Evaluation of patient radiation dose and risk of cancer from CT examinations.

Computed tomography (CT) examinations have been increasingly requested and become the major sources of patient exposure. The cancer risk from CT scans is contingent upon the amount of absorbed dose of organs. This study aims to determine the organ doses and risk of cancer incidence and mortality from CT examinations at high dose (cumulative effective dose, CED ≥ 100 mSv) in a single day to low dose (CED < 100 mSv) from common CT procedures. Data were gathered from two academic centers of patients aged 15 to 75 years old performed CT examinations during the period of 5 years. CED and organ dose were calculated using Monte Carlo simulation software. Lifetime attributable risk (LAR) was determined following Biological Effects of Ionizing Radiation (BEIR) VII report based on life table and baseline cancer rates of Thai population. At high dose, the highest LAR for breast cancer incidence in young female was 82 per 100,000 exposed patients with breast dose of 148 mGy (CT whole abdomen). The highest LAR for liver cancer incidence in male patient was 72 per 100,000 with liver dose of 133 mGy (multiple CT scans). At low dose, the highest average LAR for breast cancer incidence in young female was 23 per 100,000 while for liver cancer incidence in male patients was 22 per 100,000 (CTA whole aorta). Even though the LAR of cancer incidence and mortality was less than 100 per 100,000, they should not be neglected. The risk of cancer incidence may be increased in later life, particularly in young patients.

Strengthening education and training programmes for medical physics in Asia and the Pacific: the IAEA non-agreement technical cooperation (TC) regional RAS6088 project.

This article documents the work conducted in implementing the IAEA non-agreement TC regional RAS6088 project "Strengthening Education and Training Programmes for Medical Physics". Necessary information on the project was collected from the project counterparts via emails for a period of one month, starting from 21st September 2023, and verified at the Final Regional Coordination Meeting in Bangkok, Thailand from 30th October 2023 to 3rd November 2023. Sixty-three participants were trained in 5 Regional Training Courses (RTCs), with 48%, 32% and 20% in radiation therapy, diagnostic radiology, and nuclear medicine, respectively. One RTC was successfully organised to introduce molecular biology as an academic module to participants. Three participating Member States, namely United Arab Emirates (UAE), Nepal and Afghanistan have initiated processes to start the postgraduate master medical physics education programmes by coursework, adopting the IAEA TCS56 Guidelines. UAE has succeeded in completing the process while Nepal and Afghanistan have yet to initiate the programme. The postgraduate master medical physics programmes by coursework were strengthened in Indonesia, Jordan, Malaysia, Pakistan, Syria, and Thailand, along with the national registration of medical physicists. In particular, Thailand has revised 6 postgraduate master medical physics programmes by coursework during the tenure of this project. Home Based Assignment and RTCs have resulted in two publications. In conclusion, the RAS6088 project was found to have achieved its planned outcomes despite challenges faced due to the COVID-19 pandemic. It is proposed that a follow up project be implemented to increase the number of Member States who are better prepared to improve medical physics education and training in the region.

Establishment of national diagnostic reference levels for percutaneous coronary interventions (PCIs) in Thailand.

PURPOSE: To establish national diagnostic reference levels (DRLs) for percutaneous coronary intervention (PCI) in Thailand for lesions of different complexity. METHODS: Radiation dose quantity as kerma-area-product (KAP) and cumulative air-kerma at reference point (CAK) from 76 catheterization labs in 38 hospitals in PCI registry of Thailand was transferred online to central data management. Sixteen months data (May 2018 to August 2019) was analyzed. We also investigated role of different factors that influence radiation dose the most. RESULTS: Analysis of 22,737 PCIs resulted in national DRLs for PCI of 91.3 Gy.cm2 (KAP) and 1360 mGy (CAK). The NDRLs for KAP for type C, B2, B1 and A lesions were 106.8, 82.6, 67.9, and 45.3 Gy.cm2 respectively and for CAK, 1705, 1247, 962, and 790 mGy respectively. Thus, as compared to lesion A, lesion C had more than double the dose and B2 had nearly 1.6 times and B1 had 1.2 times CAK. Our DRL values are lower than other Asian countries like Japan and Korea and are in the middle range of Western countries. University hospital had significantly higher dose than private or public hospital possibly because of higher load of complex procedures in university hospitals and trainees performing the procedures. Transradial approach showed lower doses than transfemoral approach. CONCLUSIONS: This large multi-centric study established DRLs for PCIs which can act as reference for future studies. A hallmark of our study is establishment of reference levels for coronary lesions classified as per ACC/AHA and thus for different complexities.

