High Virologic Suppression and Favorable Profiles of Two-Drug Antiretroviral Regimens in Africa: A Systematic Review of Current Evidence.

IntroductionAs HIV has become a manageable chronic condition, a renewed and increased interest in challenging traditional three-drug HIV therapies and moving toward two-drug regimens (2DR) for initial or maintenance treatment in people living with HIV (PLWH) has developed. As PLWH are living longer, continual advancements in antiretroviral regimens have been a focus to provide optimal life-long therapy options. Although early studies may have shown poor outcomes in virologic suppression with 2DR, newer studies and treatment options have emerged to show promise in the management of HIV. The purpose of this review is to evaluate current literature and assess the efficacy of two-drug (2DR) antiretroviral therapy in treatment-naïve and -experienced people living with HIV.MethodsA systematic search was performed between January 2009 to January 2020, using EMBASE, MEDLINE, Google Scholar, and bibliographies. Combinations of the following search terms were used: HIV-1 infection, antiretroviral therapy, dual therapy, two-drug regimen, two-drug therapy, two-drug regimen, and 2DR. Included studies were those in the adult population with at least one active comparator, outcomes assessing HIV-1 RNA viral load while on treatment, and written in English.ResultsThirty-three studies were included, 13 where 2DRs were evaluated as initial therapy (3 studies with extension data) and 15 where 2DRs were evaluated as maintenance or switch therapy (2 studies with extension data).ConclusionAlthough 2DRs may not be appropriate in all patient populations, they are being utilized more frequently and have the potential to reduce costs, adverse effects, and drug interactions.

Three-drug combination antiretroviral therapy (ART) became available in 1996, dramatically improving the prognosis of people living with HIV. The clinical benefits of ART are due to the sustained viral load suppression and CD4 T cell gains. Major drawbacks of the first ART regimens were adverse events, and high pill burden, which led to the reduction of drug adherence resulting in frequent treatment discontinuations and the development of drug resistance. Due to increased viral potency of new antiretroviral drugs consideration of a two-drug combination therapy repositioning occurred in an effort to reduce adverse events, drug-drug interactions and cost, while maintaining a sustained antiviral effect. Various combinations of two-drug regimens have been studied, and non-inferiority compared to a three-drug regimen has been shown only for some of them. In addition, a two-drug combination regimen may not be suitable for every patient, especially those who are pregnant, those with tuberculosis or coexisting HBV infection. Furthermore no information has been generated concerning the secondary transmission of HIV from patients who have undetectable plasma viral load on two-drug regimens. Additional studies of two-drug combinations are also necessary to evaluate the debated existence of low viral replication in tissues and on immune activation. While there is no urgent need to routinely switch patients to two-drug combination therapy, due to the availability of drug combinations without significant toxicities, dual regimens represent a suitable option that deserve long-term evaluation before being introduced to clinical practice.

