Investigating the effects of irrigation with indirectly recharged groundwater using recycled water on soil and crops in semi-arid areas.

The utilization of direct wastewater for irrigation poses many environmental problems such as soil quality deterioration due to the accumulation of salts, heavy metals, micro-pollutants, and health risks due to undesirable microorganisms. This hampers its agricultural reuse in arid and semi-arid regions. To address these concerns, the present study introduces a recent approach that involves using indirectly recharged groundwater (GW) with secondary treated municipal wastewater (STW) for irrigation through a Soil Aquifer Treatment-based system (SAT). This method aims to mitigate freshwater scarcity in semi-arid regions. The study assessed GW levels, physicochemical properties, and microbial diversity of GW, and soil in both impacted (receiving recycled water) and non-impacted (not receiving recycled water) areas, before recycling (2015-2018) and after recycling (2019-2022) period of the project. The results indicated a significant increase of 68-70% in GW levels of the studied boreholes in the impacted areas. Additionally, the quality of indirectly recharged GW in the impacted areas improved notably in terms of electrical conductivity (EC), hardness, total dissolved solids (TDS), sodium adsorption ratio (SAR), along with certain cations and anions (hard water to soft water). No significant difference was observed in soil properties and microbial diversity of the impacted areas, except for EC and SAR, which were reduced by 50% and 39%, respectively, after the project commenced. The study also monitored specific microbial species, including total coliforms, Escherichia coli (as indicator organisms), Shigella, and Klebsiella in some of the harvested crops (beetroot, tomato, and spinach). However, none of the analysed crops exhibited the presence of the studied microorganisms. Overall, the study concludes that indirectly recharged GW using STW is a better sustainable and safe irrigation alternative compared to direct wastewater use or extracted hard GW from deep aquifers.

Socio-economic impact assessment of large-scale recycling of treated municipal wastewater for indirect groundwater recharge.

Reusing treated wastewater is an emerging solution to address freshwater scarcity, and surface water contamination faced worldwide. A unique large-scale wastewater recycling project was implemented to replenish groundwater by filling secondary treated wastewater (STW) into existing irrigation tanks in severely drought-hit areas of the Kolar districts of Southern India. This study quantifies the socio-economic impacts of this large-scale indirect groundwater recharge scheme. The changes in areas receiving STW i.e., impacted areas and those areas which did not receive STW i.e., non-impacted areas was studied. Also, pre and post recycling changes were quantified in the Kolar district. The results show that surface water quality meets India's most stringent treated wastewater discharge standards prescribed by the Hon'ble National Green Tribunal. Due to these recycling efforts, significant improvements in groundwater level and quality were found. It was observed that there was a noticeable difference in agricultural cropping areas, seasons, patterns, and production between impacted and non-impacted areas. Post-recycling, farmers tended to cultivate cash and water-intensive crops over less water-intensive crops. During the post-recycling period, livestock and milk production also increased, and in impacted areas, it was significantly higher. Post-recycling, fish production increased and land prices per hectare increased by 118 % in impacted areas. The farmer's net income under flowers and vegetable farming increased by 202 % and 150 % respectively in impacted areas compared to non-impacted areas. Furthermore, this project contributes to a circular economy transition in the water sector, which has economic, environmental, social, and cultural benefits. A key recommendation from the outcomes of the study is to draft and implement a policy that encourages the reuse of recycled water for groundwater recharge which in turn will improve the agro-economic system and food security.

Added value of the measles-rubella supplementary immunization activity in reaching unvaccinated and under-vaccinated children, a cross-sectional study in five Indian districts, 2018-20.

