Advanced Parkinson’s Disease Treatment Simplification and Long-Term Outcomes with Levodopa Carbidopa Intestinal Gel: COSMOS Romanian Subanalysis

The aim of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS) was to assess the use of levodopa/carbidopa intestinal gel (LCIG) as monotherapy in patients with advanced Parkinson’s disease (APD) in routine clinical practice. COSMOS was an international observational study with one cross-sectional visit and retrospective data collection. In Romania, 95 adult patients with APD on LCIG treatment for at least 12 months were enrolled and stratified according to their LCIG therapy after 12 months: monotherapy (without any add-on PD medication), monotherapy with night PD medication and LCIG + add-on medication. Compared to the moment of LCIG initiation, the percentage of patients on monotherapy increased at three months after LCIG initiation and remained constant up to 12 months, when 30.5% of the patients were on LCIG monotherapy and 11.6% were on monotherapy with night medication. “Off” time and “On” time with dyskinesia decreased from LCIG initiation to patient visit in all groups. LCIG monotherapy with or without night medication may provide a simplified treatment option for selected APD patients, with long-term efficacy similar to that of LCIG plus add-on medication.

Real-World Experience with Dolutegravir-Based Two-Drug Regimens

Background. Dolutegravir-based 2-drug regimens (DTG 2DRs) are now accepted as alternatives to 3-drug regimens for HIV antiretroviral treatment (ART); however, literature on physician drivers for prescribing DTG 2DR is sparse. This study evaluated treatment patterns of DTG 2DR components in clinical practice in the US. Methods. This was a retrospective chart review in adult patients in care in the US with HIV-1 who received DTG 2DR prior to July 31, 2017, with follow-up until January 30, 2018. Primary objectives of the study were to determine reasons for patients initiating DTG 2DR and to describe the demographics and clinical characteristics. All analyses were descriptive. Results. Overall, 278 patients received DTG 2DR (male: 70%; mean age: 56 years). Most patients were treatment experienced (98%), with a mean 13.5 years of prior ART. DTG was most commonly paired with darunavir (55%) or rilpivirine (27%). The most common physician-reported reasons for initiating DTG 2DR were treatment simplification/streamlining (30%) and avoidance of potential long-term toxicities (20%). Before starting DTG 2DR, 42% of patients were virologically suppressed; of those, 95% maintained suppression while on DTG 2DR. Of the 50% of patients with detectable viral load before DTG 2DR, 79% achieved and maintained virologic suppression on DTG 2DR during follow-up. There were no virologic data for 8% of patients prior to starting DTG 2DR. Only 15 patients discontinued DTG 2DR, of whom 4 (27%) discontinued due to virologic failure. Conclusions. Prior to commercial availability of the single-tablet 2DRs, DTG 2DR components were primarily used in treatment-experienced patients for treatment simplification and avoidance of long-term toxicities. Many of these patients achieved and maintained virologic suppression, with low discontinuation rates.

Antiretroviral Treatment Simplification With 2-Drug Regimens: Impact of Transmitted Drug Resistance Mutations

The frequency of clinically relevant transmitted drug resistance mutations (DRMs) against drugs used for 2-drug regimens was 15.6%, but only 2% were not eligible for 1 or more 2-drug regimens. More than 50% of patients harboring any clinically relevant DRMs were found to be part of genetic transmission clusters.

2485. Real-world Experience with Dolutegravir Plus Rilpivirine Two-Drug Regimen

Background Three-drug regimens (3DRs) have long been the mainstay of antiretroviral treatment (ART) for HIV. Dolutegravir-based two-drug regimens (DTG 2DRs) are now accepted alternatives to 3DRs, with the first 2DR single tablet regimen (STR), Juluca (DTG/rilpivirine [RPV]), FDA-approved in 2017. This study evaluated treatment patterns of DTG+RPV in clinical practice to understand use prior to availability of DTG/RPV STR. Methods A retrospective medical chart review was conducted across 10 US sites identified as using any DTG 2DRs. Eligible patients were adults initiated on DTG 2DR prior to July 31, 2017 and followed up to January 30, 2018. This analysis describes a subgroup who received DTG+RPV 2DR. Patient demographics, clinical characteristics and treatment history were abstracted from medical charts. Analyses were descriptive. Results From an overall sample of 278 DTG 2DR patients, 66 received DTG+RPV 2DR. In this DTG+RPV subgroup, mean age was 56 years, 79% were male and 68% were Caucasian. Most were treatment-experienced (97%), with an average 15.5 years of prior ART; 48% had received ≥ 4 prior regimens. The most common physician reported reasons for initiating DTG+RPV were avoidance of potential long-term toxicities (53%), toxicity/intolerance of ARVs (20%) and treatment simplification/streamlining (15%). Prior to initiation of DTG+RPV, 70% of patients were virologically suppressed (< 50 copies/mL); of those, 98% remained suppressed after switching to DTG+RPV. Of the 30% of patients with detectable viral load prior to DTG+RPV initiation, 60% achieved and maintained virologic suppression on DTG+RPV. Mean time on DTG+RPV was 1.6 years. Only 5 (8%) patients discontinued DTG+RPV by data cut-off, and one patient was lost to follow-up. Reasons for discontinuation were virologic failure (n = 2), treatment simplification/streamlining (n = 2) and toxicity/intolerance (n = 1). Physicians reported that most patients (91%) achieved the desired outcome from DTG+RPV use. Conclusion Prior to commercial availability of DTG/RPV STR in the United States, DTG+RPV was used primarily in treatment experienced patients, most commonly to avoid potential long-term toxicities. A high proportion of patients achieved the desired outcome and maintained virologic suppression while receiving DTG+RPV. Disclosures All authors: No reported disclosures.