Safe Reduction in CD4 Cell Count Monitoring in Stable, Virally Suppressed Patients With HIV Infection or HIV/Hepatitis C Virus Coinfection

Nicolás, David; Esteve, Anna; Cuadros, Anna; Campbell, Colin; Tural, Cristina; Podzamczer, Daniel; Homar, Francesc; Segura, Ferrán; Force, Lluís; Vilaró, Josep; García, Isabel Cristina Carbonell; Ferrer, Elena; Riera, Melcior; Ambrosioni, Juan; Navarro, Gemma; Clotet, Bonaventura; Gatell, Josep M.; Casabona, Jordi; Miró, José M.; Murillas, Javier; Manzardo, Christian; Masabeu, Àngels; Mercadal, J.; Cifuentes, Carmen; Dalmau, David; Domingo, Peré; Falcó, Vicenç; Curran, Adrían; Agustí, Cristina; Montoliu, Alexandra; Pérez, Iñaki; Curto, Jordi; Gargoulas, Freya; Vergara, Andrea; Rubia, JC; Zamora, Laura; Blanco, José Luis Santiago; García-Alcaide, Felipe; Martínez, Estebán; Mallolas, Josép; Llibre, JM; Sirera, Guillem; Romeu, Joan; Jou, Antoni; Negredo, Eugènia; Imaz, Arkaitz; Bolao, Ferrán; Cabellos, Carmen; Peña, C Fernández; DiYacovo, S.; Eynde, Eva Van den; Sala, Montserrat; Cervantes, Manel; Amengual, M. J.; Navarro, Mercedes; Segura, Víctor; Barrufet, Pilar; Molina, Jean Michel; Alvaro, Marcela Vitor; Payeras, T.; Mateo, María; Fernández, Juanse

doi:10.1093/cid/ciw157

Cited by 5 publications

(6 citation statements)

References 18 publications

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“…While our results support decreasing CD4 cell count and HIV-RNA monitoring in healthy populations, regular clinic visits remain critical to assess adherence, co-morbidities like HCV coinfection 16 , and psychosocial needs. Finally, our analysis included individuals initiating cART in 2000 or later, yet it is possible that monitoring frequency could have differential effects over calendar time as cART guidelines and prescribing patterns evolve.…”

Section: Discussionmentioning

confidence: 58%

“…Two randomized trials 11,12 and several observational studies, 13–16 including ours, 17 focused on CD4 cell and HIV-RNA monitoring strategies in which monitoring frequency is independent of an individual’s time-varying CD4 cell count. While these studies found no clinical harm for annual 13–17 or biannual 11,12 monitoring, further follow-up is needed to establish the long-term safety.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

et al. 2017

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BackgroundClinical guidelines vary with respect to the optimal monitoring frequency of HIV-positive individuals. We compared dynamic monitoring strategies based on evolving CD4 cell counts in virologically suppressed HIV-positive individuals.MethodsWe used data from prospective studies of HIV-positive individuals in Europe and the Americas in the HIV-CAUSAL Collaboration and The Center for AIDS Research Network of Integrated Clinical Systems. We compared three monitoring strategies, which differ with respect to the CD4 cell count threshold that is used to measure CD4 cell count and HIV-RNA every 3–6 months (when below the threshold) or every 9–12 months (when above the threshold). The strategies were defined by the thresholds 200, 350, and 500 cells/μl. We estimated hazard ratios of death and of AIDS-defining illness or death, risk ratios of virologic failure, and mean differences in CD4 cell count using inverse probability weighting to adjust for baseline and time-varying confounders.Findings47,635 eligible individuals initiated a cART regimen between January, 2000 and November, 2015 and met the eligibility criteria for our study. During follow-up, CD4 cell count and HIV-RNA were measured on average every 4 and 3.8 months, respectively. 464 individuals died (107 in threshold 200 strategy, 157 in threshold 350, and 200 in threshold 500) and 1,091 had AIDS-defining illnesses or died (267 in threshold 200 strategy, 365 in threshold 350, and 459 in threshold 500). Compared with threshold 500, the mortality hazard ratio (95% CI) was 1.05 (0.86, 1.29) for threshold 200 and 1.02 (0.91, 1.14) for threshold 350. Corresponding estimates for death or AIDS-defining illness were 1.08 (0.95, 1.22) and 1.03 (0.96, 1.12), respectively. The respective 24-month risk ratios (95% CI) of virologic failure (HIV-RNA>200 copies/ml) were 2.01 (1.17, 3.43) and 1.24 (0.89, 1.73) and 24-month mean CD4 cell count differences (95% CIs) were 0.4 (−25.5, 26.3) cells/μl and −3.5 (−16.0, 8.9) cells/μl.InterpretationOur findings suggest that decreasing monitoring to annually when CD4 cell count>200 cells/μl compared with >500 cells/μl does not worsen the short-term clinical and immunologic outcomes of virologically suppressed HIV-positive individuals, but more frequent virologic monitoring may be necessary to decrease the risk of virologic failure. Further follow-up is needed to establish the long-term safety of these strategies.