INTRODUCTION: Supplementary immunization activities (SIAs) aim to interrupt measles transmission by reaching susceptible children, including children who have not received the recommended two routine doses of MCV before the SIA. However, both strategies may miss the same children if vaccine doses are highly correlated. How well SIAs reach children missed by routine immunization is a key metric in assessing the added value of SIAs. METHODS: Children aged 9 months to younger than 5 years were enrolled in cross-sectional household serosurveys conducted in five districts in India following the 2017-2019 measles-rubella (MR) SIA. History of measles containing vaccine (MCV) through routine services or SIA was obtained from documents and verbal recall. Receipt of a first or second MCV dose during the SIA was categorized as "added value" of the SIA in reaching un- and under-vaccinated children. RESULTS: A total of 1,675 children were enrolled in these post-SIA surveys. The percentage of children receiving a 1st or 2nd dose through the SIA ranged from 12.8% in Thiruvananthapuram District to 48.6% in Dibrugarh District. Although the number of zero-dose children prior to the SIA was small in most sites, the proportion reached by the SIA ranged from 45.8% in Thiruvananthapuram District to 94.9% in Dibrugarh District. Fewer than 7% of children remained measles zero-dose after the MR SIA (range: 1.1-6.4%) compared to up to 28% before the SIA (range: 7.3-28.1%). DISCUSSION: We demonstrated the MR SIA provided considerable added value in terms of measles vaccination coverage, although there was variability across districts due to differences in routine and SIA coverage, and which children were reached by the SIA. Metrics evaluating the added value of an SIA can help to inform the design of vaccination strategies to better reach zero-dose or undervaccinated children.

Evaluation of orbital volume in unilateral orbital fracture using computed tomography.

Aim and Objective: Our study was an observational and evolutional to analyze the significance of orbital volume calculation in predicting the probability or tendency of developing late enopthalmous on patients with unilateral orbital fracture with or without associated midface injury reported to our hospital. Materials and Methods: The subjects in our study included fifteen patients between18 and 60years. They were treated surgically and conservatively. Patients were exposed to series of examination from the day of injury or reporting for a consecutive period of up to six months following injury. CT was taken prior to treatment following management to evaluate the volume change in orbit. Its correlation and significance to treatment outcome were analyzed using MIMICS software by Materialise by comparing injured orbit to opposite side normal eye. Result: Conclusive of clinical examination and summary of statistical analysis patients were categorized into three groups: Low (with volume change of less than 2%), Medium (volume change between 2 to 20%) and High (volume change more than 20%) by comparing fractured orbit to uninjured orbit and a statistically significant mean value of 27.7 ± 2.6 cu. mm for fractures eye and 25.9 ± 2.6 cu. mm for normal eye was found (P ≤ 0.05). Conclusion: Orbital volume can be considered as useful criteria in evaluation of patients with orbital fracture. Evaluation and follow up in correlation with resultant volume assessment provide a better indicator for assessment of prognosis and enopthalmous. Unlike other methods for volume assessment MIMICS software by Materialise provide a better method and it can be incorporated to working station in hospital. Every CT assessment in orbital trauma should include orbital volume as a parameter and this software is easy and user-friendly software that does not require its technical knowledge for application.

Plasma Fibrinogen: An Independent Predictor of Pediatric Appendicitis.

AIMS: Appendicitis, in spite of all the diagnostic advances, achieving an accurate and timely diagnosis of this common condition in children remains a challenge. Plasma fibrinogen (FB) is an acute inflammatory mediator and has been proposed and evaluated as an adjunct laboratory marker for improving diagnostic accuracy. The study evaluates the plasma values of Se FB along with other serum markers in pediatric appendicitis patients, to determine their diagnostic accuracy. METHODS: Prospective observational study on 120 patients between the age group of 5 and 12 years. All eligible enrolled cases underwent total leukocyte count (TLC), plasma FB, C reactive protein (CRP), neutrophil-lymphocyte ratio (NLR), absolute neutrophil count (ANC), and erythrocyte sedimentation rate on admission along with pediatric appendicitis score. Final confirmation of diagnosis and allotment of cohort was made by intra operative findings and histopathological confirmation. Two groups were defined: (1) Histopathologically confirmed acute appendicitis-Cases (2) Nonspecific abdominal pain-Controls. Laboratory results were statistically analyzed between the case and the control groups for diagnostic accuracy. RESULTS: Study reflected strong statistical significance in terms of leukocyte count, ANC, NLR, CRP, and FB levels. However, plasma FB (value above 4.02 g/L) had the highest diagnostic accuracy rate of 82.50% compared to other laboratory values (TLC-70.83%, CRP-70.00%). CONCLUSION: Plasma FB has emerged as an accurate diagnostic tool and its diagnostic accuracy is superior to all other laboratory parameter studied (TLC, CRP, NLR, and ANC). Plasma FB values above 4.02 g/L is an independent predictor of appendicitis and can help in reducing negative laparotomy in pediatric age group.

