that stigmatization and discrimination of drug users remains extensive among the general population as well as among specialists. As one respondent noted, “On paper the guidelines have changed, but do you think the situation has changed in reality?”

Care and treatment for HIV-positive IDUs in prisons. IDUs’ share of the prison population is, perhaps unsurprisingly, several times higher than their share in the general population. Many are HIV-positive, and many continue to use drugs while incarcerated. Since 2006, Latvia and its Baltic neighbours (Estonia and Lithuania) have received funds through a United Nations Office on Drugs and Crime (UNODC) project aimed at reversing the spread of HIV among IDUs in prison settings. The project not only helps support ART provision, but also helped create programs to provide methadone maintenance treatment to both HIV-negative and HIV-positive drug users. Project grants also support health education activities among inmates and prison personnel. These efforts have helped increase uptake of key health services, including HIV testing.

 

4. Opportunities and challenges

 

This section summarizes two of the major challenges to improved and enhanced HIV treatment scale-up in Latvia.

1. Government budget cuts for ART provision

Latvia has been hit particularly hard by the global economic downturn. Unemployment has surged and its gross domestic product (GDP) has fallen by double-digits over the past two years. In response to the crisis, the government has embarked on a fiscal austerity plan that emphasizes severe spending cuts across the board. Its spending on health and HIV services has not been spared.

The government’s reimbursement system for medicines does not have a separate budget line for ARVs. However, its annual budgets are based on estimated costs for ART provision. The most recent budget, for 2010, allocates total spending for the system of about 1.20 million LVL ($2.32 million). That budget was calculated based on 365 patients receiving ART, a number far less than the 439 people currently on treatment. As a result, advocates are concerned not only that treatment scale-up will be halted, but that some people currently on ART will be dropped due to lack of funds.

In response to advocates’ concerns, health officials have said that ART will continue to be provided free of charge to all in need. They have not yet stated, however, how they intend to keep their guarantee in light of the restricted budget. Among the options reportedly being considered by both government officials and advocates are:
i) removing legal and patent-related barriers to the import and use of cheaper generic medicines, perhaps by using flexibilities in the World Trade Organization’s TRIPS agreement (which Latvia has signed)20;
ii) seeking support from other EU member-states that are not facing such significant economic decline; and
iii) applying for assistance from global agencies and initiatives such as the Global Fund, a step that would require special permission because of Latvia’s EU status and relatively high per capita gross domestic product (GDP).

Although officials say they will not revoke ART from anyone already receiving it, they have implemented some policies in response to the budget crisis that will have the effect of limiting HIV treatment scale-up. For example: New regulations at LIC require patients to present a valid passport every time they visit the centre. This can be problematic for people who for one reason or another do not have valid documentation. According to some NGO respondents, a handful of people on ART have had difficulty obtaining ARVs since the new regulations were passed.
The new HIV treatment recommendations state that “within the limited health care budget possibilities the level of CD4 to initiate treatment is 200 cells/ml”, which is much lower than the new WHO recommended level of 350. That decision holds down the number of people in need of ART, according to the government’s clinical definition. Yet it represents a major threat to the health of hundreds of Latvians who could conceivably benefit from initiating treatment at an earlier stage in disease progression.

2. Limited interaction of ART and drug-treatment services

Recent policy decisions to expand access to methadone maintenance treatment suggest that drug-treatment specialists’ attitudes are changing for better and drug use-related stigma in the medical and social care fields is declining. This is an important trend, but integration of HIV care and drug-treatment services—both important for HIV-positive drug users—remains limited.

This lack of integration makes it far less likely that members of the population most vulnerable to and affected by HIV (IDUs) are able and willing to access both crucial services in the most convenient and effective way possible. IDUs are less likely to be on ART in the first place and are more likely to be non-adherent to ART and to drop out of treatment altogether. As one HIV specialist observed, that is because “we do not have access to this population”.

One potentially useful step would be to allow HIV treatment (including ART provision) to be provided directly by “medium level” medical personnel at low threshold centres for drug users. Those individuals could also be trained to help guide IDUs to HIV testing; to initiate HIV treatment, if deemed necessary; to provide adherence support; and to provide referrals to social and legal services used by PLHIV. 

