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Universal Access to HIV Treatment

In recent years, considerable energy and money have been spent trying to achieve universal access to treatment for HIV. This is part of a wider objective to provide universal access (15 million people on treatment) by 2015, as agreed in 2010.1

Most countries aspiring to expand treatment access set themselves a goal of providing antiretroviral treatment to around 80 percent of those in need. With current global treatment coverage at 65 percent, this treatment target as not yet been met on a global scale.2 Nevertheless, a number of countries have achieved or are near achieving universal access by 2015.3

In 2013 global treatment recomendations changed, stating that where feasible, people with HIV should begin treatment even earlier - at 500 cells/mm3; increasing the number of people eligible for treatment by 9.2 million. The 2013 WHO recommendations acknowledge that not all countries will be able to provide treatment at 500 cells/mm3, stating that providing treatment to people with a CD4 count of 350 cells/mm3 or less, or with advanced HIV infection, should take priority.4

Global HIV treatment targets

At the beginning of the 21st century, very few people in low- and middle-income countries had access to HIV treatment. This was in large part because of the very high prices of antiretroviral drugs (ARVs) and the international patents that stopped them from being manufactured at cheaper prices. However, in 2001 drug manufacturers in developing countries began to produce generic drugs under special terms in international trade law. In sub-Saharan Africa, countries including Kenya and South Africa passed bills that made it legal for them to purchase generic drugs from abroad. The vast reduction in price made possible by the manufacturing of generic drugs meant expansion of treatment on a global scale was possible.

In 2003, the World Health Organisation (WHO) launched the ambitious target of reaching 3 million people in low- and middle-income countries with ARVs by 2005. It was not intended as a final objective, but as a stepping stone to universal access. Though the target was not attained until 2007, it was seen by some as a success in a number of ways. Treatment was vastly expanded with coverage tripling from 400,000 people in December 2003 to 1.3 million in December 2005.6 This included an eight-fold increase in sub-Saharan Africa.

Considering the relative success of the 3 by 5 target, the international community set another target in 2006 that aimed for universal access to HIV treatment, prevention and care by 2010. However, by the time of WHO’s 2008 universal access report, the heads of UNAIDS, UNICEF and WHO conceded that most countries would not meet the 2010 targets of 80 percent of those in need receiving treatment. In 2011, the international community recommitted to the goal of universal access. This time, countries committed to achieving universal access by 2015.7 The goal of universal access is also part of Millennium Development Goal (MDG) 6 which includes the goal of halting and beginning to reverse the spread of HIV/AIDS by 2015.

Five years after WHO first introduced the goal of achieving universal access, the 2011-2015 global health strategy was released.8 This strategy outlines four key targets that countries need to achieve if universal access and MDG 6 are to be realised: reduce new infections by 50 percent among young people (15-24 years), reduce TB-related mortality by 50 percent, eliminate new infections in children, and reduce HIV-related mortality.9

Understanding antiretroviral therapy coverage

A 2010 change in WHO guidelines recommended that people living with HIV should start treatment at an earlier stage. The recommended CD4 count at which treatment should begin was changed from a CD4 count of <200 cells/mm3 to <350 cells/mm3.10 At the time, 33.3 million people were living with HIV worldwide.11 The release of new guidelines resulted in an increase in the number of people considered to be eligible for treatment, from 10 million to 14.6 million. As a result, treatment coverage figures for 2009 changed significantly from 52 percent, under the previous 2006 guidelines, to 36 percent, under the new 2010 guidelines (updated figures show actual treatment coverage was 39 percent in 2009).12 13 This change should be considered when comparing HIV treatment coverage figures from before 2010, to those after 2010, in order to accurately compare the changes in coverage and progress made.