Reduction of Occupational Exposure Using a Novel Tungsten-Containing Rubber Shield in Interventional Radiology.

This study investigates whether a novel tungsten-containing rubber shield could be used as substitute shielding material in interventional radiology to reduce the occupational exposure of operators to scattered radiation from a patient. The tungsten-containing rubber is a lead-free radiation-shielding material that contains as much as 90% tungsten powder by weight. Air kerma rates of scattered radiation from solid-plate phantoms, simulating a patient, were measured with a semiconductor dosimeter at the height of the operator's eye (1,600 mm from the floor), chest (1,300 mm), waist (1,000 mm), and knee (600 mm) with and without tungsten-containing rubber shielding (1-5 mm thickness). The tungsten-containing rubber and a commercial shielding material (RADPAD) were affixed onto the phantom on the operator's side, and reductions in air kerma rates were compared. Reduction rates for tungsten-containing rubber shielding with thicknesses of 1, 2, 3, 4, and 5 mm at each height level were as follows: 70.37 ± 0.40%, 72.17 ± 0.29%, 72.95 ± 0.31%, 72.58 ± 0.35%, and 73.63 ± 0.63% at eye level; 76.36 ± 0.19%, 77.13 ± 0.10%, 77.36 ± 0.14%, 77.62 ± 0.25%, and 77.66 ± 0.14% at chest level; 67.78 ± 0.31%, 68.12 ± 0.19%, 68.88 ± 0.28%, 68.97 ± 0.14%, and 68.85 ± 0.45% at waist level; and 0.14 ± 0.94%, 0.72 ± 0.56%, 1.08 ± 0.74%, 1.77 ± 0.80%, and 1.79 ± 1.82% at knee level, respectively. Reduction rates with RADPAD were 61.80 ± 0.67%, 60.33 ± 0.61%, 64.70 ± 0.25%, and 0.14 ± 0.66% at eye, chest, waist, and knee levels, respectively. The shielding ability of the 1 mm tungsten-containing rubber was superior to that of RADPAD. The tungsten-containing rubber could be employed to minimize an operator's radiation exposure instead of the commercial shielding material in interventional radiology.

Feasibility of a Tungsten Rubber Grid Collimator for Electron Grid Therapy.

BACKGROUND/AIM: Spatially fractionated radiotherapy (grid therapy) can control some bulky tumors which is challenging for conventional radiotherapy. This study aimed to investigate whether a novel tungsten contained rubber (TCR) grid collimator can be employed in electron grid therapy. MATERIALS AND METHODS: The TCR grid collimator placed on a solid water phantom, and percentage depth doses (PDDs) and lateral dose profiles were measured for 9 MeV electron beam with Gafchromic EBT3 films. At the lateral dose profile, the ratios of the dose in the areas with and without shielding (valley-to-peak ratios) were evaluated. RESULTS: The dmax values with the 1, 2 and 3 mm TCR grid collimators were 1.2, 1.1 and 0.7 cm, respectively, while the valley-to-peak ratios at each dmax were 0.566, 0.412 and 0.293, respectively. CONCLUSION: Only the 2 mm TCR grid collimator had adequate dosimetric features compared to the conventional grid collimator and could be substituted.

Patient doses in radiographic examinations in 12 countries in Asia, Africa, and Eastern Europe: initial results from IAEA projects.

