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Llibre and Santiago Moreno contributed equally to this study. In this scenario, it is reasonable to believe that the concept of therapeutic success, traditionally associated with CD4 cell count restoration and HIV RNA plasma viral load suppression and the absence of drug resistances, needs to be redefined to include other factors that reach beyond antiretroviral efficacy. With this in mind, a group of experts initiated and coordinated the RET Project, and this group, using the available evidence and their clinical experience in the field, has proposed new criteria to redefine treatment success in HIV, arranged into five main concepts: rapid initiation, efficacy, simplicity, safety, and QoL. Despite these positive aspects, a set of HIV-associated complications persist, related in part to the accelerated or premature ageing observed in some people living with HIV PLWH , cumulative toxicities resulting from exposure to antiretroviral drugs over decades, and other comorbidities. Traditionally, the concept of therapeutic success has been associated with CD4 cell count restoration, plasma RNA-HIV suppression, and the absence of emerging HIV drug resistance mutations and severe toxicity. Accordingly, an extensive review of the literature was performed. This work aimed to identify not only the areas in which agreement and general consensus existed, but also those gaps not covered by the current evidence and that, as such, would need to be further explored and given special consideration. This article summarizes the conclusions of the panel on the main topics that redefine the concept of therapeutic success Table 1 and Figure 1. Indeed, immediate same-day HIV diagnosis or rapid initiation of ART initiation regardless of knowing the results of baseline tests have been proposed to improve treatment outcomes. In this setting, same-day HIV testing and ART initiation were seen to be feasible and beneficial, improving retention in care and virological suppression among patients with early clinical HIV disease. Among the studies conducted in high-income countries, two were carried out in the United States and another included patients from various Western countries. These results suggested that rapid entry is feasible and could have a positive impact on HIV transmission at the population level. This study demonstrated that the rapid initiation of ART for vulnerable populations is feasible and effective, although it requires significant multidisciplinary care and municipal support. Rapid initiation is also recommended by all clinical guidelines. Furthermore, various studies have been performed 16 , 17 , 23 to evaluate the feasibility of different treatments in a rapid test and treat model of care some of which, such as the RoCHaCHa study, 23 are currently ongoing , in order to assess the regimens recommended as a preference or alternative by most clinical guidelines. Outcomes have been diversely successful and could be taken into consideration when establishing a test and treat strategy. In conclusion, rapid ART initiation has been associated with greater retention in care, better virological control and better overall outcomes than standard initiation in low—middle income countries. However, evidence of the benefits of rapid ART initiation in Western countries is not yet sufficient. Therefore, producing more evidence in settings where the information is still lacking would be an important aspect to further support this recommendation. Another important consideration is that individuals who rapidly initiate ART appear to be satisfied with the strategy. Consequently, in line with the WHO recommendations and the available evidence, we suggest that if the patient is willing, starting ART on the same day of HIV diagnosis or on the first attended provider visit may be beneficial. Finally, we strongly believe that rapid ART initiation should be incorporated into the standard of care in order to optimize results. Efforts must be made by health administrations to ensure that rapid ART initiation can be implemented in any HIV unit. If rapid ART initiation is selected, it is important to prioritize regimens with a high barrier against resistance development, low toxicity, anti-HBV activity and a low rate of drug—drug interactions DDIs. A threshold below that level has not demonstrated additional clinical benefits. Priority should be given to the use of initial ART regimens that have demonstrated high rates of optimal viral suppression in clinical trials. It is advisable to monitor blip frequency in clinical trials, given the putative differences between the new therapeutic regimens available. It is crucial to assess the frequency if any of the peaks and their further risk with virological failure in those integrase strand transfer inhibitor INSTI -based regimens. Some results suggest that in ART-naive individuals, PVL may increase over time and more sharply in older individuals, and that a higher viral load is strongly associated with an ongoing rate of CD4 cell count depletion. We focus on regimens that are currently the preferred used. Additionally, for a correct assessment of the efficacy rate of new ART strategies, outcomes from subjects with high baseline PVL need to be included in clinical evaluations. CD4 cell count is another important factor determining the efficacy of the ART. This fact should be considered when choosing the antiretroviral treatment regimen. If safe alternatives are available, strategies with doubtful efficacy in this scenario or those that lack supporting evidence should be avoided. In