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For: Pugliese P, Cuzin L, Cabié A, Poizot-Martin I, Allavena C, Duvivier C, El Guedj M, de la Tribonnière X, Valantin MA, Dellamonica P. A large French prospective cohort of HIV-infected patients: the Nadis Cohort. HIV Med 2009;14:509-15. [PMID: 19486189 DOI: 10.1111/hiv.12041] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/21/2013] [Indexed: 02/05/2023]

For:	Pugliese P, Cuzin L, Cabié A, Poizot-Martin I, Allavena C, Duvivier C, El Guedj M, de la Tribonnière X, Valantin MA, Dellamonica P. A large French prospective cohort of HIV-infected patients: the Nadis Cohort. HIV Med 2009;14:509-15. [PMID: 19486189 DOI: 10.1111/hiv.12041] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/21/2013] [Indexed: 02/05/2023]

Number

Cited by Other Article(s)

Oomen PGA, Dijkstra S, Hofstra LM, Nijhuis MM, Verbon A, Mudrikova T, Wensing AMJ, Hoepelman AIM, Van Welzen BJ. Integrated analysis of viral blips, residual viremia, and associated factors in people with HIV: Results from a retrospective cohort study. J Med Virol 2023;95:e29178. [PMID: 37861450 DOI: 10.1002/jmv.29178] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2023] [Revised: 09/07/2023] [Accepted: 10/05/2023] [Indexed: 10/21/2023]

Abstract

The etiology of viral blips is not yet fully elucidated. One of the hypotheses is that blips reflect variations in residual viremia (RV) near the detectability threshold. In this study, we evaluated whether RV is associated with viral blips and which factors are associated with RV. All treatment regimens in 2010-2020 consisting of two nucleos(-t)ide reverse transcriptase inhibitors and one anchor (integrase strand transfer inhibitor [INSTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], or protease inhibitor [PI]) in people with HIV (PWH) were evaluated for RV (detectable viremia <50 cp/mL) and blips (isolated viral loads [VLs] 50-499 cp/mL between measurements <50 cp/mL). All medical records were reviewed and regimens in which a VL ≥ 50 cp/mL was deemed to result from non-adherence (based on the documented conclusion by the treating physician) were excluded. Factors associated with blips and RV were identified using generalized linear mixed models. In total, 24 518 VLs from 1658 PWH were analyzed. VLs were measured during INSTI- (n = 5119; 20.9%), PI- (n = 8935; 36.4%), and NNRTI-use (n = 10 464; 42.7%). VLs were categorized as blips in 1.4% (n = 332). The 24,186 non-blip VLs were RNAneg (no RV) (n = 15 326; 63.4%), 1-19 cp/mL (n = 6318; 26.1%), 20-49 cp/mL (n = 1620; 6.7%), or <50 cp/mL with an unknown RV level (n = 922; 3.8%). In 193/1658 PWH (11.6%), the RV level was RNAneg in all VLs assessed. RV 1-19 cp/mL and 20-49 cp/mL (vs. RNAneg ) were significantly associated with subsequent viral blips (respective odds ratio 2.66 and 4.90 [95% confidence intervals: 1.98-3.58 and 3.41-7.04]). Zenith VL and use of PIs (vs. INSTIs/NNRTIs) were associated with higher RV and blip odds. This large cohort study showed that blips were associated with higher preceding RV. Both the anchor type and factors previously linked to the latent viral reservoir were associated with RV, suggesting blips having a multifactorial origin.

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Dijkstra S, Hofstra LM, Mudrikova T, Wensing AMJ, Oomen PGA, Hoepelman AIM, van Welzen BJ. Lower Incidence of HIV-1 Blips Observed During Integrase Inhibitor-Based Combination Antiretroviral Therapy. J Acquir Immune Defic Syndr 2022;89:575-582. [PMID: 34966148 DOI: 10.1097/qai.0000000000002898] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2021] [Accepted: 12/06/2021] [Indexed: 10/19/2022]

Abstract

BACKGROUND

As the nature of viral blips remains unclear, their occurrence often leads to uncertainty. This study compares blip incidence rates during treatment with different combination antiretroviral therapy anchors.

SETTING

Retrospective cohort study in a tertiary hospital.

