The HIV-1 GenoSure PRIme(R) for this specimen has been completed.
GenoSure PRIme(R)
HIV-1 Subtype: B
Drug Genotypic
Generic Name Brand Name Assessment Comments
-------------------------- ---------- --------
NRTI
Abacavir Ziagen Sensitive
RAMs*: M184V
Didanosine Videx Resistance Possible
RAMs*: M184V
Emtricitabine Emtriva Resistant
RAMs*: M184V
Lamivudine Epivir Resistant
RAMs*: M184V
Stavudine Zerit Sensitive 1
RAMs*: None
Tenofovir Viread Sensitive 1
RAMs*: None
Zidovudine Retrovir Sensitive 1
RAMs*: None
NNRTI
Doravirine Pifeltro Sensitive
RAMs*: Q207E
Efavirenz Sustiva Sensitive
RAMs*: None
Etravirine Intelence Sensitive
RAMs*: None
Nevirapine Viramune Sensitive
RAMs*: None
Rilpivirine Edurant Sensitive
RAMs*: None
INI
Bictegravir Bictegravir Sensitive
RAMs*: None
Dolutegravir Tivicay Sensitive
RAMs*: None
Elvitegravir Vitekta Sensitive
RAMs*: None
Raltegravir Isentress Sensitive
RAMs*: None
PI
Atazanavir/r Reyataz / r Sensitive
RAMs*: L10I, M36I, I62V
Darunavir/r Prezista / r Sensitive
RAMs*: L10I
Fosamprenavir/r Lexiva / r Sensitive
RAMs*: L10I
Indinavir/r Crixivan / r Sensitive
RAMs*: L10I, M36I
Lopinavir Kaletra Sensitive
RAMs*: L10I
Nelfinavir Viracept Sensitive
RAMs*: L10I, M36I
Ritonavir Norvir Sensitive
RAMs*: L10I
Saquinavir/r Invirase / r Sensitive
RAMs*: L10I, I62V
Tipranavir/r Aptivus / r Sensitive
RAMs*: M36I
*RAMs = Resistance Associated Mutations observed
Summary of Mutations Observed:
RT: T27S, V35I, Q102K, K122E, D123E, I135V, Q174K, M184V,
G196E, T200I, Q207E, V245M, E248Q, D250E, A272P, R277K,
T286A, E297K
IN: S17N, V31I, K42K/R, H51Y, V72I, V113I, S119P, T122I,
T124A, T125A, E198Q, V201I, K219N, N222K, V234L, S283D
PR: L10I, L19I, M36I, N37D, R41K, I62V, L63P, I64L, I93L
Genotype Comments (clinical significance may vary)
1 - Assessment for this drug was derived considering the
sensitizing effect of mutation M184V.
Assessment of drug susceptibility is based upon detected
mutations and interpreted using an advanced proprietary
algorithm (version 18).
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Interpretation algorithms for ritonavir-boosted protease
inhibitors appropriate for the following dosages: AMP/r
600mg/100mg BID; ATV/r 300mg/100mg QD; IDV/r 800mg/200mg
BID; LPV/r 400mg/100mg BID; SQV/r 1000mg/100mg BID; TPV/r
500mg/200mg BID; and DRV/r 600mg/100mg BID.
Mixtures are indicated by amino acids separated by a slash.
Assay Performance Characteristics
- Assay is highly reproducible and sufficiently sensitive
to allow testing of patient samples with viral loads as low
as 500 copies/mL.
- Detects mixtures of wild-type and drug-resistant viruses
when present at levels as low as 10% of the total
population.
- Uses Monogram's HIV genotyping algorithm, which is based
on a large database of over 100,000 matched HIV
genotype-phenotype results and is reviewed and updated on a
regular basis.
- Includes HIV-1 subtype which provides information that
can be important for long-term drug treatment strategy and
genotype interpretation.
For more information on interpreting this report, please
call LabCorp Customer Service at 800-762-4344 between the
hours of 7:00am to 6:30pm EST Monday through Friday or
8:00am to 5:00pm EST Saturday.
GenoSure PRIme is a DNA sequence assay based on primer
extension and chain termination that analyzes the protease
(amino acids 1-99), reverse transcriptase (amino acids
1-320) and integrase (amino acids 1-288) coding regions in
HIV-1. Subtype is determined using the protease and reverse
transcriptase sequence information. This test is validated
for testing specimens with HIV-1 viral loads equal to or
above 500 copies/mL and should be interpreted only on such
specimens. This assay meets the standards for performance
characteristics and all other quality control and assurance
requirements established by CLIA. The results should not be
used as the sole criteria for patient management. It has
not been cleared or approved by the FDA. This document
contains private and confidential health information
protected by state and federal law. If you have received
this document in error, please call 800-777-0177.
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