Severe acute respiratory syndrome coronavirus 2 RNA contamination of inanimate surfaces and virus viability in a health care emergency unit.

OBJECTIVES: To detect possible severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) RNA contamination of inanimate surfaces in areas at high risk of aerosol formation by patients with coronavirus disease 2019 (COVID-19). METHODS: Sampling was performed in the emergency unit and the sub-intensive care ward. SARS-CoV-2 RNA was extracted from swabbed surfaces and objects and subjected to real-time RT-PCR targeting RNA-dependent RNA polymerase and E genes. Virus isolation from positive samples was attempted in vitro on Vero E6 cells. RESULTS: Twenty-six samples were collected and only two were positive for low-level SARS-CoV-2 RNA, both collected on the external surface of continuous positive airway pressure helmets. All transport media were inoculated onto susceptible cells, but none induced a cytopathic effect on day 7 of culture. CONCLUSIONS: Even though daily contact with inanimate surfaces and patient fomites in contaminated areas may be a medium of infection, our data obtained in real-life conditions suggest that it might be less extensive than hitherto recognized.

The benefits of hepatitis C virus cure: Every rose has thorns.

To examine mid-term benefits on hepatic complications, extrahepatic clinical syndromes and quality of life associated with HCV cure; to review the few safety issues linked to oral direct-acting antivirals (DAAs); and to discuss the potential population benefits of reducing the burden of HCV infection. DAAs cure HCV infection in more than 95% of patients. The halting of liver inflammation and fibrosis progression translates into both hepatic and extrahepatic benefits and reduces the need for liver transplantation. A reduction in the frequency of extrahepatic manifestations such as mixed cryoglobulinaemia and vasculitis and improvements in quality of life and fatigue have also been described. A few safety issues linked to DAAs such as the potential recurrence of aggressive HCC, the flares of hepatitis B virus in patients with overt or occult HBV infection are been discussed. Curing HCV infection also has a high potential to reduce the burden of HCV infection at the population level. With widespread scaling up of HCV treatment, several modeling studies suggest that major reductions in HCV prevalence and incidence are possible, and that elimination of viral hepatitis is an achievable target by 2030.

Reappraisal of the F/M amplitude ratio in carpal tunnel syndrome.

The F-wave/M-wave amplitude (F/M-amp) ratio has been shown to be increased in peripheral neuropathies, provided the maximum M-wave is relatively preserved. Reduced M-wave amplitudes and central facilitation of antidromically-induced reactivation of the anterior horn cells' axon hillocks (F-wave) are believed to contribute to higher F/M-amp ratios. The present study was undertaken to re-evaluate mechanisms responsible for higher F/M-amp ratios in carpal tunnel syndrome (CTS). We enrolled 232 cases affected by CTS and 108 controls. Fand M-wave amplitudes and F-wave chronodispersion were analyzed for the median and ulnar nerves. The F/M-amp ratio of the median nerve in CTS subjects with moderate-severe nerve damage was significantly higher than that of mild CTS subjects and controls. Chronodispersion of the median nerve F-wave increased with increasing CTS severity. We conclude that the relative preservation of the median nerve F-wave is due to damage to the large diameter muscle afferent fibers responsible for the monosynaptic response. Absence of the monosynaptic response makes the small motoneurons, usually inaccessible to the antidromic volley because of its collision with the orthodromic reflex volley, able to fire in the F-wave.

Differences in the availability of diagnostics and treatment modalities for chronic hepatitis B across Europe.