METHODS

All antiretroviral regimens between 2010 and 2020 containing 2 nucleos(-t)ide reverse transcriptase inhibitors and 1 anchor in virologically suppressed people living with HIV (PLWH) from our center were evaluated for the occurrence of blips [isolated viral loads (VLs) 50-499 copies/mL between measurements <50 copies/mL]. Factors associated with blips were identified using multivariable generalized estimating equation-based negative binomial models. The relationship between blips and either persistent low-level viremia (consecutive VLs ≥ 50 copies/mL not classified as failure) or virologic failure (consecutive VLs ≥ 200 or 1 VL ≥ 500 copies/mL) was also evaluated.

RESULTS

In total, 308 blips occurred during 3405 treatment courses in 1661 PLWH. Compared with a non-nucleoside reverse transcriptase inhibitor anchor, blip incidence was higher for protease inhibitors (incidence rate ratio 1.37; 95% confidence interval 1.05 to 1.78) and lower for integrase inhibitors (INSTIs) (incidence rate ratio 0.64; 95% confidence interval: 0.43 to 0.96). In addition, blips were associated with higher zenith VL, higher VL test frequency, and shorter time since antiretroviral therapy initiation. PLWH experiencing blips were more likely to demonstrate persistent low-level viremia but not virologic failure. Blips led to extra consultations and measurements.

CONCLUSIONS

INSTI-based regimens display a low number of blips. Although we found no correlation with virologic failure, the occurrence of blips led to an increased clinical burden. Further research is needed to elucidate the implications and underlying mechanisms of these findings.

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Morsica G, Galli L, Messina E, Castagna A, Bagaglio S, Salpietro S, Liviana DT, Uberti-Foppa C, Hasson H. Risk of HIV viral rebound in HIV infected patients on direct acting antivirals (DAAs) treatment for HCV. PLoS One 2022;17:e0262917. [PMID: 35113890 PMCID: PMC8812874 DOI: 10.1371/journal.pone.0262917] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2021] [Accepted: 01/07/2022] [Indexed: 12/27/2022] Open

Ghiglione Y, Polo ML, Urioste A, Rhodes A, Czernikier A, Trifone C, Quiroga MF, Sisto A, Patterson P, Salomón H, Rolón MJ, Bakkour S, Lewin SR, Turk G, Laufer N. Hepatitis C Virus (HCV) Clearance After Treatment With Direct-Acting Antivirals in Human Immunodeficiency Virus (HIV)-HCV Coinfection Modulates Systemic Immune Activation and HIV Transcription on Antiretroviral Therapy. Open Forum Infect Dis 2020;7:ofaa115. [PMID: 32391403 PMCID: PMC7200087 DOI: 10.1093/ofid/ofaa115] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2020] [Accepted: 04/01/2020] [Indexed: 12/24/2022] Open

Affiliation(s)

Yanina Ghiglione CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
María Laura Polo CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
Alejandra Urioste CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
Ajantha Rhodes The Peter Doherty Institute for Infection and Immunity, The University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia
Alejandro Czernikier CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
César Trifone CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
María Florencia Quiroga CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
Alicia Sisto Hospital General de Agudos "Dr. J. A. Fernández," Unidad Enfermedades Infecciosas, Buenos Aires, Argentina
Patricia Patterson Fundación Huésped, Buenos Aires, Argentina
Horacio Salomón CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
María José Rolón Hospital General de Agudos "Dr. J. A. Fernández," Unidad Enfermedades Infecciosas, Buenos Aires, Argentina
Sonia Bakkour Vitalant Research Institute, San Francisco, California, USA
Sharon R Lewin The Peter Doherty Institute for Infection and Immunity, The University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia.,Department of Infectious Diseases, Alfred Health and Monash University, Melbourne, Australia
Gabriela Turk CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina
Natalia Laufer CONICET-Universidad de Buenos Aires, Instituto de Investigaciones Biomédicas en Retrovirus y Sida (INBIRS), Buenos Aires, Argentina.,Hospital General de Agudos "Dr. J. A. Fernández," Unidad Enfermedades Infecciosas, Buenos Aires, Argentina

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Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis 2019;67:1883-1889. [PMID: 29767684 DOI: 10.1093/cid/ciy382] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2018] [Accepted: 05/14/2018] [Indexed: 12/23/2022] Open

Affiliation(s)

