Sofosbuvir-based treatment is safe and effective in Indian hepatitis C patients on maintenance haemodialysis: A retrospective study.

AIM: This study evaluates the safety and efficacy of direct-acting antivirals (DAAs) including sofosbuvir, ledipasvir and daclatasvir in patients with hepatitis C viraemia who were on maintenance haemodialysis. METHODS: Data on patients who received sofosbuvir and ribavirin were analysed. Patients who experienced treatment failure with the above regimen received sofosbuvir and ledipasvir for infection with hepatitis C virus (HCV) genotype 1. Those having HCV genotype 3 infection received sofosbuvir and daclatasvir. All treatment regimens were of 12 weeks duration. Side-effects were investigated. The HCV viral load was determined by RT-PCR at 4,16 and 24 weeks after the initiation of therapy; haemoglobin levels and liver function tests were monitored at regular intervals during therapy. RESULTS: Of the 22 subjects initially treated with sofosbuvir and ribavirin, 72.72% attained sustained virologic response at 12 weeks (SVR12). Four patients experienced treatment failure and received genotype specific therapy. Patients with HCV genotype one received sofosbuvir with ledipasvir. One patient with HCV genotype 3 infection received sofosbuvir and daclatasvir. All of them attained SVR12. A statistically significant reduction in the median serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) were observed from the baseline until the end of treatment. Anaemia was observed in 45% of patients receiving ribavirin. CONCLUSIONS: Our study demonstrates that sofosbuvir-based therapy is efficacious for HCV viraemia in patients on maintenance haemodialysis. The therapy was found to be reasonably safe with no major adverse effects noted with the use of sofosbuvir, ledipasvir or daclatasvir. However, larger studies are needed to validate our results.

Cystinosis: Status of research and treatment in India and the world.

Cystinosis is an autosomally inherited rare genetic disorder in which cystine accumulates in the lysosome. The defect arises from a mutation in the lysosomal efflux pump, cystinosin (or CTNS). Despite the disease being known for more than a century, research, diagnosis, and treatment in India have been very minimal. In recent years, however, some research on cystinosis has been carried out on understanding the pathophysiology and in the development of a humanized yeast model for interrogating the CTNS protein. There has also been a greater awareness of the disease that has been facilitated by the formation of the Cystinosis Foundation of India just over a decade ago. Awareness among primary physicians is critical for early diagnosis, which in turn is critical for proper treatment. Eight different mutations have been observed in cystinosis patients in India, and the mutation spectrum seems different to what has been seen in the US and Europe. Despite these positive developments, there are immense hurdles still to be surmounted. This includes ensuring that the diagnosis is done sooner, making cysteamine more easily available, and, also for the future, to make accessible the promise of gene therapy to cystinosis patients.

An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients.

Indomethacin, a non-steroidal anti-inflammatory drug (NSAID), has been presented as a broad-spectrum antiviral agent. This randomised clinical trial in a hospital setting evaluated the efficacy and safety of this drug in RT-PCR-positive coronavirus disease 2019 (COVID-19) patients. A total of 210 RT-PCR-positive COVID-19 patients who provided consent were allotted to the control or case arm, based on block randomisation. The control arm received standard of care comprising paracetamol, ivermectin, and other adjuvant therapies. The patients in the case arm received indomethacin instead of paracetamol, with other medications retained. The primary endpoint was the development of hypoxia/desaturation with SpO2 ≤ 93, while time to become afebrile and time for cough and myalgia resolution were the secondary endpoints. The results of 210 patients were available, with 103 and 107 patients in the indomethacin and paracetamol arms, respectively. We monitored patient profiles along with everyday clinical parameters. In addition, blood chemistry at the time of admission and discharge was assessed. As no one in either of the arms required high-flow oxygen, desaturation with a SpO2 level of 93 and below was the vital goal. In the indomethacin group, none of the 103 patients developed desaturation. On the other hand, 20 of the 107 patients in the paracetamol arm developed desaturation. Patients who received indomethacin also experienced more rapid symptomatic relief than those in the paracetamol arm, with most symptoms disappearing in half the time. In addition, 56 out of 107 in the paracetamol arm had fever on the seventh day, while no patient in the indomethacin group had fever. Neither arm reported any adverse event. The fourteenth-day follow-up revealed that the paracetamol arm patients had faced several discomforts; indomethacin arm patients mostly complained only of tiredness. Indomethacin is a safe and effective drug for treating patients with mild and moderate covid-19.