Large scale purification and characterization of A21 deamidated variant-most prominent post translational modification (PTM) for insulins which is also widely observed in insulins pharmaceutical manufacturing and storage.

Biopharmaceutical development demands appropriate understanding of product related variants, which are formed due to post-translational modification and during downstream processing. These variants can lead to low yield, reduced biological activity, and suboptimal product quality. In addition, these variants may undergo immune reactions, henceforth need to be appropriately controlled to ensure consistent product quality and patient safety. Deamidation of insulin is the most common post-translational modification occurring in insulin and insulin analogues. AsnA21 desamido variant is also the most prominent product variant formed during human insulin manufacturing process and/or during the storage. Often, this deamidated variant is used as an impurity standard during in-process and final product analysis in the QC system. However, purification of large quantity of purified deamidated material is always being challenging due to highly similar mass, ionic, hydrophobic properties, and high structural similarity of the variant compared to the parent product. Present work demonstrates the simplified and efficient scalable process for generation of AsnA21 deamidated variant in powder form with ~96% purity. The mixed-mode property of anion exchange resin PolyQuat was utilized to purify the deamidated impurity with high recovery. Subsequent reversed-phase high performance liquid chromatography (RP-HPLC) step was introduced for concentration of product in bind elute mode. Elution pool undergone isoelectric precipitation and lyophilisation. The lyophilized product allows users for convenient use of the deamidated impurity for intended purposes. Detailed characterization by Mass spectrometry revealed deamidation is at AsnA21 and further confirmed that, structural and functional characterization as well as the biological activity of isolated variant is equivalent to insulin.

To Study the Role of Perfusion Index as a Predictor of Hypotension during Spinal Anesthesia in Lower Segment Cesarean Section - A Prospective Observational Study.

Background and Aims: Spinal anesthesia has become the choice of neuraxial anesthesia for cesarean delivery. Hypotension, the most common side effect of spinal anesthesia is more in parturients. Perfusion index (PI) is one of the newest methods, used noninvasively for the prediction of hypotension postspinal anesthesia, evaluation of regional block success, and a tool for pain assessment. In our study, we have used PI for predicting the occurrence of hypotension postsubarachnoid block in elective lower segment cesarean section (LSCS). Methods: In this prospective observational study, parturients posted for elective LSCS under spinal anesthesia were included. Spinal anesthesia was performed at L3-L4 interspace using 25G (gauge) Quincke needle, with 1.8 mL of 0.5% hyperbaric bupivacaine plus 20 µg fentanyl. Hypotension was defined as a decrease in systolic blood pressure >25% from the baseline. Statistical Analysis Used: Statistical analysis was performed using the paired sample t-test, Chi-square test, and independent t-test. Results: From our study, we had found that a positive correlation exists between the baseline PI of the patient and the occurrence of hypotension intraoperatively. A cutoff value of 1.75 (with P < 0.001) was found to be significant; above which the occurrence of hypotension was definite. The sensitivity of this cutoff value was 75% and specificity was 71% for this value. Conclusion: Baseline perfusion of >1.75 can predict hypotension postspinal anesthesia in LSCS. The incidence of hypotension was about 93% in parturients whose baseline was above the cutoff value.

Genetic diversity in leafy mustard (Brassica juncea var. rugosa) as revealed by agro-morphological traits and SSR markers.