The prevalence and management of chronic hepatitis B virus (HBV) infection differ among European countries. The availability and reimbursement of diagnostics and drugs may also vary, determining distinct treatment outcomes. Herein, we analyse differences in medical facilities for the care of patients with chronic HBV infection across Europe. A survey was sent to the members of the ESCMID Study Group for Viral Hepatitis, all of whom are experts in chronic HBV infection management. The comprehensive survey asked questions regarding hepatitis B surface antigen (HBsAg) prevalence, the availability of diagnostics and drugs marketed, and distinct clinical practice behaviours in the management of chronic HBV infection. World Bank data were used to assess the economic status of the countries. With 16 expert physicians responding (69%), the HBsAg prevalence rates were <1% in France, Hungary, Italy, The Netherlands, Portugal, Spain, and the UK, intermediate (1-5%) in Turkey, Romania, and Serbia, and high (>5%) in Albania and Iran. Regarding the availability and reimbursement of HBV diagnostics (HBV DNA and liver stiffness measurement), HBV drugs (interferon, lamivudine, tenofovir, and entecavir), HBV prophylaxis, and duration of HBeAg-positive and HBeAg-negative HBV infection, the majority of high-income and middle-income countries had no restrictions; Albania, Iran and Serbia had several restrictions in diagnostics and HBV drugs. The countries in the high-income group were also the ones with no restrictions in medical facilities, whereas the upper-middle-income countries had some restrictions. The prevalence of chronic HBV infection is much higher in southern and eastern than in western European countries. Despite the availability of European guidelines, policies for diagnostics and treatment vary significantly across European countries.

Skewed B cells in chronic hepatitis C virus infection maintain their ability to respond to virus-induced activation.

Chronic hepatitis C virus (HCV) infection is characterized by persistent B-cell activation, with enhanced differentiation and reduced proliferative ability. To assess the possible role of HCV in altering B-cell subset distribution, we examined ex vivo frequencies and B-cell inhibitory receptor expression in 37 chronic HCV-infected patients and 25 healthy donors (HD). In addition, we determined whether short-term exposure to culture-derived HCV (HCVcc) resulted in B-cell subset skewing and/or activation. There was a statistically significant increase in the frequencies of immature transitional, activated memory and tissue-like memory (TLM) B cells in HCV-infected patients compared with HD. We also found that the frequency of memory B cells correlated with serum HCV RNA levels. The proportion of B cells expressing the marker of exhaustion Fc receptor-like 4 (FcRL4) was generally low even though significantly higher in the patients' memory B-cell compartment compared with HD, and a positive correlation was found between the frequencies of the patients' TLM FcRL4+ B cells and serum alanine aminotransferase and histological activity index at liver biopsy. Exposure to cell-free HCVcc in vitro did not result in B-cell skewing but induced significant activation of naïve, TLM and resting memory B cells in HCV-infected patients but not in HD, in whom cell-associated virus was an absolute requirement for activation of memory B cells. These findings provide corroborative evidence in favour of significant B-cell subset skewing in chronic HCV infection and in addition show that expression of exhaustion markers in selected B-cell subsets does not impair virus-induced B-cell activation.

HCV E1E2-MF59 vaccine in chronic hepatitis C patients treated with PEG-IFNα2a and Ribavirin: a randomized controlled trial.

Hepatitis C virus (HCV) vaccines may be able to increase viral clearance in combination with antiviral therapy. We analysed viral dynamics and HCV-specific immune response during retreatment for experienced patients in a phase Ib study with E1E2MF59 vaccine. Seventy-eight genotype 1a/1b patients [relapsers (30), partial responders (16) and nonresponders (32) to interferon-(IFN)/ribavirin-(RBV)] were randomly assigned to vaccine (V:23), Peg-IFNα2a-180-ug/qw and ribavirin 1000-1200-mg/qd for 48 weeks (P/R:25), or their combination (P/R + V:30). Vaccine (100 µg/0.5 mL) was administered intramuscularly at week 0-4-8-12-24-28-32-36. Neutralizing of binding (NOB) antibodies and lymphocyte proliferation assay (LPA) for E1E2-specific-CD4 + T cells were performed at week 0-12-16-48. Viral kinetics were analysed up to week 16. The vaccine was safe, and a sustained virological response (SVR) was achieved in 4 P/R + V and 2 P/R patients. Higher SVR rates were observed in prior relapsers (P/R + V = 27.3%; P/R = 12.5%). Higher NOB titres and LPA indexes were found at week 12 and 16 in P/R + V as compared to P/R patients (P = 0.023 and 0.025, P = 0.019 and <0.001, respectively). Among the 22 patients with the strongest direct antiviral effects of IFN (ε ≥ 0.800), those treated with P/R + V (10) reached lower HCV-RNA levels (P = 0.026) at week 16. HCV E1E2MF59 vaccine in combination with Peg-IFNα2a + RBV was safe and elicited E1E2 neutralizing antibodies and specific CD4 + T cell proliferation. Upon early response to IFN, vaccinations were associated with an enhanced second phase viral load decline. These results prompt phase II trials in combination with new antiviral therapies.