More than 20 years ago, there was a revolution in the treatment of HIV-infected patients and it was soon understood that combined treatment was needed to reduce morbidity and mortality associated with this infection. Years later, the treatment paradigm in the overwhelming majority of therapeutic guidelines was the use of three-drug regimens: two nucleos(t)ide reverse transcriptase inhibitors (nucs) and one-third drug [previously a nonnuc or a protease inhibitor, currently the most consensual as a first-line, an integrase inhibitor (INI)]. Over the past 2 years, a novel therapeutic approach has been widely studied with promising results: if simplified two-drug regimens seem to have the same efficacy (noninferiority), why use three or four drugs? This is the big question. The scientific evidence of the success of those therapeutic schemes is increasing in the medical literature. The NEAT 001 [1] study showed noninferiority of ritonavir-boosted darunavir (DRV/r) with raltegravir versus DRV/r and two nucs in treatment naïve patients with CD4+ less than 200 cells/ml and HIV-1 RNA less than 100 000 copies/ml. Similar results were showed on the GARDEL study [2], in which drug-naïve patients on ritonavir-boosted lopinavir (LPV/r) and lamivudine (3TC) had similar virological suppression, lower toxicity and better tolerability compared with a three-drug regimen (LPV/r and two nucs). Equally successful results were presented by the ANDES study [3] DRV/r and 3TC versus DRV/r and two nucs. Moreover, the ACTG A5353 [4] showed virologic suppression rates greater than 90% at 24 weeks in naïve patients under dolutegravir (DTG) and 3TC even with HIV-1 RNA up to 500 000 copies/ml. More recently, the GEMINI 1 and 2 studies [5] showed noninferiority in virologic suppression of previously INI-naïve patients under DTG and 3TC with failure rates below 1% and no evidence of resistance mutations to those antiretroviral drug classes. A new systematic review and network meta-analysis, performed on a large scale comparing the use of DTG and 3TC in HIV-1 drug-naive patients versus three-drug regimens, seems to be yet another example that the therapeutic paradigm may, safely, change. Radford et al. [6] constructed a network of 14 randomized clinical trials with more than 10 000 treatment-naïve patients and analyzed it using a Bayesian methodology. In this way, Radford et al. [6] evaluated virological suppression at week 48 of three-drug regimens versus DTG and 3TC including patients with HIV RNA more than 100 000 copies/ml, as well as CD4+ T-cell count progression and safety by quantification of adverse effects. The results appear to be once again promising as DTG and 3TC behaves as well as the classical three-drug regimens evaluated with similar virologic suppression, immune recovery, and number of adverse effects at 48 weeks. In particular instances, the two-drug regimen performed even better than standard three-drug regimens, as was the case of virologic suppression at 48 weeks compared with efavirenz and disoproxil fumarate/emtricitabine. As suggested by earlier studies and by the meta-analysis published in this issue of AIDS[6], two-drug regimens appear to be equally effective compared with classic regimens, and undoubtedly represents a trend in the future of HIV treatment worldwide. Indeed, a few international guidelines already consider certain dual therapies including boosted protease inhibitor and 3TC or an INI, recommended to specific HIV-treatment groups [7,8]. The use of two-drug regimens will significantly avoid a number of disadvantages brought by standard schemes. The long-term side effects of standard treatments, including increased cardiovascular disease and bone and renal toxicities [9–11], are important issues to be considered towards such simplified schemes. Moreover, simplified schemes are also less prone to adverse drug–drug or pharmacokinetic interactions commonly seen in HIV-infected patients that have to treat other clinical conditions, including concomitant infections and malignancies [12–14]. Financial costs are expected to reduce in simplified HIV treatments, both at individual and population levels. It has been estimated that between US$ 500 million and US$ 3 billion would be saved in antiretroviral treatment costs in the United States in 5 years should a simplified DTG and 3TC regimen starts in HIV drug-naïve patients and as a switch from standard regimens to maintain virological suppression among treated people [15]. In resource-limited settings such as Brazil, where DTG-containing regimens are already the standard-of-care and where a universal public health system provides HIV therapy to large amounts of people for free (currently over 600 000 patients) [16], the impact on the country's health economy would be unprecedented. Such cost-effectiveness is expected to reach multiple nations, both resource-rich and limited, with the dissemination of simplified DTG-containing schemes. Acknowledgements No funding has been received for writing this article. Conflicts of interest F.D. has received honoraria for speaking or advising and research grants from Bristol-Myers Squibb, AbbVie, Gilead, Janssen, Merck and ViiV. M.A.S. has received honoraria for speaking from BioMérieux and has been supported by research grants from Merck in the form of subcontracts.

Background/Objectives: The objective of this retrospective, multicenter cohort study was to compare the incidence of viral load blips between two-drug and three-drug antiretroviral therapy regimens in human immunodeficiency virus (HIV) patients. Methods: A total of 121 patients were included, with 44 receiving two-drug regimens (e.g., dolutegravir/lamivudine) and 77 receiving three-drug regimens (e.g., bictegravir/tenofovir alafenamide/emtricitabine) at the time of analysis. The primary outcome was the occurrence of viral blips, defined as transient HIV-RNA elevations ≥ 50 copies/mL; a sensitivity analysis used ≥20 copies/mL. Results: Generalized estimating equation models adjusted for clinical covariates showed no significant difference in the odds of blip occurrence comparing three-drug with two-drug regimens, both for blips ≥ 50 (odds ratio [OR]: 2.64; 95% confidence interval [CI]: 0.91–7.70; p = 0.075) and ≥20 (OR: 1.76; 95% CI: 0.76–4.08; p = 0.190). In the two- and three-drug groups, the predicted probabilities of blips were 1.4% and 3.7% (p = 0.075) for blips ≥ 50, and 6.9% and 11.5% (p = 0.190) for ≥20, respectively. No virologic failure was observed. Conclusions: These findings suggest that two-drug regimens provide virologic control comparable to three-drug regimens and may be a viable clinical option due to fewer drug interactions, lower toxicity, and reduced cost.

Dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA. TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC (n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3months before switch to either DTG/3TC (n = 192) or DTG/RPV (n = 151). Clinical characteristics, treatment history, and outcomes are described. Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25-33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued. Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials.

IntroductionVariable levels of systemic inflammation are observed in people with HIV (PWH), but the clinical significance of differences among antiretroviral therapy (ART) regimens on associated levels of inflammatory markers is unclear. Based on data from previous epidemiologic studies that defined the predicted change in risk of serious non-AIDS events (SNAEs)/death by changes in interleukin-6 (IL-6) and D-dimer, we modeled the effects of differences in these markers between specific ART regimens on the long-term risk of clinical outcomes.MethodsWe used a Markov model to compare the risk of SNAEs/death with differences in IL-6 and D-dimer levels associated with remaining on specific three-drug regimens versus switching to specific two-drug ART regimens over 5 years of treatment. We used IL-6 and D-dimer data based on trajectories over time from the randomized TANGO and observational AIR studies. Age at model entry was set at 39 years. The primary endpoint was the number needed to treat for one additional SNAE/death.ResultsOver 3 years, PWH on one of the three-drug regimens studied were predicted to spend 13% more time in the low IL-6 quartile and 11% less time in the high IL-6 quartile compared with those on one of the two-drug regimens. Over 3 years, the predicted mean number of SNAEs/deaths per 100 PWH was 6.58 for a three-drug regimen associated with lower IL-6 levels versus 6.90 for a two-drug regimen associated with higher IL-6 levels. The number needed to treat for one additional SNAE/death among PWH receiving a two-drug versus three-drug regimen for 3 years was 81. Approximately 7,500 participants would be required for a 5-year clinical study to evaluate the accuracy of the model.ConclusionsOur Markov model suggests that higher IL-6 levels associated with switching from specific three- to two- drug ART regimens may be associated with an increase in the risk of SNAEs/death. Clinical studies are warranted to confirm or refute these results.

BackgroundPatients with HIV (PWH) with sustained virologic suppression (VS) on antiretroviral therapy (ART) achieve better health outcomes and pose effectively no risk of transmitting HIV to their sexual contacts. Adherence to ART is the main predictor of VS in PWH, yet no adherence benchmark has been identified. The clinical utility of ART pharmacy refill history collection is unknown. We hypothesize that pharmacy refill histories of ART represented as a percentage of days covered (PDC) will correlate with VS in PWH.MethodsWe conducted a single-center, retrospective cohort study of PWH ( ≥19 years) receiving care at a Midwestern HIV clinic between January 1, 2018 and December 31, 2018, with at least 1 HIV RNA reading during the study period. Refill histories were collected for each eligible study patient and a PDC was calculated as the “number of tablets dispensed / number of days within study period” to provide an ART coverage measure. ART regimen, sociodemographic, and clinical characteristics were abstracted from the HIV registry. An HIV RNA ≤ 50 copies/mL and a PDC of ≥80% were used as measures of VS and sufficient adherence, respectively. Pearson’s chi-square tests and binary logistic regression were used to determine the effect of PDC on VS.ResultsA total of 1019 patients were included in the study. 705 (69%) patients had a PDC ≥80% and 314 (31%) had a PDC <80%. VS between groups was 96% (PDC ≥80%) vs. 74% (PDC < 80%). A significant association was observed between VS and PDC (P < 0.0001) [HJP1]. Patients with a PDC ≥80% were 9.5 times more likely to attain VS as compared with patients with PDC < 80% (95% CI, 5.89–15.17). After adjusting for ART regimen, sociodemographic, and other clinical characteristics, the likelihood of VS remained higher for patients with a PDC ≥ 80% (aOR: 6.3; 95% CI, 3.7–11.0). Factors found to be negatively associated with VS were single marital status (aOR: 0.49; 95% CI, 0.24–0.95), current or historical opportunistic infection (aOR: 0.51; 95% CI, 0.26–0.99), and usage of a multiclass or dual ART regimen (aOR: 0.40; 95% CI, 0.16–0.98).ConclusionThe utilization of PDC as an ART adherence benchmark was significantly associated with VS. PDC is an easy measure to calculate and could be useful in the clinical care of PWH. Future prospective studies are needed to confirm these findings.DisclosuresAll authors: No reported disclosures.

