According to new findings, patients with with eosinophilic esophagitis (EoE) exhibit persistence of significant accelerated molecular aging of the esophagus relative to patient chronologic age after an initial 8-week course of topical steroids, irrespective of histologic treatment response.

“Long term assessments are needed to evaluate the implications of accelerated aging on disease progression, complications, and comorbidities,” wrote study author Elizabeth T Jensen, MPH, PhD, Wake Forest University School of Medicine. 

2022 Digestive Disease Week Annual Meeting

Previous findings showed that individuals with EoE exhibit accelerated epigenetic molecular aging of the esophagus relative to patient chronologic age. The implications of advanced molecular aging in patients with EoE are unknown and post-treatment molecular aging has not previously been examined, investigators said.

Thus, the current study aimed to determine whether post-treatment esophageal cells from EoE patients exhibit molecular aging, as well as compare post-treatment molecular age to pre-treatment molecular age. Further, it aimed to determine whether post-treatment molecular age relative to chronologic age differs as a result of treatment response.

Investigators extracted from esophageal biopsies obtained at the diagnostic endoscopy and initial post-treatment endoscopy following 8 weeks of topical corticosteroid treatment. The histologic treatment response was defined as an absence of any esophageal eosinophilia (0 eos/hpf)

Additionally, the study authors noted that pre- and post-treatment DNA methylation was assayed on the Illumina Human Methylation450 and MethylationEPIC BeadChips, respectively. Arrays were processed using standard protocol and best practices for normalization and quality control, investigators said.

Furthermore, normalized β values for 353 CpG probes were submitted to an online DNA methylation age calculator in order to calculate a patient’s methylation age. A Mann Whitney U test evaluated the difference between molecular age and chronologic age post-treatment, molecular age post- and pre-treatment and responded versus non-responder.

From a total of 14 individuals with both pre- and post-treatment samples, there were 7 responders (57% female: 100% white, 100% atopic) and 7 non-responders (57% female; 100% white; 71% atopic).

In the responder cohort, peak eosinophils decreased from 155 ± 108 eos/hpf to 0 ± 0 eos/hpf post-treatment, but were unchanged in the non-responders (baseline: 137±152 eos/hpf; post-treatment 147 ± 82 eos/hpf).

The median patient chronological age at diagnosis was 36.5 years. The median molecular age was 48.9 years pre-treatment and 46.4 years post-treatment. Then, investigators noted that post-treatment, molecular age remained significantly greater than chronological age (

 <.001), with a median difference of 18.6 years.

No difference in median molecular age was found when comparing pre- and post-treatment (

 <.44), according to investigators. Moreover, no significant difference in accelerated aging was seen by treatment responder status.

The study, “Accelerated Molecular Aging Persists Despite Successful Treatment and Histologic Resolution in Eosinophilic Esophagitis,” was presented at 

Articles

Post-treatment, data show molecular age remained significantly greater than chronological age at a median difference of 18.6 years. 


Long-Term Assessments Needed to Evaluate Impact of Accelerated Aging on EoE Progression

Cariprazine (VRAYLAR) provided statistically significant benefit versus placebo in Montgomery-Åsberg Depression Rating Scale (MADRS) total score change as an adjunctive therapy for adults with 

merican Psychiatric Association (APA) 2022 Annual Meeting

 in New Orleans this week, a team of Abbie-supported investigators reported a 1.5 mg dose of the atypical antipsychotic therapy was effective in improving MADRS and anxiety per Hamilton Anxiety Rating Scale over 6 weeks among older patients without prior response to standard-care antidepressant therapy.

Cariprazine was also observed to be well-tolerated and safe as an adjunctive therapy to antidepressant medication in the patient population, further suggesting its potential utility as an MDD agent.

 during APA 2022, study author Gary Sachs, MD, associate professor of psychiatry at Massachusetts General Hospital, discussed the impact of the phase 3 findings as they relate to complementing standard MDD care.

“Cariprazine is an interesting compound, because it now has been studied in schizophrenia, manic and mixed states of bipolar depression, and now finally, MDD,” Sachs said. “What’s happened as we as a field have learned how to use (standard antidepressants), we’ve gotten comfortable moving patients from one to another—even though, for instance, the STAR*D results show us that the law of diminishing returns happen almost immediately.”

Sachs discussed the observed MDD patient population in the phase 3 trial, whose mean age of 44.8 years old underscores the reality that they’ve likely been burdened with treatment-unresponsive depression for decades.