Sidonie Lambert-Niclot Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France
Maxime Grude INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France
Jean-Luc Meynard Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
Anne-Geneviève Marcelin Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France
Marc-Antoine Valantin Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris
Philippe Flandre INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France
Jacques Izopet INSERM, U1043, Toulouse, France.,Université Toulouse III Paul-Sabatier, Toulouse, France.,CHU de Toulouse, Laboratoire de Virologie, Toulouse, France
Laetitia Moinot Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France.,CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France
Vincent Bouteloup Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France.,CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France
Vincent Calvez Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France
Christine Katlama Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris
Pierre-Marie Girard Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France
Laurence Morand-Joubert Sorbonne Université, Paris, France.,INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.,AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France

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Quantification of HIV-DNA and residual viremia in patients starting ART by droplet digital PCR: Their dynamic decay and correlations with immunological parameters and virological success. J Clin Virol 2019;117:61-67. [PMID: 31229934 DOI: 10.1016/j.jcv.2019.06.004] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2019] [Revised: 04/28/2019] [Accepted: 06/13/2019] [Indexed: 11/21/2022]

Abstract

BACKGROUND

Accurate quantification of total HIV-DNA and residual-viremia by sensitive assays is extremely useful to optimize monitoring of ART-treated patients.

OBJECTIVES

To evaluate the performances of two ddPCR-based assays for HIV-DNA and residual-viremia quantification, and the correlations of pre-ART HIV-DNA with plasma HIV-RNA, CD4 + T, CD4/CD8 and virological-success (VS) during first-line ART.

STUDY DESIGN

Plasma HIV-RNA, total HIV-DNA, CD4 + T, CD4/CD8 were evaluated at baseline of ART, at VS (viral-load <50copies/ml), and at 6 months after VS (6moVS) in 57 newly-diagnosed HIV-1 infected patients, receiving first-line modern ART. HIV-DNA (log10 copies/106CD4 + T) and residual-viremia (copies/ml) were measured with in-house ddPCR assays. Correlations were assessed by Spearman and Jonckheere-Terpstra tests.

RESULTS

HIV-DNA and residual-viremia assays showed a good linear trend between the expected and obtained values (R2 = 0.9913 and 0.9945); lower limits of detection were 32 copies/106CD4 + T and 2 copies/ml, respectively. At baseline, median (IQR) plasma HIV-RNA and HIV-DNA were 4.88(4.28-5.36)log10 copies/ml and 4.00(3.36-4.51) log10 copies/106CD4 + T cells. Residual-viremia was 8(2-26) and 4(2-12) copies/ml at VS and 6moVS. Pre-ART HIV-DNA positively correlated with plasma HIV-RNA at BL (Rho = 0.708, p < 0.001), and with residual-viremia at VS (Rho:0.383,p = 0.002). Notably, higher HIV-DNA correlated with longer time to achieve VS (median[IQR],weeks: 17.8[12.3-29.0] for HIV-DNA ≥4.5 vs. 7.4[4.1-8.7] for HIV-DNA<4.5, p < 0.001). Furthermore, pre-ART HIV-DNA negatively correlated with CD4 + T and CD4/CD8 at baseline, VS and 6moVS.

CONCLUSIONS

Our results support the adoption of ddPCR-based assays for both HIV-DNA and residual-viremia quantifications and corroborate that pre-ART HIV-DNA is an excellent indicator in predicting viroimmunological response and VS in patients starting ART.

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Gianotti N, Galli L, Galizzi N, Ripa M, Andolina A, Nozza S, Spagnuolo V, Poli A, Lazzarin A, Castagna A. Time spent with residual viraemia after virological suppression below 50 HIV-RNA copies/mL according to type of first-line antiretroviral regimen. Int J Antimicrob Agents 2018;52:492-499. [PMID: 30009958 DOI: 10.1016/j.ijantimicag.2018.07.001] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2018] [Revised: 06/28/2018] [Accepted: 07/07/2018] [Indexed: 01/19/2023]

Abstract

PURPOSE

To investigate if the regimen used when starting antiretroviral therapy (ART) affects the time spent with residual viraemia (RV) after achieving <50 HIV-RNA copies/mL.

