NTRUHS PG Medical Admissions under Management Quota, check out Counselling Procedure

Andhra Pradesh- Dr NTR University of Health Sciences (Dr NTRUHS) has commenced the counselling procedure for admission into the Postgraduate (PG) (Medical) Degree/Diploma Courses under Management Quota (MQ) for the academic year 2024-25. In this regard, Dr NTRUHS has released an information brochure detailing the Counselling Procedure for the said admission.

As per the information brochure, candidates are informed that there is no limit of choices (number) for exercising web options. Candidates can exercise any number of options for any number of specialities and colleges available. Candidates are instructed to be cautious in exercising web options and are advised to take the printout of the saved options. Candidates are advised to exercise options in Courses and colleges in which they are genuinely interested. If candidates are not interested in joining a particular speciality or college, they are advised not to select options for those thereby, allowing the next meritorious candidates a fair opportunity.

Also Read: NTRUHS Invites Applications for BDS Management Quota Admissions 2024 After 47 Seats remain vacant

The selected candidates can download the provisional allotment order on payment of the University Fee of Rs.49,600/- through the payment gateway and report to the Principal of the Allotted College on or before the date specified in the allotment letter. University fee once paid is not refundable under any circumstances. The selected candidates shall produce all the Original certificates, pay the Tuition fee, necessary bonds etc., and complete the process of admission. If the candidate does not fulfil the criteria as per regulations to complete the admission process on the specified dates of admission, their admission will be cancelled automatically.

The verification of original certificates will be conducted at the time of admission in the respective College and in case of any discrepancy, the Provisional allotment will be cancelled and action will be initiated. If the candidate slides to other colleges (i.e., affiliated colleges of Dr.NTR UHS) during subsequent Phases of counselling the tuition fee will be sent to the slided college by the concerned college where the amount is held.

Meanwhile, the procedure for exercising web options of Phase-II Counselling, Phase-III/Mop Up Round and stray vacancy counselling is the same as Phase I Counselling.

PHASE 1 COUNSELLING

1 If a candidate of Phase-I counselling has not joined/reported in the allotted seat then that particular seat shall not be available for that candidate to exercise web options in Phase-II and all further phases of counselling to prevent the blocking of seats.

2 The Joined candidates of Phase-I Counselling are eligible for upgradation up to Phase-III (Mop Up) round only.

3 Regardless of whether they report to the allotted college of Phase-I in Management Quota, can participate in Competent Authority Quota counselling up to Phase-III.

4 Candidates who have reported the allotted seat of Phase-I can opt for free exit as per the schedule which will be notified.

Also Read: NTRUHS cancels 75 MBBS allotments made in 2 medical colleges, Notifies On Revised Special Vacancy Round

PHASE 2 COUNSELLING

1 ELIGIBILITY

i All the candidates who have been allotted a seat in Phase-I and reported.

ii All the candidates who have not been allotted any seat in Phase-I counselling.

iii All candidates who have been allotted a seat in Phase-I but have not reported/not joined at the allotted colleges. However, if a candidate has not joined/reported in the allotted seat of Phase-I then that particular seat shall not be available for that candidate to exercise web options in Phase-II counselling.

iv The Joined candidates of Phase-I/Phase-II Counselling are eligible for upgradation up to Phase-III (MoP Up) round only.

2 Regardless of whether they report to the allotted college of Phase-I in Management Quota, can participate in Competent Authority Quota counselling up to Phase-III.

3 Candidates who have reported the allotted seat of Phase-I and/or Phase-II can opt for free exit as per the schedule which will be notified.

4 In this phase, the unfilled seats from Phase-I and vacancies arising due to nonjoining/free exit are filled.

5 Reported Phase-I candidates can upgrade from Phase-I to Phase-II. Candidates getting upgraded in Phase II shall not have any claim on Phase-I seats.

6 The Phase-I seat vacated because of the up-gradation during the course of Phase-II counselling will be added and allotted simultaneously to the next candidates as per the merit and rules.

Also Read: NTRUHS Begins Round 1 Counselling for PG AYUSH Courses 2024, Releases Seat Matrix

PHASE III/MOP UP ROUND

1 ELIGIBILITY

i All the candidates who have been allotted and reported to the Phase-I/Phase-II seat.

ii All the candidates who have not been allotted any seat in Phase-I/Phase-II counselling.

iii All candidates who have been allotted a seat in Phase-I/Phase-II but have not reported/not joined at the allotted colleges. However, if a candidate has not joined/reported in the allotted seat of Phase-I/Phase-II then that particular seat shall not be available for that candidate to exercise web options in Phase-III/Mop Up counselling.

iv The Joined candidates who are holding a seat in Phase-I or Phase-II or Phase-III (Mop Up) Counselling are not eligible for Stray or any further rounds.