“To have some drugs now with proven efficacy added on to the standard drugs to take away that forced choice…now we have another kind of option, and I can say to a patient, ‘This has been proven to have efficacy for the diagnosis you have’,” he said.

In this role as an efficacious adjunctive therapy, cariprazine would also be a “fault-tolerant” option, Sachs said. A patient reliant on standard short-acting antidepressant regimens has more pressure to adhere to daily care.

Though 1.5 mg cariprazine fared better in efficacy outcomes than 3 mg doses, Sachs said more interpretation into dosing and long-term use is still under work. He also expressed interest in seeing the benefit of cariprazine in treating patients with anxious distress.

“In turns out the biggest predictor of who’s not going to respond (to antidepressants) are those subject to, in addition to low mood, symptoms of anxiety,” Sachs said. “That is clearly a more worrisome, less responsive group. And in this study…you see a benefit on the Hamilton Anxiety Rating Scale, which is intriguing, but we don’t really have all the breakout of data to know whether this is a beneficial drug for those who meet anxious distress.”

The study, “Cariprazine for the Adjunctive Treatment of Major Depressive Disorder: Results of a Randomized Phase 3 Placebo-Controlled Study (Study 301),” was presented at APA 2022.

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New phase 3 data presented at APA 2022 support the agent as an adjunctive in older patients without benefit from monotherapy antidepressant medication.

Adjunctive Cariprazine with Antidepressants Benefits Adult Major Depressive Disorder

New research shows a lot of similarities in efficacy and safety for ozanimod and ustekinumab in treating patients with 

A team, led by Marla C. Dubinsky, Icahn School of Medicine at Mount Sinai, used a matching-adjusted indirect comparison to compare the efficacy and safery of ozanimod and ustekinumab in patients with moderately to severely active ulcerative colitis.

Ozanimod is the first oral spingosine 1-phospate receptor modulator that has garnered approval for adults with moderately to severely active ulcerative colitis. Ustekinumab is a human interleukin (IL)-12 and IL-23 antagonist that is also approved for patients with ulcerative colitis.

However, there has been no head-to-head randomized controlled trials comparing the 2 treatments.

Digestive Disease Week (DDW) 2022 Annual Meeting

 in San Diego, the investigators weighted individual patient-level data from the True North trial of ozanimod to match patient populations based on aggregate data from the UNIFI study of ustekinumab.

They also matched baseline characteristics, including age, sex, total Mayo score, disease extent, and prior biologic use.

The team assessed clinical remission, clinical response, endoscopic improvement, and mucosal healing using the placebo arm as an anchor in both the induction and maintenance phases based on feasibility analysis and compared durable clinical remission during the maintenance periods.

Next, they compared efficacy outcomes in the overall population, as well as in the subgroups of biologic-naïve and biologic-experienced patients.

Finally, the investigators compared safety outcomes in the overally population, including serious treatment-emergent adverse events (TEAEs), infectious adverse events, and serious infectious adverse events.

Prior to matching, patients from the ozanimod trial had a higher likelihood of left-sided colitis (62.5% vs 52.5%; 

<0.01) and a lower proportion with prior biologic use (32.9% vs 54.3%; 

<0.001) compared to the ustekinumab trial.

However, following matching, the adjusted baseline characteristics were balanced.

In the induction phase, there was a comparable efficacy between the 2 groups in the overall population and the biologic-naïve subgroup.

For biologic-experienced patients, treatment with ozanimod had comparable clinical remissiom, clinical response, and mucosal healing compared with ustekinumab.

During the maintenance period, the efficacy was comparable between the 2 treatments in the overall population, as well as both subgroups.

The safety profile was also comparable between the 2 drugs, but ozanimod had significantly lower rates of infectious adverse events (risk difference vs UST, −24.9%; 

“The MAIC results showed a comparable benefit-risk profile for OZA vs UST overall and in the biologic-naïve and biologic-experienced subgroups,” the authors wrote. “Safety was comparable, with more favorable infection AE rates with OZA.”

Su1500: COMPARATIVE EFFICACY AND SAFETY OF OZANIMOD AND USTEKINUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

The data presented at DDW show similar safety and efficacy for the 2 treatments.

Ustekinumab, Ozanimod Have Comparable Profiles for Ulcerative Colitis

American Psychiatric Association (APA) 2022 Annual Meeting

 in New Orleans this weekend convened to review the Diagnostic and Statistic Manual of Mental Disorders, which is currently in its fifth edition with a text revision from this past year (DSM-5-TR).