METHODS

Retrospective cohort study on patients infected with human immunodeficiency virus (HIV), followed prospectively, who started ART with a boosted protease inhibitor (PI/r)-, a non-nucleoside reverse transcriptase inhibitor (NNRTI)- or an integrase inhibitor (InSTI)-based triple regimen, or a regimen with more than three drugs. RV was defined as any detectable polymerase chain reaction (PCR) signal <50 HIV-RNA copies/mL, as assessed by kinetic PCR or Abbott real-time PCR. The percentage of time spent with RV (%RV) was calculated as the cumulative follow-up time spent with RV on the observed follow-up, and was estimated using a generalized linear model.

RESULTS

Seven hundred and seventy-one patients (33%, 32%, 30% and 5% receiving PI/r-, NNRTI-, InSTI-based triple regimens, or a regimen with more than three drugs, respectively) were included in the analysis. After a median of 2.16 (interquartile range 1.27-3.16) years of follow-up, adjusted means of %RV were 37.9% [95% confidence interval (CI) 30.3-45.4%], 23.9% (95% CI 16-31.8%), 25.3% (95% CI 17.8-32.7%) and 45.5% (95% CI 34.6-56.4%) in the PI/r, NNRTI, InSTI and more than three drugs groups, respectively; %RV was significantly higher in patients who started ART with a regimen with more than three drugs (P=0.030), and was significantly lower in patients who started ART with an NNRTI-based regimen (P<0.0001) or an InSTI-based regimen (P=0.030) than in those who started ART with a PI/r-based regimen. %RV was independently associated with pre-ART HIV-RNA (P<0.0001), time to HIV-RNA <50 copies/mL (P<0.0001), NRTI backbone (P=0.037) and baseline HIV-RNA (P<0.0001).

CONCLUSION

First-line regimens based on PIs/r or on more than three drugs are associated with a greater percentage of time spent with RV after achieving virological suppression.

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Parisi SG, Andreis S, Basso M, Cavinato S, Scaggiante R, Franzetti M, Andreoni M, Palù G, Cattelan AM. Time course of cellular HIV-DNA and low-level HIV viremia in HIV-HCV co-infected patients whose HCV infection had been successfully treated with directly acting antivirals. Med Microbiol Immunol 2017;206:419-428. [PMID: 28864951 DOI: 10.1007/s00430-017-0518-x] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2017] [Accepted: 08/27/2017] [Indexed: 12/21/2022]

Porter DP, Kulkarni R, Garner W, Miller MD, White KL. Viral blips were infrequent in treatment-naive adults treated with rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF through 96 weeks. Antivir Ther 2017;22:495-502. [PMID: 28091393 DOI: 10.3851/imp3128] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/22/2016] [Indexed: 10/20/2022]

Abstract

BACKGROUND

The clinical impact of transient episodes of HIV viraemia (viral blips) on virological failure and resistance development is not fully understood. Here we investigated the blip frequency and virological outcomes of HIV-1-infected subjects experiencing viral blips among treatment-naive subjects initiating therapy on rilpivirine (RPV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or efavirenz (EFV)/FTC/TDF through 96 weeks of treatment.

METHODS

Subjects treated with at least one dose of study drug and with at least one post-baseline HIV-1 RNA value were included in this analysis. All on-drug HIV-1 RNA data points and FDA snapshot outcome data through week 96 were utilized. A viral blip was defined as after achieving confirmed suppression (two consecutive HIV-1 RNA values <50 copies/ml), any HIV-1 RNA value ≥50 copies/ml preceded and followed by HIV-1 RNA <50 copies/ml.

RESULTS

Of the 717 subjects with confirmed suppression, 67 (9.3%) experienced ≥1 blip through week 96 with similar blip frequencies occurring in both treatment arms (10.7% RPV/FTC/TDF versus 8.0% EFV/FTC/TDF; P=0.25). A significantly higher proportion of subjects with baseline HIV-1 RNA >100,000 copies/ml experienced blips compared to subjects with baseline HIV-1 RNA ≤100,000 copies/ml and this was observed in both arms. Of 72 total blip events, 61 (85%) were low-level (50-199 copies/ml). Overall, among subjects with blips, 79% were virological successes at week 96, similar to those subjects without blips (83%; P=0.50). More subjects with blips ≥200 copies/ml experienced virological failure compared to subjects with blips <200 copies/ml (36.4% versus 7.1%; P=0.02).

