medical society

Five-year long-term data of the HIV-1 drug Biktarvy (ingredient name bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) was added to the approval requirements.

Gilead Sciences Korea announced on the 27th that the Ministry of Food and Drug Safety on January 30th added clinical information on 5-year long-term data conducted on adults infected with HIV-1 after initial treatment.

The clinical trial information reflected in the approval was a randomized, double-blind, active trial that evaluated the efficacy and safety of Biktarvy in 634 HIV-1-infected people without previous Anti-Retroviral Therapy (ART) experience. These are the results of 5-year long-term follow-up of two controlled phase 3 clinical trials (Study 1489 and Study 1490).

Both clinical trials were evaluated in a double-blind manner from the first dose to 144 weeks, followed by additional open-label administration of Biktarvy for 96 weeks, an optional extension phase.

When analyzed with Missing=Excluded (M=E), the primary efficacy evaluation variable of the two clinical trials, the virus level suppression effect at week 48 (HIV-1 RNA less than 50 copies/mL), was more than 99% in the Biktarvy monotherapy group. appeared high.

Afterwards, despite the virus suppression effect at week 240, which is the secondary efficacy evaluation variable, it achieved and maintained a non-detection level of more than 98%, and in both clinical trials, no case of treatment failure due to resistance was observed among the Biktarvy monotherapy groups.

By week 240, the median change in CD4+ cell count was 313 cells/μL in Study 1489 and 331 cells/μL in Study 1490.1 The CD4+ cell count remained stable for 5 years.

In both clinical trials, the rate of treatment-related adverse events of grade 3-4 or higher during 240 weeks was low at 1 and 2 patients, respectively, and the rate of discontinuation of treatment due to treatment-related adverse events in the Biktarvy monotherapy group was less than 1%.

Lee Seung-woo, CEO of Gilead Sciences Korea, said, “As the importance of long-term management of HIV infection is gradually emerging, we are delighted to be able to deliver additional news on the approval of long-term data for 5 years of initial treatment.” We will continue to work hard to develop and supply innovative drugs that can be taken without worry.”

While the number of elderly patients with liver cancer is increasing, a study has found that the prognosis during treatment intervention is similar to that of non-elderly patients. In particular, in the case of advanced liver cancer accompanied by vascular invasion or liver metastasis, 40.2% of elderly patients who did not receive treatment reached 40.2%, indicating that awareness of the need for treatment should be improved.

On the 2nd, the Korean Liver Cancer Society held the 7th Liver Cancer Day ceremony at the Westin Chosun Hotel and presented a study on appropriate liver cancer treatment in the aging era.

In a recent large-scale study using data from the National Health Insurance Service, the incidence of liver cancer decreased in all age groups, while in those aged 80 and older, it continued to increase at an average annual rate of 9.0% from 70.0 per 100,000 people in 2008 to 160.2 per 100,000 people in 2018.

It has been reported that the predicted crude incidence rate will also gradually increase and will quadruple by 2028 compared to 2008 (521 per 100,000 person-years in 2008 → 2055 in 2028).

On this day, the society emphasized the seriousness of the problem and the justification for intervention in elderly patients through the liver cancer registration project committee’s random liver cancer registration project data analysis.

As a result of liver cancer registration project data analysis, among 15,186 patients newly diagnosed with liver cancer from 2008 to 2017, elderly patients aged 65 or older accounted for 38.4%.

In the elderly, hepatitis B-associated liver cancer accounts for a small percentage (29.7% vs. 68.1%), but hepatitis C (18.1% vs. 6.1%), alcoholic liver disease (16.8% vs. 7.9%), and other liver diseases compared to non-elderly people. (28.0% vs. 10.0%) associated liver cancer was higher.

In this regard, Lee Han-ah, a member of the planning committee (division of gastroenterology at Ewha Womans University Mokdong Hospital), said, “In the liver cancer registration project data analysis, it was found that elderly patients with liver cancer did not receive treatment after being diagnosed with liver cancer more than non-elderly patients (25.5% vs. 16.9%). “In particular, in the case of advanced liver cancer accompanied by vascular invasion or liver metastasis, 40.2% of elderly patients who did not receive treatment were concerned.”

“Even for early liver cancer, which can be cured with hepatectomy or radiofrequency ablation, elderly patients were more likely to receive local treatment, carotid artery chemoembolization, than non-elderly patients,” he said. However, with the recent increase in life expectancy of liver cancer patients, it is necessary to reconsider this treatment trend.”

Aggressive liver cancer treatment is known to help improve survival rates regardless of age, so the society judged that it was not appropriate to give up treatment just because of old age. In fact, in the liver cancer registration project data analysis, the survival rate of elderly patients who received treatment was significantly higher than that of patients who did not receive treatment, confirming the importance of active treatment.

Member Lee said, “In the liver cancer registration project data analysis conducted by the society, it was found that there was no difference in treatment results between elderly and non-aged liver cancer patients, as in other foreign studies.” There is no difference in the survival rate after surgery or radiofrequency ablation, which is an effective treatment, compared to that of non-elderly patients,” insisting on the need for active treatment.

“Especially, there was no difference between the elderly and non-elderly patients in the survival rate after carotid arterial chemoembolization, radiation therapy, or immuno-anticancer drug treatment, even in the stage past early liver cancer,” he said. can be received,” he explained.