patients with late diagnosis of HIV infection and concomitant opportunistic events, it is necessary to use a regimen with a lower DDI potential, adjusted to the drugs necessary for the treatment of opportunistic events and specifically not including pharmacokinetic enhancers. Transmission was observed in only eight couples receiving ART; four transmissions occurred before the index patient achieved virological suppression and another four occurred during index patient virological failure. In the case of vertical transmission of HIV, it is worth considering that this is an exceptional event in pregnant women who have suppressed PVL. Regarding the time to virological suppression TVS , several regimens have been evaluated. The use of INSTI-based regimens has the advantage of being faster to reach an undetectable viral load, and this may have an impact on reducing HIV transmission. However, in some regions these recommendations have not been adequately implemented. In this scenario, it is important that health policy encourages HIV programmes to properly implement these guidelines. The barrier against resistance development impacts the development of drug resistance mutations in the virological failure. It is known that this phenomenon is not homogeneous among the different starting ART regimens. Given the impact of drug resistance mutations on treatment efficacy and the limitations of subsequent ART options, it seems reasonable to give priority to the use of ART regimens that are less likely to select resistance mutations in virological failure. It is considered that adherence is equally as important as the potency of a regimen, while the complexity of medication regimens is a known determinant of adherence across a range of chronic diseases. Among the factors influencing adherence to ART in naive patients, an observational study conducted between and in 27 patients from the USA identified ethnicity, income level and the use of STRs. Several studies have analysed the specific advantages of reducing the number of pills in HIV patients. Additionally, higher adherence rates were associated with higher levels of viral suppression in 13 out of 18 studies. Furthermore, STRs also reduced healthcare resource utilization and demonstrated cost-effectiveness compared with MTRs, and a trend toward lower discontinuation rates with the former was observed. Importantly, the benefits of STRs were demonstrated regardless of the number of doses per day. This study included both naive and pre-treated patients and analysed the impact of once-daily q24h versus twice-daily regimens on treatment adherence. The observed effect was more pronounced at the time of treatment initiation and for regimens in which all medications were taken once a day. Based on the available data, PLWH prefer simple regimens, with as few doses and pills as possible. Furthermore, ART regimens with a low number of pills and low dosing frequency are associated with better adherence, and some strategies to simplify ART are associated with better virological control. STRs prevent selective non-compliance and thus reduce the risk of resistance selection due to partial non-adherence. We believe that the simplicity of ART must be a factor to be considered when redefining therapeutic success because data from clinical trials and observational studies favour the use of STRs administered on a once-daily basis to improve treatment adherence and virological response. Furthermore, in some patient profiles, especially those with low adherence rates, we believe that simpler and easier ways of administration, such as those provided by STRs, would be beneficial. Consequently, the administration of simple regimens should be considered an essential element in the care of people with HIV. They present a favourable safety profile compared with other alternatives and, consequently, should be used preferentially. These AEs include headache, fatigue, insomnia, anxiety, abnormal dreams and nausea, and may occur with most of the drugs. Regimens currently considered as preferential for treatment initiation or simplification are associated with low toxicity rates and low toxicity-related discontinuation rates, favouring compliance and contributing to better patient QoL. If such AEs are detected, possible alternative causes should be explored. If no other reasons are found, and if they are associated temporally with exposure to a given drug, a change in treatment should be assessed. In Spain, the prevalence of bone disease in subjects with HIV infection is 2. Furthermore, the use of tenofovir disoproxil fumarate should be avoided in subjects with or at risk of developing osteopenia or osteoporosis. In Spain, the prevalence of renal disease in people with HIV infection is 5. Moreover, the CKD incidence rate remains disproportionately higher in blacks versus non-blacks. Consequently, for the early diagnosis of tenofovir disoproxil fumarate-associated renal effects and to allow for recovery after drug withdrawal, a systematic routine monitoring of glomerular and tubular renal function is continuously required. In boosted regimens, and if tenofovir is to be included, the use of tenofovir alafenamide is preferable to tenofovir disoproxil fumarate because of its clinical renal safety profile. Controversy currently surrounds a possible increase in CVD in HIV-infected subjects without other associated comorbidities and not exposed to toxic antiretroviral drugs not in current use. Heart failure, sudden death and stroke are clearly the cardiovascular events with the greatest incremental risk in PLWH. Specifically, the