Affordable hiv drugresistance testing for monitoring of. Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections see fact. However, hiv drug resistance hivdr poses a potential threat to the longterm. Drugresistance testing laboratory testing adult and. Hiv1 drug resistance testing hiv1 drug resistance testing can be performed phenotypically or genotypically. Combination antiretroviral therapy has resulted in marked improvements in. Jordan, md, mphb,c, silvia bertagnolio, mdd, robert w. Genotype treatmentnaive with chronic hiv recommended. Dhhs guidelines recommend hiv 1 drug resistance testing 1.
Drug resistance test results help determine which hiv medicines to include in a persons first hiv regimen. Dhhs guidelines recommend hiv1 drug resistance testing 1. 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. Hiv 1 drug resistance testing is an important component of hiv treatment. Review hiv1 drug resistance and resistance testing dana s. Hiv drugresistance testing is recommended at entry into care for persons with hiv to guide selection of the initial antiretroviral therapy art regimen aii.
She returns to the clinic for prep refill and an hiv test approximately 6 months after her seroconversion. Hiv1 drug resistance in treatmentnaive, chronically. Increased provision of antiretroviral therapy in subsaharan africa has led to a growing number of patients with therapy failure and acquired drugresistant hiv. People with hiv should start taking hiv medicines as soon as possible after their hiv is diagnosed. Hiv1 drug resistance testing can be performed phenotypically or genotypically. The whohivresnet global hiv drug resistance hivdr prevention, surveillance and monitoring strategy was developed by the world health organization who beginning in. Infection, genetics and evolution hiv drug resistance. If therapy is deferred, repeat testing may be considered at the time of art initiation ciii. Hiv 1 drug resistance testing hiv 1 drug resistance testing can be performed phenotypically or genotypically. 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.
The use of drug resistance testing has become an integral part of hiv clinical care. Hiv drug resistance hivdr is caused by a change mutation in the genetic structure of hiv that affects the ability of a. Pdf antiretroviral drug resistance testing in adults with. Drug susceptibility data comprising 25,434 pi, 19,858 nrti, 11,548 nnrti and 4,606 ini susceptibility results from hiv 1 virus isolates. Hiv1 drug resistance and resistance testing sciencedirect. 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. Hiv antiretroviral drug resistance testing, genotypic.
Role of hiv drug resistance testing in antiretroviral drug. Once hiv treatment is started, a viral load test is used to monitor whether the hiv medicines are controlling a persons hiv. Recommendations for surveillance of transmitted hiv drug resistance in countries scaling up antiretroviral treatment pdf, 7kb. 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. Pdf antiretroviral drug resistance testing in adult hiv1. Human immunodeficiency virus hiv drug resistance is an. 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. Drug susceptibility data comprising 25,434 pi, 19,858 nrti, 11,548 nnrti and 4,606 ini susceptibility results from hiv1 virus isolates. Clinical outcome data comprising genotype, treatments, plasma hiv 1 rna levels and cd4 counts from 14 clinical trials and 1500 treatmentchange episodes. 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. 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.
Antiretroviral drug resistance testing in adults with hiv infection. 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. Drugresistance testing identifies which, if any, hiv medicines wont be effective against a persons hiv. 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. Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections. 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. Recommendations for drug resistance testing antiretroviral therapy. Drug resistance test results will guide treatment options, including recommendations to initiate 2nd line regimen if needed for the policy maker. Preexposure prophylaxis prep and hiv drug resistance. Indications for hiv drugresistance testing evaluation. Mar 16, 2020 drugresistance testing identifies which, if any, hiv medicines wont be effective against a persons hiv. Panels recommendations regarding drugresistance testing. Resistance refers to certain strains of the hiv virus that do not respond to hiv drugs.
Drug resistance testing rationale for the individual client and provider. Although laboratories with greater expertise in drug resistance testing have improved performance, quality controls will clearly be important for this rapidly evolving and complex. Analyzing drug resistance test results across all prep users who become hiv infected will provide important information. 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. Dried blood spots for hiv 1 drug resistance and viral load testing. Role of hiv resistance testing in antiretroviral drug. Susceptibility is usually reported as the arv concentration that inhibits hiv1 replication by 50% ic 50. If the viral load rises above 200 copiesml, it might be ign of emergence of drug resistance mutations. Susceptibility is usually reported as the arv concentration that inhibits hiv 1 replication by 50% ic 50. Infection, genetics and evolution hiv drug resistance database. 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. Pdf clinical management of hiv drug resistance researchgate.