Advances and challenges in antiretroviral therapy for acquired immunodeficiency syndrome.

Background Antiretroviral treatment with a three drug-regimen is the initial treatment recommended for chronic HIV infection. For various reasons, the combination of three drugs can be modified to a two-drug...

The emergence of dual therapy for antiretroviral (ARV)-experienced persons living with HIV (PWH) offers the opportunity to reduce lifetime exposure to unnecessary ARV drugs while maintaining viral suppression and reducing the cost of care. Our objective, using retrospective analysis of a quality care initiative, was to examine in routine clinical practice the clinical impact of switching PWH stable on a three-drug to a two-drug single-tablet formulation (STF) ARV regimen. We also examined the cost implications of this STF adjustment. Between January 1, 2020 and January 1, 2021 eligible patients (i.e., virally suppressed, no active hepatitis B infection, no documented nucleoside reverse transcriptase inhibitors/integrase strand transfer inhibitor resistance) were offered, on a convenience basis and as part of routine care, the opportunity to adjust their current three-drug STF to a two-drug STF (dolutegarvair/lamivudine). The acceptance, clinical efficacy, safety, tolerability, and cost of treatment were measured for patients who switched in 2020. Of 989 eligible PWH, 408 were approached and 391 (39.5%) switched to two-drug regimen; 99% remained on the two-drug STF at year's end (median 240 days follow-up). Only 2/391 patients who switched lost viral control. The total ARV drug cost for all 989 patients decreased by 10.3% generating an actual savings of $1,596,666 among patients approached and switched in 2020. Patient interest and uptake in switching to two-drug STF was substantial and resulted in few discontinuations for any reason. It provided significant and immediate cost savings within the first year. Our results bring clarity to discussions on whether using two-drug regimens would be practical and acceptable in nonclinical trial settings.

BackgroundTenofovir disoproxil fumarate (TDF)-induced nephrotoxicity is a well-recognized complication and one of the reasons for treatment switching in HIV-infected patients. Salvage regimens in renal impairment such as abacavir(ABC)-based regimen or two-drug regimens such as boosted protease inhibitor (PI) plus lamivudine (3TC) are the options for switching. However, ABC is contraindicated in patients with a high risk for cardiovascular disease. In resource-limited setting, only some PIs such as lopinavir and atazanavir are available options.MethodsWe conducted a prospective, open-label, randomized controlled trial in a tertiary center in Bangkok. We recruited HIV-infected adults who had viral suppression, with TDF-induced proximal tubulopathy and/or a significant decrease in estimated glomerular filtration rate(eGFR). The patients were randomized to receive ABC/3TC plus efavirenz (ABC-based regimen) or LPV/r+3TC. The primary outcome was the proportion of patients with viral suppression at 24 weeks. The secondary outcomes were the immunologic response, recovery of eGFR, proximal tubular function and change in lipid profile at 24 weeks.ResultsBetween August 2018 - February 2019, we screened 87 patients and enrolled 24 patients were randomly assigned to the ABC-based regimen and 23 patients to LPV/r+3TC regimen. In the intention-to-treat population, virologic response at 24 weeks was noted in 21 (87.5%) patients assigned to ABC-based regimen and 19 (82.6%) patients assigned to LPV/r+3TC regimen (P = 0.635). There were no differences in the improvement of the percentage change of eGFR, fractional excretion of phosphate, renal tubular reabsorption of phosphate (TmP/GFR), fractional excretion of uric and UPCI at 24 weeks. Triglyceride levels were significantly increased in LPV/r+3TC regimen compared with ABC-based regimen at 24 weeks (91.32% vs. 20.46%; P = 0.001).ConclusionOur study showed no difference in virologic suppression after switching to ABC-based regimen or LPV/r+3TC regimen in patients with TDF-induced nephrotoxicity. There was no difference in percentage change of eGFR, recovery of proximal tubular function in both arms after discontinuation of TDF. There was a significant change in triglyceride levels in LPV/r +3TC regimen.DisclosuresAll authors: No reported disclosures.

