Viral Load Monitoring For HIV
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Viral load monitoring for HIV is the regular measurement of the
viral load Viral load, also known as viral burden, is a numerical expression of the quantity of virus in a given volume of fluid, including biological and environmental specimens. It is not to be confused with viral titre or viral titer, which depends on the ...
of individual
HIV-positive people HIV-positive people, seropositive people or people who live with HIV are people who have the human immunodeficiency virus HIV, the agent of the currently incurable disease AIDS. According to estimates by WHO and UNAIDS, 34.2 million people were i ...
as part of their personal plan for treatment of HIV/AIDS. A count of the viral load is routine before the start of HIV treatment.


Types

Various viral load tests might be used. One way to classify tests is by whether it is a
nucleic acid test A nucleic acid test (NAT) is a technique used to detect a particular nucleic acid sequence and thus usually to detect and identify a particular species or subspecies of organism, often a virus or bacterium that acts as a pathogen in blood, tissu ...
or non-nucleic acid test. Variation in cost and the time it takes to get a result may be factors in selecting the type of test used.


Uses

Viral load monitoring is used by
HIV-positive people HIV-positive people, seropositive people or people who live with HIV are people who have the human immunodeficiency virus HIV, the agent of the currently incurable disease AIDS. According to estimates by WHO and UNAIDS, 34.2 million people were i ...
to develop a plan for their personal treatment of HIV/AIDS. A count of the viral load is routine before the start of HIV treatment. If the treatment is not changed, then viral load is monitored with testing every 3–4 months to confirm a stable low viral load. Patients who are medically stable and who have low viral load for two years may get viral load counts every 6 months instead of 3. If a viral load count is not stable or sufficiently low, then that might be a reason to modify the HIV treatment. If HIV treatment is changed, then the viral load should be tested 2–8 weeks later.


Typical interpretation of results

Previous treatment guidelines recommended that anyone with a viral load greater than 100,000 copies/mL of blood should begin treatment. It is now standard of care in the United States to begin anti-retroviral treatment upon discovery of HIV positive status. HIV is a
retrovirus A retrovirus is a type of virus that inserts a DNA copy of its RNA genome into the DNA of a host cell that it invades, thus changing the genome of that cell. Once inside the host cell's cytoplasm, the virus uses its own reverse transcriptase ...
, an RNA virus that enters a host
cell Cell most often refers to: * Cell (biology), the functional basic unit of life Cell may also refer to: Locations * Monastic cell, a small room, hut, or cave in which a religious recluse lives, alternatively the small precursor of a monastery ...
and uses the host DNA replication machinery and the
enzyme Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as products. A ...
reverse transcriptase A reverse transcriptase (RT) is an enzyme used to generate complementary DNA (cDNA) from an RNA template, a process termed reverse transcription. Reverse transcriptases are used by viruses such as HIV and hepatitis B to replicate their genomes, ...
to produce DNA from the viral
RNA genome Ribonucleic acid (RNA) is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes. RNA and deoxyribonucleic acid ( DNA) are nucleic acids. Along with lipids, proteins, and carbohydr ...
. HIV also produces an
integrase Retroviral integrase (IN) is an enzyme produced by a retrovirus (such as HIV) that integrates—forms covalent links between—its genetic information into that of the host cell it infects. Retroviral INs are not to be confused with phage int ...
enzyme which is used to integrate the newly produced viral DNA into the host's DNA. The virus is then replicated every time the host cell's DNA replicates. Due to the nature of the virus the drugs used to treat HIV are called antiretroviral medicines, and the course of treatment is called antiretroviral therapy (ART). These potent medicines cannot cure an individual; they can however manage the virus and slow the progression of the HIV infection. Strict compliance with the prescribed ART regimen is vital to controlling the disease.
Highly active antiretroviral therapy The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multip ...
(HAART) is the current recommended treatment for HIV. HAART entails taking a combination (regimen) of three or more ART medications from at least two different classes of drugs. There are six classes of ART medications: *
non-nucleoside reverse transcriptase inhibitors Reverse-transcriptase inhibitors (RTIs) are a class of antiretroviral drugs used to treat HIV infection or AIDS, and in some cases hepatitis B. RTIs inhibit activity of reverse transcriptase, a viral DNA polymerase that is required for replicatio ...
(NNRTIs) * Nucleoside reverse transcriptase inhibitors (NRTIs) * protease inhibitors (PIs) *
entry inhibitors Entry inhibitors, also known as fusion inhibitors, are a class of antiviral drugs that prevent a virus from entering a cell, for example, by blocking a receptor. Entry inhibitors are used to treat conditions such as HIV and hepatitis D. HIV entr ...
* Fusion inhibitors *
Integrase inhibitor Integrase inhibitors (INIs) are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the DNA of the host cell. Since integration is a vital step in retroviral replication, bloc ...
s Each class of medications uses a different mode of action to blocks the virus. Treatment is more effective in controlling the virus when a combination of medications from different classes is used. HAART also reduces the risk of developing drug resistance. Viral load tests are used to monitor the effects ART, to track viral suppression, and detect treatment failure. Successful combination ART should give a fall in viral load of 1.5 to 2 logs (30-100 fold) within six weeks, with the viral load falling below the limit of detection within four to six months. Laboratory monitoring schedule for patients using ART:


CD4 count indication

Viral load monitoring for HIV complements the CD4 count, which is another sort of test associated with monitoring HIV. Confusion about when to take a CD4 test is common. The results of a viral load test help determine when a CD4 count is indicated. CD4 cells are the primary target of HIV. A CD4 test quantifies
Helper T cell The T helper cells (Th cells), also known as CD4+ cells or CD4-positive cells, are a type of T cell that play an important role in the adaptive immune system. They aid the activity of other immune cells by releasing cytokines. They are consider ...
s and is often combined with viral load testing to monitor the progression of HIV. CD4 testing shows the strength of the immune system, but does not report viral activity. As established by the
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC), a person with HIV and a CD4 count below 200 or a CD4 percentage below 14% is considered to have
AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual m ...
. An increased CD4 count can result from an immune response to an infection or a recent
vaccination Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating ...
. A decreased CD4 count, in combination with higher numbers on a viral load test, indicates an increased risk of getting sick from
opportunistic disease An opportunistic infection is an infection caused by pathogens (bacteria, fungi, parasites or viruses) that take advantage of an opportunity not normally available. These opportunities can stem from a variety of sources, such as a weakened immune ...
s.


Blips in data

While receiving ART some patients with undetectable viral load measurements may experience an increase in viral load, to a low level (usually below 400 copies/mL blood), and then returned to an undetectable level. These transient blips do not indicate that the virus is developing resistance to drug therapy. Blips appear to be more common in the winter, suggesting a connection with illness such as colds and influenza. Viral load blips are partially explained by various patient related factors, and thought to be relatively common. High level and sustained increases in viral load are frequently related to the development of
drug resistance Drug resistance is the reduction in effectiveness of a medication such as an antimicrobial or an antineoplastic in treating a disease or condition. The term is used in the context of resistance that pathogens or cancers have "acquired", that is, ...
and/or viral mutations, and often dictate changes in ART.


Special populations

The
window period In medicine, the window period for a test designed to detect a specific disease (particularly infectious disease) is the time between first infection and when the test can reliably detect that infection. In antibody-based testing, the window period ...
for a test is the amount of time from the initial infection event until the disease can be detected. Exposure to HIV, followed by replication of the virus, may take as long as six months to reach a level detectable in many testing methods. An HIV antibody test usually detects the HIV
antibodies An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of the ...
within two to eight weeks, but can have a valid negative result for a long as 2 to 6 months after initial infection. Viral load tests can also be used to diagnose HIV infection, especially in children under 18 months born to mothers with HIV, where the presence of maternal antibodies prevents the use of antibody-based (
ELISA The enzyme-linked immunosorbent assay (ELISA) (, ) is a commonly used analytical biochemistry assay, first described by Eva Engvall and Peter Perlmann in 1971. The assay uses a solid-phase type of enzyme immunoassay (EIA) to detect the presence ...
)
diagnostic tests A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic te ...
. Pooled viral RNA testing shortens the window period to a median of 17 days (95% CI, 13-28 Days). Although it is not the standard of care to use this test for diagnosis, in communities with high HIV prevalence, this test has a significantly improved negative predictive value over 3rd and 4th generation tests for detecting acute HIV infections.