Treatment access has expanded extensively over the last few years, increasing by 63 percent between 2009 and 2011.14 Treatment reached 8 million people in 2011, the first time the number of people being treated for HIV exceeded the number of those who were eligible but going without. Between 2011 and 2012 an unprecedented increase in people starting treatment was seen, so that today 9.7 million people are on antiretroviral treatment.15

Regional antiretroviral therapy coverage16

Region (lower- and middle-income countries) Antiretroviral therapy coverage Estimated number of people receiving antiretroviral therapy Estimated number of people eligible for antiretroviral therapy
Sub-Saharan Africa 56% 6,200,000 11,000,000
Latin America and the Caribbean 68% 580,000 850,000
Asia and the Pacific 46% 1,100,000 2,400,000
Eastern Europe and Central Asia 25% 130,000 510,000
North Africa and the Middle East 15% 17,000 116,000
Total 54% 8,000,000 14,800,000

Over the last few years the number of low-and middle-income countries achieving universal access has increased. Currently, twelve countries (Botswana, Cambodia, Cuba, Dominican Republic, Fiji, Guyana, Mexico, Namibia, Rwanda, Sao Tome and Principe, Swaziland and Zambia) had met this target.17

Achieving universal access to treatment

Universal access is broadly defined. It does not necessarily mean 100 percent coverage of all services but can be seen as a desire to move to a high level of access for the most effective interventions that are "equitable, accessible, affordable, comprehensive and sustainable over the long-term".18 Scaling-up the number of people on treatment involves great challenges including the need for:

* widespread awareness of the value of testing and subsequent treatment

* life-long commitment to antiretroviral drugs (ARVs) and supporting patients to adhere to a daily regimen

* adequate health infrastructure including health staff

* supply chains of effective drugs

Counselling, testing and treatment awareness levels

Before people can be treated they need to know they are infected. This requires not only HIV testing facilities but also widespread knowledge of the importance of testing and where it can be done. People may be more inclined to test if they are aware of the benefits of antiretroviral therapy and know they could be treated if they test positive. Confronting stigma and denial are absolutely necessary as these are "the two factors that often determine whether a person seeks an HIV test or not".19 Testing and treatment services also need to reach marginalised and difficult-to-reach groups, such as men who have sex with men and sex workers.

“Universal access means more than ensuring that those who need treatment or prevention services receive them. It implies an extra effort to reach those who are marginalized, criminalized or disenfranchised.”Secretary-General Ban Ki-moon20

The median number of HIV testing and counselling facilities per 100,000 population in low- and middle-income countries rose by 28 percent between 2008 and 2009.21

When HIV treatment should begin

Accessing antiretroviral treatment in Botswana

The ideal point to begin HIV treatment is, according to WHO 2013 guidelines, 500 cells per cubic millimetre (mm3).22 It is acknowledged, however, that this is not feasible for many countries, and that people with a CD4 count of 250 cells/mm³ should take priority for treatment. National treatment guidelines determine when a person starts antiretroviral treatment.

In most countries, the threshold for treatment is a CD4 count that has dropped below 350 cells/mm³ of blood, previously recommended by WHO in their 2010 guidelines.23 The stage of infection at which people are eligible to begin taking ARVs provides some context to the percentage of people regarded as in ‘need’ of treatment at a national level. Someone with a CD4 count of 300 cells/mm3 in the United Kingdom, for example, would be considered in need of treatment, whereas someone with a similarly advanced infection in a country which is not following the latest WHO guidelines, may not be regarded as needing treatment.

Deferring treatment until infection has progressed may seem a cheaper option for funders of treatment programmes, but initiating treatment earlier has been shown to be cost-effective in the long run.24 This is because the costs of a deferred treatment approach are ‘substantially increased’ by intensive clinical care, having to make more likely switches to expensive second-line treatment, an increased infection rate, and the loss of patients’ economic productivity.25 However, despite the potential cost savings, treating patients earlier will inevitably require greater initial spending on antiretroviral drugs.

As of December 2011, 88 of 93 countries reporting to WHO had adopted the 2010 guidelines, including China, Kenya, Lesotho, Malawi, Tanzania, Zambia and Zimbabwe and some countries in Eastern Europe such as Romania and Ukraine.26

2013 antiretroviral treatment recommendations for adults and adolescents

Patient retention

Deciding when, how and who initiates treatment is one set of issues that need to be considered when establishing and maintaining HIV treatment programmes. However, keeping people on treatment programmes – patient retention – should be considered as important a factor as boosting the numbers of people beginning treatment.

