Care, Support & Treatment for PLHIV in Indonesia
By: Chris W. Green and Katherine Nagar
Since the launch of the ‘3 by 5’ initiative by the WHO in 2003, there has been a significant scaling up of Care, Support & Treatment (CST) for people living with HIV (PLHIV) in Indonesia. Prior to this, antiretroviral therapy (ART) had been available on a very limited basis, through only a handful of hospitals, and at considerable expense. Many people were only able to afford therapy with two antiretroviral (ARV) drugs, initially d4T plus ddI, but later with AZT plus 3TC. Nevirapine became available in the early 2000’s, and triple therapy with AZT, 3TC and nevirapine (often in a fixed dose combination from Aurobindo in India) became more widely available, although at a considerable cost – around $125 per month, clearly out of reach for most.
In early 2004, a number of meetings to discuss the ‘3 by 5’ initiative resulted in development of a CST policy by the then Indonesian Department of Health (Depkes). This policy included the decision to start local production of generic ARVs by a government-owned pharmaceutical company, Kimia Farma (KF), to be provided on a subsidized basis to PLHIV who met the WHO criteria for starting ART. KF started to produce a fixed-dose combination (FDC) of AZT + 3TC, which they named Duviral, with nevirapine offered separately, with the name Neviral. With the subsidy, PLHIV in Indonesia would be required to pay more than US$20 per month – well beyond the pocket of most. Following a vigorous advocacy campaign, Depkes agreed to a full subsidy, but this would require halving the total treated to 5000. This was accepted, given that the slow scale up of counselling and testing was unlikely to identify even that many cases.
Because of intellectual property rights (IPR) concerns, the government had to officially designate KF as the producer, with the proviso that the ARVs had to be sold to and delivered by the government. It was therefore determined that ART would be provided by a number of referral hospitals. Initially 25 referral hospitals were designated to offer ART and other CST services. Each referral hospital was required to nominate two doctors, a nurse, a counsellor and a case manager for training to be carried out by Depkes with WHO support. Each referral hospital was required to form an AIDS working group (Pokja AIDS), involving doctors from all of the needed specializations, including paediatric, neurology, pharmacy, dental etc.
In 2007, another policy was established to further government use of patents for efavirenz, lamivudine, and nevirapine. In 2012, the President of Indonesia declared that the existing government decree covering the three older patents was no longer sufficient. A new decree was enacted that licensed efavirenz again and added six more drugs to the protocol: abacavir; didanosine; the fixed dose combination (FDC) of lopinavir and ritonavir; tenofovir; the FDC of tenofovir and emtricitabine; and the FDC of tenofovir, emtricitabine and efavirenz. However, domestic production of these drugs has not yet started, and the triple combination of efavirenz, tenofovir and lamivudine/emtricitabine is not yet available. The new protocol created new opportunities to procure from additional suppliers, facilitating generic competition and in turn driving down the cost of medication. It also grants MoH the authority to appoint pharmaceutical companies to exploit patents for and on behalf of the government.
Out of the estimated $1.1 billion budget needed to carry out the 2010-2014 National AIDS Strategy and Action Plan, 28% ($308,000,000) is to be allocated towards care, support and treatment services. Indeed, one of the primary objectives of the Action Plan is to provide quality CST services that are accessible, affordable and client-friendly for all people living with HIV who need services. MoH maintains that there are currently 378 active CST services providing ART. CST programs, however, continue to face limitations in availability of service that result in limited access for key populations, including PLHIV. The effectiveness of CST programs is also limited by weakness in the logistics and supply systems related to ARV drugs. In order for CST programs to reach their full potential, greater leadership commitment is needed, as well as improved collaboration, coordination, and HIV-related skills training.
The 2004 Depkes plan provided for a rapid scale up in the number of referral hospitals, initially so that there would be at least one in each province, and later to one in all of the almost 500 districts. From the initial 25 referral hospitals in 2004, this number has grown to 262 in 2013.