Clinical findings and electrodiagnostic testing in 108 consecutive cases of lumbosacral radiculopathy due to herniated disc.

STUDY AIM: This prospective study aim to examine whether clinical findings and electrodiagnostic testing (EDX) in patients with lumbosacral monoradiculopathy due to herniated disc (HD) differ as a function of root involvement level (L5 vs. S1) and HD zone (paramedian vs. intraforaminal). PATIENTS AND METHODS: All patients with L4, L5 or S1 monoradiculopathy were prospectively enrolled at four electromyography (EMG) labs over a 2-year period. The diagnosis was based on a congruence between patient history and MRI evidence of HD. We compared the sensitivities of clinical findings and EDX with respect to both root involvement level and HD zone. Multivariate logistic regression was performed in order to verify the association between abnormal EMG, clinical, and neuroradiological findings. RESULTS: One hundred and eight patients (mean age 47.7 years, 55% men) were consecutively enrolled. Sensory loss in the painful dermatome was the most frequent finding at physical examination (56% of cases). EMG was abnormal in at least one muscle supplied by femoral and sciatic nerves in 45 cases (42%). Inclusion of paraspinal muscles increased sensitivity to only 49% and that of proximal muscles was useless. Motor and sensory neurography was seldom abnormal. The most frequent motor neurographic abnormalities were a delay of F-wave minimum latency and decrease in the compound muscle action potential amplitude from extensor digitorum brevis and abductor hallucis in L5 and S1 radiculopathies, respectively. Sensory neurography was usually normal, the amplitude of sensory nerve action potential was seldom reduced when HD injured dorsal root ganglion or postganglionic root fibres. Multivariate logistic regression analysis showed that EMG abnormalities could be predicted by myotomal muscular weakness, abnormal deep reflexes, and paraesthesiae. The only clinical and electrophysiological differences with respect to root involvement level concerned deep reflexes and motor neurography of deep peroneal and tibial nerves. CONCLUSIONS: Only some EDX parameters are helpful for the diagnosis of lumbosacral radiculopathy. EMG was abnormal in less than 50% of cases and its abnormalities could be predicted by some clinical findings. However, neurography is useful as a tool for differential diagnosis between radiculopathy and more diffuse disorders of the peripheral nervous system (polyneuropathy, plexopathy).

Who is more likely to respond to dual treatment with pegylated-interferon and ribavirin for chronic hepatitis C? A gender-oriented analysis.