OBJECTIVE: The purpose of this study was to survey image quality and the entrance surface air kerma for patients in radiographic examinations and to perform comparisons with diagnostic reference levels. SUBJECTS AND METHODS: In this multinational prospective study, image quality and patient radiation doses were surveyed in 12 countries in Africa, Asia, and Eastern Europe, covering 45 hospitals. The rate of unsatisfactory images and image quality grade were noted, and causes for poor image quality were investigated. The entrance surface doses for adult patients were determined in terms of the entrance surface air kerma on the basis of X-ray tube output measurements and X-ray exposure parameters. Comparison of dose levels with diagnostic reference levels was performed. RESULTS: The fraction of images rated as poor was as high as 53%. The image quality improved up to 16 percentage points in Africa, 13 in Asia, and 22 in Eastern Europe after implementation of a quality control (QC) program. Patient doses varied by a factor of up to 88, although the majority of doses were below diagnostic reference levels. The mean entrance surface air kerma values in mGy were 0.33 (chest, posteroanterior), 4.07 (lumbar spine, anteroposterior), 8.53 (lumbar spine, lateral), 3.64 (abdomen, anteroposterior), 3.68 (pelvis, anteroposterior), and 2.41 (skull, anteroposterior). Patient doses were found to be similar to doses in developed countries and patient dose reductions ranging from 1.4% to 85% were achieved. CONCLUSION: Poor image quality constitutes a major source of unnecessary radiation to patients in developing countries. Comparison with other surveys indicates that patient dose levels in these countries are not higher than those in developed countries.

Medical Physics Education and Clinical Training in Thailand.

Medical Physics education and clinical training should be available at the university with the attachment in clinical practice at department of radiology. The curriculum should cover physics in all three specialties of radiation oncology, diagnostic radiology and nuclear medicine. Anatomy and physiology for medical physicist, Radiation physics, Radiation dosimetry, Radiation Biology and Radiation Protection should be core subjects. Selected subjects, Medical Physics Seminar, Research Methodology and thesis are included in the curriculum.

Patient Radiation Dose in Neurointerventional Radiologic Procedure: A Tertiary Care Experience.

PURPOSE: Neurointerventional radiology procedures often require a long time to perform. Patient radiation dose is an important issue due to the hazards of ionizing radiation. The objective of this study was to measure the peak skin dose (PSD) and effective dose to estimate the deterministic and stochastic effects of a therapeutic interventional neuroradiologic procedure. MATERIALS AND METHODS: The cumulative dose (CD) and dose area product (DAP) were automatically recorded by a fluoroscopic machine and collected prospectively between April and November 2015. The study included 54 patients who underwent therapeutic neurointerventional radiology procedures. The CD of each patient was used to estimate the peak skin dose and the DAP was also calculated to estimate the effective dose. RESULTS: The average estimated peak skin dose was 1,009.68 mGy. Two patients received radiation doses of more than 2 Gy, which is the threshold that may cause skin complications and radiation-induced cataract. The average effective dose was 35.32 mSv. The majority of patients in this study (85.2%) who underwent therapeutic neurointerventional radiologic procedures received effective doses greater than 20 mSv. CONCLUSION: Not all therapeutic neurointerventional radiology procedures are safe from deterministic complications. A small number of patients received doses above the threshold for skin complications and radiation induced cataract. In terms of stochastic complications, most neurointerventional radiology procedures in this study were quite safe in terms of radiation-induced cancer.

The difference in ocular lens equivalent dose to ERCP personnel between prone and left lateral decubitus positions: a prospective randomized study.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed in a prone or left lateral decubitus (LLD) position. The ocular lens equivalent doses between the two positions may be different because in the LLD position the tube voltage will automatically increase to maintain the image quality, and the increased distance between the image intensifier and the X-ray tube may result in more scattered radiation. We aimed to compare the ocular lens equivalent doses of ERCP personnel between the two different positions. PATIENTS AND METHODS: Fifty-five patients with ERCP indications were randomized to either prone or LLD positions. One patient in an LLD position was excluded due to technical reasons. Indications for ERCP, patients' vertical thicknesses, fluoroscopy parameters, patients' skin dose rates, and the ocular-lens equivalent doses of ERCP personnel were compared. RESULTS: Baseline characteristics were no different except for vertical thickness, which was significantly higher in the LLD group. The ocular lens equivalent doses (prone vs. LLD) of the primary endoscopist (19.2 vs. 30.7 µSv, P  = 0.035), and the nurse anesthetist (17.3 vs. 42.2 µSv, P  = 0.002) were significantly lower in the prone group than in the LLD group. The calculated annual number of procedures not to exceed the exposure allowance in prone and LLD positions were 1,042 and 651 procedures for the primary endoscopist and 1,157 and 473 procedures for the nurse anesthetist, respectively. CONCLUSIONS: Ocular-radiation exposure to ERCP personnel was one-third lower in the prone than in LLD position. Therefore, more annual ERCPs could be performed by the personnel.

