Catherine Kolonko

A group of diabetic patients who received non-invasive shockwave therapy for a condition commonly known as frozen shoulder had improved range of motion and diminished pain, according to results of a small pilot study in Italy. 

The study evaluated the effect of extracorporeal shock therapy as treatment for adhesive capsulitis on 50 patients with either type 1 or type 2 diabetes, according to an article in Diabetes Care, a journal of the American Diabetes Association. The therapy is delivered by sound waves as non-invasive shocks applied to the shoulder area.

Extracorporeal shock therapy has previously been used on patients who are not diabetic to treat adhesive capsulitis of the shoulder (ACS), a condition marked by intense shoulder pain with progressive limitation of joint mobility, states the article. Researchers of this study believe that it is the first to assess the therapy on functional outcomes in patients with diabetes and ACS.

Other treatment options for the condition include oral or intra -articular steroid injections, which may not be ideal for patients with diabetes because continued use of steroids can lead to heightened glucose levels, “thus affecting glycemic control in patients with diabetes,” notes lead author Flavia Santoboni.

“Therefore, it would be preferable to avoid steroids and opt for alternative therapies in these individuals,” Santoboni states in the article.

Adhesive capsulitis can negatively impact quality of life and it also can lead to increased health costs for patients who experience it, the authors note. It is the most prevalent musculoskeletal disorder of the upper extremity among people who have diabetes, according to the article.

The study conducted at the Sant’ Andrea Hospital in Rome was an uncontrolled, observational intervention trial that enrolled men and women with diabetes (seven patients with type 1 and 43 with type 2). All participants had ACS and at the time of the study had experienced shoulder pain, had restricted range of motion for at least 3 months and had received no treatment besides analgesics for that period, states the article.

At least two weeks before the study started, all patients had shoulder radiographs, soft-tissue sonography and or MRIs completed. Functional outcome evaluations and questionnaires were conducted at baseline and following treatment at designated timepoints up to six months.

Patients in the study were given shockwave treatment once weekly for three weeks. The treatment involved 2,400 shots in an anterior-to posterior direction on the anterior shoulder joint using a low to moderate energy flux density, depending on a patient’s pain tolerance.

Results of functional outcomes indicated that in all cases, range of motion in arm, shoulder and hand improved and pain scores decreased, according to the article. The improvements continued for months after the treatment, indicating that as a long-term solution, shockwave therapy may be a viable treatment option for patients needing to avoid steroids, the article stated. 

The authors concluded that extracorporeal shockwave therapy “may be effective, feasible, and well tolerated and can therefore represent a valid alternative to steroids for ACS treatment in patients with diabetes,” but they noted that “these findings need to be confirmed by a randomized controlled trial.”

Extracorporeal Shockwave Therapy Improves Functional Outcomes of Adhesive Capsulitis of the Shoulder in Patients With Diabetes

Articles

Diabetic patients who received non-invasive shockwave therapy for frozen shoulder had improved range of motion and diminished pain.

Shockwave Therapy Improves Frozen Shoulder in Diabetes Patients

A new analysis suggests there’s a need for frequent testing after the hepatitis C virus (HCV) has been cleared. Data from 3 European countries and the United Kingdom indicate a rise in reinfection of acute HCV among men with HIV who have sex with men (MSM).

Moderate cure rates of acute HCV have been reported in the last decade among MSM and also are infected with HIV. However, many who either clear the infection spontaneously or through treatment are later re-infected, researchers noted.

“With a high treatment uptake in this population even in the interferon era and with higher response rates to treatment in the acute phase of infection, reinfections are most likely occurring due to maintained risk behaviors,” the study authors wrote in the 

Chronic infection of HCV can lead to cirrhosis and other serious liver damage, including liver cancer. The authors pointed out that for patients with HIV, liver disease is a major cause of morbidity and mortality.

The research team examined more than a decade of data on patients with a documented cure of acute HCV between 2002 and 2014. It included data from 8 centers in Austria, France, Germany, and the UK, which are part of the NEAT consortium (European AIDS Treatment Network).

