Hepatitis C currently infects more than 170 million people around the world, leading to significant morbidity and mortality. The current standard of care for HCV infection, including one of the two protease inhibitors, telaprevir or boceprevir, for 12-32 weeks, along with pegylated interferon alfa-2a (PEG-IFN-α) and ribavirin for up to 48 weeks, is unsatisfactory in many cases, either because of lack of efficacy or because of treatment-related adverse effects. There is an urgent need of new drugs with improved efficacy as well as a safety profile. Sofosbuvir, a recently approved nucleotide analog, is a highly potent inhibitor of the NS5B polymerase in the Hepatitis C virus (HCV), and has shown high efficacy in combination with several other drugs, with and without PEG-INF, against HCV. It offers many advantages due to its high potency, low side effects, oral administration, and high barrier to resistance. The efficacy and safety were demonstrated in many large and well-designed phase 2 and phase 3 clinical trials like NEUTRINO, PROTON, ELECTRON, ATOMIC, COSMOS, FUSION, FISSION, NUCLEAR, POSITRON, and the like. It is generally well-tolerated. Adverse events that occurred include: Headache, insomnia, fatigue, nausea, dizziness, pruritis, upper respiratory tract infections, rash, back pain, grade 1 anemia, and grade 4 lymphopenia; however, the exact safety profile can only be judged when this drug is actually used on a large scale.
Multidrug-resistant tuberculosis (MDR-TB) is a global public health problem. It requires treatment with combination therapy consisting of four to six drugs including combinations of bactericidal and bacteriostatic drugs, usually for a period of 2 years. There is alarming rise in MDR and XDR-TB all over the world and better treatment options are needed to control the global MDR-TB and XDR-TB epidemic. Drugs which can shorten the treatment duration and which are free from serious adverse effects are urgently needed. Bedaquiline (TMC-207) is a newly FDA approved anti-TB drug, having unique mechanism of action i.e. causes inhibition of the proton pump activity of the ATP synthase in M. tuberculosis and targets the energy metabolism. It is found to active within macrophages, and is a promising agent in shortening the duration of anti- TB treatment. It is metabolized by CYP3A4, so interactions with inducers and inhibitors of this enzyme are expected. It has shown promising results in preclinical and clinical studies and it seems to be a good option for MDR and XDR-TB. Adverse effects reported in various studies were of mild nature except nausea which was the most commonly associated. Few cases of prolongation of QT intervals were reported, so it demands careful monitoring and use of bedaquiline as a reserve drug for patients in whom conventional regimens are not effective. Currently it is approved as part of combination therapy in adults of ≥18 year with pulmonary MDR-TB. Long term studies are needed to explore its full safety profile. [Int J Basic Clin Pharmacol 2013; 2(2.000): 96-102
We report a case of congenital tuberculosis, a rare entity itself; complicated by pulmonary interstitial emphysema, thus leading to air entrapment in lungs and prolonged oxygen dependence. The diagnosis of congenital tuberculosis is often missed and under-reported due to low index of suspicion and less sensitivity of diagnostic tools.
A 46-years-old male, with past history of road traffic accident and with no current/past history of substance abuse and no family history of sleep-walking, took zolpidem 10 mg without any prescription and after few days, the patient's son noticed the patient waking up in the middle of night and walking into their room with a staring expression and some incoherent speech. The patient had no memory of this event in the morning. This sleep-walking episode was attributed to zolpidem, as no medication change was made besides new start of zolpidem and the patient had no history of such episodes in the past. Zolpidem treatment was stopped, and since then, no further complaints of sleep-walking were reported.
Aims:The aim was to compare efficacy and cost-effectiveness of bimatoprost 0.03% and brimonidine 0.2% in primary open-angle glaucoma (POAG)/ocular hypertension (OHT).Settings and Design:Open, randomized, cross-over, comparative study.Materials and Methods:Forty patients of POAG or OHT with intraocular pressure (IOP) <30 mm Hg were included in the study after a written informed consent. The patients were divided randomly into two groups of 20 patients each. Patients of group A were administered bimatoprost 0.03% eye drops once daily, and those of group B brimonidine 0.2% eye drops twice daily for a period of 4 weeks. After a washout period of 4 weeks, the patients were crossed over that is, group A was administered brimonidine 0.2% and group B bimatoprost 0.03%. Fall in IOP at 4 weeks was recorded. The daily cost of each drug was calculated by maximum retail price and the average number of drops per bottle. The cost-effectiveness was then calculated as the cost of drug/mm Hg fall in IOP.Statistics:Independent samples t-test was used to compare the efficacy of both drugs.Results:IOP lowering with bimatoprost (8.9 ± 1.598 mm Hg) was significantly (P < 0.0001) higher than brimonidine (6.55 ± 1.26 mm Hg). The number of drops/ml were 33.43 ± 0.52 and 25.49 ± 0.26, respectively, for bimatoprost and brimonidine. Treatment with bimatoprost was costlier than brimonidine with daily costs/eye Rs. 4.02 ± 0.06 and 3.14 ± 0.03, yearly costs/eye Rs. 1467.46 ± 20.74 and 1147.75 ± 11.15, respectively. Bimatoprost was more cost-effective than brimonidine with the cost-effectiveness ratio (CER) respectively Rs. 13.10 ± 2.61/mm Hg and Rs. 13.96 ± 2.86/mm Hg. Incremental CER Rs. 10.43/mm Hg implies lower costs/mm Hg extra IOP lowering by bimatoprost than Rs. 13.96 for brimonidine.Conclusion:In spite of being costlier, bimatoprost is more efficacious and cost-effective than brimonidine.