Radiation dose to medical staff in interventional radiology.

OBJECTIVE: The purposes of the present study were to determine the dose to medical staff in interventional radiology at different locations on the body measured by thermoluminescent dosimeter (TLD) and to relate the medical staff dose to patient dose measured by the dose-area product (DAP) meter. MATERIAL AND METHOD: The present study covered 42 patients in three interventional radiology procedures with three x-ray machines. Thermoluminescent dosimeters were stuck at eight positions on the radiologist's skin during the procedure. In addition, direct reading from the DAP meter placed in front of the collimator of the x-ray tube, was recorded to estimate the patient radiation dose. RESULTS: The surface dose to the primary radiologist showed maximum value at the left forearm of 407 microGy. The ratios between the maximum interventional radiologist surface dose and patient dose are 12.88 microGy per 10 Gycm2 for transarterial oily chemoembolization TOCE (Siemens Polystar), 22.58 microGy per 10 Gycm2 for transarterial oily chemoembolization TOCE (Siemens Neurostar), 148.29 microGy per 10 Gycm2 for percutaneous transhepatic biliary drainage PTBD (Siemens Polystar) and 100.46 microGy per 10 Gycm2for endoscopic retrograde cholangiopancreatography ERCP (GE Advantx). CONCLUSION: The interventional radiologist surface dose can be estimated from the mentioned ratio if the patient dose is measured. This will help the radiologists to avoid receiving an excess dose during their work.

The current status of eye lens dose measurement in interventional cardiology personnel in Thailand.

Workers involved in interventional cardiology procedures receive high eye lens doses if radiation protection tools are not properly utilized. Currently, there is no suitable method for routine measurement of eye dose. In Thailand, the eye lens equivalent doses in terms of Hp(3) of the interventional cardiologists, nurses, and radiographers participating in interventional cardiology procedures have been measured at 12 centers since 2015 in the pilot study. The optically stimulated luminescence (OSL) dosimeter was used for measurement of the occupational exposure and the eye lens dose of 42 interventional cardiology personnel at King Chulalongkorn Memorial Hospital as one of the pilot centers. For all personnel, it is recommended that a first In Light OSL badge is placed at waist level and under the lead apron for determination of Hp(10); a second badge is placed at the collar for determination of Hp(0.07) and estimation of Hp(3). Nano Dots OSL dosimeter has been used as an eye lens dosimeter for 16 interventional cardiology personnel, both with and without lead-glass eyewear. The mean effective dose at the body, equivalent dose at the collar, and estimated eye lens dose were 0.801, 5.88, and 5.70 mSv per year, respectively. The mean eye lens dose measured by the Nano Dots dosimeter was 8.059 mSv per year on the left eye and 3.552 mSv per year on the right eye. Two of 16 interventional cardiologists received annual eye lens doses on the left side without lead glass that were higher than 20 mSv per year, the new eye lens dose limit as recommended by ICRP with the risk of eye lens opacity and cataract.

22nd International Conference on Medical Physics 2016, Bangkok, Thailand; Medical physics propelling global health.

As medical technology evolves and patient needs increase, the need for well-trained and highly professional medical physicists (MPs) becomes even more urgent. The roles and responsibilities of MPs in various departments within the hospital are diverse and demanding. It is obvious that training, continuing education and professional development of MPs have become essential. One of the ways for an MP to advance his or her knowledge is to participate in conferences and congresses. Last year, the 22nd International Conference of Medical Physics (ICMP 2016) took place in Bangkok, Thailand. The event attracted 584 delegates with most of the participants coming from Asia. It attracted also delegates from 42 countries. The largest delegations were from Thailand, Japan and South Korea. ICMP 2016 included 367 oral presentations and e-posters, most of these being in the fields of Radiation Therapy, Medical Imaging and Radiation Safety. All abstracts were published as an e-book of Abstracts in a supplement to the official IOMP Journal. Many companies had exhibition stands at ICMP2016, thus allowing the participants to see the latest developments in the medical physics-related industry. The conference included 42 mini-symposia, part of the first "IOMP School" activity, covering various topics of importance for the profession and this special issue follows from the success of the conference.