v Candidates allotted a seat in Phase III (Mop-Up) cannot participate in subsequent rounds of State Counselling, regardless of whether they report to the allotted college.

vi MCC of DGHS will share the data of joined candidates in Round 1, Round 2, and Round 3 counsellings with all the participating States. Similarly, the participating States will also share the data of joined candidates. Candidates who have joined up to Round 3 of MCC counselling, the allotted candidates of Stray Vacancy round of MCC counselling and CQ Stray Vacancy round of AP State will be filtered and weeded out before processing for MQ Stray Vacancy round of counselling of AP State.

vii As per MCC Counselling Scheme 2024, the joined candidates up to Round 3 of MCC counselling cannot upgrade or resign after Round 3. If any candidate is allotted a seat in Round 3 of AIQ/Deemed/Central Quota and also allotted a seat in Phase-III/ Mop Up counselling of the AP State, later found that the candidate has joined in Round 3 of AIQ/Deemed/Central Quota, in such cases the seat allotted in Phase-III/ Mop Up counselling of the AP State shall be automatically cancelled at any stage, without any prior notice. Vacancies arising due to such cancellation will be filled up in the Stray Vacancy round. Hence, candidates are advised to exercise caution while deciding to join in either Round 3 of AIQ or Phase-III (Mop Up) of State Counselling.

2 Reported Phase-I & Phase-II candidates can upgrade to Phase-III. Candidates getting upgraded in Phase III shall not have any claim on Phase-I or Phase-II seats.

3 The Phase-I or Phase-II seat vacated because of the up-gradation during Phase III counselling will be added and allotted simultaneously to the next candidates as per the merit and rules

STRAY VACANCY COUNSELLING

There will be fresh registrations and fresh choice filling for the Final Stray Vacancy Round. The choices filled during earlier phases will not be considered for allotment in the Stray Vacancy Round. Candidates whose names are already present in the Merit list and not holding any seat are also eligible for Stray vacancy provided they satisfy the eligibility conditions of the Stray vacancy round and hence they need not apply again for Stray vacancy notification. Additionally, The choices filled during Phase III (Mop Up) will not be considered for allotment in the Stray Vacancy Round.

ELIGIBILITY

i The candidates who have not been allotted in Phase I, Phase II and Phase III of counselling.

ii The candidates who have been allotted, but not joined in Phase I, Phase II of State Quota and All India Quota are eligible to participate in this counselling. However, if a candidate has not joined/reported in the allotted seat of Phase-I/Phase-II then that particular seat shall not be available for that candidate to exercise web options in Stray Vacancy counselling.

iii Candidates not allotted or not holding any seat in Phase-I, Phase-II, and candidates not allotted any seat in Phase-III of (AIQ/State/Deemed) are only eligible for State Stray vacancy round counselling.

NON-ELIGIBILITY

i The candidates who are holding PG Medical seats in Phase I, Phase II and Phase III (Mop Up) of State Counselling are not eligible to participate in the Stray round of counselling.

ii The candidate who is holding a seat allotted in Round 1, Round 2 and Round 3 in All India Quota/Deemed universities/other States (shared by MCC/DGHS).

iii The candidates who have been allotted in the stray round of All India Quota/Deemed universities/other States (shared by MCC/DGHS) are not eligible to participate in the State Stray Round of counselling.

iv The candidates who have been allotted in the stray round of the Competent Authority Quota of the AP State are not eligible to participate in the State MQ Stray Round of counselling.

v Candidates allotted a seat in Phase III (Mop-Up) cannot participate in subsequent rounds of State Counselling, regardless of whether they report to the allotted college.

However, if a candidate is allotted a seat in the Stray round, he/she has to report & join the allotted seat/college else he/she shall be debarred from participating in A.P. State Counselling for admission to PG Medical Courses under both Competent Authority Quota seats & Management Quota seats for subsequent 1 (one) academic year

To view the information brochure, click the link below

https://medicaldialogues.in/pdf_upload/dr-ntruhs-begin-pg-medical-admissions-for-2024-25-under-management-quota-know-all-counselling-procedure-details-here-263397.pdf

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Newborn with Severe deformities: Kerala Govt says 4 doctors not at fault

Thiruvananthapuram: Four doctors who were booked in a medical negligence case for allegedly failing to detect fetal abnormalities during prenatal care of a pregnant woman—leading to severe internal and external deformities in her newborn baby—have been cleared of all charges following an investigation by the Kerala Health Department. 

These four accused doctors included two female doctors from the Kadappuram Government Women and Child Hospital in Alappuzha and two doctors from private diagnostic labs.