metabolic profile of darunavir is no worse in terms of risk of insulin resistance, arterial hypertension, diabetes or weight gain, although a worse lipid profile has been confirmed, 20 , 92 , 93 while data on its association with AMI are conflicting. Specifically, an association between abacavir use and increased risk of AMI has been suggested. However, results from both meta-analyses of randomized clinical trials and cohort observational studies have been inconclusive. However, most guidelines recommend avoidance or caution with abacavir in subjects with intermediate or elevated CVD risk. All patients should be encouraged to lead a healthy lifestyle diet and physical exercise. Regular monitoring of blood pressure should be performed at 6 monthly visits, and optimal treatment for arterial hypertension, hyperlipidaemia, antiplatelet aggregation and type II diabetes mellitus should be prescribed when required. Furthermore, abacavir should be avoided in subjects with moderate or high cardiovascular risk. Based on the available evidence, we believe that the comprehensive care of HIV-infected individuals should also include systematic screening for smoking, access to smoking cessation programmes and detection of subsequent relapses. Obesity is a multifactorial disease that affects individuals the world over, regardless of sex, race, age, racial condition or geography. On the other hand, black race and female sex increase this risk of weight gain and metabolic syndrome, and the sum of different factors has an additive or synergistic effect on weight gain and obesity rates. Efavirenz has been associated with weight loss in many trials and tenofovir disoproxil fumarate shows a protective effect against weight gain. The trials studying a switch from tenofovir disoproxil fumarate to tenofovir alafenamide suggest that most of the difference is due to stopping tenofovir disoproxil fumarate rather than starting tenofovir alafenamide. Most of these individuals have lost weight due to HIV-associated wasting and show a return to health associated with weight recovery in the first year of treatment. To date, no data have been obtained from randomized clinical trials to support a specific switch regimen in the case of excessive weight gain or to suggest that obesity should be considered when choosing initiation ART. Despite the lack of convincing data on the impact of specific drug regimens on weight gain and obesity metabolic syndrome, there is enough evidence pointing to body weight and BMI as relevant concerns in PLWH, at least in some populations with special risk. In individuals with a significantly greater weight gain than expected, not justified by other causes and associated over time with exposure to a given ART, the possibility of changing to a regimen that does not include these drugs should be considered. In obese individuals, dietary intervention and structured exercise should be recommended. NAFLD is diagnosed by imaging techniques, such as liver elastography with controlled attenuation parameter CAP measurement, ultrasound and MRI, all of which can differentiate hepatic fibrosis from steatosis. Some scores constructed from liver biomarkers that show acceptable diagnostic certainty are also available. Finally, in advanced stages NASH , liver biopsy may be required to confirm the diagnosis. NAFLD in HIV-infected subjects should be actively assessed, especially in the presence of obesity, diabetes mellitus and lipodystrophy. Optimal control of the lipid profile is recommended. Given the prevalence of psychiatric disorders among HIV patients and their impact on their QoL and on therapeutic success, active surveillance should be maintained to detect possible symptoms, assess treatment suitability and, when present, evaluate their putative relationship with exposure to drugs, including ART. External causes should be also evaluated. When symptoms are determined to be temporarily associated with exposure to an antiretroviral regimen and are not easily attributed to a known external cause, the possibility of switching to a safer option should be assessed, as in most instances the effect is reversible upon discontinuation of the drug. However, targeted questions are often required for detection of such problems. When detected, hypogonadism, peripheral artery disease and psychological causes anxiety, stigma should be specifically ruled out, and the appearance of sexual dysfunction as a potential pharmacological adverse effect must be considered especially with PIs. The presence of sexual dysfunction should be proactively assessed. After ruling out organic causes or psychological factors, an adverse pharmacological effect must be considered. If indicated, phosphodiesterase-5 inhibitors should be prescribed for men with impotence, smoking cessation should be encouraged, and blood pressure and diabetes control optimized. In addition, the practice of chemsex is common among some patients with HIV, and involves potential DDI-associated risks. However, the therapeutic index of the latter is narrow, making it potentially dangerous. The use of chemsex can be difficult to detect in routine HIV follow-up visits because it is often inadequately addressed by clinicians or because of patient concealment. There is a significant association between chemsex use and the presence of sexually transmitted infections STIs , particularly in MSM because of the coexistence of high-risk behaviours that facilitate both. If possible, when efficacy and safety profiles are the same, a regimen with a lower DDI potential, specifically not including pharmacokinetic enhancers, are