“High rates of attrition from treatment programs thus poses a serious challenge to program implementers and constitute an inefficient use of scarce treatment resources.”Sydney Rosen, Center for International Health and Development, Boston University27

Patients who do not start treatment or who do not continue with treatment are often classified as “lost to follow-up”. This could be for a range of possible reasons including simply stopping or interrupting treatment, death, or finding alternative sources of ARVs. The nature of loss to follow-up is that very often a patient’s eventual whereabouts or outcome is unknown, even if efforts are made to trace such patients.

A review of treatment programmes in sub-Saharan Africa estimated that 70 percent of people were still receiving treatment two years after initiating antiretroviral therapy.28 Another study examining data on 5,491 patients beginning antiretroviral therapy in 15 treatment programmes in Africa, South America and Asia, found 21 percent of patients became lost within six months, including 4 percent who were not seen since receiving their first prescription of ARVs.29

Some studies suggest that patient retention actually suffers as a result of the drive to boost patient initiation.30 Research across three continents found the proportion of patients who were lost to follow-up was greater in 2003-2004 than in 2000 or earlier.31 This, it was suggested, was due to difficulties following-up the growing patient numbers:

“Early patient losses were increasingly common when programmes were scaled up and were associated with a fee for service and advanced immunodeficiency at baseline.”32

The delay between eligibility for antiretroviral treatment and actually starting treatment is also an issue of concern according to studies in South Africa, Malawi and Uganda. When patients test HIV positive, they may not all be ready to take ARV drugs yet but many of those who are eligible do not start treatment on time. Substantial numbers have also shown to be lost before they should start taking treatment.33

Why do people stop treatment?

A variety of factors influence why individuals discontinue their treatment. Cost has a major impact on patient retention and mortality levels.34 Similarly, associated costs such as transportation or “opportunity costs” such as having to forgo a day’s pay are other more structural factors. Adverse side effects of ARVs may cause someone to stop taking them, as could successful therapy if it leads people to become complacent.

Social, cultural and psychological influences should also be considered. Perceptions of disease severity, susceptibility and the benefits or disadvantages of staying on treatment are key in determining clinical attendance. Believing that God or alternative medicine can cure HIV can also influence treatment patterns. Similarly, misconceptions about ARVs can alter patients’ motivation to stick with them.35

“Those medicines were so confusing. Sometimes you hear that if you use those medicines you will die. So it used to confuse people so much…we used to fear it so much that it means if you take these medicines you may die.”ART patient, Tanzania36

Nutritional support is vital too as a lack of adequate food security could determine whether people remain on treatment. Some medications can only be taken on a full stomach while some ARV side effects are reduced by having adequate nutrition.37

Keeping people on treatment

Sticking to a treatment regimen for life that involves taking daily medication, with potential side effects, presents many challenges that must be overcome if patients are to successfully remain on treatment. If drug resistance occurs through failure to adhere to ARVs, far more expensive second-line therapy, may be necessary. In some cases drug-resistant strains of HIV are transmitted, which can impact upon national treatment programmes.38 Drug resistance has been found to be more prevalent, the longer a country has provided antiretrovirals; reflecting the national importance of encouraging adherence to treatment.

Having supportive family and community environments, as well as strong networks of people living with HIV are key to promoting adherence to ARV treatment. This could come in the form of very practical assistance such as transport to a clinic or help with other activities. Patients may require emotional support to continue their treatment both from their family and HIV-positive peers. The success of other people on ARVs can encourage patients to continue with their therapy.39 One study in Kenya has also shown that the use of mobile phones texts by nurses to check on patients is effective in improving adherence. One reason why the patients involved were 'highly satisfied' by the service and wanted it to continue was because they felt "like someone cares."40 Community involvement is particularly important for reaching high-risk groups such as sex workers, men who have sex with men or injecting drug users. These groups are more likely to be criminalised and either find it difficult or are unwilling to access public services. However, they are more likely to trust fellow members, or 'peers', of their group.