Leafy mustard (B. juncea var. rugosa) constitutes an important group of vegetable mustard crops in India and is mainly cultivated in home-backyard and hilly regions of Uttarakhand and some North-eastern states. In the present study, various agro-morphological traits, physiological and biochemical traits along with SSR markers were used for genetic diversity evaluation in a germplasm collection of leafy mustard. This study revealed a significant variation among 59 accessions of leafy mustard in both qualitative and quantitative agro-morphological traits indicating the accessions' promising potential for consumption purpose and for use in breeding programs. Maximum variability was recorded for leaf area elongation rate (CV = 53.12%), followed by total plant weight (TPW) (CV = 50.63%) and seed yield per plant (CV = 44.33%). In molecular analysis, 155 SSRs evaluated resulted in 482 alleles and the number of alleles varied form 1 to 8 with an average of 3.11 alleles per marker. A total of 122 (78.70%) SSRs resulted into polymorphic amplicons. PIC value varied from 0.32 to 0.77 with an average value of 0.44 per SSR locus. The unweighted neighbour-joining-based dendrogram analysis divided all the 59 accessions into two major groups on the basis of both agro-morphological traits and SSR markers, whereas, three subpopulations/subgroups were predicted by population STRUCTURE analysis. AMOVA indicated the presence of more variability within population than among population. Overall, agro-morphologically better performing and genetically diverse genotypes have been identified which could be further used as donors for leafy mustard improvement programs.

Confirmation of Induced Tolerance to Alternaria Blight Disease in Indian Mustard (Brassica juncea L.).

Indian mustard (Brassica juncea L.) is an important edible oilseed crop in India. Low productivity is the major concern which is adversely affected by biotic stresses. Alternaria blight (Alternaria brassicae) is one among major diseases that has no resistant cultivar until now. Keeping in view, an experiment was conducted for isolation of Alternaria blight-tolerant mutants in Indian mustard using gamma radiation and EMS mutagens during four consecutive years in Rabi (winter season). Furthermore, the morphologically and economically superior mutants of Brassica juncea were screened artificially at cotyledonary and adult stage against Alternaria blight. Tolerance to Alternaria blight is observed in DRMR-M-163 (11.7%), DRMR-M-158 (13.1%), DRMR-M-174 (13.8%) and DRMR-M-177 (18.6%) with minimum conidia in infected cotyledons. Mutant DRMR-M-178 (19.8%) had the highest radical scavenging activity, while DRMR-M-162 (104.9 mg/g AAE), DRMR-M-169 (96.9) and DRMR-M-161 (96.9) had higher antioxidant capacity that appears to act as defence to pathogen. DRMR-M-168 (8.4%), DRMR-M-173 (8.3), DRMR-M-171 (7.9), DRMR-M-165 (7.4), DRMR-M-175 (7.2) and DRMR-M-172 (6.9) had higher phenol content which may be responsive for resistance, although DRMR-M-161 (192.7 mg/g), DRMR-M-163 (187.7 mg/g), DRMR-M-164 (132.7 mg/g), DRMR-M-167 (149.3 mg/g), DRMR-M-173 (196.0 mg/g) and DRMR-M-178 (192.7 mg/g) mutants are found to contain low levels of total soluble sugar compared with susceptible Rohini (379.3). Based on biochemical parameter's similarity, mutants are grouped in 4 major clusters. Cluster 4 contained significantly different mutant DRMR-M-172. Relative expression of mitogen-activated protein kinase 3 (MAPK3) gene was found highest in DRMR-M-177, DRMR-M-174, DRMR-M-175, DRMR-M-178, DRMR-M-170, DRMR-M-176, DRMR-M-172 and DRMR-M-173 which resulted the better response to AB stress. Based on biochemical analysis, realtime PCR and cluster analysis, DRMR-M-172 mutant appears more tolerant to Alternaria. DRMR-M-178, DRMR-M-167 and DRMR-M-177 mutants seem tolerant and could be utilized for further breeding programme.

Milling interventions for the production of atta for Indian flat bread with low carbohydrate digestibility.