We assessed, in real-life practice, viral, demographic, genetic and metabolic factors influencing the sustained virologic response (SVR), with a gender-oriented analysis, in patients with chronic hepatitis C virus (HCV) treated with pegylated interferon and ribavirin. Six hundred and seventy naïve patients were treated with dual therapy and evaluated by gender and HCV genotype. Associations between baseline variables and SVR were assessed by multivariate logistic regression analysis. Among 362 genotype 1 patients, SVR was achieved in 158 patients (44%), and SVR was independently associated with age less than 50 years (OR 2.12; 95% CI 1.09-4.30; P=0.039) and C/C genotype rs12979860 SNP (OR 2.83; 1.19-6.74; P=0.002) in 163 females, while absence of visceral obesity (OR 2.491; 1.131-5.487; P=0.023), HCV-RNA lower than 400,000 IU/mL (OR 2.66; 1.273-5.558; P=0.009) and C/C genotype rs12979860 SNP (OR 4.969; 2.401-10.283; P<0.001) were independently associated with SVR in 199 males. Combining favourable baseline variables, the probability of obtaining SVR ranged from 27.6% to 84.2% in females, and from 14.3% to 85.7% in males. The rate of SVR was 81.1% in 175 genotype 2 patients, and 69% in 100 genotype 3 patients. Rapid virologic response was the only valid predictor of SVR regardless of other features. In conclusions, in the setting of HCV genotype 1, chronic hepatitis, combining rapid virologic response and predictive factors, which are different for females and males, allows clinicians to single out a group of patients whose likelihood of SVR exceeds 80%. For these patients, triple therapy with first-generation protease inhibitors may be unwarranted.

Sensory nerve action potential amplitude is rarely reduced in lumbosacral radiculopathy due to herniated disc.

OBJECTIVE: Normal sensory nerve action potential (SNAP) amplitude is a classical neurographic rule whether damage is located proximal to the dorsal root ganglion (DRG) as in radiculopathy. The study's aim is to check SNAP reduction in patients with lumbosacral radiculopathy due to herniated disc (HD). METHODS: A total of 108 consecutive patients with lumbosacral monoradiculopathy were prospectively enrolled. The diagnosis was based on clinical findings and magnetic resonance imaging (MRI). Electromyography of muscles of L4-S1 myotomes, motor neurography of peroneal and tibial nerves and sensory neurography of saphenous, superficial peroneal and sural nerves were performed. Percentage decrease in SNAP amplitude of nerves between healthy and affected sides was calculated. RESULTS: Significant SNAP amplitude asymmetry was observed in superficial peroneal nerve in seven patients with L5 (12.1%) and in sural nerve in one patient with S1 (2.4%) radiculopathies. All these patients had foraminal HD. CONCLUSIONS: SNAP amplitude reduction of sensory nerve originating from damaged root is present only in 7% of radiculopathies and is likely due to DRG compression when located proximal to the spinal foramen or within the intraspinal canal. SIGNIFICANCE: Preservation of SNAP amplitude in radiculopathy remains an electrophysiological dogma with a little exception. If the reduction of SNAP amplitude affects other nerves, causes other than radiculopathy should be sought.

Polyneuropathy in cerebrotendinous xanthomatosis and response to treatment with chenodeoxycholic acid.

Polyneuropathy has been reported in cerebrotendinous xanthomatosis (CTX), although its nature and possible association with certain genotypes and phenotypes are unclear. The effect of chronic administration of chenodeoxycholic acid (CDCA) on peripheral nerve conduction parameters is still debated. We report clinical, laboratory, and electrophysiological findings in 35 CTX patients. Twenty-six subjects (74.2 %) showed peripheral nerve abnormalities. Polyneuropathy was predominantly axonal (76.9 % of patients) and generally mild. No correlation was found between its presence and clinical or biochemical data. In polyneuropathic patients, CDCA treatment improved electrophysiological conduction parameters, irrespective of the duration of therapy. Improvement mainly concerned nerve conduction velocities, whereas most nerve amplitudes remained unchanged. This means that CDCA treatment did not influence the number of axons activated by maximum electrical stimulation but increased the conduction of the still-excitable fibers. Our findings may suggest that CDCA treatment promotes myelin synthesis in nerve fibers with residual unaffected axons. The effect of therapy may therefore depend largely on the extent of irreversible structural damage to axons.

Consistence and discrepancy of neuropathic pain screening tools DN4 and ID-Pain.