It was also planned that the range of services offered by the referral hospitals should be extended, covering not only clinical services, but also laboratory, including provision of CD4 and viral load tests, and also enhancing diagnostic capability.
The policy also allows for designation of satellite clinics, supported by referral hospitals. Unfortunately, the policy does not yet define how these should be set up, monitored, trained and supported so this is left to the individual referral hospitals to determine. Nevertheless, 116 community health centres (puskesmas) and TB clinics around the country have been designated as satellites. Most are not (in theory) allowed to start PLHIV on ART, but can take over the provision after the first few months. There are currently 116 satellite clinics in operation. It should be noted that some at least are doing an excellent job of providing integrated services. For example, Puskesmas Kasi-Kasi in Makassar is providing ART, TB therapy, methadone substitution, and a drop-in centre for PLHIV with support from its own peer support group.
Perhaps one of the most disheartening facts is that despite their being a combined 378 referral hospitals and satellite clinics designated to provide CST services, only 92 of them are regularly reporting on ARV treatment, meaning that MoH cannot continue to distribute supplies to the 280 who are not.
In accordance with WHO guidelines, the following drugs are provided free-of-charge through the referral hospitals:
- Preferred first line: AZT/zidovudine + 3TC/lamivudine (usually FDC, 300mg AZT + 150mg 3TC) + NVP/nevirapine, usually locally produced; AZT available alone in 100mg capsule, 3TC available alone in 150mg tablet
- Alternatives for first line: d4T/stavudine (30mg, usually locally produced), EFV/efavirenz (600mg, imported), ABC/abacavir (300mg, imported)
- Second line: TDF/tenofovir (imported) + 3TC (local) or FTC/emtricitabine (imported, FDC with TDF) + Aluvia (lopinavir)
- Paediatric formulations: AZT + 3TC + NVP (FDC), d4T + 3TC and d4T + 3TC + NVP (FDCs)
- Alternative for second line: ddI/didanosine (buffered, imported)
No other ARVs are available through the government system. A few originator ARVs are sometimes reported to be available in pharmacies, primarily Retrovir (AZT) and Epivir (3TC). Some PLHIV obtain other drugs from overseas (Thailand, USA) through a variety of means. There is a system to allow import of non-approved drugs for personal use through a doctor.
Note: while drugs are provided without charge, there is usually a hospital registration charge (usually US$1 or less) and a consultation charge (often a bit more). These charges should be reduced or waived for indigent patients with the right paperwork.
The policy is that first line drugs should be provided through the national budget, while second line drugs will be paid for by the Global Fund (GFATM), although some first line drugs have been supplied through GFATM. Since KF is not WHO pre-qualified, drugs paid for by GFATM must be imported from an approved source. This results in two different procurement systems.
Supply chain management is weak at all levels, from forecasting and procurement to reporting by hospitals. One result is frequent stock shortages, which cause stress among PLHIV; although there are few reports of people having to stop therapy, many can only obtain sufficient for a few days at each visit, and must return, sometimes every three days, to obtain more. Efforts to address this challenge have borne fruit, but stock-outs still occur.
MoH releases an occasional report on numbers of PLHIV in treatment, on ART, drop-out, etc. The latest report may be accessed here.
Depkes has published a number of guidelines on CST. Most are not available on the web, and are also out of print. The first, ‘Tatalaksana Klinis Infeksi-HIV di Saran Pelayanan Kesehatan (Clinical Management of HIV Infection in Health Care Facilities)’ was published in 2001. This was followed by ‘Pedoman Nasional Perawatan, Dukungan dan Pengobatan bagi Odha (National Guidelines for Care, Support and Treatment of PLHIV)’ in 2003. In 2004, Depkes published the first ‘Pedoman Nasional Terapi Antiretroviral (National ART Guidelines)’ based on the 2003 Revised WHO Guidelines. It was updated once again in 2011 and published as: Pedoman Nasional Tatalaksana Klinis Infeksi HIV dan Terapi Antiretroviral pada Orang Dewasa (National Guidelines for the Clinical Management of HIV Infection and Antiretroviral Therapy in Adults). (Link) This revision was based on 2010 WHO guidelines Antiretroviral Therapy for HIV Infection in Adults and Adolescents in Resource-Limited Settings: Towards Universal Access Recommendations for a Public Health Approach. It also refers to the 2007 WHO SEARO publication, Management of HIV Infection and Antiretroviral Therapy in Adults and Adolescents, A Clinical Manual. The WHO recently released new guidelines in June 2013 called Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. It is expected that some recommendations from these guidelines will be incorporated in part into future MoH guidelines and national HIV-AIDS policy.