A few days ago, the Kerala Health Department launched an investigation into the birth of a baby with severe deformities. A report of the investigation was recently submitted to Health Minister Veena George which revealed that the doctors could not have detected the disability during the initial pregnancy scan performed on the mother. 

Also read- 4 doctors booked for alleged failure to diagnose genetic disorders before baby’s birth

However, the report indicated that the doctors could have informed the mother and her family about the possible risks. Accordingly, the report recommends the creation of a medical board responsible for overseeing the child’s treatment and care, Manthrubhumi reports. 

This comes after the parents of the newborn filed a complaint against these four doctors. The couple accused them of failing to detect the fetus’s abnormalities before birth despite multiple ultrasounds during her pregnancy. 

Medical Dialogues had reported that the incident took place at a hospital in Alappuzha, where the baby was born with severe deformities. The parents of the newborn alleged that the doctors failed to detect or disclose the genetic abnormalities during prenatal scans, instead assuring them that the reports were normal. The couple also claimed that they were shown the baby only four days after delivery.

The FIR stated that Surumi, 35, was undergoing treatment for her third pregnancy at Kadappuram Women and Child Hospital. On October 30, Surumi was admitted for delivery. However, the FIR said that she was referred to Government Medical College Hospital (MCH) in Vandanam, Alappuzha, citing the absence of fetal movement and heartbeat. 

On November 8, the baby was delivered following surgery at MCH and was found to have severe internal and external deformities, including facial abnormalities, a heart defect, non-functional and misaligned eyes and ears, limb deformities, and an inability to open its mouth.

Meanwhile, one of the accused doctors, responding to the allegations, said she had treated Surumi only during the initial months of her pregnancy. However, the doctors associated with the diagnostic labs maintained that there were no errors in the scan reports.

Defending the doctors here, the investigation report submitted by Dr. V. Meenakshi, Additional Director of the Health Department revealed that the disability could not have been detected in the initial anomaly scan. However, it notes a critical communication failure. 

“Doctors did not adequately inform the mother and her family about the possible risks, including excess fluid and the potential for defects. A warning to doctors is necessary regarding this matter,” mentioned the report, reported by Mathrubhumi. 

The report highlights that while some minor defects might not be visible in scans, serious issues related to the spine or limbs can often be detected. It also stresses the importance of clearer communication with expectant parents about potential risks. It also notes concerns regarding the reliance on external scanning centres, some of which have been found lacking in proper patient documentation and comprehensive examination procedures.

Also read- Deviating from prescribed test by doctor is negligence- HC refuses to quash criminal case against Lab Technician

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Deprescribing antihypertensive medication not tied to risk of stroke or MI hospitalization in long-term care: JAMA

Researchers have found that in the long-term care setting, among residents aged 65 years and older, deprescribing of antihypertensive medications does not significantly increase risk for hospitalization with a diagnosis of myocardial infarction (MI) or stroke. A recent study was published in the journal JAMA Network Open conducted by Michelle and colleagues.

Retrospective comparative effectiveness research study used data from the long-term care residents who were admitted to Veterans Affairs (VA) community living centers between October 1, 2006, and September 30, 2019. The participants were over 65 years of age and were on at least one antihypertensive medication.

Deprescribing was operationally defined as at least 30% reduction in medication dose or number, measured over a follow-up period of 12 weeks. The main outcomes are defined as hospitalization due to MI or stroke, any time within two years post follow-up, and evaluated according to International Classification of Diseases (ICD-9 and ICD-10) codes. The study applied pooled logistic regression with inverse probability of treatment and censoring weighting (IPTW and IPCW) to correct the biases due to confounding.

The key findings were:

  • The study comprised 13,096 long-term care residents, whose median age was 77 years (IQR, 70-84 years). Of these, 97.4% were men.

  • Of the residents, 17.8% of them had their antihypertensive medication deprescribed in a period exceeding 12 weeks.

  • The unadjusted cumulative incidence of MI or stroke hospitalization within two years for those deprescribed was 11.2%, and for the continued therapy, it was 8.8% (difference: 2.4 percentage points; 95% CI: −2.3 to 7.1).

  • After full adjustment, there was no significant association between deprescribing and increased risk of MI or stroke (hazard ratio: 0.93; 95% CI: 0.70-1.26).

  • The participant characteristics were well-balanced after applying IPTW and IPCW, with standardized mean differences of less than 0.05 for all variables.

In older residents of long-term care facilities, deprescribing antihypertensive drugs did not increase the risk for hospitalization for acute MI or stroke. The results support the safe introduction of deprescribing in elderly populations, providing clinicians with a data-driven strategy for minimizing the burden of medications without loss of cardiovascular safety.

