RITM to stop giving CD4 count to PLHIVs on treatment

HIV treatment hub Research Institute for Tropical Medicine-AIDS Research Group (RITM-ARG) is slated to stop giving the every-six-months CD4 count to people living with HIV (PLHIV) who are enrolled to receive treatment, care and support (TCS) from one of the pioneering treatment hubs in the Philippines. As of press time, no date was specified when this will commence.

A CD4 count is a lab test that gauges the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. The CD4 count of an uninfected adult/adolescent who is generally in good health ranges from 500 cells/mm3 to 1,200 cells/mm3; while a very low CD4 count (less than 200 cells/mm3) is one of the ways to determine if a PLHIV has progressed to stage 3 infection (AIDS). As such, a CD4 count is considered as one of the “most important laboratory indicators of how well (the) immune system is working and the strongest predictor of HIV progression”.

Instead, RITM-ARG will provide viral load test, which measures the number of HIV virus particles in a milliliter of blood. “Viral load” refers to the amount of HIV in a sample of blood – that is, if the viral load is high, there is more HIV in the body, and it could mean that the immune system is not fighting HIV as well even with antiretroviral therapy (ART, or the treatment with HIV medicines).

Communicating through email, Dr. Rossana A. Ditangco, research chief at RITM-ARG, stated to Outrage Magazine that “CD4 level does not have good correlation with treatment response. The most reliable test for treatment response is viral load. In fact, there are now questions among experts to scrap even baseline CD4 since the current recommendation globally is to treat all regardless of CD4 count.”

NEW APPROACH

In the past, RITM-ARG provided every PLHIV free CD4 and CBC tests every six months. And yearly, during the “anniversary” of a PLHIV, RITM-ARG provided free CD4, CBC, blood chemistry (depending on what antiretroviral medicines the PLHIV is taking), and viral load tests. If the doctor suspects treatment failure, a free viral load test will be done anytime, plus HIV drug resistance testing.

Now, with this development, RITM-ARG will still do baseline CD4 test to determine if a person living with HIV will need prophylaxis for opportunistic infection/s, and will do viral load instead of CD4 test after six months of initiating treatment. There will be another viral load on the 12th month.

In essence, since RITM-ARG will still provide viral load test that it has been providing annually anyway, it is only the CD4 count that will now no longer be offered to PLHIV continuing their treatment.

“If viral load is consistently undetectable, then viral load will be monitored every 12 months thereafter,” Ditangco stated.

IN LINE WITH INTERNATIONAL PRACTICES

The move is actually in line with the World Health Organization (WHO) guidelines on ART (released in July 2013), which recommended the use of viral load testing as the preferred method of monitoring response to ART and detecting treatment failure.

As per WHO, “although evidence from clinical trials for a survival benefit of viral load testing is limited, it can provide an early indication of treatment failure, and the 2013 guidelines strongly recommend using it for detecting virological failure and/or confirming treatment failure among people with evidence of clinical and/or immunological failure… The main rationale for recommending viral load monitoring as the preferred approach compared with immunological and clinical monitoring is to provide an early and more accurate indication of treatment failure and the need to switch to second-line drugs, reducing the accumulation of drug-resistance mutations and improving clinical outcomes. Measuring viral load can also help to discriminate between treatment failure and non-adherence… and can serve as a proxy for the risk of transmission at the population level.”

WHO, nonetheless, stated that “there is still limited evidence to support any additional survival benefit of viral load monitoring over CD4 and/or clinical monitoring among individuals with HIV receiving ART.”

VIRAL LOAD TEST IN A DEVELOPING COUNTRY

As it is, viral load measurement is already a method of choice for detecting treatment failure in developed countries. However, there are studies that note that the “determination of the HIV load is not recommended in developing countries because of the costs and technical constraints” (See also THIS, THIS, THIS and THIS, among others).

According to WHO (from reports by the Clinton Health Access Initiative, UNITAID and Médecins Sans Frontières), the “price per viral load test can range widely ($10 to $60) depending on the manufacturer and country”.

Recently, The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund), the largest funder of the international HIV response, teamed up with seven manufacturers of the test to bring down the cost from as high as $85 per test to $15 inclusive of all costs.

In the Philippines, though, viral load measurement remains prohibitive, with a test costing upwards of P6,000. In contrast, CD4 count costs around P2,000.

PHILHEALTH ISSUE

RITM-ARG’s Ditangco also stated that “the decision not to do post-treatment CD4 has nothing to do with PhilHealth.”

In the Philippines, a PLHIV enrolled in PhilHealth is covered by the Outpatient HIV/AIDS Treatment (OHAT) package. The revised OHAT Package released last June 2015 states that “covered items under this benefit are drugs and medications, laboratory examinations based on the specific treatment guideline including Cluster of Differentiation 4 (CD4) level determination test, viral load (if warranted), and test for monitoring anti-retroviral (ARV) drugs toxicity and professional fees of providers.”

Outrage Magazine already reached out to PhilHealth to get its take on this development, but no response has been received as of press time (Outrage Magazine will continue following up not only with PhilHealth, but also with other concerned offices regarding this issue – Ed).

As it is, various treatment hubs all over the country already give PLHIV different services even if they pay the same premium to PhilHealth, so that Department of Health Undersecretary Vicente Y. Belizario Jr. earlier stated to Outrage Magazine that the DOH is pushing for “harmonization”.

REVERBERATING EFFECT

In Cagayan de Oro City, Stephen Christian Quilacio of the Northern Mindanao AIDS Advocates (NorMAA) expressed concern over the “repercussions of the big change.”

As it is, “the inconsistency in the delivery of services of treatment hubs is already lamentable,” Quilacio said.

With this development, Quilacio is worried of “the eventual response of other treatment hubs, particularly those outside of Metro Manila, which will not surprisingly follow suit.” In his way of seeing, “basta himuon sa Manila, sundon lang baya sa local (practices done in Manila are also done in local settings).”

And while Quilacio said that “putting in best practices is ideal – perhaps as in the case of using viral load measurement over CD4 count – we have to be realistic with the capacities of treatment hubs.”

In Mindanao, for instance, many PLHIV do not have viral load measurement at all (with treatment hubs having no machines to do the test), and there are times when even CD4 count is not done because of the unavailability of CD4 count machines and/or reagents.

Quilacio’s sentiments were shared by Fritzie Estoque, chairperson of the Misamis Oriental-Cagayan de Oro AIDS Network (MOCAN). Particularly if the same effort (i.e. cancellation of CD4 count) is done in treatment hubs outside Metro Manila, “sana (hopefully) health authorities will first conduct a thorough evaluation of the service delivery capacities of the treatment hubs in the rural areas before doing this move. As per the experiences of our clients, it really takes forever to get them scheduled to have viral load tests. And already considering the difficult process of getting viral load tests in provincial treatment hubs, if you also remove the CD4 measurement tests, then what will be left for PLHIV here? A plan without a thorough evaluation and assessment is equal to failure of health service delivery. Failure of health service delivery will result to early deaths of PLHIV,” Estoque said.

“We have to make sure that if we take big leaps to progress, we don’t leave any people – in this case, PLHIV outside of Metro Manila – behind,” Quilacio ended.

THIS IS A DEVELOPING STORY, AND OUTRAGE MAGAZINE WILL CLOSELY FOLLOW UP WITH OTHER PARTIES OF INTEREST TO GET THEIR TAKE ON THIS ISSUE.