Drug reaction with eosinophilia and systemic symptoms (DRESS) is a life threatening cutaneous drug reaction with visceral involvement and hematological abnormalities. Being a rare side effect, it is often under-reported and misdiagnosed. The fatal adverse drug reaction is associated most commonly with aromatic anti-epileptics phenytoin, carbamazepine and less frequently with phenobarbitone. Here, we report a case of phenobarbitone induced DRESS in a 1 year old male child. He succumbed to fulminant hepatic failure inspite of being put on steroids, hepatoprotectives, antibiotics and ventilatory support. [Int J Basic Clin Pharmacol 2013; 2(3.000): 333-335
Background: Understanding the magnitude and clinical profile of pediatric HIV is essential for the clinicians and policy makers. The study was aimed to determine the rate of HIV seropositivity in pediatric patients with high risk clinical profile, study the clinical presentations and the mode of transmission of HIV in children.Methods: This prospective hospital-based study to screen 244 children aged 18 months to 12 years with high risk clinical profile for HIV seropositivity was carried out for a period of 1 year.Results: Of the 244 children screened, the commonest clinical features associated with high risk profile were failure to thrive in 200 (81.97%), persistent fever in 151 (61.89%), chronic diarrhoea in 76 (31.15%), cough >1month 112 (45.90%) patients. HIV seropositivity was reported in 11/244 (4.51%) patients; with failure to thrive in 10/11 (90.90%), chronic diarrhoea in 09/11 (81.81%), seborrheic dermatitis in 2/11 (18.18%) patients followed by persistent cough, severe malnutrition, oral thrush, generalized lymphadenopathy and recurrent bacterial skin infections in 1 patient each out of 11(9.09%). Chronic diarrhoea was a significant independent clinical risk factor for predicting HIV seropositivity (Chi2 = 13.81, p<0.001, Odds ratio=11.15). The probability of HIV seropositivity increased significantly with the number of risk factors concomitantly present, with 30% seropositivity in those with four clinical risk factors (Chi2 =32.89, D. F=1, P<0.001). The parents of all seropositive children were seropositive.Conclusions: The probability of HIV infection in a child depends upon the nature and number of clinical manifestations present. All HIV positive children h HIV positive parents in this study indicating vertical transmission.
Background: Multi-Drug resistant tuberculosis, has emerged as a challenge to public health due to long duration of treatment with high pill burden, associated adverse drug reactions. We have thus investigated the adverse drug reactions with MDR-TB Cat-IV regimen under programmatic study settings and analysed the impact of these ADR's on culture conversion. Methods: This prospective cohort observational study was conducted at DOTS-PLUS site, Amritsar, Punjab (India). Adverse drug reactions reported by Eighty consecutive MDR-TB patients,and recognized by laboratory and/or clinical evidence were recorded after informed consent.The culture conversion rates at 6 months in patients with adverse drug reactions and without adverse drug reactions were compared using Chi2 exact test. Results: A total of eighty patients reported 76 adverse drug reactions, with a mean age 32.38± 13.60 years, male: female ratio of 5:3. Forty two (52.5%) patients experienced at least one adverse event.The adverse effects warranted discontinuation of the suspected offending medicine in 22(27.5%) patients. The rates of occurrence of ADR's were: Gastrointestinal side effects:31.25%, Ototoxicity:23.75%, psychiatric symptoms:11.25%, arthralgia/ hyperuricemia: 10%, hepatotoxicity: 5%, nephrotoxicity: 5%, injectable related problems: 3.75%, skin rash:2.5%, peripheral neuropathy:2.5%. The difference in culture conversion rates in patients with ADR's(50%) and without ADR's(52%) was not statistically significant (p value 0.6474,odds ratio 0.75,95% CI 0.3042 to 1.849) Conclusion: There is a high frequency of ADR's in MDR-TB cases.When appropriately monitored and managed,ADR's do not effect rates of culture conversion .Newer and less toxic drugs are urgently needed to treat MDR TB patients.
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