Pain is a subjective condition that cannot be objectively measured; for this reason, self patient-perspective is crucial. Recently, several screening tools to discriminate between nociceptive and neuropathic pain have been developed. We aimed at assessing the consistence and discrepancy of two widely used screening tools, The Douleur Neuropathique 4 (DN4) and the 6-item questionnaire (ID-Pain), by comparing their ability in discriminating neuropathic from nociceptive pain. DN4 and ID-Pain were administered to 392 Italian patients attending 16 outpatient services for peripheral nerve diseases. Based on medical history, clinical findings and diagnostic tools, patients were divided into two groups (neuropathic and nociceptive). Globally, ID-Pain identified neuropathic pain in 60 % of patients (38 % probable, 22 % likely). Interestingly also DN4 diagnosed neuropathic pain in 60 % of cases. A discrepancy was observed in 16 % of cases. DN4 and ID-Pain resulted to be highly interrelated in the identification of neuropathic pain. Sensitivity of DN4 was 82 % and specificity was 81 %, while ID-Pain (considering both probable and likely groups) showed sensitivity 78 % and specificity 74 %. Reliable screening tools for neuropathic pain are well related between them; hence, they are available for researchers and clinicians who may choose the most appropriate for their activity. Since the gold standard for the diagnosis and treatment of neuropathic pain cannot do without a neurological evaluation, perhaps DN4, that includes physician objective measures, may help reducing the percentage of dubious cases. Conversely, when needing a more agile tool (not needing a physician) ID-Pain may be adopted.

Distal symmetric polyneuropathy in diabetes. Differences between patients with and without neuropathic pain.

AIMS: To demonstrate whether in distal symmetric polyneuropathy (DSPN) in diabetes there are differences between patients with and without neuropathic pain and whether pain is associated with demographic, clinical and electrophysiological variables. PATIENTS AND METHODS: We prospectively enrolled 154 consecutive patients (mean age 67 years, 64% men) in an electromyography (EMG) lab. The differences were calculated between DSPN patients with (no.78) and without neuropathic pain (no.76) relating to age, sex, BMI, type, duration, treatment and complications of diabetes, HbA1c, type and duration of DSPN symptoms, DSPN clinical severity score (with Diabetic Neuropathic Index-DNI), electrophysiological findings of lower limb muscles and nerves. RESULTS: The differences between DSPN patients with and without pain included the presence of symptoms (burning and weakness), DNI score and neurographic findings of all nerves and neurogenic EMG. But in the logistic regression models enter only the following variables: DNI score, neurogenic EMG, and among symptoms "burning". CONCLUSIONS: The presence of pain in DSPN is associated with DSPN clinical severity, neurogenic EMG and presence of "burning- symptom but not with demographic or neurographic findings, or diabetes related variables. Therefore, the neuropathic pain in DSPN does not associate with the degree of involvement of large diameter sensory fibres or diabetes severity.

Prevalent involvement of thenar motor fibres in vineyard workers with carpal tunnel syndrome.

OBJECTIVE: Carpal tunnel syndrome (CTS) has a high prevalence in agricultural workers, especially those engaged in vineyards. We postulated that vineyard CTS was electrophysiologically different from CTS of other subjects. We performed a retrospective cross-sectional electrophysiological study of two cohorts of consecutive patients with CTS, the first consisting of vineyard workers and the second, of other unselected types of workers, housewives and pensioners. METHODS: Thirty-three vineyard workers (mean age 46.8years, 42% women) and 205 patients with other occupations (mean age 53.7years; 66% women) were enrolled. All patients underwent sensory and motor neurography of the median and ulnar nerves. Differences in demographic and electrophysiological findings between groups were calculated and multiple linear regression analysis was performed to eliminate the influence of potential confounding factors (age, sex, BMI, clinical severity of CTS) on the results of univariate difference analysis. RESULTS: Univariate analysis showed that DML was longer and compound muscle action potential amplitude of the median nerve, recorded from the abductor pollicis brevis muscle, was smaller in vineyard workers than in the other CTS patients. These differences remained significant after adjusting the results for confounding factors. CONCLUSIONS: The vineyard workers showed a different pattern of CTS than the other patients: thenar motor fibres were more affected, presumably due to chronic compression on the thenar branch. This suggests an association between "common" CTS and thenar mononeuropathy. SIGNIFICANCE: Occupational physiologists should clarify the mechanisms of neuromuscular engagement in particular jobs and ergonomists design suitable working tools, because many "individual" risk factors are difficult to change, but workplace-related risk factors can be modified.