Reference:

Odden, M. C., Graham, L. A., Liu, X., Dave, C. V., Lee, S. J., Li, Y., Jing, B., Fung, K., Peralta, C. A., & Steinman, M. A. (2024). Antihypertensive deprescribing and cardiovascular events among long-term care residents. JAMA Network Open, 7(11), e2446851. https://doi.org/10.1001/jamanetworkopen.2024.46851

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Eating dark but not milk chocolate linked to reduced risk of type 2 diabetes

Eating five servings of dark chocolate a week is associated with a reduction in the risk of type 2 diabetes, according to a long-term US study published by The BMJ today.

Global rates of type 2 diabetes are set to rise to 700 million by 2045. Chocolate contains high levels of flavanols (a natural compound found in fruits and vegetables) which have been shown to promote heart health and reduce the risk of type 2 diabetes. But the link between chocolate consumption and risk of type 2 diabetes remains controversial due to inconsistent results.

In addition, most previous studies have not looked at whether eating dark and milk chocolate – which have different cocoa, milk and sugar content – might have different impacts on the risk of type 2 diabetes.

To explore this further, researchers combined data from three long-term US observational studies of female nurses and male healthcare professionals with no history of diabetes, heart disease or cancer when they were recruited.

Using food frequency questionnaires completed every four years, they analysed associations between type 2 diabetes and total chocolate consumption for 192,208 participants, and chocolate subtype (dark and milk) consumption for 11,654 participants over an average monitoring period of 25 years.

As changes in bodyweight strongly predict risks of type 2 diabetes, the authors also used these food questionnaires to assess participants’ total energy intake.

In the analyses for total chocolate, 18,862 people developed type 2 diabetes. After adjusting for personal, lifestyle, and dietary risk factors, the authors found that people who ate at least five servings a week of any type of chocolate (where one serving is equal to a standard chocolate bar/pack or 1 oz) showed a significant 10% lower rate of type 2 diabetes compared with those who rarely or never ate chocolate.

In analyses by chocolate subtypes, 4,771 people developed type 2 diabetes. After adjusting for the same risk factors, people who ate at least five servings a week of dark chocolate showed a significant 21% lower risk of type 2 diabetes, but no significant associations were found for milk chocolate intake.

The researchers also found a 3% reduced risk of type 2 diabetes for each additional weekly serving of dark chocolate (a dose-response effect). Increased consumption of milk, but not dark, chocolate was associated with long term weight gain.

Although dark chocolate has similar levels of energy and saturated fat to milk chocolate, the authors explain that the high levels of flavanols in dark chocolate might offset the effects of saturated fat and sugar on weight gain and the risk of other cardiometabolic diseases such as diabetes.

The authors acknowledge that the observational nature of this study prevents firm conclusions from being drawn about causality and, although they took account of lifestyle and dietary factors linked to type 2 diabetes, other unknown factors may have affected the results. Most participants were non-Hispanic older white adults, so the findings may not apply to other groups, they add.

However, they point out that results remained largely unchanged after adjusting for additional factors, suggesting that they are robust.

As such, they conclude: “Increased consumption of dark, but not milk, chocolate was associated with lower risk of type 2 diabetes. Increased consumption of milk, but not dark, chocolate was associated with long term weight gain. Further randomized controlled trials are needed to replicate these findings and further explore the mechanisms.”

Reference:

https://www.bmj.com/content/387/bmj-2023-078386

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Diabetic complication severity index directly associated with Cancer risk, claims research

A recent groundbreaking study
revealed that cancer risk escalates in individuals with severe diabetic complications.
This is more pronounced in individuals who have an earlier onset of diabetes,
as per results that were published in the Journal of Diabetes Investigation.

Diabetes is a global pandemic,
causing potential healthcare and economic burdens. It can cause multiple
complications like vascular and nonvascular issues. Apart from the healthcare burdens,
it also causes an increased risk of cancers. Research shows that the
accumulation of advanced glycation end products is leading to the development
of diabetic complications and also cancer. As there is ambiguity on the
association between diabetic complications and cancer risk, researchers from
Taiwan have conducted a study to assess the association between the degree of
disease severity and the risk of cancer in patients with diabetes.

A 13-year retrospective cohort
study was conducted using the National Health Insurance Research Database from
2000 through 2013. The study also included newly diagnosed diabetics. All
the vascular and metabolic complications were collected to develop an adapted
diabetic complication severity index (aDCSI) that ranges from 0-13. The aDCSI
includes seven categories of complications: cardiovascular disease, stroke,
peripheral vascular disease, retinopathy, nephropathy, neuropathy, and
metabolism, with a total score of 0–13. All the individuals were followed up
from the diabetes onset to the detection of cancer or death. Cancer diagnosis
due to any reason was the outcome of interest.

