I. Improving viral load monitoring to improve HIV treatment
Viral load testing measures the amount of HIV in a person’s blood; when there are less than 50 copies of HIV’s genetic material per milliliter of blood, a person’s viral load is said to be ‘undetectable.’ This means the virus has been suppressed to a level where a person can live a healthy life and is also much less likely to transmit the virus. The tool primarily used for HIV monitoring in developing countries today is a measurement of people’s CD4 white blood cell count, which does not paint an accurate enough picture of how a person is responding to treatment. Viral load testing identifies problems earlier than measuring CD4 count.
Viral load testing is critical for two reasons. First, it identifies people who are having problems regularly taking their medicines, and can be used to trigger additional adherence counselling. Second, it identifies people who have indeed developed drug resistance and need to be switched to another treatment regimen. Viral load testing helps avoid unnecessarily switching patients to more expensive drugs and reducing future treatment options. It also helps identify patients who are taking their drugs but no longer benefiting from a given combination because of resistance.
Increased access to viral load monitoring can help people stay on antiretroviral combinations as long as possible, and help stave off resistance. WHO guidelines recommend the use of HIV-1 RNA viral load to confirm ART treatment failure, and routine viral load tests every six months “where available”.
Routine viral load monitoring is still the exception rather than the rule in resource-limited settings owing to a number of barriers to implementation. The lack of point-of-care viral load testing, coupled with the need to send blood samples to laboratories that can carry out the test, make it difficult to carry out viral load testing for every patient
Recent CAT-s has found a very low level of access to viral load monitoring in all countries.
No viral load test vs. change of ART regimen (%)
• Six-monthly viral load testing of patients taking antiretroviral therapy (ART) at primary health clinics in rural Kenya reduced the risk of virologic failure at 18 months of follow-up by 46%.1
• Number of currently existing and new viral load technologies are coming to market, ranging from point-of-care tests to those that can be used at district laboratory level.
• Use of dried blood spots (DBS) as a medium of collection for blood and plasma samples for the detection of virologic failure (above 1000 copies/ml) showed that dried-blood-spot has sensitivity ranging 84 to 93%.2
• Most countries are currently or in-process of applying/receiving the Global Fund grant, presenting opportunities to invest in feasibility studies and expansion of services.
Possible counter arguments:
• Viral Load test is expensive, complicated and difficult to perform.
• Lab health workers are overburdened with conflicting priorities. Current tests need specialized human resource and sophisticated labs that are not available outside big cities.
• There is a geographical challenge to viral load testing, as patients are often from remote areas, where such complicated services cannot be feasible.
• Dried blood spots have a number of potential limitations, including concerns about stability at high temperatures and over time, and questions about the correlation between HIV RNA levels in plasma and whole blood, which might lead to poorer sensitivity of dried-blood-spot testing.3
• A number of clinicians believe that viral load monitoring is not essential while patients have achieved stable CD4 counts above 200 cells/mm3.
II. Advocacy for Phase out of Stavudine:
In 2010 the World Health Organisation (WHO) changed the HIV treatment guidelines for resource limited settings and recommended switching from stavudine (D4T) to tenofovir disoproxil fumarate (TDF) for all patients on first line treatment. Stavudine (D4T) was previously one of three antiretroviral drugs (ARVs) recommended as first-line treatment but serious side effects, seen in many studies and treatment programmes, led to calls to use better, less toxic drugs. Even though changing to TDF costs more, the outcomes for people living with HIV on TDF are good and the drug is better tolerated with less side effects than those who are kept on d4T.
Our study have found out that the use of Stavudine at the time of study is in up-to 26% in some countries. Six out of seven study countries still using Stavudine: Indonesia- 6.7%, Laos 16.7%, Nepal 29.4%, Pakistan 20.4%, Philippines 9% Vietnam 16.6%, Bangladesh 0%. This information was related to the Global Fund (TGF) as all of these countries are now (or in the recent past) was TGF grant recipient. Fund portfolio mangers enquire about the current use of Stavudine to national AIDS programs. They were told that the country has already phased out use of Stavudine and the CATs finding is not true/valid. TGF has asked APN+ to validate the findings of the study in a short time within current program resources.
• A study in the early 1990s of about 10,000 people with HIV looked at D4T 30 and 40mg vs. D4T 20 and 15mg. Both groups had a high incidence of peripheral neuropathy with 21% in the higher dose group and 15% in the lower dose group.4
• A study by Brennan et al in South Africa found that between 2005 and 2011 patients receiving d4T were 60% more likely to die than those on TDF over the first year on treatment. People receiving TDF had similar rates of leaving the treatment programme, but were at less risk of drug changes due to toxicity compared to patients given d4T.5
Possible counter arguments:
• TDF is more expensive than Stavudine and the WHO guidelines do recognize the cost differences between the two drugs.
• Patients are at times reluctant to change medicines thinking that their health has been good with D4T.
• Country has stocks form previous procurement that they cant afford to waste. As most ARV programs are donor funded, national programs are worried that such loses will be held as their mistakes.
• Clinicians are often not conducive to change of any regimens and with conflicting priorities and lack of time, they see no incentive in convincing patients to switch to TDF.
• There may have been a significant switch of regimens already in past 12 months or so and our data could have been outdated to held anything against any HIV program that is still using Stavudine.
Effective advocacy largely depends on the evidence gathered, coupled with knowledge of the subject matter. A well thought of advocacy strategy should also anticipate counter arguments and develop strategies to address them.
1. Sawe, F et al. Superiority of routine viral load monitoring in rural Kenya: the Kericho Clinic-based ART Diagnostic Evaluation (CLADE) Trial. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 151, 2013
2. Metcalf C et al. Use of finger-prick dried blood spots for quantifying HIV-1 viral load, a diagnostic accuracy study: Thyolo, Malawi. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 608, 2013
3. Metcalf C et al. Use of finger-prick dried blood spots for quantifying HIV-1 viral load, a diagnostic accuracy study: Thyolo, Malawi. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 608, 2013.
4. Anderson R et al. Design and implementation of the stavudine parallel track programme. Comparison of safety and efficacy of two doses of stavudine in a simple trial in the US parallel track programme. J Inf Dis. 1995; 171:118-22. http://www.ncbi.nlm.nih.gov/pubmed/7861016
5. Brennan A, Shearer K, Fox M. The impact of the change from stavudine to tenofovir in first-line antiretroviral therapy in South Africa. Johannesburg: HE2RO Policy Brief Number 4, Health Economics and Epidemiology Research Office, 2012. http://www.bu.edu/cghd/files/2012/10/HERO-policy-brief-4-Tenofovir-1-Oct-2012.pdf