Study was aimed to produce atta for chapati, an Indian flat bread with low carbohydrate digestibility through different milling interventions; processing and formulating a functional ingredient mix (FM). Granulation, physico-chemical, rheological and chapati making characteristics of chakki atta, CA (control), roller mill atta (RA); RA replaced with 5, 10 and 15% FM (5, 10 and 15% RAFM) were evaluated. RA and RAFM samples showed lower water absorption, higher dough stability, pasting temperature and peak viscosity than CA. Evaluation of carbohydrate digestive profile showed differences in the pattern of carbohydrate digestibility and glucose release between the chapatis prepared from CA, RA and 10% RAFM. Rapidly available glucose (RAG), an indicator of glycemic response in vivo, was found to be lower in the 10% RAFM than CA. It can be concluded that milling interventions and compositional differences together determine the carbohydrate digestibility of the atta.

Potash fertilizer promotes incipient salinization in groundwater irrigated semi-arid agriculture.

Incipient groundwater salinization has been identified in many arid and semi-arid regions where groundwater is increasingly used for irrigation, but the dominant processes at stake in such context are yet uncertain. Groundwater solutes originates from various sources such as atmospheric inputs, rock dissolution and fertilizer residues, and their concentration is controlled by hydrological processes, in particular evapotranspiration. Here, we propose a deconvolution method to identify the sources and processes governing the groundwater Chloride concentration in agricultural catchments, using the relative variations of Sodium and Chloride and using a neighbouring pristine catchment as a reference for the release rate of Na by weathering. We applied the deconvolution method to the case of the Kabini Critical Zone Observatory, South India, where groundwater was sampled in 188 farm tubewells in the semi-arid catchment of Berambadi and in 5 piezometers in the pristine catchment of Mule Hole. In Berambadi, groundwater composition displayed a large spatial variability with Cl contents spanning 3 orders of magnitude. The results showed that the concentration factor due to evapotranspiration was on average about 3 times more than in the natural system, with higher values in the valley bottoms with deep Vertisols. Linked with this process, large concentration of Chloride originating from rain was found only in these areas. At the catchment scale, about 60 percent of the Chloride found in groundwater originates from fertilizer inputs. These results show that Potassium fertilization as KCl is an important source of groundwater salinization in semi-arid context, and stress that identifying dominant drivers is crucial for designing efficient mitigation policies.

Obesity and its association with chronic periodontitis: A cross-sectional study.

BACKGROUND: Relationship among periodontitis, obesity, and chronic diseases may be multidirectional. Inflammatory diseases such as periodontitis induce the production of pro-inflammatory cytokines such as TNF-α, IL-1, and IL-6. It has been suggested that the secretion of TNF-α by adipose tissue triggered by lipopolysaccharides from periodontal Gram-negative bacteria promotes hepatic dyslipidemia and decreases insulin sensitivity. AIM: To study the association of obesity with the severity of periodontitis and to compare the blood glucose levels and plasma lipid profile in obese and non-obese subjects with chronic periodontitis. METHODOLOGY: A total of 84 systemically healthy subjects, aged 30-60 years, were included in the study. Periodontal status of the subjects was assessed by recording Community Periodontal Index (CPI) and Gingival Index (Loe and Silness, 1963). Body mass index (BMI) and waist circumference (WC) were used as measures to assess obesity. The fasting plasma lipids level and fasting blood glucose level were measured. Data were analyzed by unpaired 't'test, Fisher's Exact test, and Chi-square test. RESULTS: There was a statistically significant difference in Gingival Index and Community Periodontal Index between the obese and non-obese group. Total cholesterol, triglycerides, and low-density lipoprotein (LDL) levels showed significant difference between the two groups. There was no statistically significant difference in mean age, high-density lipoprotein (HDL) levels, and fasting blood glucose levels between the two groups. CONCLUSION: The present study showed a positive association between obesity and chronic periodontitis. Further long-term studies involving larger sample size are required to confirm this association.

Prolonged-Release vs Immediate-Release Tacrolimus Capsules in Black vs White Kidney Transplant Patients: A Post Hoc Analysis of Phase III Data.