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Section: Discussionmentioning

confidence: 58%

Section: Introductionmentioning

confidence: 99%

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

et al. 2017

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“…PISCIS is an ongoing observational cohort study that has included prospectively all HIV‐infected patients aged ≥ 16 years newly seen in 12 hospitals in Catalonia and two in the Balearic Islands (Spain) since January 1998. The methods applied have been described elsewhere . The PISCIS data set currently contains data for more than 22 000 adults, of whom 13 000 are under active follow‐up.…”

Section: Methodsmentioning

confidence: 99%

Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort

et al. 2019

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Objectives The aim of the study was to assess the rates of discontinuation of integrase inhibitor regimens because of any neuropsychiatric adverse event (NPAE) and the factors associated with discontinuation. Methods A population‐based, prospective, multicentre cohort study was carried out. Treatment‐naïve subjects starting therapy with a regimen containing integrase inhibitors, or those switching to such a regimen, with plasma HIV‐1 RNA < 50 HIV‐1 RNA copies/mL in 14 hospitals in Catalonia or the Balearic Islands (Spain) were included in the study. Every discontinuation because of adverse events (AEs) was double‐checked directly with treating physicians. Multivariable Cox models identified factors correlated with discontinuation. Results A total of 4165 subjects (37% treatment‐naïve) started regimens containing dolutegravir (n = 1650; 91% with abacavir), raltegravir (n = 930) or elvitegravir/cobicistat (n = 1585). There were no significant differences among regimens in the rate of discontinuation because of any AE. Rates of discontinuation because of NPAEs were low but higher for dolutegravir/abacavir/lamivudine [2.1%; 2.9 (95% confidence interval (CI) 2.0, 4.2) discontinuations/100 patients/year] versus elvitegravir/cobicistat (0.5%; 0.8 (95% CI 0.3, 1.5) discontinuations/100 patients/year], with significant differences among centres for dolutegravir/abacavir/lamivudine and NPAEs (P = 0.003). We identified an association of female gender and lower CD4 count with increased risk of discontinuation because of any AE [Incidence ratio (IR) 2.3 (95% CI 1.4, 4.0) and 1.8 (95% CI 1.1, 2.8), respectively]. Female gender, age > 60 years and abacavir use were not associated with NPAE discontinuations. NPAEs were commonly grade 1–2, and had been present before and improved after drug withdrawal. Conclusions In this large prospective cohort study, patients receiving dolutegravir, raltegravir or elvitegravir/cobicistat did not show significant differences in the rate of discontinuation because of any toxicity. The rate of discontinuations because of NPAEs was low, but was significantly higher for dolutegravir than for elvitegravir/cobicistat, with significant differences among centres, suggesting that greater predisposition to believe that a given adverse event is caused by a given drug of some treating physicians might play a role in the discordance seen between cohorts.

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“…10,13 Furthermore, there are no treatment strategies to increase CD4 + cell count during periods of viral suppression. A CD4 + count drop below 200 cells/mL is currently seldom observed during successful ART, [14][15][16][17] and frequent testing may cause unnecessary anxiety in patients with clinically inconsequential fluctuations. Therefore, the utility of their monitoring has become a matter of debate.…”

Section: Introductionmentioning

confidence: 99%

“…18 In this context, some guidelines recommend optional or stop monitoring CD4 + cell counts once virological suppressions (VS) are sustained, and the immunological status is stabilized. 1,3,18 There are no randomized comparisons of individuals following different CD4 + count monitoring strategies as they are difficult to be performed, and although it is well established that CD4 + cells falling below 200 cells/mL occur infrequently while viral load is suppressed, [14][15][16][17]19 robust estimates of CD4 + cells dropping below 200 cells/mL over long follow-up are limited. Furthermore, relevant differences might emerge when comparing data collected in countries with different organizations of the social health system.…”

Section: Introductionmentioning

confidence: 99%

Brief Report: Drop in CD4+ Counts Below 200 Cells/μL After Reaching (or Starting From) Values Higher than 350 Cells/μL in HIV-Infected Patients With Virological Suppression

Gianotti

Marchetti

Antinori

et al. 2017

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Safe Reduction in CD4 Cell Count Monitoring in Stable, Virally Suppressed Patients With HIV Infection or HIV/Hepatitis C Virus Coinfection

Abstract: From our data, it can be inferred that CD4 cell count monitoring can be safely performed annually in HIV-monoinfected patients with CD4 cell counts >300 cells/µL and HIV/HCV-coinfected patients with counts >350 cells/µL.

Cited by 5 publications

References 18 publications

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort

Brief Report: Drop in CD4+ Counts Below 200 Cells/μL After Reaching (or Starting From) Values Higher than 350 Cells/μL in HIV-Infected Patients With Virological Suppression

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