Also Read: Robotics and Beyond: Advances in Lung Cancer Surgery

Findings:

  • Within the mean follow-up period of 9 years, the
    rates of cancer incidence per 100,000 person-years were 482.0, 585.4, 662.1,
    724.4, 748.5, and 815.2 among men with aDCSI scores of 0, 1, 2, 3, 4 and 5+,
    respectively.
  • Similarly, the cancer rates in women were 358.9,
    436.4, 501.3, 515.6, 544.2, and 611.1 with aDCSI scores of 0, 1, 2, 3, 4, and
    5+, respectively.
  • The risk of cancer was 1.7- to 1.9-fold for the
    top vs bottom quartiles of aDCSI in diabetic onset age of 40–44.
  • However, among patients with diabetic onset age
    of 60–64, the associations between the severity of diabetic complications and
    cancer risk were attenuated in women.
  • There is an 8–17% and 7–20% increase in the risk
    of cancers with higher aDCSI in males and females, respectively.
Also Read: Preterm birth associated with increased mortality risk into adulthood, study finds

Thus, the study is the first of
its kind to establish an association between the severity of diabetic
complications and the risk of cancer. This can help evaluate the cancer risk
using glucose levels that vary considerably in individuals based on cancer
outcomes. The researchers also encourage enhanced cancer screening
protocols targeting the high-risk group of individuals. They also suggest using
the adapted diabetic complication severity index (aDCSI) as a tool for early
detection.

Further reading:

Tseng YH, Tsan YT, Chen PC.
Association between severity of diabetic complications and risk of cancer in
middle-aged patients with type 2 diabetes. J Diabetes Investig.
Published online November 22, 2024. doi:10.1111/jdi.14364.

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MR study doesn’t support causal association between serum vitamin D levels and urolithiasis

MR study doesn’t support a causal association between serum vitamin D levels and urolithiasis.

In light of inconsistent evidence from previous observational studies regarding the correlation between serum vitamin D levels and urolithiasis, this study aimed to investigate the genome-wide causal association between genetically predicted serum 25(OH)D levels and urolithiasis using the Mendelian randomization (MR) approach. In this study, we utilized genome-wide association studies (GWAS) summary statistics from the UK Biobank and SUNLIGHT consortium for serum vitamin D levels, as well as urolithiasis data from FinnGen. We employed bidirectional two-sample MR analysis to evaluate potential causal relationships. The primary MR analysis relied on the inverse variance weighted (IVW) method, supplemented by MR-Egger, weighted median, and weighted mode approaches. Sensitivity analyses were conducted to ensure result robustness, including Cochran’s Q test, MR-Egger intercept test, leave-one-out tests, and MR pleiotropy residual sum and outlier (MR-PRESSO) test. Results: The MR analysis indicated no significant causal effects of serum 25(OH)D levels on urolithiasis [IVW method: (kidney and ureteral stones: OR = 1.134;95% CI, 0.953 to 1.350, p = 0.155; lower urinary tract stones: OR = 1.158; 95% CI, 0.806 to 1.666, p = 0.428)]. However, according to the IVW results, genetically predicted kidney and ureteral stones were associated with decreased serum 25(OH)D levels (beta = -0.025; 95% CI, -0.048 to -0.003; p = 0.028), while they did not indicate a causal effect of lower urinary tract stones on serum 25(OH)D levels (beta = -0.002; 95% CI, -0.013 to -0.008; p = 0.662). A sensitivity analysis suggested the robustness of these causal associations. The MR study did not provide evidence supporting a causal association between serum 25(OH)D levels and urolithiasis among individuals of European descent. However, there might exist a negative causal association between kidney and ureteral stones and serum 25(OH)D levels.

Reference:

Zhang, QF., Zhang, HZ., Wang, S. et al. Causal association of serum vitamin D levels with urolithiasis: a bidirectional two-sample Mendelian randomization study. Eur J Nutr 64, 39 (2025). https://doi.org/10.1007/s00394-024-03553-1

Keywords:

MR study, support, causal association, serum, vitamin D levels, urolithiasis, European Journal of Nutrition, Zhang, QF., Zhang, HZ., Wang, S, Mendelian randomization, Vitamin D, 25-hydroxyvitamin D, Urolithiasis, Kidney and ureteral stones, Lower urinary tract stones

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Persisting oral infection linked to posttransplant infectious complications, suggests study

Persisting oral infection linked to posttransplant infectious complications, suggests study published in the Journal of Evidence-Based Dental Practice.