The introduction of combination antiretroviral therapy (ART) in the 1990s has fundamentally transformed the landscape of HIV medicine, greatly improved disease morbidity and mortality, and reduced transmission rates across all demographic groups. Central to this success was the idea that to achieve best disease outcomes and minimize the development of drug resistance, at least three antiretroviral agents should be used for HIV treatment. This therapeutic strategy is a core tenet of HIV medicine, backed by incontrovertible scientific evidence, and made easy to deploy by the high compliance levels with once-daily coformulations, which have generally been well tolerated. However, there has been increasing support for a paradigm shift toward dual therapy in recent years, particularly during the maintenance therapy phase of treatment. This concept advocates that once virologic suppression has been achieved with at least three antiretroviral drugs during the treatment initiation phase, a switch to a two-drug regimen should be possible. The results of Phase III of the SWORD trials (Llibre et al., Abstract 44LB) and LAMIDOL trial (Joly et al., Abstract 458) presented at the 2017. Conference on Retroviruses and Opportunistic Infections earlier this year seemed to lend support this hypothesis. More new evidence was recently presented at the 2107 International HIV/AIDS Society (IAS) meeting in Paris that adds to the growing body of evidence in favor of a two-drug regimen approach in maintenance therapy. The LATTE-2 study (Eron et al., Abstract 5628) was of major interest because of the exciting new therapeutic options that long-acting injectable antiretroviral agents may bring in the near future. However, more than that, the findings of comparable response between a traditional three-drug oral regimen and a novel injectable two-drug regimen at 96 weeks were quite noteworthy. In this Phase II, multicenter open-label study of 286 HIV-infected ARTnaïve patients, once-daily oral cabotegravir/abacavir/lamivudine achieved virologic suppression in 84% of study participants. In comparison, 87% in the injectable cabotegravir/rilpivirine once every 4-weekly group and 94% in injectable cabotegravir/rilpivirine once every 8-weekly group remained suppressed at 96 weeks. Crucially, no drug resistance mutations were seen in study participants who remained on their regimen. While the idea of a two-drug regimen has been entertained for maintenance therapy, there may be little willingness to push this further into the area of antiretroviral treatment initiation, for the justifiable concerns that exist around the emergence of drug resistance. Despite this, new data presented at the IAS 2017 showed that the idea is not without merit. In a proof of concept, the ACTG A5353 single-arm pilot study of 120 treatment naïve HIV-infected participants with high viral load (VL ≥1000 and >500,000 copies/mL), showed that once-daily dolutegravir/lamivudine had virologic efficacy of 90% at 24 weeks, with 96% of the as-treated study population achieving VL >50 copies/mL (Taiwo et al., Abstract MOAB0107LB). The regimen was well tolerated, with no reported drug resistance mutations while on treatment. There are many real-world advantages to a two-drug regimen approach, among them lower costs (crucial in resource-limited settings where affordability may be a limiting factor), fewer adverse effects or drug toxicities, and possibly improved compliance. These are all important considerations, given that improved mortality now means patients are going to stay on ART treatment for much longer than previously seen. But how the two-drug regimen approach will hold up against firmly held norms and tradition is far from clear, and it is almost certain that the understandable nervousness that surrounds this idea will continue to last. Until the case for the two-drug regimen approach is made more convincingly in ongoing and future trials, the "three or more" rule will reign, not only as the orthodoxy but also as the cornerstone of good clinical practice.