The fight against a human immunodeficiency virus hiv pandemic is progressively advancing towards the ambitious 909090 goal. 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. Pdf antiretroviral drug resistance testing in adults. Clinical use of genotypic and phenotypic drug resistance.
The global scaleup of antiretroviral arv therapy art has led to dramatic reductions in hiv 1 mortality and incidence. 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. A novel sequential sampling technique for the surveillance of transmitted hiv drug resistance by crosssectional survey for use in low resource settings pdf, 225kb. At entry into care to guide selection of initial art regimen. Hiv 1 diagnosis was made based on a screening rapid hiv 12 antibody test and confirmed with western blot testing. On this path towards eradication, strong epidemiologic surveillance mechanisms have warned of an increase in. Hiv resistance testing aids information, education, action. Hiv antiretroviral drug resistance testing, genotypic labcorp. The first clinical description of hiv resistance to an antiretroviral agent was published in 1989, when patients taking.
Pdf affordable hiv drugresistance testing for monitoring of. Who surveillance of transmitted hiv drug resistance. 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. The stanford hiv drug resistance database keeps an uptodate record that helps clinicians and programmers to interpret results from drug resistance tests.
For antiretroviral therapynaive persons hiv drugresistance testing is recommended at entry into care. Identifying core performance measures that are most critical to the care and treatment of people. This revised portfolio focuses on critical areas of hiv care and treatment, and aligns with milestones along the hiv care continuum. Hiv drug resistance south africa, how to address the. Hiv drug resistance testing the quest for pointofcare the lancet. The hivaids bureau established a revised performance measure portfolio in november 20.
Drug resistance test results will guide treatment options, including recommendations to initiate 2nd line regimen if needed for the. Hiv drug resistance testing hiv drug resistance testing has been developed to evaluate the susceptibility of hiv strains to individual arv drugs. Therefore, resistance testing is performed upon diagnosis of hiv and if a medication regimen is no longer keeping the viral load suppressed. 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 and resistance testing request pdf. 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. She misses her next clinic visit and continues taking truvada as prep inconsistently. Antiretroviral drug resistance testing in adult hiv1 infection. At virologic failure to assist in the selection of active drugs when changing art regimens. 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. For characterizing the utility of an antiretroviral drug, both phenotypic and genotypic resistance testing have strengths and limitations as discussed in this guidance. Finally, the impact of pharmacologically enhanced regimens on the interpretation of drug resistance testing for hiv 1 awaits further study. Hiv drug resistance testing the quest for pointofcare. Patients included in the study were 18 years of age or older, had documented hiv 1 infection and were able to provide written consent.
Viral load monitoring is still not available for everyone in limited resource settings. Indications for hiv drugresistance testing evaluation and. Hiv can develop resistance to all currently available arvs. However, dtg efficacy may also be at stake when a patients virus is already resistant to the art drug backbone, and represents a possible.
The global scaleup of antiretroviral arv therapy art has led to dramatic reductions in hiv1 mortality and incidence. Pretreatment hiv drug resistance among treatmentnaive infants newly diagnosed with hiv. The hiv aids bureau established a revised performance measure portfolio in november 20. Definitions of terms used in the field of hiv drug resistance testing term definition drugresistance mutations specific mutations in the hivgenome that are associated with a reduced in vitro. In coordination with the plans for universal access to antiretroviral therapy art, the. Developing a reporting system for the surveillance of hiv drug. Testing for hiv drug resistance in drugnaive individuals and in patients in whom antiretroviral drugs are failing, and the. 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. Gunthard,1 vincent calvez,2 roger paredes,3,4 deenan pillay,5 robert w. But before a person starts taking hiv medicines, drug resistance testing is. 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.
This revised portfolio focuses on critical areas of hiv care and treatment, and aligns with milestones along. 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. 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. Genotypic resistance testing using dna sequencing is often used before. Hiv resistance testing aids information, education. At entry into care to guide selection of initial art. Hiv antiretroviral drug resistance testing, genotypic lab. Hiv1 genetic variability results from the high rate of hiv1 reverse transcriptase rt processing errors, recombination when more than one viral variants infect. Drugresistance testing is done using a sample of blood. Her resistance test results show high levels of resistance to truvada. Clinical resistance shows up as a higher viral load, lower cd4 count, or opportunistic infections see fact sheet 500.
387 323 1043 1099 782 401 44 284 421 807 1401 995 524 1380 770 380 1464 583 356 1192 1198 793 576 469 80 763 126