Education and screening for chronic kidney disease in Indian youth: pilot program results.

BACKGROUND: There is a paucity of information on kidney education and screening programs in Indian youth. METHODS: Participants (n=2,158) from Chennai colleges were educated about the kidneys and chronic kidney disease (CKD) and screened in a pilot program from April to May 2013. This entailed: 1) a presentation and educational video and 2) an on-site assessment of weight, blood pressure, and demographic information. Urinalysis (UA) kits were distributed and returned in ≤48 hours. We examined participant characteristics and their association with dipstick proteinuria using logistic regression. RESULTS: The mean (standard deviation [SD]) age was 18.9 (1.6) years, and 1,451 (68%) were men. Mean (SD) body mass index (BMI) was 21.9 (4.3) kg/m2; 745 (36%) had a BMI consistent with being overweight or obese. Mean (SD) systolic blood pressure (SBP) was 118.7 (13.1) mm Hg, and 94 (5%) of the participants had SBP ≥140. Mean (SD) diastolic blood pressure (DBP) was 70.9 (11.4) mm Hg, with 119 participants (6%) having ≥90 mm Hg. A total of 136 participants had glycosuria (UA≥1+) and 120 (6%) had proteinuria (UA≥1+). In unadjusted analyses, sex (odds ratio [OR]=1.64 [confidence interval, CI 1.06-2.55]; p=0.026 men vs. women) and age (OR=1.13 per year [CI 1.01-1.26]; p=0.032) were significantly associated with proteinuria. In the analysis adjusted for age, sex, SBP, DBP, glycosuria, and BMI, age remained independently associated with higher odds for proteinuria (OR=1.14 per year [1.02-1.29]; p=0.026). Males showed a trend of higher risk compared with women (OR=1.57 [CI 1.00-2.50]; p=0.051). CONCLUSION: This education and screening pilot program in a population of college students offers unique opportunities for identification, education, and early intervention for CKD.

Microbiology, clinical spectrum and outcome of peritonitis in patients undergoing peritoneal dialysis in India: Results from a multicentric, observational study.

BACKGROUND: Peritoneal dialysis (PD)-related peritonitis is a major risk factor for drop out of patients on continuous ambulatory PD (CAPD) and automated PD (APD). Factors affecting PD-related peritonitis and centre-specific microbiological data are lacking in India. A multicentric prospective observational study was designed to overcome the gaps in the existing data regarding causative organism and outcome. METHODOLOGY: The present study was a prospective, uncontrolled, open-label; observational study conducted in 21 centres representing all the four geographical regions (North, South, East and West) of India between April 2010 and December 2011. RESULTS: A total of 244 patients on chronic PD with peritonitis were enrolled in the study (CAPD and APD), who met the inclusion criteria, from 21 centres covering the different geographical areas of India. Amongst the 85 samples that were culture positive, 38 (44.7%) were in the monsoon season followed by 23 (27.1%) in the post-monsoon, 18 (21.2%) during winter and 11 (12.9%) during summer. Maximum culture positivity (72.7%) was observed with automated culture technique. Microorganisms could be isolated in only 85 cases (35.3%) while the remaining samples were culture negative (156/241, 64.7% of samples). Organisms isolated were Gram-negative in 47.8%, Gram-positive in 36.7%, fungal in 13.3% and Mycobacterium tuberculosis in 2.2%. CONCLUSION: This large multicentre study of peritonitis offers insights into the aetiology and outcomes of infectious complications of chronic PD in India that are germane to clinical decision-making.

Predictors of long-term survival on peritoneal dialysis in South India: a multicenter study.