The review of the standard for mental conditions came at what one committee member called a “very interesting inflection point” for the future of 

—a time when ideas around contextual factors of health are being considered more directly in diagnoses and care.

 during APA 2022, roundtable member Jonathan Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences at Montefiore Health Systems and Albert Einstein School of Medicine, discussed the growing embrace of both social determinants of mental health in reviewing the DSM—as well as “broad dimensions of behavior” including attention or motivation that are present in most psychiatric conditions.

“The idea is, how do you integrate those 2 worlds: the world that looks at things in terms of specific diagnoses…and the world that looks at broad dimensions which might have their own neurobiologic underpinnings and social factors that contribute to them,” Alpert said.

Alpert additionally discussed the roundtable’s discussion around addressing measurements of psychiatric function—moving from a previously-shelved clinician-based score that introduced bias to clinical scales of function, to model similar to the World Health Organization Disability Assessment Scale (WHODAS) 2.0.

“The very nice thing about the WHODAS scale is that it’s been studied across more than 30 countries, it’s translated into multiple languages, it’s a self-assessment form that patients can fill out on their own,” Alpert said. “Their clinicians can fill it out, their guardians can fill it out…and it asks about different domains of function.”

Alpert praised the scale’s flexibility—asking patient perspective on various factors and lifestyle behaviors that constitute function—and use of “concrete questions.”

“In many ways, it breaks down the traditional barriers between mental functioning and the rest of function, because they’re really all interconnected, when you think about it,” Alpert said.

On the matter of seeking new definitions for future DSM editions, Alpert said there’s many areas that psychiatrists are still “trying to get a better grasp on.” He cited the text revision’s addition of prolonged grief disorder to differentiate major depression from bereavement-borne mental issues—as well as still-lacking refinements in eating disorders—as evidence of missing work in psychiatric diagnoses.

“An attempt continues to be made—and this will continue for years—to try to notice what are the clinical scenarios and conditions that people are recognized to have that somehow haven’t had a home in DSM,” Alpert said.

Montefiore psychiatry chair Jonathan Alpert, MD, PhD, discusses suggested updates to the DSM-5—with consideration to social determinants and patient-reported functioning.

How Mental Illness Definitions Are Still Being Uncovered and Refined

RBX2660, a live microbiota therapeutic, resulted in a lower incidence rate of recurrent 

 infections (CDI) in data presented during Digestive Disease Week (DDW) 2022 Annual Meeting in San Diego.

A team, led by Sahil Khanna, MD, MBBS, Mayo Clinic, reported on the time to recurrence for patients who experienced CDI recurrence.

Managing the growing threat of CDI is often complicated by recurrence, usually within 8 weeks of a previous C difficile episode.

However, several companies are preparing a new class of drugs called live microbiota therapeutics. This includes RBX2660, an investigational microbiota-based biotherapeutic that has shown promise in clinical trials in reducing the recurrence of CDI using a binary outcome measurement.

The investigators examined data from the PUNCH CD3, a prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 trial and PUNCH CD2, a phase 2b study.

Each patient in the study was at least 18 years with documented recurrent CDI. They also completed standard-of-care antibiotic therapy prior to treatment with RBX2660 or placebo.

The investigators defined CDI recurrence as the presence of CDI diarrhea and a positive C difficile toxin test.

They also defined time to CDI recurrence as the number of days from study treatment to the first assessment indicating a CDI event, which was presented based on the Kaplan-Meier method.

Overall, there were 262 patients from the PUNCH CD3 study, 69.1% (n = 181) were women. Each patient was randomized to receive either placebo (n = 85) or RBX2660 (n = 177).

At the 8 week mark, 37.6% (n = 32) of the placebo group and 28.8% (n = 51) of the RBX2660 had a CDI recurrence.

The time to recurrence corresponding to the 25th percentile of the KM estimate was 14 days for the placebo group and 30 days for patients treated with RBX2660.

This is consistent with the results of the PUNCH CD2 trial, where investigators found CDI recurrence occurred during the first 2 weeks regardless of treatment.

“Recurrence tended to occur earlier in participants treated with placebo compared to those treated with RBX2660 during the first month of treatment,” the authors wrote. “Participants who received RBX2660 had a lower incidence of CDI recurrence at 8 weeks compared to those who received placebo.”

TIME TO RECURRENCE IN PATIENTS WITH CLOSTRIDIOIDES DIFFICILE INFECTION TREATED WITH PLACEBO OR RBX2660

Recurrence commonly occurred during the first 2 weeks regardless of treatment.