Posttransplant infections may lead to dire consequences in immunocompromised organ recipients. Oral foci of infection are therefore often eliminated prior to solid organ transplantation to reduce posttransplant morbidity. However, despite increasing numbers of organ transplantations the necessity of pretransplant dental treatment and its effect on transplant outcome remains uncertain. The present systematic review aimed to evaluate the impact of oral foci of infection and pretransplant dental treatment on adverse events following solid organ transplantation. Studies on adult patients undergoing solid organ transplantation with/without oral infection or with/without pretransplant dental treatment were eligible. An electronic search in PubMed, Scopus, Web of Science, CINAHL and Cochrane was conducted up to June 11, 2024. Screening of eligibility, data extraction and risk-of-bias assessment of the included studies with the Newcastle-Ottawa Scale were done independently by two reviewers. Data were synthesized with a narrative approach.

Results: In total, 4035 unique publications were identified. After full text assessment of 75 studies nine cohort studies on liver, kidney, heart and/or lung transplantation based on 727 patients were included. Two studies based on 161 patients found a significant increase of infectious complications after liver transplantation when no dental treatment was performed. Presence of oral foci increased the risk of hospitalization after kidney transplantation in one study but was associated with lower infection rate after lung transplantation in another study. No studies found significant impact on mortality or on organ rejection. Overall, the quality of the included studies was good with a low or medium risk of bias. This is the first systematic review on the impact of oral infection on organ transplantation. The results suggest a possible link between persisting oral infection and posttransplant infectious complications, thus supporting the elimination of oral infectious foci before solid organ transplantation.

Reference:

Jenny Olsson, Sylvia Hunfjörd, Oscar Braun, Birgitta Häggman-Henrikson, Anna Ljunggren,

Impact of Oral Infection on Organ Transplantation: A Systematic Review,

Journal of Evidence-Based Dental Practice, Volume 24, Issue 4, 2024,102035, ISSN 1532-3382. https://doi.org/10.1016/j.jebdp.2024.102035.

(https://www.sciencedirect.com/science/article/pii/S153233822400085X)

Keywords:

Persisting, oral, infection, linked, posttransplant, infectious, complications, suggests, study, Journal of Evidence-Based Dental Practice, heart transplantation, liver transplantation, transplantation, kidney transplantation, dentistry, dental focal, infection, Jenny Olsson, Sylvia Hunfjörd, Oscar Braun, Birgitta Häggman-Henrikson, Anna Ljunggren

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Clinical trial reveals twice-yearly injection to be 96% effective in HIV prevention

For oral medications that prevent new HIV infection to be effective, the patient must take certain actions, including attending doctor’s visits every three months and — most importantly-consistency.

These daily oral antiretrovirals, more commonly referred to as PrEP (pre-exposure prophylaxis), such as Truvada®, are extremely effective at HIV prevention, but only if they are taken daily as directed. Truvada’s efficacy is greatly compromised when taken inconsistently.

However, results from a recent Gilead-funded clinical trial (Purpose-2) led by physicians at Emory University and Grady Health System indicate that a twice-yearly injection of Lenacapavir offers a 96% reduced risk of infection overall, making the injection significantly more effective than the daily oral PrEP. The findings were recently published in the New England Journal of Medicine.

“Seeing these high levels of efficacy-at almost 100%-in an injectable that people only have to take every six months is incredible,” says Colleen Kelley, MD, lead author of the study and professor in the School of Medicine at Emory University. “This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV.”

In the randomized, double-blind, Phase III clinical trial comparing the efficacy of the two medications, 99% of the participants in the Lenacapavir group did not acquire an HIV infection. During the trial, only two participants in the Lenacapavir group, comprised of 2,179 people, acquired HIV. This compares to nine new HIV infections in the Truvadagroup, which had 1,086 people. The trial showed that adherence to the injectable was higher than of the daily oral pill.

Kelley, also the co-director of the Emory Center for AIDS Research, and Associate Dean for Research for Emory at Grady adds that while PrEP is incredibly effective at preventing infection, part of what made the injection more effective in the clinical trial was the challenges associated with adherence to a daily oral pill.

“What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors,” says Kelley, referencing healthcare disparities in general. “Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.”

The inclusion of racially, ethnically, and gender-diverse participants in the clinical trial was notable because it was representative of populations disproportionately impacted by HIV in real time. For example, the trial groups were comprised of cisgender men and gender-diverse people at 88 sites in Peru, Brazil, Argentina, Mexico, South Africa, Thailand, and the U.S.

According to the study, the same populations that are disproportionately impacted by HIV are the same populations that have limited access to PrEP — or may have difficulty consistently taking the oral antiretroviral medication — ultimately highlighting the need for more options. The study also indicates that more than half of the new HIV infections nationwide in 2022 were among cisgender gay men, and 70% of those were among Black or Hispanic individuals.

Valeria Cantos, MD, associate professor in the School of Medicine at Emory University, physician at Grady Memorial Hospital, and the principal investigator for the clinical trial at the Grady research site, emphasized the importance of having trials that include populations truly representative of the patients that Grady serves.