Information gathered for the analysis included age, genotype, diagnosis date, as well as the date of cure and whether it was from treatment or spontaneous clearance of the HCV and the date of last follow-up visit.

Among the 606 patients, 494 men (81.5%) had achieved sustained virologic response—indicating a cure&mdash;after being treated for the virus with pegylated interferon and ribavirin. One hundred and eleven men (18.3%) cleared the virus spontaneously.

Documentation and details were lacking for the remaining patient. Results showed that 149 of 606 men (24.6%) later presented with subsequent HCV infection. In some cases, patients became reinfected for a second, third, or fourth time.

“Thirty out of 70 (43%) who cleared again or were successfully treated, presented with a second reinfection, 5 with a third, and 1 with a fourth reinfection,” wrote lead author, Patrick Ingiliz, MD, of the Center for Infectiology in Berlin, Germany, and colleagues. “The reinfection incidence was 7.3/100 person-years (95% CI 6.2—8.6).”

The authors found the incidence of reinfection “alarming” and noted that the study findings underline a need for intervention during follow-up care after a patient is cured of HCV. They recommended prevention strategies such as testing for reinfection of HCV every 3 to 6 months among this high-risk group.

“Prevention strategies — both treatment and behavioral – are needed to target high risk groups to reduce morbidity and treatment costs,” the team concluded. “Patients as well as clinicians have to be aware of the specific risk behavior in this setting and counseling should be accompanied by behavioral interventions to avoid reinfections.”

The study, “HCV reinfection incidence and spontaneous clearance rates in HIV-positive men who have sex with men in Western Europe” appears in the February issue of the 

For patients with HIV, liver disease is a major cause of morbidity and mortality. 

Rates of Hepatitis C Coinfection in Patients With HIV

Top-line results for an investigational drug regimen proved a 99% success rate for the hepatitis C virus (HCV).

Glecaprevir/pibrentasvir is indicated as an 8-week treatment for HCV among patients without cirrhosis. It’s a once daily co-formulation dosed in 3 tablets, which the pharmaceutical company, AbbVie, has tested in several clinical trials. Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor.

AbbVie is seeking review of the regimen in a New Drug Application (NDA) it filed in December with the FDA. If granted approval, the drug would offer an 8-week ribavirin-free treatment option for patients with HCV across the 6 major genotypes of the virus.

Results on the trial, dubbed the Certain-1 study, involved Japanese patients who were chronically infected with genotype 1 HCV and did not have cirrhosis. It is estimated that more than a million people are infected with HCV in Japan, which has one of the highest infection rates of the virus in the industrialized world.

The phase 3 clinical trial showed that 105 of 106 patients (99%) had sustained virologic response (SVR) 12 weeks after treatment with glecaprevir/pibrentasvir ended; 1 patient was lost to follow up, according to a company news release. Treatment is considered successful when a patient achieves SVR, an indication that the virus is no longer detectable in the blood.

"Due to patient characteristics and virological considerations, people living with hepatitis C in Japan have specific treatment challenges and needs," Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, stated in the release.

Among those treated with glecaprevir/pibrentasvir who achieved SVR after 8 weeks of treatment, 23 patients had the Y93H variant of the virus, which is associated with reduced cure rates. Japan treatment guidelines recommend that before receiving treatment, some patients involved in a clinical trial get tested for Y93H, an altered amino acid that makes some patients with HCV resistant to first generation NS5A inhibitor-based therapies, a company spokesperson explained.

“The study demonstrated the potential of G/P in patients with specific treatment challenges, including those with the Y93H resistance-associated variant,” AbbVie senior manager of public affairs, Markeisha Marshall, told 

The safety and efficacy of 8 weeks of glecaprevir/pibrentasvir regimen with 12 weeks of ombitasvir/paritaprevir/ritonavir, an approved AbbVie HCV drug, which is marketed in Japan under the brand name Viekirax. The company said it met the study’s primary endpoint, which was to show that the investigational drug was not inferior to that of the 12-week comparator regimen.