BackgroundEfavirenz-based antiretroviral therapy (ART) regimens are preferred for treatment of adult HIV-positive patients co-infected with tuberculosis (HIV/TB). Few studies have compared outcomes among HIV/TB patients treated with efavirenz or non-efavirenz containing regimens.MethodsHIV-positive patients aged ≥16 years with a diagnosis of tuberculosis recruited to the TB:HIV study between Jan 1, 2011, and Dec 31, 2013 in 19 countries in Eastern Europe (EE), Western Europe (WE), and Latin America (LA) who received ART concomitantly with TB treatment were included. Patients either received efavirenz-containing ART starting between 15 days prior to, during, or within 90 days after starting tuberculosis treatment, (efavirenz group), or other ART regimens (non-efavirenz group). Patients who started ART more than 90 days after initiation of TB treatment, or who experienced ART interruption of more than 15 days during TB treatment were excluded. We describe rates and factors associated with death, virological suppression, and loss to follow up at 12 months using univariate, multivariate Cox, and marginal structural models to compare the two groups of patients.ResultsOf 965 patients (647 receiving efavirenz-containing ART, and 318 a non-efavirenz regimen) 50% were from EE, 28% from WE, and 22% from LA. Among those not receiving efavirenz-containing ART, regimens mainly contained a ritonavir-boosted protease inhibitor (57%), or raltegravir (22%). At 12 months 1.4% of patients in WE had died, compared to 20% in EE: rates of virological suppression ranged from 21% in EE to 61% in WE. After adjusting for potential confounders, rates of death (adjusted Hazard Ratio; aHR, 95%CI: 1.13, 0.72–1.78), virological suppression (aHR, 95%CI: 0.97, 0.76–1.22), and loss to follow up (aHR, 95%CI: 1.17, 0.81–1.67), were similar in patients treated with efavirenz and non-efavirenz containing ART regimens.ConclusionIn this large, prospective cohort, the response to ART varied significantly across geographical regions, whereas the ART regimen (efavirenz or non-efavirenz containing) did not impact on the proportion of patients who were virologically-suppressed, lost to follow up or dead at 12 months.

BackgroundContemporary antiretroviral-therapy (ART) regimens have simple dosing, low toxicity, minimal side-effects, and few drug interactions. We evaluated ART regimens in an urban, safety-net, adult HIV clinic in the United States to determine proportions of patients on contemporary ART and identify opportunities to optimize ART for patients on older regimens.MethodsData including current ART regimen, HIV-1 RNA level, and age were extracted from the electronic medical record (EMR) for all patients seen in the prior 13 months. Viral suppression was defined as HIV-1 RNA < 200 copies/mL. A patient was “off-ART” if there were no fills within 270 days or ART had a stop date >90 days prior to end of the study. Unclear regimens from the EMR (n = 179) were chart reviewed. ART regimens were assigned the following designations: contemporary first-line, contemporary non-first-line, older three-drug, two-drug, salvage, or off-ART. ART was also categorized as boosted (containing cobicistat/ritonavir) vs. unboosted, by single-tablet regimen (STR) vs. multi-tablet regimen (MTR), and frequency of dosing. Correlations between ART regimen, viral suppression, and age were analyzed.ResultsThe ART review included 1,215 individuals. Most patients (64%) were on contemporary first-line regimens; 20% were on contemporary non-first-line regimens (figure). Patients on salvage regimens had lower rates of viral suppression than those in other ART categories (80% vs. 90%, P <0.05). Most patients (90%) were prescribed once daily regimens, and of those, 39% were prescribed STRs. There were no significant associations between viral suppression and regimen complexity (P = 0.8). There were 447 (37%) patients on boosting agents with no difference in viral suppression rate (88% suppressed on boosted regimens vs. 90% on unboosted, P = 0.3). Patients on older regimens and greater than equal to twice daily MTRs were older than those on contemporary regimens and STRs. Individuals off ART were younger than those on ART (average age 41 vs. 46 years).ConclusionIn a US urban, safety-net clinic, most patients were on contemporary ART regimens and 90% were on once-daily therapy. Despite these encouraging findings, systematic review identified many patients that could be considered for modernization and simplification with intent to minimize toxicity, side-effects, drug interactions, and cost.DisclosuresAll authors: No reported disclosures.

BackgroundIsolated HBV anti-core antibodies (HBcAb) positivity is not an absolute contraindication for using two-drug regimen (2DR) antiretroviral therapy, even if the absence of nucleos(t)ide reverse transcriptase inhibitors (NRTIs) with long-term...