BACKGROUND: Little is known about survival on peritoneal dialysis (PD) in Indian patients since the initiation of continuous ambulatory PD (CAPD) in India in 1991. Survival data from single centers with small numbers have been published. OBJECTIVE: A retrospective 4-center analysis for predictors of survival >3 years in south Indian chronic PD patients. METHODS: A total of 309 patients were trained during the observation period (from 1999 to 2004) and were analyzed in a multicenter study (4 centers), including 150 patients (male:female 109:41) that survived > or = 3 years and 59 patients that did not survive > or = 3 years (nonsurvivors; male: female 43:16) that were taken as controls. The patients were on chronic PD, predominantly CAPD, using double-bag disconnect systems. They were supervised by 4 nephrologists. Mean age in the nonsurvival group was 56.6 +/- 10.6 years. In the survival group, mean age was 50.9 +/- 14.9 years; there were 92 (62%) nondiabetics and 58 (38%) diabetics; the majority were nonvegetarians; 148 patients were doing 6 - 8 L exchanges and 2 were doing >8 L exchanges daily; 93 of 102 patients were average transporters based on peritoneal equilibration testing. At the beginning, mean combined Kt/V was 2.31 and weekly creatinine clearance was 73 L. Patients making one lifetime payment were 46% and 21% belonged to the full reimbursement group. RESULTS: Body mass index (BMI) was normal in 114 patients (76%). Ultrafiltration volume was 1377 +/- 452 at the start and 1400 +/- 461 mL/day after 3 years. Anuric patients at the start were 12% and after 3 years 44%; urine output decreased from 527 +/- 26 to 253 +/- 14 mL/day from the start to after 3 years. Peritonitis rate was 1 episode/75 patient-months at the beginning and after 3 years it was 1 episode/30 patient-months. Exit-site care was done daily by 88% and 3 times weekly by 12%. Nonsmokers were 92% and smokers were 8%. Those that lived in the city were 62% and rural areas were 38%. Mean blood pressure was 143 +/- 16/88 +/- 10 and 136 +/- 18/85 +/- 9 mmHg, calcium x phosphorus product 44.6 +/- 15.6 and 45.9 +/- 15.7 mg(2)/dL(2), albumin 3.33 +/- 0.5 and 3.25 +/- 0.4 g/dL, hemoglobin 9.18 +/- 2 and 9.48 +/- 1.8 g/dL at the beginning and after 3 years, respectively. Statistical analysis showed a significant fall in both systolic (p < or = 0.001) and diastolic blood pressure (p < or = 0.05), an increase in BMI (p < or = 0.01), and a decrease in blood urea (p < or = 0.001) in the survival group. Those with Hb > or = 11 g/dL survived longer (p < or= 0.001), those with serum albumin > or = 3 g/dL had better survival (p = 0.001), and anuric patients survived longer (p = 0.001). CONCLUSION: This multicenter cohort study of prevalent continuous PD patients in south India showed nondiabetics, average transporters, nonsmokers with reasonable nutritional status, with Hb 11 g/dL, with low peritonitis rate, with over 1 L ultrafiltration volume per day, the great majority that joined the once per lifetime payment scheme, and the reimbursement group survived for 3 years or longer.

Ribavirin therapy for Chikungunya arthritis.

BACKGROUND: Chikungunya is an acute viral infection presenting with a febrile episode and severe arthralgia, swelling of soft tissues, especially around the ankles. Many patients recover with nonspecific treatment of analgesics. Some patients continue to have subacute crippling arthritis in the legs affecting their mobility. This study was undertaken to see the effect of the antiviral drug Ribavirin in the clinical outcome of these patients. METHODOLOGY: Ten patients who continued to have crippling lower limb pains and arthritis for at least two weeks after a febrile episode were taken up for the drug study. Ten similar patients during the same period were included as controls. In the study group Ribavirin was given at 200 mg twice a day for seven days. Both groups were followed up for four weeks. RESULTS: All patients in the drug group reported improvement in the joint pains with six of them capable of walking freely. The soft tissue swelling also reduced in eight. In three patients the pain returned after mobilization. Seven patients continued not to receive analgesics after four weeks. CONCLUSIONS: Ribavirin may have a direct antiviral property against Chikungunya leading to faster resolution of joint and soft tissue manifestations.