“In several studies, there was no difference in the incidence of complications after hyperthermia therapy in elderly and non-elderly patients, so local treatment can be applied to elderly patients who do not have enough surgical resection,” he added. Since there is no difference in the incidence rate, it can be performed in elderly patients, but if the tumors are large or the number is large, radioembolization can be performed considering postoperative complications or safety.”

While many elderly patients diagnosed with advanced liver cancer in the past gave up treatment due to lack of safe and effective systemic therapy, recently, the role of extracorporeal radiation therapy has gradually expanded, and many elderly patients are actually receiving radiation therapy safely.

Commissioner Lee said, “As the era of immuno-anticancer drug treatment has recently opened, it has become possible to significantly reduce tumors and side effects while maintaining quality of life.” necessary,” he said.

The side effect issue of diabetic retinopathy (DR) of type 2 diabetes treatment glucagon-like peptide-1 receptor agonist (GLP-1 RA) has been reconfirmed.

At the time of the development of semaglutide, an increase in retinopathy patients was observed in clinical trials, but as a similar trend was found in a meta-analysis involving a total of 60,000 patients, monitoring for high-risk groups is expected.

The results of a study on the relationship between GLP-1 medication administration and retinopathy, conducted by Stuart G. Albert of the Department of Endocrinology at St. Louis Medical School, USA, were published in the January issue of Diabetes and Metabolic Syndrome: Clinical Studies and Reviews (doi.org/10.1016/j. dsx.2022.102696).

GLP-1 is a drug that reduces major cardiovascular side effects in patients with type 2 diabetes and cardiovascular disease (CVD), and has recently expanded its use to obesity treatment.

The problem is that an abnormal increase in diabetic retinopathy was observed during the course of the SUSTAIN clinical trial of the drug semaglutide.

As related information was reported at the American Diabetes Association in 2017, interpretations were divided among experts regarding the cause. The most convincing hypothesis is that a sharp drop in glycated hemoglobin (A1c) aggravated the symptoms.

The researchers undertook a meta-analysis to comprehensively analyze multiple studies to determine whether the worsening of diabetic retinopathy was affected by a reduction in drug type or A1c.

Regression analysis was performed on 7 studies (n = 56 004) and 11 studies (n = 11 894 participants) on semaglutide that looked at the main cardiovascular outcome trial (CVOT) of GLP-1 RA. did.

As a result of the analysis, overall, GLP-1 preparations did not significantly increase the relative rate (RR) of retinopathy (RR 1.09), but it was confirmed that the decrease in A1c and the duration of administration correlated with the increase in diabetic retinopathy. .

In a sub-analysis of 11 studies on semaglutide, differences were observed depending on the formulation.

Six studies (n = 5610) administered oral semaglutide and five studies (n = 6284) administered subcutaneous semaglutide, and overall the relative incidence of new and worsening retinopathy was increased ( RR 1.22).

In particular, for diabetic retinopathy, when subcutaneous semaglutide was administered for more than one year, the relative rate (RR) increased by 56%, and when A1c decreased by more than 1.0%, it increased by 59%. These two items are the main risks Confirmed that it is a factor.

“This meta-analysis shows that rapid improvement in A1c is correlated with an increase in retinopathy rates as well as improved cardiovascular events,” said the researchers. It can help,” he said.

“Unlike the increased risk of subcutaneous semaglutide, there was no such difference with oral administration,” he said. “Therefore, close cooperation with ophthalmologists to assess the risk of retinopathy according to the high-risk group and dosage form after starting GLP-1 medication. It has to be done,” he added.

Studies have shown that high-density lipoprotein (HDL-C), the cholesterol that is good for cardiovascular health, is negative for bone health.

For cardiovascular health, high HDL-C is good, but for bone health, it means you need to find the right trade-off.

The results of a study on the association between plasma HDL-C levels and fracture risk, conducted by researchers including Sultana Monira Hussein of the University of Melbourne Medical School in Australia, were published on the 18th in the international journal JAMA Network (doi:10.1001/jamacardio.2022.5124).

Previous studies have reported that high HDL-C levels reduce the number and function of osteoblasts that play a role in bone formation, thereby reducing bone density.

The research team approached ASPREE, a double-blind, randomized, placebo-controlled, large-scale clinical trial of aspirin, in a sub-analysis to confirm whether a similar trend was observed in actual clinical trials given that the study was only preclinical.

In this cohort study of 16,262 participants aged 70 years and older without cardiovascular disease, dementia, physical disability or life-threatening chronic disease, 1659 experienced at least one fracture during a median follow-up of 4 years.

711 minor traumatic fractures and 948 other traumatic fractures were included, mostly reported as falls from stairs, ladders or chairs.

As a result of adjusting variables, the risk of fracture increased by 14% for every 1-SD increase in HDL-C level (HR 1.14). there was no

In particular, the fracture rate was high in the highest quintile of HDL-C levels, with an average of 89 mg/dL. When analyzed by quintile, participants with the lowest versus highest HDL-C had a 33% higher risk of fracture (HR 1.33).

“This study suggests that higher HDL-C levels are associated with an increased risk of fracture,” the researchers concluded. “This association worked independently of common risk factors for fracture.”