Indications for hiv drugresistance testing evaluation. Dhhs guidelines recommend hiv1 drug resistance testing 1. Hiv1 drug resistance and resistance testing sciencedirect. Recommendations for surveillance of transmitted hiv drug resistance in countries scaling up antiretroviral treatment pdf, 7kb. Hiv 1 drug resistance testing hiv 1 drug resistance testing can be performed phenotypically or genotypically. Aug 22, 2011 drug resistance testing is used to determine whether a patient with the human immunodeficiency virus hiv has a mutated form of the virus that does not respond to antiretroviral therapy art. In addition, one observational cohort study found that the use of genotypic drug resistance testing in artexperienced patients with detectable plasma hiv rna was independently associated with improved survival. Viral load monitoring is still not available for everyone in limited resource settings. Hiv drug resistance hivdr is caused by a change mutation in the genetic structure of hiv that affects the ability of a. Finally, the impact of pharmacologically enhanced regimens on the interpretation of drug resistance testing for hiv 1 awaits further study. Hiv1 drug resistance testing is an important component of hiv treatment. Genotypic drug resistance testing is widely used for clinical and surveillance purposes by laboratories in developed countries and is the technique recommended by the who for hivdr surveillance and monitoring.
The global scaleup of antiretroviral arv therapy art has led to dramatic reductions in hiv 1 mortality and incidence. Testing for hiv drug resistance in drugnaive individuals and in patients in whom antiretroviral drugs are failing, and the. Combination antiretroviral therapy has resulted in marked improvements in. Pdf antiretroviral drug resistance testing in adults with. Recommendations for drug resistance testing antiretroviral therapy. Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections see fact sheet 500. Drug resistance test results will guide treatment options, including recommendations to initiate 2nd line regimen if needed for the. A novel sequential sampling technique for the surveillance of transmitted hiv drug resistance by crosssectional survey for use in low resource settings pdf, 225kb. Genotypic resistance testing using dna sequencing is often used before. Hiv1 drug resistance testing can be performed phenotypically or. The genetic code of hiv has mutations that are linked to drug resistance.
Mar 16, 2020 drugresistance testing identifies which, if any, hiv medicines wont be effective against a persons hiv. The hivaids bureau established a revised performance measure portfolio in november 20. Human immunodeficiency virus hiv genotypic antiretroviral drug resistance testing evaluates the likelihood that the hiv strain infecting an individual is resistant or has developed resistance to one or. Therefore, resistance testing is performed upon diagnosis of hiv and if a medication regimen is no longer keeping the viral load suppressed. Center for drug evaluation and research this guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus hiv infection.
She returns to the clinic for prep refill and an hiv test approximately 6 months after her seroconversion. Hiv1 drug resistance and resistance testing request pdf. For characterizing the utility of an antiretroviral drug, both phenotypic and genotypic resistance testing have strengths and limitations as discussed in this guidance. The global scaleup of antiretroviral arv therapy art has led to dramatic reductions in hiv1 mortality and incidence. Consequently, only some of the resistance mutations depicted on the figure can be used to identify transmitted drug resistance. Hiv genotypic antiretroviral resistance testing is used to help select a drug regimen that will likely be effective in treating a person with an hiv infection. Routine resistance testing is also recommended for all pregnant women before the initiation of therapy and for those with detectable hiv rna levels cpm while on therapy. Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections see fact. Preexposure prophylaxis prep and hiv drug resistance. Affordable hiv drugresistance testing for monitoring of. Infection, genetics and evolution hiv drug resistance.
Role of hiv resistance testing in antiretroviral drug. Drug resistance testing rationale for the individual client and provider. Pdf antiretroviral drug resistance testing in adults. Hiv resistance testing aids information, education. Hiv can develop resistance to all currently available arvs. Hiv antiretroviral drug resistance testing, genotypic. The first clinical description of hiv resistance to an antiretroviral agent was published in 1989, when patients taking zidovudine monotherapy accumulated mutations within the reverse transcriptase gene, resulting in a marked increase in drug resistance 1. Hiv1 drug resistance testing hiv1 drug resistance testing can be performed phenotypically or genotypically.