BACKGROUND: Black kidney transplant patients experience inferior outcomes compared with other ethnicities. Because scrutiny is required when immunosuppressant drugs are used in such at-risk populations, we report the first large-scale clinical efficacy data assessing prolonged-release tacrolimus (PR-T) in black de novo kidney transplant patients. METHODS AND MATERIALS: We used logistic regression and proportionate hazards to compare a composite outcome measure (biopsy-proven acute rejection, graft loss, mortality, and loss to follow-up) in black and white patients in treatment groups longer than 24 weeks, from 3 large Phase III randomized controlled trials. Secondary endpoints included tacrolimus trough concentration, dose, and estimated glomerular filtration rate. RESULTS: The study included 2162 patients whose treatments belonged to two categories (immediate-release tacrolimus: 77 black patients, 721 white patients; and PR-T: 87 black patients, 1277 white patients). Despite demographic factors generally predictive of worse outcomes, efficacy failure among black patients who received PR-T was non-inferior to that among white patients who received either therapy. Compared with immediate-release tacrolimus, black patients who received PR-T achieved stable tacrolimus concentrations 2.5 times faster (21 vs 56 days, P = .04), and more achieved stable target concentrations (76.7% vs 69.3%). Treatment-emergent adverse events were consistent with those reported separately in pivotal trials. CONCLUSIONS: Overall, black patients who received PR-T achieved non-inferior outcomes compared to white patients, despite higher pretransplant risk among black patients. Moreover, PR-T improved the time to achieve, and the likelihood of reaching, stable therapeutic concentrations among black patients, suggesting that PR-T could improve the consistency of tacrolimus exposure in this patient population.

Comparative study on alveolar bone healing in postextraction socket versus healing aided with autologous platelet-rich fibrin following surgical removal of bilateral mandibular impacted third molar tooth: A radiographic evaluation.

AIM: This study was to evaluate and compare the bone regeneration potential of autologous platelet-rich fibrin (PRF) placed in one of the extracted sockets after the surgical removal of bilateral impacted mandibular third molars. PATIENTS AND METHODS: Twenty-five patients (10 females and 15 males; 18-35 years old) were taken for surgical removal of bilateral impacted mandibular third molar, performed in the same session. The autologous PRF was placed in one of the extracted sockets whereas the opposite side was taken as control side, and primary closure was done. Radiographic examination with orthopantomogram was done preoperatively and 1 month, 3 months, and 6 months postoperatively to assess the degree of bone regeneration at the extracted site and compare it with the control side using MATLAB software and the data are statistically analyzed using paired t-test. RESULTS: PRF side had better healing and bone formation when compared with the control side as indicated by significant P values of (P = 0.06>5%) 1 month, (P = 0.00<1%) 3 month, and (P = 0.00<1%) 6 month postoperatively. The repeated-measures ANOVA showed a significant difference seen on 1st, 3rd, and 6th months postoperatively on PRF side (P = 0.001). CONCLUSION: The autologous PRF improves and fastens the bone regeneration and healing in the extracted sockets.

Regulation of phytosterol biosynthetic pathway during drought stress in rice.

Plants respond to drought stress in the form of various physio-biochemical and molecular changes at both cellular and molecular levels. Drought stress causes the destruction of cell membranes by disintegration of membrane lipids. One of the major groups of membrane lipids that plays important role in preserving the integrity of cell membranes is phytosterols. HMG-CoA reductase (HMGR) is the principal enzyme in the biosynthesis of plant sterols, synthesized via mevalonic acid pathway. Phospholipid: sterol acyltransferase (PSAT) is another important enzyme that plays an important role in turnover of phytosterols into steryl esters and helps maintain homeostasis of membrane lipids. In this study, the expression of both HMGR and PSAT genes in drought sensitive (IR64) and drought tolerant (N22) rice cultivars under applied drought conditions were found to be elevated. The increase in expression of these genes was proportional to the level of severity of applied drought stress. This is substantiated by the negative correlation of HMGR and PSAT expression to relative water content (RWC) and membrane stability index (MSI). Expression of PSAT was also found to be positively correlated to ABA content and HMGR expression.

Critical Review on the Analytical Mechanistic Steps in the Evaluation of Antioxidant Activity.