“At Grady, our focus is on increased representation of underserved and vulnerable populations, acknowledging and addressing the distrust towards research held by some community members due to prior abuses or neglect of these populations by research institutions in the past,” Cantos says. “Grady is an established, trusted research site because of its commitment to equity.”

At the Grady clinical trial site, medical materials were available in Spanish, and bilingual staff members recruited and enrolled trial participants who only spoke Spanish. Cantos also indicated that the site enrolled participants who are representative of the populations that would benefit the most from Lenacapavir. In addition to Grady, the Hope Clinic and Emory Midtown Hospital were among the 88 sites supporting the clinical trial.

“We are not reaching everyone we need to reach with our current HIV prevention interventions, such as those who are disproportionately impacted by HIV and health care disparities,” says Kelley. “For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative.”

Since the Phase III clinical trial has been completed and submitted by the FDA for consideration, Kelley is hopeful that Lenacapavir may be approved by 2025 for commercial use.

“”The results of this study add to the armamentarium of novel tools for HIV prevention. Long acting antiretrovirals offer new hope for those who are not able to take oral medications,” says Carlos del Rio, MD, chair of the Department of Medicine at Emory University School of Medicine. “The challenge is now to roll out and make these tools available and accessible in an equitable way — only then we will see new HIV infections dramatically decreased locally and globally,” adds del Rio, also co-director of the Emory Center for AIDS Research.

Reference:

Colleen F. Kelley, Maribel Acevedo-Quiñones, Allison L. Agwu, Anchalee Avihingsanon, Paul Benson, Jill Blumenthal, Cynthia Brinson, Carlos Brites, Pedro Cahn, Valeria D. Cantos, Jesse Clark, Meredith Clement, Cathy Creticos, Gordon Crofoot, Ricardo S. Diaz, Susanne Doblecki-Lewis, Jorge A. Gallardo-Cartagena, Aditya Gaur, Beatriz Grinsztejn, Shawn Hassler, Juan Carlos Hinojosa,  Pamela Wong, Renu Singh, Lillian B. Brown, Christoph C. Carter, Moupali Das, Jared M. Baeten, Onyema Ogbuagu. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. New England Journal of Medicine, 2024; DOI: 10.1056/NEJMoa2411858.

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Indoor Air Purification Significantly Improves Respiratory Health of Children, reports JAMA study

Researchers have found improvements in the respiratory health of children due to indoor air purification, which would be highly relevant in areas with high pollution. It has long been documented that particulate matter of size 2.5µm (PM2.5) is harmful to respiratory health in children, although the benefit of air purification on pulmonary health has not yet been clearly understood. A recent study was published in JAMA Pediatrics journal conducted by Jian Lie and colleagues in China.

The study was conducted in 79 healthy children aged 10-12 years, between April and December 2021. Each participant received two-stage intervention: true air purification and sham purification, lasting for 76 days each with an 88-day washout period in between. Personal PM2.5 exposure levels and respiratory health outcomes were measured before and after each intervention. Improvements were analyzed with the use of linear mixed-effects models while metabolomics analysis identified the EBC metabolites that mediate the effects.

The study found significant improvements in respiratory health during the true air purification period:

  • Reduction in PM2.5 Exposure: Time-weighted personal PM2.5 concentration decreased by 45.14%, from 39.17 µg/m³ (sham purification) to 21.49 µg/m³ (true air purification).

Improved Pulmonary Function:

  • Forced expiratory volume in 1 second increased by 8.04% (95% CI, 2.15%-13.93%).

  • Peak expiratory flow improved by 16.52% (95% CI, 2.76%-30.28%).

  • Forced vital capacity rose by 5.73% (95% CI, 0.48%-10.98%).

  • FEF25%-75% enhanced by 17.22% (95% CI, 3.78%-30.67%).

  • Peak expiratory flow at 75% FVC was increased by 14.60% (95% CI, 0.35%-28.85%).

  • Peak expiratory flow at 50% FVC increased by 17.86% (95% CI, 3.65%-32.06%).

  • Peak expiratory flow at 25% FVC increased by 18.22% (95% CI, 1.73%-34.70%).

  • Anti-Inflammatory: Fractional exhaled nitric oxide reduced by 22.38% (95% CI, 2.27%-42.48%).

Metabolic Mediation: The metabolites L-tyrosine and β-alanine were among those found to be the respiratory benefit mediators.

This clinical trial demonstrated that multisetting air purification significantly improves respiratory health in children by enhancing pulmonary function and reducing airway inflammation. The findings advocate for broader adoption of air purification interventions to mitigate the adverse effects of air pollution on pediatric populations.