Hiv 1 genetic variability results from the high rate of hiv 1 reverse transcriptase rt processing errors, recombination when more than one viral variants infect the same cell, and the accumulation of proviral variants during the course of infection abram et al. Hiv drug resistance testing hiv drug resistance testing has been developed to evaluate the susceptibility of hiv strains to individual arv drugs. Infection, genetics and evolution hiv drug resistance database. This revised portfolio focuses on critical areas of hiv care and treatment, and aligns with milestones along the hiv care continuum. The hiv aids bureau established a revised performance measure portfolio in november 20. Drug susceptibility data comprising 25,434 pi, 19,858 nrti, 11,548 nnrti and 4,606 ini susceptibility results from hiv 1 virus isolates. Dried blood spots for hiv 1 drug resistance and viral load testing. At virologic failure to assist in the selection of active drugs when changing art regimens.
Hiv resistance testing during antiretroviral drug development and marketing and serves as a focus for continued discussion among the division of antiviral products davp, pharmaceutical sponsors. Increased provision of antiretroviral therapy in subsaharan africa has led to a growing number of patients with therapy failure and acquired drugresistant hiv. Pdf affordable hiv drugresistance testing for monitoring of. Resistance refers to certain strains of the hiv virus that do not respond to hiv drugs. Pdf clinical management of hiv drug resistance researchgate. Whohivresnet global hiv drug resistance strategy the whohivresnet global hiv drug resistance hivdr prevention, surveillance and monitoring strategy was developed by the world health organization who beginning in 2000. Although laboratories with greater expertise in drug resistance testing have improved performance, quality controls will clearly be important for this rapidly evolving and complex. Hiv antiretroviral drug resistance testing, genotypic labcorp. Hiv resistance testing aids information, education, action.
Drug resistance test results help determine which hiv medicines to include in a persons first hiv regimen. Hiv drug resistance testing the quest for pointofcare the lancet. Analyzing drug resistance test results across all prep users who become hiv infected will provide important information. The 2012 southern african arv drug resistance testing guidelines do not recommend resistance testing in hivinfected adults upon diagnosis or art initiation however, baseline resistance testing is recommended for children who have been exposed to art for prevention of mothertochildtransmission therapy and subsequently become hivinfected. At entry into care to guide selection of initial art. Jordan, md, mphb,c, silvia bertagnolio, mdd, robert w.
Human immunodeficiency virus hiv drug resistance is an. The test is used to determine whether the hiv strain infecting an individual is resistant or has developed resistance to one or more drugs used to treat hiv. In coordination with the plans for universal access to antiretroviral therapy art, the. Developing a reporting system for the surveillance of hiv drug.
However, hiv drug resistance hivdr poses a potential threat to the longterm success of art and is emerging as a threat to the elimination of aids as a public health problem by. The national hiv curriculum is an aids education and training center aetc program supported by the health resources and services administration hrsa of the u. Mar 01, 2001 although laboratories with greater expertise in drug resistance testing have improved performance, quality controls will clearly be important for this rapidly evolving and complex technology. For antiretroviral therapynaive persons hiv drugresistance testing is recommended at entry into care. This revised portfolio focuses on critical areas of hiv care and treatment, and aligns with milestones along. The 2012 southern african arv drug resistance testing guidelines do not recommend resistance testing in hivinfected adults upon diagnosis or art initiation however, baseline resistance testing is. Gunthard,1 vincent calvez,2 roger paredes,3,4 deenan pillay,5 robert w. If the viral load rises above 200 copiesml, it might be ign of emergence of drug resistance mutations.
Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections. On this path towards eradication, strong epidemiologic surveillance mechanisms have warned of an increase in. Pretreatment hiv drug resistance among treatmentnaive infants newly diagnosed with hiv. Hiv1 genetic variability results from the high rate of hiv1 reverse transcriptase rt processing errors, recombination when more than one viral variants infect. But before a person starts taking hiv medicines, drug resistance testing is. People with hiv should start taking hiv medicines as soon as possible after their hiv is diagnosed. Pdf antiretroviral drug resistance testing in adult hiv1. She misses her next clinic visit and continues taking truvada as prep inconsistently. If therapy is deferred, repeat testing may be considered at the time of art initiation ciii. Hiv drugresistance testing is recommended at entry into care for persons with hiv to guide selection of the initial antiretroviral therapy art regimen aii. To maximize the likelihood of successful virologic suppression, resistance testing should be performed in all patients newly diagnosed with hiv infection, including pregnant women, adolescents and perinatally infected infants. Role of hiv drug resistance testing in antiretroviral drug. Drugresistance testing is done using a sample of blood.
Hiv antiretroviral drug resistance testing is used to help select a drug regimen that will likely be effective in treating a person with an hiv infection. Identifying core performance measures that are most critical to the care and treatment of people. However, hiv drug resistance hivdr poses a potential threat to the longterm success of art and is emerging as a threat to the elimination of aids as a public health problem by 2030. Panels recommendations regarding drugresistance testing. Hiv drug resistance testing the quest for pointofcare. Dhhs guidelines recommend hiv 1 drug resistance testing 1.
Once hiv treatment is started, a viral load test is used to monitor whether the hiv medicines are controlling a persons hiv. Who surveillance of transmitted hiv drug resistance. The fight against a human immunodeficiency virus hiv pandemic is progressively advancing towards the ambitious 909090 goal. Drugresistance testing identifies which, if any, hiv medicines wont be effective against a persons hiv. Guidelines the 2012 southern african arv drug resistance. Hiv 1 drug resistance testing is an important component of hiv treatment. Review hiv1 drug resistance and resistance testing dana s. Drug resistance test results will guide treatment options, including recommendations to initiate 2nd line regimen if needed for the policy maker. The stanford hiv drug resistance database keeps an uptodate record that helps clinicians and programmers to interpret results from drug resistance tests. Hiv1 drug resistance in treatmentnaive, chronically.
The whohivresnet global hiv drug resistance hivdr prevention, surveillance and monitoring strategy was developed by the world health organization who beginning in. The use of drug resistance testing has become an integral part of hiv clinical care. There are three main tests used to detect hivdr in an individual these are genotypic, phenotypic and viral load tests. Her resistance test results show high levels of resistance to truvada. Indications for hiv drugresistance testing evaluation and. Clinical use of genotypic and phenotypic drug resistance.
Antiretroviral drug resistance testing in adult hiv1 infection. Hiv antiretroviral drug resistance testing, genotypic lab. Antiretroviral drug resistance testing in adults with hiv infection. This document is intended as a support document for the clinical and laboratory guidelines for the use of hiv1 drug resistance testing as part of treatment management recommendations for the. However, hiv drug resistance hivdr poses a potential threat to the longterm. Drugresistance testing laboratory testing adult and. The first clinical description of hiv resistance to an antiretroviral agent was published in 1989, when patients taking. Hiv drug resistance south africa, how to address the. At entry into care to guide selection of initial art regimen. However, dtg efficacy may also be at stake when a patients virus is already resistant to the art drug backbone, and represents a possible. Susceptibility is usually reported as the arv concentration that inhibits hiv1 replication by 50% ic 50. Testing for hiv drug resistance there are three main tests used to detect hivdr in an individual these are genotypic, phenotypic and viral load tests. Phenotypic in vitro susceptibility assays measure arv susceptibility in cell culture. A novel sequential sampling technique for the surveillance of transmitted hiv drug resistance by crosssectional survey for use in low resource settings pdf.
Specifically, this guidance addresses the food and drug administrations fdas current thinking regarding the role of hiv resistance testing during antiretroviral drug development and. Hiv1 drug resistance testing can be performed phenotypically or genotypically. Hiv 1 diagnosis was made based on a screening rapid hiv 12 antibody test and confirmed with western blot testing. Patients included in the study were 18 years of age or older, had documented hiv 1 infection and were able to provide written consent.
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