Electrophysiological systems are prone to release free radicals for functioning of biological system with proper balancing of antioxidant-prooxidant ratio for establishing a healthy living system. The biostress condition releases different reactive oxygen species, such as hydroxyl, alkoxyl, superoxide, hydrogen peroxide, hydroperoxyl, ozone, singlet oxygen, hypochlorus acid, thiyl radical, etc. This review tries to discuss the general aspects of the antioxidant assay methodologies that are currently used for the detection of antioxidant property. The entire review has been divided into three different sections. The first deals with the release of free radical by mitochondrial dysfuctioning and its curbing action by local antioxidants. The second and third sections discuss the general procedure adopted and reaction mechanism involved in the assay procedure along with the limitations and advantages.

Effect of surfactants and hydrophilic polymers on the stability of an antihypertensive drug candesartan cilexetil: Evaluation by HPLC.

OBJECTIVES: The objective of this study is to investigate the effect of surfactants (polysorbate 80 and sodium lauryl sulphate) and hydrophilic polymers (polyvinylpyrrolidone and polyethylene glycol 6000) on the stability of candesartan cilexetil under isothermal stress conditions (100°C, 48h). METHODS: HPLC method was employed to evaluate the drug content and formation of degradation products in stress samples. Drug and degradation products were separated on Hypersil BDS C18 (250×4.6mm, 5µ) column using acetonitrile-water (pH 2.8) in the ratio of 85:15% v/v as a mobile phase. RESULT: Similar degradation behaviour of drug was observed with polyvinylpyrrolidone, polyethylene glycol 6000 and polysorbate 80; four common degradation peaks were observed at the retention time of 3.7, 4.5, 7.8 and 11minutes. One extra common degradation peak of very low intensity was also observed with polyethylene glycol 6000 and polysorbate 80 at the retention time of 4.2min. The drug was eluting at the retention time of 5.4min. In the case of sodium lauryl sulphate, two prominent degradation peaks were observed at the retention time of 3.7 and 13.25min along with few very low-intensity degradation peaks. CONCLUSION: The drug showed 41%, 64%, 72% and 98% degradation in presence of polyvinylpyrrolidone, polyethylene glycol 6000, polysorbate 80 and sodium lauryl sulphate, respectively.

Directly observed therapy of sofosbuvir/ribavirin +/- peginterferon with minimal monitoring for the treatment of chronic hepatitis C in people with a history of drug use in Chennai, India (C-DOT).

We assessed the feasibility of field-based directly observed therapy (DOT) with minimal monitoring to deliver HCV treatment to people with a history of drug use in Chennai, India. Fifty participants were randomized 1:1 to sofosbuvir+peginterferon alfa 2a+ribavirin (SOF+PR) for 12 weeks (Arm 1) vs sofosbuvir+ribavirin (SOF+R) for 24 weeks (Arm 2). SOF+R was delivered daily at participant chosen venues and weekly peginterferon injections at the study clinic. HCV RNA testing was performed to confirm active HCV infection and sustained virologic response 12 weeks after treatment completion (SVR12). No baseline genotyping or on-treatment viral loads were performed. Median age was 46 years. All were male and 20% had significant fibrosis/cirrhosis. All self-reported history of injection drug use, 18% recent noninjection drug use and 38% alcohol dependence. Six discontinued treatment (88% completed treatment in each arm). Of 22 who completed SOF+PR, all achieved SVR12 (22/25=88%); 15 of 22 who completed SOF+R achieved SVR12 (15/25=60%; P=.05). Among those completing SOF+R, SVR12 was significantly less common in participants reporting ongoing substance use (36% vs 100%) and missed doses. Active substance use and missed doses did not impact SVR with SOF+PR. Field-based DOT of HCV therapy without real-time HCV RNA monitoring was feasible; however, achieving 100% adherence was challenging. SOF+PR appeared superior to SOF+R in achieving SVR12, even when doses were missed with no discontinuations due to side effects. Further exploration of short duration treatment with peginterferon plus direct-acting antivirals is warranted.