Adverse effects

Safe sex Safe sex is sexual activity using methods or contraceptive devices (such as condoms) to reduce the risk of transmitting or acquiring sexually transmitted infections (STIs), especially HIV. "Safe sex" is also sometimes referred to as safer se ...
practices are recommended for people with low viral load, just the same as for everyone else. Researchers have questioned whether people who are told that they have a low viral load will respond to this information by lowering their use of safe sex practices. As of 2010, further research might clarify the uncertainty around that idea.


History

In January 2008, researchers from Switzerland published what would be termed the Swiss Statement, controversially arguing that HIV-positive individuals 1) on antiretroviral therapy, 2) with a viral load under 40 copies per mL, and 3) with no other sexually transmitted diseases themselves or in their partners could be assumed to not transmit the disease to healthy, HIV-negative partners. Concerns were raised that blood-based measures of HIV viral concentrations at the time might not reflect actual viral counts in semen, and thus the Statement could encourage needlessly risky sexual practices, though the Statement authors argued they had taken this into account. On June 15, 2010, the FDA approved the first diagnostic test capable of detecting HIV antigens and HIV antibodies. The Abbott ARCHITECT HIV Ag/Ab combo test, a fourth-generation test, has an increased sensitivity for detecting infections during the acute phase (when compared to 1st and 3rd generation tests), when the immune system is still developing antibodies and the virus is replicating unchecked, and in one study, was able to detect 83% of such infections.


Society and culture

A person, who may be unaware of the infection, is highly infectious during this time yet may test negative for HIV using tests that detect anti-HIV antibodies only. Although Nucleic Acid Amplification Testing NAAT is more expensive and can take a week for processing, some have argued that it may still be a preferred way to screen for HIV.


Contagiousness

The higher the viral load value, the more viral elements there are in blood and other body fluids. For example, individuals with HIV are most contagious during the earliest (acute) stages of the infection, sometimes with millions of copies of HIV per centiliter of blood. According to one estimate, the majority of transmissions among gay men in the UK occur during primary infection. This is because, at this phase, the immune response is still developing. Antibody levels against the virus during acute infection are often too low to be detected, meaning that an antibody test for a highly infectious individual can come back negative. There is at least one documented case of an HIV-positive individual with an undetectable viral load infecting his partner. Nevertheless, two recent major studies of serodiscordant couples in which the positive partner had an undetectable viral load have found no linked transmission events despite at least some unprotected sex among the couples.
HPTN 052 HPTN 052 is the name of a clinical trial conducted in nine countries which examined whether starting people living with HIV on antiretroviral therapy (ART) can reduce the chance that they will pass HIV on to their sexual partners who do not have HIV ...
, a third study, found one linked transmission event in a test group of 886 couples, although it is unclear whether the originally infected partner in this case had achieved an undetectable viral load at the time of transmission. Viral load in blood corresponds imperfectly to viral load in other parts of the body. Individuals with undetectable viral loads in their blood might not have undetectable viral loads in other bodily fluids, such as semen or vaginal secretions. In one recent study, of 83 men with undetectable viral loads, 21 had very slight but not undetectable viral loads in their semen. However, it is unclear how much this actually increases transmission risk.


Distributors


Nucleic acid test

Nucleic acid test A nucleic acid test (NAT) is a technique used to detect a particular nucleic acid sequence and thus usually to detect and identify a particular species or subspecies of organism, often a virus or bacterium that acts as a pathogen in blood, tissu ...
s are a typical way to measure viral load, including for HIV.


Non-nucleic acid-based tests

ExaVir™ Load
Version 3 fro
Cavidi AB
is a largely manual test, which has the European regulatory approval (CE-Mark) for clinical use and is also used for viral load monitoring. Virus-associated reverse transcriptase (RT) activity is measured and can therefore detect all types and subtypes of HIV. The technology does not require sophisticated laboratories.


References


External links


Viral load
a consumer presentation from
AIDS.gov HIV.gov, formerly known as AIDS.gov, is an internet portal for all United States federal domestic HIV and AIDS resources and information. On World AIDS Day, December 1, 2006, the U.S. Department of Health and Human Services launched AIDS.gov. The ...
{{DEFAULTSORT:Viral Load Virology HIV/AIDS Medical tests