Ulnar neuropathy at the elbow: how frequent is the idiopathic form? An ultrasonographic study in a cohort of patients.

OBJECTIVE: Ulnar neuropathy at the elbow (UNE) is the second most frequent focal neuropathy of the arm. The aim of our study was to establish the frequency of anatomical changes of the cubital tunnel capable of causing UNE. METHODS: Ninety-one consecutive patients affected by UNE, as established by neurophysiological studies, were enrolled in the study. All patients underwent ultrasonographic examination of the elbow, paying particular attention to the cubital tunnel, which was studied with either static or dynamic scans. RESULT: Fifty-four of the 91 patients (59.3%) had at least one anatomical alteration of the cubital tunnel. The changes observed in our patients were: subluxation of the ulnar nerve (18.7%), luxation of the ulnar nerve (9.9%), presence of osteophytes (6.6%), presence of accessory muscle (8.8%), articular ganglion (1.1%), post-traumatic lesions (3.3%), presence of osseous fragment (1.1%). CONCLUSIONS: A possible cause of ulnar nerve entrapment at the elbow was found in more than half of the patients. Joint ultrasonography is indispensable for the identification of such alterations as it allows for both static and dynamic evaluation of the ulnar nerve.

Italian multicentre study of peroneal mononeuropathy: multiperspective follow-up.

The main objective of this study is to assess the course of peroneal mononeuropathy (PM). The study design includes Clinical and Prospective study. The setting involves neurophysiological Service. From November 2002 to January 2004, we enroled 69 consecutive patients and prospectively followed up 49 patients with multiple measurements. Comparison was made between follow-up and baseline values, and baseline factors were used to predict the PM evolution in multiple regression analysis. At follow-up, we observed a significant improvement of all clinical, neurophysiological and disability measurements, and physical aspects of quality of life (QoL). Greater muscle strength of tibialis anterior and higher conduction velocity of peroneal nerve at baseline were seen to be positive prognostic factors. A better evolution of mental aspects of QoL was observed in the subacute group and in younger patients, while a better physical evolution in QoL was observed in women. Rehabilitation is ambiguously associated with a better Deambulation Index but lower ratings in mental aspects of QoL. In conclusion, PM shows a positive spontaneous course and rehabilitation seems to help the recovery of deambulation. Further studies on the effects of conventional rehabilitation are needed.

Ultrasonography in ulnar neuropathy at the elbow: relationships to clinical and electrophysiological findings.

INTRODUCTION: Though ultrasonography (US) is commonly used in the diagnosis of carpal tunnel syndrome (CTS), there are only few studies on the utility of US in ulnar neuropathy at the elbow (UNE). The aims of this study were to measure the cross-sectional area (CSA) of the ulnar nerve at the elbow and to correlate CSA values with clinical and electrophysiological findings. PATIENTS AND METHODS: Thirty-three UNE patients (mean age 50.1 years) were consecutively enrolled. Diagnosis was based on clinical findings and slowing of the motor conduction velocity (MCV) of the ulnar nerve across the elbow. CSAs of the ulnar nerve were measured within the cubital tunnel at the level of the medial epicondyle (CSA-M) and approximately 2cm proximal to this point (CSA-I). Correlations between CSA and demographic, clinical (ordinal severity scale and self-administered symptom questionnaire), and electrophysiological findings (neurographic results and ordinal electrophysiological severity scale) were calculated using Spearman's correlation coefficient. RESULTS: The mean CSA-M and CSA-I were 9.6+/-8.5 and 9.3+/-5.6mm2, respectively. Fifteen (45.5%) and eight (24.5%) cases showed abnormal CSA-M and CSA-I values, respectively (mean+2S.D. compared to a control group of the same age). All cases with abnormal CSA-I had abnormal CSA-M except one. Significant relationships were only found between CSA-M and CSA-I with across elbow MCV, sensory action potential amplitude, and the electrophysiological severity scale score. DISCUSSION: Our study showed anomalous CSA values in less than 50% of the UNE cases. This is less than the reported percentages in the few literature reports. This difference may be due to our enrolment criteria or to the electrophysiological and US techniques. It is likely that the CSAs measured by axial scan at a fixed level of the cubital tunnel may have lower diagnostic sensitivity than the same technique used in CTS.