Among patients with genotype 1 of the virus who did not have cirrhosis and were treated with glecaprevir/pibrentasvir, no one discontinued treatment as a result of adverse events (AEs). The most common AEs were inflammation of the throat and nasal passages and itchiness.

Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor for hepatitis C patients without cirrhosis. 

Phase 3 Trial Shows High Cure Rates for Hepatitis C Drug

Top-line results for an investigational drug regimen proved a 99% success rate for hepatitis C.

Glecaprevir/pibrentasvir is indicated as an eight-week treatment for hepatitis C among patients without cirrhosis. It’s a once daily co-formulation dosed in three tablets, which the pharmaceutical company, AbbVie, has tested in several clinical trials. Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor.

AbbVie is seeking review of the regimen in a New Drug Application (NDA) it filed in December with the FDA. If granted approval, the drug would offer an eight-week ribavirin-free treatment option for patients with hepatitis C across the six major genotypes of the virus.

Results on the trial, dubbed the Certain-1 study, involved Japanese patients who were chronically infected with genotype 1 hepatitis C and did not have cirrhosis. It is estimated that more than a million people are infected with hepatitis C in Japan, which has one of the highest infection rates of the virus in the industrialized world.

The phase 3 clinical trial showed that 105 out of 106 patients (99%) had sustained virologic response (SVR) 12 weeks after treatment with glecaprevir/pibrentasvir ended; one patient was lost to follow up, according to a company news release. Treatment is considered successful when a patient achieves SVR, an indication that the virus is no longer detectable in the blood.

Among those treated with glecaprevir/pibrentasvir who achieved SVR after eight weeks of treatment, 23 patients had the Y93H variant of the virus, which is associated with reduced cure rates. Japan treatment guidelines recommend that before receiving treatment, some patients involved in a clinical trial get tested for Y93H, an altered amino acid that makes some patients with hepatitis C resistant to first generation NS5A inhibitor-based therapies, a company spokesperson explained.

“The study demonstrated the potential of G/P in patients with specific treatment challenges, including those with the Y93H resistance-associated variant,” AbbVie senior manager of public affairs, Markeisha Marshall, told MD Magazine.

The safety and efficacy of eight weeks of glecaprevir/pibrentasvir regimen with 12 weeks of ombitasvir/paritaprevir/ritonavir, an approved AbbVie hepatitis C drug, which is marketed in Japan under the brand name Viekirax. The company said it met the study’s primary endpoint, which was to show that the investigational drug was not inferior to that of the 12-week comparator regimen.

Among patients with genotype 1 of the virus who did not have cirrhosis and were treated with glecaprevir/pibrentasvir, no one discontinued treatment as a result of adverse events. The most common side effects were inflammation of the throat and nasal passages and itchiness.

Glecaprevir/pibrentasvir is indicated as an eight-week treatment for hepatitis C among patients without cirrhosis.

Novel Hepatitis C Drug Shows High Cure Rates

The European Commission has approved a drug called Zepatier to treat 

 with or without the use of ribavirin in patients with genotype 1 or 4 of the virus, according to a Merck & Co announcement.

Zepatier is already approved in the US and Canada for treatment of hepatitis C, a bloodborne virus that if left unchecked can cause serious liver damage over time. Millions of people worldwide are believed to be infected with the virus including an estimated 15 million people who live in Europe, notes a news release from Merck & Co (MSD), the maker of Zepatier.

“The approval of Zepatier in the European Union, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus genotype 1 or 4,” Roger Perlmutter MD, president of Merck Research Laboratories, a US division of Merck & Co (MSD) said in the release. “Zepatier is the most recent advance from MSD in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world.”

The European Commission’s granting of a marketing authorization for Zepatier allows Merck to sell the drug in 28 countries that are European Union members and also in Iceland, Liechtenstein and Norway, members of the European Economic Area, according to the release. The company expects to launch the drug beginning in late 2016 or early 2017.

Zepatier was approved as a once daily, fixed dose combination tablet recommended for most patients as a 12- week course to treat chronic hepatitis C in patients with genotypes 1 and 4. It is a combination of the drugs elbasvir and grazoprevir, which targets the proteins NS3/4A and NS5A.