“…other patients who used to hide themselves have seen their fellows who come to these services are getting relief so they now turn up too.”ART clinic staff member, Tanzania41

There is also a risk that people may experience unplanned treatment interruptions - where a person may have to stop their treatment for reasons beyond their control. Floods in Mozambique, the unstable political and economic situation in Zimbabwe, and the 2007 and 2010 public sector strikes in South Africa, are all situations where people taking ARVs may have had difficulty in accessing their medication.42

“AIDS poses a challenge for health systems that is fundamentally different from all of the other health problems ever faced. Transforming a deadly disease into a manageable chronic one turns millions of people into chronic patients, in need of life-long regular follow-up. This implies that present efforts and commitments will have to be continuously increased for many years to come.”Wim Van Damme, Institute of Tropical Medicine, Belgium43

The effect of universal treatment on prevention

Apart from the effects of treatment on quality of life and productivity, HIV treatment is also a possible preventative measure (treatment as prevention). This is because a higher level of HIV in the blood, or viral load, increases the risk of HIV transmission and antiretroviral therapy reduces the levels of HIV in the blood. A number of studies have shown that reducing the viral load in a population in turn reduces new infections and it is already known that antiretroviral therapy can drastically reduce the risk of HIV transmission from mother-to-child.44 45 The feasibility of rolling out large-scale treatment programmes, that would immediately treat people on diagnosis of HIV on a global scale, is unlikely however due to the costs and ethical considerations involved (drug resistance, side effects of drugs and need for patient consent).

Therefore, increased treatment coverage is not a substitute for other preventative measures that have been proven to work in reducing new HIV infections. Yet, one result of the drive to rapidly boost treatment figures may be a reduced focus on other areas of HIV and AIDS work. Even in 2006, it was believed energy and resources were being redirected from prevention towards treatment:

“In Africa many grass roots organizations and NGOs…traditionally involved in community mobilization and prevention, have shifted their focus to treatment support activities” Wim Van Damme, Institute of Tropical Medicine, Belgium46

This raises questions about the approach of boosting the numbers on treatment at the expense of prevention programmes designed to reduce new HIV infections in the long term. The effects of the economic crisis and reduced external funding are expected to impact prevention programmes the most, as their effects are harder to measure. Prevention programmes such as HIV/AIDS education in schools, condom distribution, counselling and testing, and targeted prevention programmes for high risk groups like sex workers and men who have sex with men must therefore be expanded alongside treatment programmes.

“The implications of HIV prevention failures are clear: unless we act now, treatment queues will get longer and longer and it will become more and more difficult to get anywhere near universal access to antiretroviral therapy.” Former head of UNAIDS, Peter Piot47

Resources needed to achieve universal access

Trained staff

Many health staff are required at various stages of treatment programmes. However, countries with higher HIV prevalence tend to have lower health staff-to-patient ratios compared with more developed countries. Malawi, for example, has just one doctor per 50,000 people compared to the United States with one per 390 people.48 On average, there are 15 times the number of doctors and 8 times the number of nurses in Europe compared to Africa.49 The World Health Organization estimates that the global shortage of trained health care staff exceeds four million.50

There are several reasons for this, one of which is AIDS itself. In Botswana, for example, 17 percent of the health-care workforce died due to AIDS between 1999 and 2005.51

Migration of health staff from poorer to wealthier countries has also damaged the health infrastructure of countries ravaged by AIDS. It has even been suggested that the widespread recruitment of African health workers by more developed countries should be viewed as an ‘international crime’.52

One proposal for tackling HIV with diminished staff capacity is to train or permit lesser-qualified health workers to perform tasks which they were previously unqualified to do. This is known as ‘task-shifting’. Allowing nurses to perform some of the tasks of doctors, and community workers the roles of nurses, for example, could facilitate access to ART and improve adherence and management of therapy. It is argued that quality of care would not be compromised and that it could be more cost-effective than the present division of labour.53 54 However, as a study in Uganda has shown, a transfer of tasks is not always accompanied by appropriate training.55

Task-shifting has existed in Zambia since 2004,56 and was implemented in South Africa in May 2010.57

Reliable supply chains

Ensuring there are no interruptions in treatment requires a guaranteed supply of antiretroviral drugs from the factories where they are produced, to the treatment centres in perhaps remote areas of a country. Laboratory supplies, testing kits and information also needs to pass along the supply chain.