Ultrasonography before and after surgery in carpal tunnel syndrome and relationship with clinical and electrophysiological findings. A new outcome predictor?

OBJECTIVE: To measure the cross-sectional area (CSA) of the median nerve by ultrasonography (US) before and after surgery in subjects with carpal tunnel syndrome (CTS), and to verify whether the normalization of presurgical parameters can be predicted by presurgical CSA values. PATIENTS AND METHODS: Sixty-seven consecutive cases, mean age 60.5 years, underwent surgical decompression. Before surgery, clinical and electrophysiological severity and self-assessment of symptoms (using the Boston questionnaire, BQ) were recorded. CSAs were measured proximal to the carpal tunnel inlet (CSA-I), at mid-tunnel (CSA-M), and at the tunnel outlet (CSA-O). Follow-ups were performed 1 and 6 months after surgery. Logistic regressions were performed with normalization of CSA, clinical and electrophysiological parameters as independent variables, and presurgical findings as dependent variables. RESULTS: Before and after surgery there were correlations between CSA-I and clinical and electrophysiological severity scales. After 1 and 6 months, the clinical, electrophysiological, and BQ findings improved. CSA-I reduced at the 1-month follow-up and CSA-O increased between the first and second follow-up. Presurgical values of CSA-I could predict the normalization of its postsurgical value, normalization of the clinical severity scale, BQ, and full patient satisfaction postsurgery. CONCLUSIONS: CSA-I is the most sensitive US measurement before surgery. The presurgical value of CSA-I is a predictor of postsurgical normalization of clinical parameters and of its own value.

Assessment of hepatitis C virus-RNA clearance under combination therapy for hepatitis C virus genotype 1: performance of the transcription-mediated amplification assay.

Monitoring of HCV-RNA in blood during antiviral therapy is performed mostly by commercially available reverse transcription polymerase chain reaction-based (RT-PCR) assays, with a lower detection limit of 30-50 IU/mL of HCV-RNA. Use of different tests in the pivotal trials of combination therapy has generated some discordance, in terms of predictive value of the early virological response (EVR). To evaluate whether the use of a more sensitive test, as a qualitative assay based on transcription mediated amplification (TMA) with a lower detection limit of 5-10 IU/mL of HCV-RNA, may obtain a better prediction of EVR and of the ultimate virological outcome, we retrospectively evaluated serial samples from 108 naïve patients with HCV genotype 1 chronic hepatitis, treated with pegylated alpha2b interferon plus ribavirin for 48 weeks and with a 24 weeks stopping rule. Serum samples of patients, obtained during treatment at weeks 4, 12, 24 and 48 and after treatment at week 24, were evaluated by TMA. Comparison of the RT-PCR and TMA assays for the qualitative detection of HCV-RNA showed no significant differences in performance when these tests were used at the end of the treatment period for assessing patients without an on-treatment virological response and those who eventually obtain a sustained virological response. Our results show instead that the use of TMA assay to detect HCV-RNA at 12 and 24 weeks of the combination therapy is more effective than RT-PCR in identifying patients with the highest probability of sustained HCV-RNA clearance.