preferred. Because of the risk of potential DDIs, subjects practising chemsex should not receive a boosted regimen including cobicistat or ritonavir if other alternatives are available. A regimen with a long half-life and a long forgiveness period, which makes therapeutic failure difficult in case of occasional ART forgetfulness e. Consequently, they should not receive a boosted regimen including cobicistat or ritonavir if there is an equally safe alternative with a more favourable interaction profile, even if the use of chemsex has not been captured in the follow-up, because of the significant association with even occasional use of chemsex and the risk of developing DDIs. Discrimination: to eliminate laws, regulations or policies that discriminate against people with HIV, especially in the healthcare setting. The same year, based on the available evidence demonstrating that PLWH who have achieved viral suppression still must contend with other intense challenges negatively impacting their QoL, Lazarus et al. Since HIV infection has become a chronic disease with a similar life expectancy to that of the general population, achieving this target must also be considered of utmost importance. Consequently, to meet the needs of PLWH, health systems must become more integrated and patient centred. Additionally, once ART has reached high efficacy and durability levels, it should also ensure a good QoL through a greater simplicity, better tolerability and reduced toxicity. When managing people with HIV, greater emphasis must be placed on comprehensive healthcare, to ensure that patients have a better QoL and that they are free from stigma and discrimination. Strategies addressed specifically at improving this QoL should be implemented in HIV care programmes. ART should contribute to this by being simpler, better tolerated and less toxic. Finally, there is a need of more research on QoL based on the different settings and geographical scenarios. Thus, they can be measured in absolute terms, such as the severity of a symptom or sign, or the change from a previous measurement. These data can only be obtained by specifically asking the patient, because they involve symptoms that are not usually obvious to the observer, such as tiredness or headaches, or psychological symptoms anxiety or depression , or those that occur when the observer is not present i. In a review of systematic reviews, nine generic and seven HIV-specific questionnaires were analysed. However, these questionnaires need to be validated and adapted to each country and language. Finally, we think that developing actions to correct the lower-scoring HRQoL factors detected when applying these tools should be a priority. PROs have their greatest value when performed in double-blind clinical trials. The influence of the treating physician in open-label studies can introduce a significant bias in the results. Based on the available evidence, the application of PRO questionnaires in double-blind randomized clinical trials of new ART is advisable, especially in scenarios of equality in terms of efficacy and safety, as they may serve to discriminate between different treatment options. Questionnaires validated for HIV infection should be used, preferably validated for the geographical context in which they have been developed. In a systematic review of 13 randomized clinical trials and one open-label study analysing the use of electronic tools in patients with chronic conditions to detect drug-related AEs, significant increases in medication switches to correct side effects were observed, and in more than half, symptoms improved after medication changes. All of these approaches facilitate the detection of the main problems of patients and how they change over time. It is essential that these tools are adapted to the target population, and that they are easily accessible and understandable. Electronic tools devices, websites, applications that may facilitate PRO research and contribute to improving the QoL of patients are currently available. These tools should be adapted to each population, well integrated into clinical management and easily accessible and understandable. Stigma is a huge problem among PLWH with many consequences late testing, less adherence and retention on care. There are few well-designed intervention studies that document stigma reduction. Indeed, to date, few projects involve PLWH in their design and implementation, despite the already demonstrated relevance of this fact on their impact and sustainability. There is a lack of knowledge about how to address stigma in populations disproportionately affected by HIV and how to prevent discrimination in healthcare settings outside of HIV-specific care, which impedes greater access to management of psychiatric disorders and comorbidities. The possibility of HIV transmission has been and continues to be one of the factors causing and contributing to increased stigma, and that negatively impacts on self-stigma. Evidence from recent randomized clinical trials and cohorts showing that sustained undetectability is associated with lack of HIV transmissibility has helped to reduce this cause of self-stigma. Therefore, promotion of safe sexual practices must continue also in patients with suppressed HIV viraemia. The patient, the healthcare setting, support groups and the general population should be targets for the reduction of HIV-related stigma. Although not one single case of HIV transmission has been described from a patient with undetectable viral load, continued treatment adherence is of paramount importance in this