Adherence to ART
In 2013, Spiritia carried out a research study together with Universitas Muhammadiyah Prof. DR. Hamka (UHAMKA) to determine levels of adherence to ART throughout Indonesia, and identify factors that affect this adherence. Results of this study are still being compiled, and details will be provided shortly.
According to the most recent MOH report, 1,629 infants aged four years and below have been diagnosed with HIV infection in Indonesia since 1987, with another 914 aged 5-14 years old. Around 3% of AIDS cases are paediatric, resulting from mother-to-child transmission. Many have been successfully treated with ART, often by grinding up adult formulations, since paediatric formulations have only recently become available under the MoH scheme. Guidelines on treatment of infants and children with HIV were issued in 2008, but have yet to be updated; this requires urgent attention. There are still few paediatricians who have been trained in treating HIV, but community advocacy efforts are being initiated to press for action in this area.
Parents and health care providers face challenges in diagnosing HIV among babies less than 18 months. While it should now be possible to arrange diagnosis at the age of six weeks using viral load tests, these are priced beyond the reach of most families. As laboratories extend the ability to accept dried blood spots (DBS) for diagnosis, this must receive greater attention.
Prison settings have been a focal point of HIV-AIDS prevention policy and programs for several years now. In 2005, the Ministry of Justice and Human Rights launched the National Strategy for Prevention and Control of HIV-AIDS and Drug Abuse in Indonesian Correction and Detention Centres for the period of 2005-2009. The document, the first of its kind in Asia, provided the framework for prevention and CST of the HIV-AIDS epidemic inside the prison system. The scaling up of prison-based HIV-AIDS programs has been underway since. Policies supporting these programs include:
- National Strategy to Respond to HIV and AIDS and Drug Abuse in Prison and Detention Centres
- Master Plan for System Strengthening and Provision of Clinical Services Related to HIV and AIDS in Prisons and Detention Centres
- Technical Guideline for Prison-Based HIV and AIDS Care, Support and Treatment; SOP for Methadone Service in Prisons and Detention Centres
- Circular Letter from Directorate General of Prisons on Monitoring and Evaluation of the Response to HIV and AIDS in Prisons and Detention Centres.
IDUs within the prison setting are named as one of the priority groups in the current National AIDS Strategy and Action Plan. The most recent policy is the 2012 MoH publication, Pedoman Layanan Komprehensif HIV-AIDS & IMS di Lapas, Rutan dan Bapas (Guidelines for Comprehensive HIV-AIDS & STI Services in Prisons, Detention Centres and Parole Services). As of 2009, the Directorate General of Corrections had expanded its HIV programs to 149 correction facilities in 25 provinces. According to MoH First Quarter 2013 reports, there are currently 147 prison settings offering Information, Education and Communication services (IEC), 82 offering HIV outreach services, 77 with peer support groups, 78 conducting VCT, 149 implementing HIV coordination services, and 139 conducting HIV-AIDS referral services. Some are doing an excellent job; the clinic in the Banceuy prison in Bandung is one, again providing a wide range of services including ART and methadone. Often the care provided in such satellites is better than that at the huge institutional referral hospitals. The main obstacles for prison-based HIV-AIDS programs implementation and expansion continue to be limits in funding and human resources, together with the desperate overcrowding in many prisons.