Eye lens dosimetry and the study on radiation cataract in interventional cardiologists.

PURPOSE: To determine the eye lens dose of the Interventional Cardiology (IC) personnel using optically stimulated luminescent dosimeter (OSLD) and the prevalence and risk of radiation - associated lens opacities in Thailand. METHODS AND RESULTS: 48 IC staff, with age- and sex- matches 37 unexposed controls obtained eye examines. Posterior lens change was graded using a modified Merriam-Focht technique by two independent ophthalmologists. Occupational exposure (mSv) was measured in 42 IC staff, using 2 OSLD badges place at inside lead apron and at collar. Annual eye lens doses (mSv) were also measured using 4 nanoDots OSL placed outside and inside lead glass eyewear. The prevalence of radiation-associated posterior lens opacities was 28.6% (2/7) for IC, 19.5% (8/41) for nurses, and 2.7% (1/37) for controls. The average and range of annual whole body effective dose, Hp(10), equivalent dose at skin of the neck, Hp(0.07) and equivalent dose at eye lens, Hp(3) were 0.80 (0.05-6.79), 5.88 (0.14-35.28), and 5.73 (0.14-33.20) mSv respectively. The annual average and range of eye lens dose using nano Dots OSL showed the outside lead glass eyewear on left and right sides as 8.06 (0.17-32.45), 3.55(0.06-8.04) mSv and inside left and right sides as 3.91(0.05-14.26) and 2.44(0.06-6.24) mSv respectively. CONCLUSION: Eye lens doses measured by OSLD badges and nano Dot dosimeter as Hp(10), Hp(0.07) and Hp(3). The eyes of the IC personnel were examined annually by two ophthalmologists for the prevalence of cataract induced by radiation.

Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification: An IAEA phantom study.

Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing 133Ba, which was chosen as a surrogate for 131I. The sources, with nominal volumes of 2, 4, 6 and 23mL, were calibrated for 133Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to about 6% with planar imaging and SPECT (with Chang-AC) and within 2% for SPECT-CT.

The difference among stress and rest normal reference databases using non-corrected, scatter corrected, and scatter with attenuation corrected Bull's eye myocardial perfusion scintigraphy in both genders.

OBJECTIVES: To compare 3 types of Bull's eye normal reference maps; non-corrected, scatter corrected, and scatter with attenuation corrected Bull's eye in both genders. MATERIAL AND METHOD: Sixty-seven normal healthy males and females volunteered for the present study. After screening tests to identify low post-test (exercise EKG) likelihood of coronary artery disease, 41 subjects (20 males and 21 females) had stress and rest myocardial perfusion scintigraphy (99mTc-sestamibi). The data were reconstructed by filtered back projection reconstruction in three ways as follows; (1) non-correction (NoC), (2) scatter elimination only (SC), (3) scatter elimination and attenuation correction (SC+AC). Three sets of reconstructed data of both stress and resting studies were added into 6 sets of Bull's eye. The data of each Bull's eve were normalized to 100% of the maximum count. Percentage of uptake in each area was compared by t-test statistics. RESULTS: Stress and rest count distribution of NoC and SC sets were lowest at the inferior wall, followed by the septal wall, anterior wall, and lateral wall in both genders. In the SC+AC sets; septum and lateral walls showed more uptake than anterior and inferior walls. A significant difference of percentage uptake between stress and rest images at septum in NoC and SC images in male and in SC image in female was observed. No difference was seen in the SC+AC groups. CONCLUSION: There was similarity of count distribution between NoC and SC images. SC+AC caused more uniform image. However; some non-uniformity was observed. The use of sex-independent SC+AC bull's eye is possible. Stress study can be omitted for bull's eye collection of normal files.

Automated tumour boundary delineation on (18)F-FDG PET images using active contour coupled with shifted-optimal thresholding method.