Reference:

Lei J, Sun Q, Chen R, et al. Respiratory Benefits of Multisetting Air Purification in Children: A Cluster Randomized Crossover Trial. JAMA Pediatr. Published online December 02, 2024. doi:10.1001/jamapediatrics.2024.5049

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Ocular Pressure Adjusting Pump provides sustained reduction in IOP, suggests Study

Glaucoma is a leading cause of global blindness. Intraocular
pressure (IOP) remains the only clinically-validated and modifiable risk factor
associated with development and progression of glaucoma. Current treatment
methods all target the reduction of IOP including topical ocular medications,
laser procedures, and surgeries ranging from micro-invasive glaucoma procedures
to traditional filtering procedures to facilitate an alternative drainage
pathway. Although the glaucoma treatment landscape has undergone considerable
advancement over the last decade, the currently available treatment options
have limitations and risk factors and often require the clinician to weigh
effectiveness versus safety. Currently, there is no treatment option available
to reduce IOP which can be categorized as non-surgical or non-pharmacological.

The Ocular Pressure Adjusting Pump, or OPAP (FYSX™ Ocular
Pressure Adjusting Pump, Balance Ophthalmics, Inc., USA) is a novel treatment
device that consists of a pair of pressure-sensing goggles connected to a
pressure-modulating pump. When the goggles are worn by a subject, negative
pressure (or vacuum) is applied to create a localized decrease in atmospheric
pressure contacting the eye, leading to a corresponding decrease in IOP. This
mechanism of action is based on Pascal’s law, which states that when there is a
change in pressure at any point in a confined fluid, there is an equal change
throughout the fluid. The design of the Ocular Pressure Adjusting Pump allows
for individualized and titratable negative pressure application to each eye.

The Ocular Pressure Adjusting Pump was FDA approved in July
2024 and the IOP-lowering efficacy of the device has been well established by
multiple previous studies; however, in prior work, the IOP measurements were
not measured repeatedly throughout the treatment interval or involved a removal
of the device to place specially designed goggles for IOP measurement during
negative pressure application. Further, because no current tonometry methods
allow for IOP measurements through the goggles during negative pressure
application, a novel method of measurement was developed.

The present study aimed to evaluate the sustained reduction
in IOP throughout an extended duration of uninterrupted negative pressure
application.

Prospective, controlled, open-label, randomized, single
site, pilot study. Subjects with primary open-angle glaucoma (OAG) were
enrolled. One eye of each subject was randomized to receive negative pressure
application; the fellow eye served as a control. The study eye negative
pressure setting was programmed for 60% of the baseline IOP. Subjects wore the
Ocular Pressure Adjusting Pump for 8 consecutive hours and IOP measurements
occurred at 2-hour intervals for a total of 5 IOP measurements (08:00, 10:00,
12:00, 14:00, 16:00).

Nine subjects successfully enrolled and completed the study.
The mean programmed negative pressure setting was −12.0 mmHg. At baseline, the
mean IOP in the study eye was 21.4 ± 4.3 mmHg. The mean IOP reduction in the
study eye at hours 0, 2, 4, 6, and 8 was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3
(34%) and 6.7 (31%), respectively. All IOP measurements during negative
pressure application were reduced from baseline. There were no serious adverse
events.

The current IOP-lowering treatment options for glaucoma
include medications, laser procedures, implantable devices, and a variety of
filtering procedures. Even with the emergence and introduction of numerous
novel medical and surgical options, many patients do not achieve an adequate
reduction in IOP and demonstrate progression of disease despite having an apparent
“controlled” IOP value. Furthermore, it is difficult to lower IOP further on
patients who are already on medications or have IOPs in the low teens. This is
particularly true in patients with normal-tension and severe open angle
glaucoma, two subsets of glaucoma in which the current range of treatments such
as lasers, medications and MIGS procedures have diminished IOP-lowering effect.
Traditional, filtering surgical options offer favorable IOP-lowering results
but have an increased risk profile and high rate of failure. The Ocular
Pressure Adjusting Pump is a promising new treatment option that has shown
consistent IOP-lowering results across multiple studies and would represent the
first non-pharmacologic, non-procedural option for reduction of IOP.

The results of this study demonstrate that the IOP reduction
conferred by the Ocular Pressure Adjusting Pump is sustained while the device
is worn with active negative pressure with an IOP reduction exceeding 25%
across 8 hours of continuous wear. Further, the safety profile of this study is
consistent with prior work evaluating the device with an absence of IOP spikes
following wear of the device. As the first non-surgical, non-pharmacologic
option for IOP reduction, the OPAP holds promise as a potential new treatment
option for patients with glaucoma.

Source: Ferguson et al; Clinical Ophthalmology 2024:18

https://doi.org/10.2147/OPTH.S492530

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