Abstract
Dear Editor
The ongoing COVID-19 pandemic is rapidly reshaping the organization of healthcare systems worldwide, prompting the creation of COVID-19–dedicated wards and services at the expense of pre-existing structures. 1
European countries are now facing the “second wave” of the COVID-19 epidemic, with increasing numbers of cases and deaths; hence, people with chronic conditions, including those living with HIV (PLWHIV), are struggling to maintain their routine disease management, resulting in missed medical visits and the risk of lower adherence to treatment.2,3
In our clinical center in Rome, Italy, we conducted a retrospective study aimed at observing how PLWHIV were followed-up during the “first wave” of the COVID-19 epidemic in the country and during the national lockdown from March 9th to May 28th, 2020.
We analyzed all treatment-experienced, virologically suppressed PLWHIV who had had at least one visit between March 10th and June 1st, 2020, and collected viroimmunological parameters. We compared this group of PLWHIV with the patients observed over the same period in 2019. Our primary aim was to assess the rate of virological failures (VF, defined as two consecutive HIV-RNA ≥ 50 copies/mL or a single HIV-RNA ≥ 1000 copies/mL). Predictors of VF were assessed using Cox regression analysis.
Patients’ characteristics at baseline.
During 184.3 Patient-Years of Follow-Up (PYFU) of the 2020 group, we observed 23 VF, a rate of 12.5 per 100 PYFU. In patients experiencing VF, we performed a genotypic test to investigate acquired mutations: among the 23 analyzed individuals, two of them, both on a 2NRTI+raltegravir (RAL) strategy, presented newly discovered mutations (one had both the 138K and the 148R mutations and the other had the 155H mutation) conferring resistance to RAL.
Interestingly, patients on a dual regimen had significantly less probability of showing VF compared to patients on 3+ drug regimens: 6-month probability of remaining virologically suppressed was 98.8% vs 90.5%, respectively (log-rank p = 0.031). In the calendar period of 2019, we observed 50 VF during 675 PYFU, a rate of 7.4 per 100 PYFU.
Time of virological suppression (aHR = 0.96 per month longer, 95%CI 0.95–0.98, p < 0.001) emerged as the only predictor of VF in the 2020 cohort after adjusting for age, sex, time on current ARV regimen, previous AIDS-defining event, and nadir CD4+ cell count. Similarly, in the 2019 cohort, time of virological suppression (aHR = 0.97 per month longer, 95%CI 0.96–0.98, p < 0.001) was the only predictor of VF after adjusting for years from HIV diagnosis and peak HIV-RNA. In 2019, we observed no differences in VF risk between patients on 2DR and patients on other treatment strategies (log-rank p = 0.111).
To rule out a possible selection bias, we carried out an additional analysis on patients who had had a clinical visit in both 2019 and 2020; we found that 212 patients met this criterion. In this sub-analysis, we registered 11 VF during 115 PYFU in 2020 (a rate of 9.6 per 100 PYFU) and six VF during 136 PYFU in 2019 (a rate of 4.4 VF per 100 PYFU). The probability of maintaining virological suppression was significantly different between groups (log-rank p < 0.001); time of virological suppression remained the sole predictor of VF in both 2020 (aHR = 0.91 per month longer, 95%CI 0.85–0.97, p = 0.005) and 2019 (aHR = 0.94 per month longer, 95%CI 0.89–099, p = 0.043).
The data emerging from our study are particularly alarming. Compared to data from the previous year and from other works on the same cohort,4,5 we found that the rate of VF during the months of the COVID-19 pandemic increased dramatically. In our population, patients on a dual-regimen appeared to have a lower risk of VF, probably because they had already been selected in terms of adherence to treatment and linkage to care before starting a simplified, reduced drug regimen. In conclusion, the findings from this real-life observational study should prompt clinicians to pay even more attention to the regular monitoring of PLWHIV during this pandemic to prevent a dangerous increase in the rate of virological failures.
Footnotes
Acknowledgments
The authors would like to thank Prof. Claire Montagna for proofreading the manuscript and performing English language revision.
Declaration of conflicting interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.C. has received travel grants from ViiV Healthcare. A.B. has received fees for board participation from ViiV and Janssen. S.D.G. has received speakers' honoraria, grants for research and personal fees from Janssen-Cilag, ViiV Healthcare and Gilead Sciences.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Contributorship
Transparency declarations: A.C. has received travel grants from ViiV Healthcare. A.B. has received fees for board participation from ViiV and Janssen. SD.G. has received speakers’ honoraria, grants for research, and personal fees from Janssen-Cilag, ViiV Healthcare, and Gilead Sciences.