Clinical trials leading to Zepatier’s approval included thousands of patients worldwide with chronic hepatitis C infection, according to the company release. The trial was designed to encompass treatment challenges of patients with compensated cirrhosis and those who had unsuccessful treatment that involved the use of peginterferon and ribavirin.

The overall sustained virologic response after 12 weeks of Zepatier, a marker for a cure, was achieved in 96% of patients with genotype 1b strain of the virus. In patients infected with genotype 4 of the virus, 94% were cured after 12 weeks of Zepatier treatment, according to the release.

Headache and fatigue were common side effects for patients who were treated for Zepatier for 12 weeks, states the release. Other common adverse reactions included decreased appetite, insomnia, anxiety depression, dizziness, nausea, diarrhea, constipation, abdominal pain, dry mouth, vomiting, pruritus, alopecia, arthralgia, myalgia asthenia, and irritability.

Hepatic laboratory testing should be done before therapy with Zepatier begins, states the release. In certain patients, a 16-week course that includes ribavirin may be considered and additional hepatitis testing should be conducted at the 12th week of treatment. 

Zepatier is already approved in the United States and Canada for treatment of hepatitis C.

Hepatitis C Drug Gets European Approval

The number of deaths associated with the hepatitis C virus climbed well above those of several other infectious diseases over a 10-year period ending in 2013, according to a recent government study.

To gather current trends estimates related to hepatitis C mortality, researchers looked at data on multiple cause of death and compared it to trends in deaths that were associated with 60 other nationally notifiable infectious conditions (ONNIC) that are routinely reported to the US Centers for Disease Control and Prevention. Results were published in March in the journal Clinical Infectious Diseases.

“Despite improving therapies, our study found that deaths associated with HCV continued to rise while deaths associated with 60 other ONNICs that are routinely reported to CDC declined,” lead author Kathleen Ly stated in the journal article.

Results from the study and previous analyses show that the hepatitis C-related deaths occurred mainly in adults between the ages of 55 to 64, the so-called baby boom generation, “indicating the premature loss of life and economic burden with HCV infection,” note the authors. Recent health campaigns worldwide have encouraged people in this age group to be tested for the bloodborne virus, which can seriously damage the liver over time.

People from the baby boom generation could have been unknowingly infected if they had a tainted blood transfusion before 1992 when blood supplies were not universally screened. Health officials warn that the virus can live in someone for decades without any symptoms of illness.

Researchers examined death certificate information obtained from the National Center for Health Statistics public use data. They examined two disease categories; hepatitis C and ONNIC as classified by the International Classification of Diseases, 10th Revision.  

The results of the analysis showed that the number of deaths associated with hepatitis C nearly doubled over a decade, increasing from 11,051 in the year 2003 to 19,368 in 2013. In contrast, the number of deaths associated with the combined 60 other infectious conditions dropped from 24,745 in the year 2003 to 17,915 in 2013, the article stated.  

The authors attribute the decline in ONNIC-related deaths largely to a 41.8% decline in the number of deaths related to HIV, which fell from 15,168 in 2003 to 8,831 deaths in 2013. Steep declines in the number of deaths related to 2 other conditions, pneumococcal disease (31.0%) and tuberculosis (28.2%), also helped shrink the number of ONNIC-related deaths over the ten years studied.  Effective public health programs and policies likely contributed to these declines, states the article.  

Since late 2013, FDA regulators have approved Sovaldi and a handful of other all-oral antiviral drugs that work faster with fewer side effects than traditional treatments involving use of interferon.

Despite enthusiasm for these newer drugs, the continued health burden and escalating mortality related to hepatitis C “remain underappreciated,” according to the study authors.  

“The unabated increasing trend in the number of hepatitis C—related deaths documented from 1999 to 2013, predominantly among middle-aged persons, underscores the urgency in finding, evaluating, and treating patients in the largest infectious disease epidemic in the United States,” the authors concluded.   

HCV-related deaths continued to rise while deaths from 60 other infectious diseases declined.