RBX2660 Reduces Risk of CDI Recurrence at Week 8

As disaster-level events become more prevalent globally, a greater proportion of people are being exposed to potential trauma. From this trend has come a growing prevalence of 

—an informal focus of mental health care for decades that is becoming more vital.

 in New Orleans, Linda Chokroverty, MD, assistant clinical professor of psychiatry and behavioral sciences and pediatrics at Montefiore Health Systems and the Albert Einstein College Of Medicine, discussed the state of disaster psychiatry—a field which emerged about 40 years ago.

“It’s really a subset of psychiatry—but not necessarily so, because it involves regular psychiatrists most of the time,” Chokrovery said. “There’s some people who really become experts in the field and spend more time studying it. They would be more the specialists in the realm, but by and large, disasters are very common and increasing because of the climate situation.”

As Chokroverty explained, psychiatrists are often “inadvertently” providing aide in the event of disasters, which are capable of affecting anyone’s mental health regardless of their location or severity. Though Chokroverty and colleague’s session at APA 2022 focused on disaster psychiatry for children, the role of a family system in addressing pediatric mental health essentially makes the topic applicable to all parties.

Key symptoms of disaster-based psychiatric harm include anxiety, uncertainties about the future, fear, poor sleep health and a general sense of unease, Chokroverty said. “And that’s pretty normal, and part of our job as psychiatrists is to help people understand that…provided we do our best to resume routines and structure,” she said.

On the subject of improving affected children’s sleep, Chokroverty said it’s critical to consider a multitude of factors—from the sleep habits modeled by parents and guardians, to the resources any physician can provide that promote sleep health.

“Sleep is difficult to improve when you’ve had a lot of disruption, especially if you’ve had highly traumatic experiences,” she said. “It’s important still to try and maintain structure in the form of good sleep-promoting habits.”

Linda Chokroverty, MD, discusses the role psychiatrists play in managing the mental health effects of disasters, and how children specifically may be impacted.

The Need for Disaster Psychiatry Care

Acid suppression could reduce the mortality risk for patients with 

 (GERD) following lung transplantation in data presented during

A team, led by Wai-Kit Lo, Brigham and Women’s Hospital, examined clinical outcomes in lung transplantation with acid suppression therapy with proton pump inhibitor or histamine-2 receptor antagonist use with a particular focus on early mortality within 1 year.

GERD is often linked to allograft rejection and failure following lung transplantation. This ultimately increases the risk of mortality.

Antireflux surgery is known to modulate GERD-associated risk of poor transplant outcomes, but the role of medical reflux treatment with acid suppression in lung transplant patients is poorly defined and inconsistently applied across different centers.

In the retrospective cohort study, the investigators examined lung transplant recipients at a tertiary care center between 2007-2022. The team excluded patients with pre-transplant antireflux surgery.

The investigators sought outcomes of all-cause mortality and pulmonary mortality within 1 year of transplantation. They also obtained objective reflux data from per0transplant ambulatory reflux monitoring and applied time-to-event analysis using Cox proportional hazards models.

Participants not meeting the outcome were censored at death, last clinic visit, or Nissen fundoplication.

The investigators also assessed differences between treatment cohorts using Fisher’s exact test and student’s t-test.

They identified a total of 467 patients with similar demographics, comorbidities, and pre-transplant cardiopulmonary function.

Overall, 6% (n = 28) of the patients died within 1 year of transplantation, 4.7% (n = 22) because of pulmonary disease, with pneumonia being the most likely cause.

However, both post-transplant PPI and histamine-2 receptor antagonist use were independently associated with reduced risk of 1-year mortality because of pulmonary disease after controlling for confounders, including objective acid and nonacid reflux.

Post-transplant PPI use was associated with reduced all-cause mortality within the first year, but treatment with histamine-2 receptor antagonist was not.

“Acid suppression therapy with PPI or H2RA after lung transplantation was independently associated with decreased 1-year mortality,” the authors wrote. “These findings suggest that pharmacologic treatment of GER may have a role in the management of early mortality following lung transplantation.”

A key finding was the protective effects were independent of evidence of the disease, which shows the potential mechanisms beyond acid suppression alone, such as possible direct anti-inflammatory effect by PPI as suggested in prior in vitro studies.

“Further investigations are needed on more standard applications of acid suppression therapy in this patient population to improve outcomes,” the authors wrote.