CONCLUSIONS

Viral blips were infrequent and similar among subjects treated with RPV/FTC/TDF or EFV/FTC/TDF. Most blips were low-level and most subjects with blips remained virologically suppressed through week 96 without experiencing virological failure.

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Sauné K, Raymond S, Boineau J, Pasquier C, Izopet J. Detection and quantification of HIV-1 RNA with a fully automated transcription-mediated-amplification assay. J Clin Virol 2016;84:70-73. [PMID: 27728849 DOI: 10.1016/j.jcv.2016.09.002] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2016] [Revised: 08/29/2016] [Accepted: 09/01/2016] [Indexed: 02/04/2023]

Rojas J, Blanco JL, Marcos MA, Lonca M, Tricas A, Moreno L, Gonzalez-Cordon A, Torres B, Mallolas J, Garcia F, Gatell JM, Martinez E. Dolutegravir monotherapy in HIV-infected patients with sustained viral suppression. J Antimicrob Chemother 2016;71:1975-81. [PMID: 27021341 DOI: 10.1093/jac/dkw078] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/12/2016] [Accepted: 02/17/2016] [Indexed: 11/15/2022] Open

Abstract

OBJECTIVES

We reviewed the 24 week outcomes of HIV-infected patients from our hospital who had their ART switched to dolutegravir monotherapy on an individual clinical basis.

METHODS

Retrospective hospital database assessment of virally suppressed patients in whom the treating physician had switched to 50 mg of dolutegravir once daily due to one or more of the following reasons: antiretroviral-related adverse effects; comorbidities; risk of interactions; or archived resistance. Patients had ≥24 weeks of follow-up. Population, virological and immunological responses and safety and tolerability are described.

RESULTS

Thirty-three (22 on PIs, of whom 18 had ritonavir-boosted PI monotherapy) patients were identified: median (IQR) age of 56 (50-62) years, 55% women, median (IQR) of 19 (17-23) years of known HIV infection, 39% prior AIDS events, median (IQR) of 8 (4-13) years with undetectable plasma HIV-1 RNA and median (IQR) CD4 cell count of 596 (420-843) cells/mm(3). Twenty-five (76%) patients had antiretroviral-related adverse effects, 32 (97%) patients had comorbidities, 28 (85%) patients had risk of interactions and 16 (48%) patients had archived resistance. One patient with suboptimal adherence had low-level virological failure through weeks 4-24. HIV RNA genotypic resistance tests detected no integrase mutations at weeks 4 and 24, but 118R was detected in 7% of the integrated HIV DNA at 24 weeks. Patients had significant median decreases in triglycerides (-117 mg/dL), total cholesterol (-36 mg/dL), the total cholesterol/HDL cholesterol ratio (-0.7) and high-sensitivity C-reactive protein (-0.05 mg/dL) (P ≤ 0.007), although the Chronic Kidney Disease Epidemiology Collaboration equation also decreased (-7.1 mL/min) (P < 0.0001).

CONCLUSIONS

These data suggest the efficacy of dolutegravir monotherapy as a maintenance strategy to be further confirmed in randomized clinical trials.

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Naqvi A, Giordanengo V, Dunais B, de Salvador-Guillouet F, Perbost I, Durant J, Pugliese P, Joulié A, Roger PM, Rosenthal E. Virological response and resistance mutations to NS3/4A inhibitors in hepatitis C virus-human immunodeficiency virus coinfection. World J Hepatol 2015;7:2177-2183. [PMID: 26328030 PMCID: PMC4550873 DOI: 10.4254/wjh.v7.i18.2177] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2014] [Revised: 03/17/2015] [Accepted: 07/23/2015] [Indexed: 02/06/2023] Open

Abstract

AIM: To evaluate virological response to telaprevir or boceprevir in combination with pegylated interferon and ribavirin and resistance mutations to NS3/4A inhibitors in hepatitis C virus-human immunodeficiency virus (HCV-HIV) coinfected patients in a real life setting.