As the number of women with HIV increases, so does the need to scale-up PMTCT services. The implementation of PMTCT services began in 2007 and was primarily focused in areas with high HIV prevalence. By 2008, 30 PMTCT service units were in place, integrated with existing antenatal care. During its inaugural year, 5,167 women were tested, and 1,306 were found to be HIV positive (25%). Out of that number, only 165 received ARV prophylaxis. It is estimated that the number of women in need of PMTCT services by 2014 will increase to 8,170. To date, there are 113 PMTCT services units available. The main goal of the Action Plan in regards to PMTCT is to significantly increase the number of pregnant women and their partners who test for HIV, and to expand availability of PMTCT services by integrating them into existing mother and child health services. The 2011 MoH ART Guidelines provide automatic eligibility for ART to all HIV-infected pregnant women, regardless of CD4 count. Still, women face substantial dilemmas when deciding whether or not to share HIV status with their sexual partners and family members, as ART requires life-long adherence and is unlikely to be sustained in an unsupportive relationship situation. Hence, PMTCT services should not be limited to testing and treatment, but must also include couples counselling and community-based initiatives to assist women prior to, during and post-disclosure address negative outcomes should they occur. In the absence of such initiatives, ART rates among pregnant women will continue to be low.
CD4 testing is becoming more widely available, but primarily through private sector laboratories, which send samples to a central referral hospital. Although in theory a CD4 test is provided free-of-charge, this is rarely possible, and the test usually costs around US$10 or more. Quality assurance is questionable.
Viral load testing is available at a handful of hospitals. Charges vary (some provide a limited number free), but often the cost is around US$55 or more. There are reports that some laboratories can accept samples as dried blood spots (DBS), but it is not clear how common this is, or if this is covered by policy.
Resistance testing is not offered. It was reported that a central lab had been set up to carry out resistance surveillance, but there has been no recent news of this.
Therapeutic drug monitoring is not offered.
Microbiology testing for diagnosis of opportunistic infections is very limited.
Since 2013, an increasing number of hospitals and laboratories have been provided with GeneXpert machines, capable of identifying active TB and TB resistant to rifampisin in less than two hours. Some 30 of these machines are currently in use around the country, primarily in hospitals designated as multi-drug resistant TB (MDR-TB) referral centres.
The main opportunistic infection among PLHIV is TB (41%). Many PLHIV present with smear-negative TB, and chest X-rays are rarely definitive. Extra-pulmonary TB is common. Pulmonologists rarely understand HIV-TB co-infection, and often use non-standard diagnostic methods and treatment regimens, sometimes also unaware of the risk of interactions between TB treatment and ART. Accelerated treatment of suspected TB among PLHIV is now becoming more common. However, too frequently the result is that by the time correct action is initiated, the patient is in terminal state and often dies soon after ART is started. This has contributed to fear among many PLHIV that ART is contributes to mortality.
As noted, MoH is now moving to address the challenges of MDR-TB, and cases have been identified among PLHIV. There are also reports of extremely drug resistant TB (XDR-TB) among PLHIV, and these will surely increase, adding to the challenges.
The second and third most commonly reported opportunistic infections are chronic diarrhoea (21%), cause unreported, followed closely by candidiasis. These are the opportunistic infections that have been known to cause death among people with AIDS, yet PLHIV are still susceptible to a great many opportunistic infections which may not prove to be fatal but are extremely detrimental to quality of life.
Treatment for opportunistic infections often depends on early diagnosis. Because HIV is often not suspected, the diagnosis of the opportunistic condition is delayed, sometimes with fatal results. Most simple opportunistic infections, such as PCP and toxoplasmosis can be treated and cured. In addition, cotrimoxazole prophylaxis is now almost universally offered after diagnosis, at least to adults. But the more advanced opportunistic infections are more difficult to manage; CMV retinitis is relatively common, but ganciclovir is generally not available or affordable, let alone implants. Other advanced infections, such MAC, are rarely considered. There is also little appreciation of the risk and management of immune reconstitution inflammatory syndrome (IRIS). There have been several cases of CMV retinitis leading to blindness after starting ART as a result of IRIS. There has also been one report of Hansen’s disease occurring from IRIS.