Sa1189: ACID SUPPRESSION THERAPY IS INDEPENDENTLY ASSOCIATED WITH REDUCED RISK OF 1-YEAR MORTALITY FOLLOWING LUNG TRANSPLANTATION

Both post-transplant PPI and histamine-2 receptor antagonist use were independently associated with reduced risk of 1-year mortality.

Acid Suppression Results in a Decrease in Mortality for GERD Patients Following Lung Transplantation

Like many public health crises, climate change does not affect all Americans equally. In fact, as 2 collaborating psychiatrists discussed with 

, the most historically oppressed populations are facing a greater—and more diverse—brunt of the 

 in New Orleans this weekend, a pair of New Mexico psychiatrists discussed the relationship between social determinants of mental health and climate change—particularly among Black, Indigenous and people of color (BIPOC).

Edward J. Neidhardt, MD, a psychiatrist with Christus St. Vincent Regional Medical Center, discussed the burden of “eco-anxiety” in younger US generations; as he noted, long-term decisions like whether to start a family, or even their perspective on the future itself, can be severely impacted by the psychological effect of environmental crisis.

“Many of them have eco-anxiety, and that amount of anxiety has been increasing over the last few years—a lot of it because of climate change and our political situation as well,” Neidhardt said. “As you get anxious, you tend to see things in a more negative way.”

Neidhardt emphasized the need to “empower” affected patients to contribute to solutions against their greatest worries; a solution to eco-anxiety can be as simple as being more active in environmental protection or rehabilitation.

But the issue may be greater in BIPOC communities, where outside contributing factors to mental health—such as poverty rates or lacking resources to care—are coupled with generally worse exposure to climate change.

Mary Hasbah Roessel, MD, a psychiatrist with Santa Fe Indian Hospital, is Navajo. She discussed how she has observed the impact of “historical trauma” on mental health outcomes among BIPOC in both her personal experiences and as a practicing psychiatrist.

“When you have indigenous people who have been displaced, forcibly removed from their homes to go to boarding or residential schools…you have the impact of having to deal with regaining your culture, your values, your family systems again,” she explained.

And, many of the reservations or regions where these populations have been settled into are more adversely impacted by climate change. “It’s a really devastating combination of circumstances,” Roessel said.

Roessel also discussed the unique impact of climate change on the mental wellbeing of indigenous people who historically practiced “living within the land” in their culture.

“Adverse weather events, climate change, all of these issues become more pertinent and devastating for us, in terms of poverty and food insecurity especially,” she said.

Neidhardt discussed the need for broadened perspective on the contributing factors to mental health.

“In dealing with this, we really need to take a broad look at how we cope, and how we teach our patients, both dealing with acute symptoms of anxiety but also if they have PTSD, taking more active treatments…and looking at the other factors such as housing, employment, and all the things that impact people as well,” he said.

A pair of psychiatrists discuss how climate change and other social determinants of health are affecting the mental wellbeing of indigenous people.

Eco-Anxiety and Contributing Mental Health Factors Among BIPOC

New findings suggest a higher adherence to the Dietary Approach to Stop Hypertension (DASH) diet had strong protection against 

incident non-alcoholic fatty liver disease (NAFLD)

 risk. On the other hand, higher scores in the Mediterranean diet study cohort had a weak, but inverse association with this same outcome.

“In the entire cohort, 18.6% developed NAFLD, and on average, liver fat increased for all participants,” wrote study author Ioanna Yiannakou, MS, Department of Medicine, Preventive Medicine and Epidemiology, Boston University School of Medicine. 

2022 Digestive Disease Week Meeting in San Diego, California

Although diet is essential for treatment of NAFLD, particularly in the early stages of the disease course, the optimal diet remains to be known, according to investigators. The current study investigated whether adherence to a specific diet was associated with changes in liver fat or incident NAFLD in the Framingham Heart Study.

Yiannakou and colleagues additionally investigated whether these associations were modifiedby cardiometabolic dysfunction. They included individuals who had undergone an abdominal computed tomography scan and were found free of NAFLD, for the incident NAFLD analyses.

However, they excluded those with heavy alcohol intake, which they defined as >7 drinks a week for women or >14 drinks a week for men. Investigators then calculated the liver fat attenuation on a CT scan to determine liver fat and derived dietary data from food frequency questionnaires for both DASH and Mediterranean Diet adherence scores.

Further, they used modified poisson regression models to compute incidence NAFLD risk ratios (RR) and 95% confidence intervals (CI) associated with score categories after adjustment for age, sex, educational status, alchol intake, current cigarette smoking, physical activity, and multivitamin use. Linear regression models computed the adjusted means of liver fat change over 6 years of median follow-up, according to the study authors.