METHODS: Patients with HCV genotype 1-HIV coinfection followed in Nice University Hospital internal medicine and infectious diseases departments who initiated treatment including pegylated interferon and ribavirin (PegIFN/RBV) + telaprevir or boceprevir, according to standard treatment protocols, between August 2011 and October 2013 entered this observational study. Patient data were extracted from an electronic database (Nadis^®). Liver fibrosis was measured by elastometry (Fibroscan^®) with the following cut-off values: F0-F1: < 7.1 kPa, F2: 7.1-9.5 kPa, F3: 9.5-14.5 kPa, F4: ≥ 14.5 kPa. The proportion of patients with sustained virological response (SVR) twelve weeks after completing treatment, frequency and type of adverse events, and NS3/4A protease inhibitor mutations were described.

RESULTS: Forty-one patients were included: 13 (31.7%) patients were HCV-treatment naïve, 22 (53.7%) had advanced liver fibrosis or cirrhosis (Fibroscan stage F3 and F4); none had decompensated cirrhosis or hepatocellular carcinoma; all were receiving antiretroviral treatment, consisting for most them (83%) in either a nucleoside reverse-transcriptase inhibitor/protease inhibitor or/integrase inhibitor combination; all patients had undetectable HIV-RNA. One patient was lost to follow-up. SVR was achieved by 52.5% of patients. Five patients experienced virological failure during treatment and four relapsed. Seven discontinued treatment due to adverse events. Main adverse events included severe anemia (88%) and rash (25%). NS3/4A protease mutations were analyzed at baseline and at the time of virological failure in the 9 patients experiencing non-response, breakthrough or relapse. No baseline resistance mutation could predict resistance to HCV protease inhibitor-based treatment.

CONCLUSION: Telaprevir and boceprevir retain their place among potential treatment strategies in HIV-HCV coinfected patients including those with advanced compensated liver disease and who failed previous PegIFN/RBV therapy.

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Residual viremia is preceding viral blips and persistent low-level viremia in treated HIV-1 patients. PLoS One 2014;9:e110749. [PMID: 25354368 PMCID: PMC4212971 DOI: 10.1371/journal.pone.0110749] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2014] [Accepted: 09/08/2014] [Indexed: 01/15/2023] Open

Amendola A, Marsella P, Bloisi M, Forbici F, Angeletti C, Capobianchi MR. Ability of two commercially available assays (Abbott RealTime HIV-1 and Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 Version 2.0) to quantify low HIV-1 RNA Levels (<1,000 copies/milliliter): comparison with clinical samples and NIBSC working reagent for nucleic acid testing assays. J Clin Microbiol 2014;52:2019-26. [PMID: 24671791 PMCID: PMC4042785 DOI: 10.1128/jcm.00288-14] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2014] [Accepted: 03/21/2014] [Indexed: 11/20/2022] Open

Abstract

Concordance between molecular assays may be suboptimal at low HIV-1 viremia levels (<1,000 copies/ml); therefore, it may be difficult to define and compare virologic endpoints for successful and failed therapy. We compared two commercial assays (the Abbott RealTime HIV-1 and the Roche Cobas AmpliPrep/TaqMan HIV-1 version 2.0) for their ability to detect and quantify low viral loads. A comparison was performed using 167 residual clinical samples (with values ranging from "not detected" to 1,000 copies/ml, as measured by the Abbott assay) and the National Institute and Biological Standards and Control (NIBSC) HIV-1 RNA working reagent 1 for nucleic acid amplification techniques (NAT) assays (serially diluted to a range from 1 to 1,000 copies/ml). Quantitative results were compared using Lin's concordance correlation coefficient and a Bland-Altman plot. Concordance with the qualitative results was measured by Cohen's kappa statistic. With clinical samples, the degree of interassay concordance of the qualitative results at a 40-copies/ml HIV-1 RNA threshold was substantial (κ = 0.762); the correlation among the quantified samples was suboptimal (concordance correlation coefficient, 0.728; P < 0.0001); the mean difference of the values between the Roche and Abbott assays was 0.193 log10 copies/ml. Using the HIV-1 RNA working reagent 1 for NAT assays, the results provided by the Roche assay were, on average, 3 times higher than expected, while the Abbott assay showed high accuracy. The Roche assay was highly sensitive, being able to detect a level as low as 3.5 copies/ml HIV-1 RNA with 95% probability. The performance characteristics of each molecular assay should be taken into account when HIV-1 RNA threshold values for "virologic suppression," "virologic failure," "persistent low viral loads," etc., are defined and indicated in the support of clinical decisions.

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