In order to be cost-effective, accurate forecasting of the necessary quantity of drugs is needed. Over-purchasing of ARVs can put strains on money and storage space, and may lead to wasting of drugs with limited shelf-life.58 Under-estimating may lead to stockouts and the need to purchase costlier emergency supplies.59 One report found stockouts were ‘commonplace’ in China, India, Uganda, Russia and Zimbabwe.60 It was conservatively estimated that 30 people were dying daily in Free State, South Africa, after ARVs ran out towards the end of the 2009 financial year.61 Such events not only adversely affect those who desperately need to begin treatment but also patients who are on treatment already and who may develop drug resistance.

The transportation phase of the supply chain requires delivery tracking and needs to account for potential customs barriers. Special refrigerated containers may also be needed. In unstable regions theft of the drugs may be a concern and armed escorts and decoy trucks are known to protect expensive deliveries.62

Intermediate storage of the medication – such as in large regional warehouses – needs to be safe and secure and be able to efficiently process orders and distribute ARVs to health facilities. Similarly, local facilities should be able to safely and securely store medication at controlled temperatures.63

All of these requirements mean that the costs involved in distributing the drugs are higher than the antiretroviral drugs themselves. World Health Organization's Director of HIV/AIDS, Gottfried Hirnschall, points out:

"About 20 to 30 percent of the costs related to treatment are drug-related costs, and the other 70 to 80 percent are systems and delivery costs...We need to shift the conversation towards asking how we can use resources that we have more efficiently and effectively."64

The massive international logistical exercise involved in creating a reliable supply chain for thousands of vital deliveries has meant the consortium that operates PEPFAR’s supply chain, the Supply Chain Management System, was the organisation that received the most money from PEPFAR in 2007.65

Effective drugs and equipment

It goes without saying that HIV treatment programmes need a steady supply of drugs. However, the quality and type of drugs that are available will also have an impact on the effectiveness of the programme. Until 2010 stavudine, or d4T, was an antiretroviral drug widely used to treat HIV infection. However, due to the severe side effects linked to stavudine, 2010 WHO treatment guidelines recommended that the use of this drug should be phased out. Such side effects may dissuade patients from taking their medication, whereas better quality, though often more expensive, ARVs may encourage people to continue treatment and could require fewer costly treatment switches.66

Whilst stavudine has been discontinued as a treatment option in high-income countries, it continues to be used as part of treatment regimens in many low-and middle-income countries. The most common treatment regimen is d4T (stavudine) + 3TC (lamivudine) + NVP (nevirapine). However, figures show that progress is being made in phasing out the use of stavudine and in 2011 84 out of 87 reporting low- and middle-income countries had adopted international guidelines that recommend phasing out stavudine.67

One cost saving measure being explored is the chemical manipulation of antiretroviral drugs to make them cheaper to manufacture, while maintaining or even increasing their effectiveness. For example, research commissioned by the Clinton Health Access Initiative (CHAI) has reduced the costs of producing tenofovir by 20 percent for one Indian pharmaceutical that manufactures the drug and sells it to South Africa.68 Apart from the chemical manipulation of drugs, identifying cheaper sources of raw materials for drugs is also one way which CHAI and the international drug purchase facility, UNITAID have sought to secure price reductions for ARVs.