The data show participants with higher DASH or Mediterranean Diet scores were mostly women with a mean age of 51 ± 9 years and were less likely to be current smokers, with lower BMI and abdominal adiposity at baseline.

A higher adherence to the DASH diet compared to a lower one was associated with 37% reduced risk of incident NAFLD (95% CI, 0.43 - 0.92) and a statistically significantly less increase in liver fat over study follow-up, investigators found.

They additionally observed anthropometric and medical-related factors modified the protective effects of the DASH score. They exemplified this findings by showing participants with a higher DASH score who had lower abdominal adiposity had a lower NAFLD risk (RR: 0.15; 95% CI, 0.07 - 0.32) than those with either the risk factor alone (RR for higher DASH scores: 0.82, 95% CI: 0.56 - 1.19; RR for lower adiposity: 0.30, 95% CI, 0.21 - 0.43).

Meanwhile, a higher DASH score combined with no prevalent hypertension or diabetes had the lowest NAFLD risk. Additionally, the association with higher Mediterranean diet adherence score was weaker except in those with a lower ratio of fasting triglyceride to high-density lipoprotein (RR: 0.51, 95% CI, 0.37 - 0.71).

The study, “Higher Diet Quality is Associated with Lower Non-Alcoholic Fatty Liver Disease in the Framingham Heart Study,” was presented at 

DASH diet was inversely associated with NAFLD risk, independent of BMI changes. 

Higher Adherence to DASH Diet Linked to Stronger Protection Against NAFLD Risk 

Digestive Disease Week (DDW) 2022 Meeting

 in San Diego, investigators find that ribavirin is not a suitable option for patients with genotype 3 hepatitis C virus (HCV) and compensated cirrhosis.

A team, led by Wen Xin Flora Xu, National University of Singapore, evaluated the efficacy and safety of sofosbuvir/velpatasvir with or without ribavirin in genotype 3 compensated patients with cirrhosis.

The current guidelines for genotype 3 HCV care for patients with compensated cirrhosisthat were treated with 12 weeks of Sofosbuvir/Velpatasvir call for the use of ribavirin for unless baseline resistant-associated substitution mutations were excluded.

However, this testing is not yet widely available and the clinical differentiation between compensated cirrhosis from advanced fibrosis is challenging in the primary care setting.

“A safe and simplified regimen is crucial for global hepatitis C Virus (HCV) elimination,” the authors wrote.

The investigators suggest balancing the risk of treatment-related adverse events and the need for closer monitoring in adding ribavirin to a sofosbuvir/velpatasvir regimen.

In the systematic review and analysis, the investigators identified studies from inception to June 2021 involving HCV genotype 3 compensated patients with cirrhosis treated with sofosbuvir/velpatasvir with and without ribavirin.

The team sought secondary outcomes of treatment-related adverse events, defined by symptomatic anemia requiring transfusion or a drop in hemoglobin beyond 2 g/dL.

Overall, the final analysis included 7 studies involving 1088 patients.

Sustained virologic response at 12 weeks was similar in both intention-to-treat (RR, 1.03; 95%CI, 0.99-1.07; I

= 0%) and per-protocol analysis (RR, 1.03; 95%CI, 0.99-1.07; I

= 48%) of patients treated with sofosbuvir/velpatasvir.

The overall pooled rate of treatment-related adverse events was 7.2%.

In addition, ribavirin use increased the overall pooled risk of treatment-related adverse events (RR, 4.20; 95%CI, 1.29-13.68; I

= 0%). In the subgroup analysis, the investigators found ribavirin wax related to an increased sustained virologic response at weeks in patients with baseline resistant-associated substation mutation, but it did not significantly increase the sustained virologic response at 12 weeks among treatment-experienced patients.

“In GT3 compensated cirrhosis patients treated with 12 weeks of SOF/VEL, RBV was associated with higher adverse events without significant improvement in SVR12,” the authors wrote. “Our findings suggest routine RBV is not mandatory for GT3 compensated cirrhosis patients treated with SOF/VEL.”

EP1198: EFFICACY AND SAFETY OF ADDING RIBAVIRIN FOR GENOTYPE 3 HCV COMPENSATED CIRRHOSIS RECEIVING 12-WEEKS OF SOFOSBUVIR/VELPATASVIR: A META-ANALYSIS

The treatment did not improve sustained virologic response but did increase the rate of treatment-related adverse events.

Ribavirin Not Effective, Safe for Genotype 3 HCV

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