Apart from TB (discussed above), viral hepatitis presents what may be the biggest long term challenge. Hepatitis C (HCV) co-infection is common amongst HIV patients, particularly IDUs, and is a risk factor for disease progression of HIV. Since most would have been infected in the early 2000’s and the effects of hepatitis infection usually take more than ten years to appear, we have yet to feel the full impact of viral hepatitis co-infection. The actual infection rate is not clear, but probably many are indeed chronically infected, since they have had multiple exposures. Evidence from liver function tests seems to confirm this.
For some unfathomable reason, although most HIV-infected injecting drug users (IDU) are tested for HCV infection, it seems that few are tested for hepatitis B. We therefore have no clear picture of the extent of HBV infection, and it is probable that doctors are prescribing ART without concern for its effects on possible HBV infection. Still, because generic drugs are available HBV treatment, it HBV co-infection is more manageable at the moment than HCV co-infection.
Most PLHIV in Indonesia, or at least those aware of their status, have a relatively clear picture of their HIV and its treatment. Their hepatitis co-infection, however, is often a ‘black hole’ about which they know little and understand less. What most know is that current testing and treatment for hepatitis C is not covered by insurance and is unaffordable. The cost of testing alone (viral load, genotype, and biopsy) is the same cost as buying a new motorcycle. PLHIV with HCV can sometimes be effectively treated with pegylated interferon and ribavirin combination therapy for a recommended 48 weeks. Yet, seeing as there is currently no generic manufacturing of pegylated interferon, the cost remains extremely expensive and beyond the reach of most, equivalent to buying a new car. Even if PLHIV manage to afford treatment for HCV, they are often uninformed of its low success rate or its severe side effects.
WHO guidelines stipulate that HCV treatment should be offered as part of the comprehensive package of services for drug users, but Indonesia cannot make this treatment available while the drug costs continue to be so high.
In theory, all referral hospitals can offer all the services needed to support patients with HIV. In practice, referral hospitals may have no beds available or out-of-stock of ARV supplies.
Some have set up separate AIDS wards or clinics (e.g. Tropical Diseases Institute in the Soetomo Hospital in Surabaya, East Java), but most have integrated in-patient services in wards appropriate to the disease. Many have a ‘VCT-clinic’, which is the normal centre for out-patient services for PLHIV, usually including monthly prescription refills.
Testing is primarily passive, effectively provider initiated, when doctors finally suspect that a sick patient might perhaps be HIV-infected and refer him or her to the VCT clinic. VCT clinics are rarely well-promoted, user-friendly, free of charge, or attractive.
All hospitals are supposed to be capable of providing normal in-patient services to PLHIV except ART. Nonetheless, many maintain that they are still ‘not ready’, and thus immediately pass on patients found to be HIV-positive to referral hospitals. There have been some improvements in reducing discrimination toward PLHIV amongst health care service providers. Unfortunately, there are still an abundance of reports of PLHIV experiencing discrimination from health care workers, including some doctors trained in CST.
Despite these shortcomings, there is no doubt that there has been a major improvement in the situation since attention started to be given more widely to CST for PLHIV in 2004. While previously, people diagnosed with HIV infection rarely survived more than a few years, and there was a continual turn-over in peer support activities, now people are staying healthy and living a full life. The challenge is to maintain that progress and reach out to the more than 50% of PLHIV in Indonesia who do not know that they are infected.
During this decade, other conditions, including viral hepatitis and non-AIDS cancers will start to impact on survival of PLHIV who are now living longer with the benefit of ART. Many PLHIV in Indonesia follow unhealthy life-styles, including heavy smoking, insufficient exercise, poor nutrition, and substance abuse. This will exacerbate the expected health challenges resulting from increasing age, with morbidity and mortality resulting from lung conditions, liver and kidney failure, and cardiovascular conditions. Greater efforts will be needed to promote healthier life styles, together with activities and treatments to mitigate these conditions.
Please note that this article reflects the view of the writers, and not necessarily those of the Spiritia Foundation.
Last update: 24 August 2013