This study presents an automatic method to trace the boundary of the tumour in positron emission tomography (PET) images. It has been discovered that Otsu's threshold value is biased when the within-class variances between the object and the background are significantly different. To solve the problem, a double-stage threshold search that minimizes the energy between the first Otsu's threshold and the maximum intensity value is introduced. Such shifted-optimal thresholding is embedded into a region-based active contour so that both algorithms are performed consecutively. The efficiency of the method is validated using six sphere inserts (0.52-26.53 cc volume) of the IEC/2001 torso phantom. Both spheres and phantom were filled with (18)F solution with four source-to-background ratio (SBR) measurements of PET images. The results illustrate that the tumour volumes segmented by combined algorithm are of higher accuracy than the traditional active contour. The method had been clinically implemented in ten oesophageal cancer patients. The results are evaluated and compared with the manual tracing by an experienced radiation oncologist. The advantage of the algorithm is the reduced erroneous delineation that improves the precision and accuracy of PET tumour contouring. Moreover, the combined method is robust, independent of the SBR threshold-volume curves, and it does not require prior lesion size measurement.

Dose reduction in CT while maintaining diagnostic confidence: diagnostic reference levels at routine head, chest, and abdominal CT--IAEA-coordinated research project.

PURPOSE: To measure radiation doses for computed tomography (CT) of the head, chest, and abdomen and compare them with the diagnostic reference levels, as part of the International Atomic Energy Agency Research coordination project. MATERIALS AND METHODS: The local ethics committees of all participating institutions approved the study protocol. Written informed consent was obtained from all patients. All scanners were helical single-section or multi-detector row CT systems. Six hundred thirty-three patients undergoing head (n = 97), chest (n = 243), or abdominal (n = 293) CT were included. Collected data included patient height, weight, sex, and age; tube voltage and tube current-time product settings; pitch; section thickness; number of sections; weighted or volumetric CT dose index; and dose-length product (DLP). The effective dose was also estimated and served as collective dose estimation data. RESULTS: Mean volumetric CT dose index and DLP values were below the European diagnostic reference levels: 39 mGy and 544 mGy . cm, respectively, at head CT; 9.3 mGy and 348 mGy . cm, respectively, at chest CT; and 10.4 mGy and 549 mGy . cm, respectively, at abdominal CT. Estimated effective doses were 1.2, 5.9, and 8.2 mSv, respectively. CONCLUSION: Comparison of CT results with diagnostic reference levels revealed the need for revisions, partly because the newer scanners have improved technology that facilitates lower patient doses.

Changes in body composition and mitochondrial nucleic acid content in patients switched from failed nucleoside analogue therapy to ritonavir-boosted indinavir and efavirenz.

BACKGROUND: Body composition changes complicate antiretroviral therapy. Improvements in lipoatrophy after a switch in nucleoside reverse-transcriptase inhibitors (NRTIs) have been demonstrated. We investigated 60 patients switching from failed NRTIs to ritonavir-boosted indinavir and efavirenz. METHODS: Body composition (assessed by dual-energy x-ray absorptiometry scan and by single-slice computed tomography of the abdomen through the level of the fourth lumbar vertebra [L4] and the mid-right thigh) and fasted metabolics were measured at the baseline time-point at switch and at weeks 48 and 96 thereafter. Mitochondrial DNA and RNA were extracted from right-thigh subcutaneous fat and peripheral-blood mononuclear cells (PBMCs) at weeks 0 and 48. The primary end point was the change in mean limb fat over 48 weeks. RESULTS: At week 96, we observed increases in mean (standard deviation [SD]) limb fat (+620 [974] g; P=.003), L4 subcutaneous adipose tissue (+20 [35] cm(2); P<.001), mid-thigh subcutaneous adipose tissue (+5 [10] cm(2); P<.001), and L4 visceral adipose tissue (+11 [34] cm(2); P=.01), but we also observed reduced lean limb mass (-831 [1,100] g; P=.3). Mean (SD) mtDNA content in subcutaneous fat and in PBMCs increased (+109 [274] and +45 [100] copies/cell, respectively). Improved virological control or immune recovery did not explain the results. Triglyceride, total cholesterol, estimated low-density lipoprotein cholesterol, ratio of total cholesterol to high-density lipoprotein cholesterol, and blood glucose levels deteriorated (i.e., had increased by 206%, 67%, 58%, 19%, and 6%, respectively, at week 96). CONCLUSIONS: This regimen was associated with statistically significant but clinically modest increases in peripheral fat, visceral fat, and mitochondrial nucleic acid content. A predominantly adverse metabolic profile developed.