 

5. Recommendations

 

National government
For the reasons of public health and human rights of PLHIV government should ensure funding for ART should be increased annually (and becoming adequate) covering all patients in need for treatment.
National government should ensure that activities stated in the National HIV Strategy receive adequate funding for their implementation.
Government should ensure generic ARVs were available in Latvia (thus lowering ART costs per patient and allowing inclusion of more people in treatment) by making necessary amendments in the legislation and by employing flexibilities in TRIPS agreement such as parallel importing and compulsory licensing

Ministry of Health
Stakeholders – MoH, CHE, LIC, NGOs – should agree on one, clear set of values, priorities and principles to guide the HIV treatment and care response in the future, including estimates, the number of people in need for treatment, UA goals and targets.
MoH must carry into effect the direct order by Prime Minister on allocating funding for the NGO-run activities on annual basis.
National HIV coordination commission twice a year should analyse risks, gaps, problems and new developments arising in the implementation of the National HIV/AIDS Strategy and decisions for improvements should be made.
MoH should fund development and implementation of integrated and co-located drug treatment, harm reduction and HIV treatment services across country accessible to IDUs to improve uptake of ART among the most vulnerable and marginalized population: IDUs.

Treatment guidelines
National treatment guidelines should be revised so they meet international best standards of treatment initiation at 350 CD4 cells per microliter instead of currently set 200.
Health Economics Centre should conduct cost-effectiveness study of the treatment regimens in the country and based on evidence national treatment guidelines should be revised.

Treatment providers
MoH should work actively in addressing efforts of ART provision across country, especially outside Riga and in prison setting, by increasing HIV treatment literacy among health care workers.
The function of support counselling and social services for PLHIV currently provided by the government-run treatment service providers should be directed towards NGOs with allocated financial resources.

Drug and HIV treatment services
HIV treatment providers should work together with NGOs dealing with hard-to-reach populations (e.g. IDUs, CSWs, etc.) for increased access to these populations and to reduce high levels of non-adherence, particularly among IDUs.

Advocacy partners
Specific information and educational materials for PLHIV should be developed by the MoH and civil society groups to increase treatment literacy levels among various groups of PLHIV.  Similarly information materials  should be developed for health care workers addressing issues of human rights and stigmatization.

 

Resource:

Latvian Infectology Centre (LIC), 2010.  Official statistics on new HIV infections in Latvia.
Joncheere K. et al. Evaluation of the Access to the HIV/AIDS Treatment and Care in Latvia, 2009.
European Centre for Disease Prevention and Control/WHO Regional Office for Europe. HIV/AIDS surveillance in Europe 2008. Stockholm: European Centre for Disease Prevention and Control, 2009.
Cilvēka imūndeficīta vīrusa (HIV) infekcijas izplatības ierobežošanas programma 2009.–2013. gadam. [National Programme for Limiting HIV and AIDS in Latvia 2009–2013.]
Interview with Agita Sēja, NGO DIA+LOGS. January 2010.
Interviews with Aleksandrs Molokovskis, Apvieniba HIV.LV. January-February 2010.
Interviews with LIC: Dr. Inga Januškēviča, Dr.Ķūse,  January 2010.
Data from the Latvian Infectology Centre, 2010. Official data on ART provision in Latvia and updated monthly. Accessed via LIC webpage.
Webpage www.ehpv.ee (Estonian Network of PLHIV), accessed February 2010.
Veselības ekonomikas centrs. Racionālas farmakoterapijas rekomendācijas no valsts budžeta līdzekļiem apmaksātai antiretrovirālai terapijai HIV/AIDS infekcijas ārstēšanai. Rīga: Veselības ekonomikas centrs, 2009 [The Centre of Health Economics. (2009) Rational pharmacotherapy guidelines for the antiretroviral treatment of HIV/AIDS from the state budget. Riga: The Centre of Health Economics.]
Interview with Signe Rotberga, UNODC, January 2010.
Discussion with Apvieniba HIV.LV when finalizing report, February 2010.
The Agreement on Trade Related Aspects of Intellectual Property Rights.