Other medical supplies besides antiretroviral drugs are also required. In developed countries, HIV positive patients on antiretroviral therapy undertake routine tests to monitor treatment efficacy and toxic effects. These tests require expensive equipment, electricity and trained technicians, and so are often difficult to access in less economically developed countries. Such is the expense associated with the upkeep of laboratories, that laboratory costs account for around a third of overall HIV treatment costs in low- and middle-income countries - as much as the antiretroviral drugs themselves.69

A major study in Uganda and Zimbabwe looked at whether the availability of these tests had a significant impact on the long-term clinical outcomes of HIV-infected patients receiving antiretroviral therapy.70 Conclusions drawn from the DART trial suggest that first-line antiretroviral therapy can be delivered safely without these routine tests. However, routine monitoring tests appear to be slightly more beneficial when switching to second-line therapy.

Although more research is needed in this area, the findings suggest there will be a greater public health benefit if money is channelled into providing more people with antiretroviral drugs than providing those already receiving treatment with routine laboratory monitoring.71

Cost of HIV treatment

It has been estimated that between US$22-24 billion will be needed annually by 2015, in order to reach global targets. In 2011, there was a total global investment of 16.8 billion, a gap in resources of 30 percent.72

This was a positive improvement compared to 2010, when funding had decreased due to the economic downturn73 The Global Fund, which provides antiretroviral treatment to 2.5 million people worldwide, received $11.3 billion for three years in 2010 out of the $20 billion it calculated it needed over this period.74 Funding from the US government, mainly through PEPFAR, was also flat-lined from 2009-2010 for the first time since its creation in 2003.75 That year the PEPFAR budget for antiretroviral treatment was also reduced and funds for ARV drugs fell by 17 percent.76 The percentage of countries where antiretroviral treatment programmes were adversely affected by reduced external funding rose from 11 percent to 21 percent from July 2008 to July 2009.77

International funding still deteriorated in 2011 - the improvement in global available resources was largely a result of many countries increasing their domestic investment in HIV and AIDS.78 Domestic spending in low- and middle-income countries increased from US$ 3.9 billion in 2005 to nearly $8.6 billion in 2011, and for the first time, that year domestic resources outnumbered international resources in the HIV response.

Eastern Europe and Central Asia are seen as particularly vulnerable to the effects of reduced external funding and the economic crisis. Already less than a quarter of people in need of treatment in the region are receiving it but drug stock-outs are common and government health expenditure on HIV and AIDS treatment programmes has fallen sharply, according to UNAIDS country coordinators.79 In September 2010, the arrests of activists in Moscow protesting against ARV drug stock outs in hospitals highlighted the grave lack of access to HIV treatment in Russia.80

Achieving universal access to HIV and AIDS prevention, treatment and care

Since 1995, antiretroviral treatment has added 14 million life years in low- and middle-income countries, including 9 million in sub-Saharan Africa.81 A far greater number years of life will be saved if universal access is reached globally.

Treatment expansion led to a ten-fold increase in the number of people on treatment in low- and middle-income countries by the end of 2008 (around 4 million) compared with 2003 (around 400,000) when the ‘3 by 5’ target was set. Although the ‘3 by 5’ and universal access target were not met on time, it is likely that they have played a major part in progressing treatment levels far beyond what would have been achieved otherwise.

It is now clear that improving HIV and AIDS education for health workers and the general public is critical for achieving universal access to treatment. Ensuring that people start treatment early and that access and adherence to treatment is as straightforward as possible is vital to the overall aim of achieving universal access to HIV/AIDS prevention, treatment and care. In 2011, the international community committed to extending access to HIV treatment to 15 million people by 201582 and UNAIDS produced guidelines for every member state to monitor their progress towards achieving this goal.83 In order to for the goal to become a reality, huge and sustainable investments on the part of governments, multinational organisations and citizens are needed; investment in better health infrastructure, medical research, and in the most effective drug treatments available.

In 2010, UNAIDS outlined a comprehensive approach to HIV treatment designed to cut deaths from AIDS by ten million by 2025. ‘Treatment 2.0’ emphasises the role that improved access to treatment can play in stemming the epidemic, by reducing mortality from AIDS but also by cutting new infections.84

 

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