scenario. All of this information will help to reduce a factor that generates significant self-stigma. Nowadays, in countries with universal access to ART and without resource limitations, PLWH are mostly stable and enjoying a normal life. Still, they are not free of suffering many complications that affect their HRQoL, mainly related to ageing, emergent comorbidities or, in some cases, because of AEs related to ART. This change of scenery must be considered to achieve the best HRQoL possible for our patients. In that line, our model of care should be adapted to a multidisciplinary approach. This may be reached in different ways depending on the place where care is delivered. In other words, stratification should be made to deliver every patient tailored interventions while maintaining the main objectives of sustained virological suppression, immunological recovery and absence of opportunistic diseases. We would like to thank members of the RET Group for their collaboration and involvement in the elaboration of this manuscript. Valencia for providing medical writing services. 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Patient-reported symptoms over 48 weeks among participants in randomized, double-blind, phase III non-inferiority trials of adults with HIV on co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus co-formulated abacavir, dolutegravir, and lamivudine. Patient ; 11 : — The use and effects of electronic health tools for patient self-monitoring and reporting of outcomes following medication use: systematic review. J Med Internet Res ; 20 : e Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care. AIDS Care ; 28 : — Med Care ; 57 Suppl 5 Suppl 1 : S52 — 8. Stigma reduction interventions in people living with HIV to improve health-related quality of life. Lancet HIV ; 7 : e — Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Advertisement intended for healthcare professionals. Sign in through your institution. BSAC Journals. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents Abstract. Rapid initiation of ART. Efficacy of the ART. Simplicity of the ART. Safety: toxicity and interactions. Conclusions and future perspectives. Journal Article. Redefining therapeutic success in HIV patients: an expert view. Antonio Antela , Antonio Antela. Complejo Hospitalario Universitario de Santiago. Oxford Academic. Antonio Rivero. Josep M Llibre. Hospital Universitari Germans Trias i Pujol. Santiago Moreno. Corresponding author. E-mail: smguillen salud. Members are listed in the Acknowledgements. Select Format Select format. Permissions Icon Permissions. Figure 1. Open in new tab Download slide. Table 1. Open in new tab. Rapid initiation. Quality of Life. Also avoid TDF in subjects with any kind of renal disease or higher susceptibility of developing it Implement strategies addressed specifically at improving QoL in HIV care programmes. Consider ART change if significantly greater weight gain than expected is detected not justified by other causes Use available electronic tools devices, websites, applications to facilitate PRO research and contribute to improving the QoL of patients. If chemsex is practised, indicate regimens with a long half-life and a long forgiveness period. Avoid boosted regimens including cobicistat or ritonavir. Google Scholar Crossref. Search ADS. Google Scholar PubMed. For commercial re-use, please contact journals. Issue Section:. Download all slides. Views 5, More metrics information. Total Views 5, Email alerts Article activity alert. Advance article alerts. New issue alert. Receive exclusive offers and updates from Oxford Academic. Citing articles via Web of Science Latest Most Read Most Cited Pharmacokinetics and safety of daptomycin administered subcutaneously in healthy volunteers: a single-blinded randomized crossover trial. Genetic basis of macrolide resistance in porcine Pasteurella multocida isolates from the German national resistance monitoring program GE RM -Vet — Use of echinocandin outpatient parenteral antimicrobial therapy for the treatment of infection caused by Candida spp. More from Oxford Academic. Clinical Medicine. Clinical Pharmacology and Therapeutics. Infectious Diseases. Medical Microbiology and Virology. Medicine and Health. Authoring Open access Purchasing Institutional account management Rights and permissions. Get help with access Accessibility Contact us Advertising Media enquiries. Prioritize initial ART regimens that have demonstrated high rates of optimal viral suppression in clinical trials. Avoid the use of TDF especially in subjects with or at risk of osteopenia or osteoporosis. Also avoid TDF in subjects with any kind of renal disease or higher susceptibility of developing it. Regular blood pressure monitoring at 6 monthly visits, along with treatment for other cardiovascular-related pathologies if required. Developing actions to correct low-scoring HRQoL factors detected when applying these tools should be a priority. Prioritize the use of ART regimens that are less likely to develop resistance mutations in virological failure. Consider ART change if significantly greater weight gain than expected is detected not justified by other causes. Use available electronic tools devices, websites, applications to facilitate PRO research and contribute to improving the QoL of patients. Administer metabolic neutral ART schemes to these patients. Actively assess possible ART-related neuropsychiatric events and consider the possibility of a change of regimen. If possible, choose regimens with a lower DDI potential.

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