Blank

Emtricitabine nda

Common Questions and Answers about Emtricitabine nda

truvada

Avatar f tn I was also a reciever. After 40 hours I went to the first clinic and they gave me PEP (TenofovirDF, emtricitabine + lamivudine). The clinic looks very unprofessional, but it was my only chance. I didn't do any hiv or std test, a month before the exposure i had HIV test which was negative. After few days I had a mild sore throat, i still have it, i don't have fever, running nose, rash or anything else. My questions are..
Avatar m tn An international study found the antiviral combination of tenofovir and emtricitabine (Truvada) was most effective in treating younger adult hepatitis B patients with high viral load and normal ALT levels. Doctors historically have not treated this group because there appeared to be no sign of liver damage. However, doctors now know that high viral loads may increase patients’ risk of liver damage and cancer as they age, despite their normal ALT levels.
181575 tn?1250198786 Atripla is a drug used to treat HIV. It actually consists of 3 drugs, emtricitabine and tenofovir (which also works against HBV) and efavirenz (doesn't work against HBV). Combination treatment is common practice for HIV so they combine multiple drugs into 1 pill. Of course Atripla is NOT an FDA approved therapy for HBV. Sometime in the future when the standard practice is combo treatment for HBV, they will combine entecavir and tenofovir into 1 pill and call it XcalibR 300.
Avatar m tn What are my chances of getting infected. Another question was administered a PEP drug emtricitabine and tenofovir, can it prevent me from contracting HiV.
Avatar m tn Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
29837 tn?1414534648 Spoke to my contact at Vertex today. They are still compiling all data for the NDA (New Drug Application) of Telaprivir. This means they are hopeful all data will be submitted to the FDA before the end of the year. Unfortunately, this means more waiting. However, once they do present the final data, there will be a Fast-Track priority for the FDA to approve or not approve the drug. Once all the data is in the hands of the FDA scrutinizers, they have to approve or disapprove within 6 months.
29837 tn?1414534648 Merck has started to start applying; "We are excited by the results of these pivotal studies," said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories. "In these studies, boceprevir substantially increased success rates compared to standard therapy, both for patients who received 48 weeks of treatment and for patients treated with the response-guided therapy approach, many of whom were able to be treated for 28 to 36 weeks," he added.
Avatar m tn Gilead filed the NDA (new drug application) for ledipasvir/sofosbuvir (LDV/SOF) February 10, 2014 and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options.
Avatar m tn This meeting is to discuss the treatments for hepatitis C that Gilead has submitted to the FDA for approval in April of this year. Gilead filed the NDA (New Drug Application) for sofosbuvir on April 8, 2013.
Avatar f tn Before getting pregnant, my HBeAg was (-) and NDA viral load was 10 log 3. Now after 3 months, my HbeAg turns (+) and NDA viral load increases to 10 log 6, and my ALT is 43 (normal upper range is <40). My ALT was well below the uppper range before. My doctor prescribed Zefffix to be taken 1st week of month 5 prenancy but I am reluctant to take as I dont know what it will do to my little one. Any advice please!! I am so confused now. Thank you all!!
Avatar m tn This is a potential concern because the drugs in Truvada – tenofovir and emtricitabine – are active against HBV as well as HIV. HIV and HBV are spread through some common transmission routes, including sexual transmission, vertical transmission (mother to child) and via multi-person use of injection equipment.
Avatar f tn I asked her of her status and she stated clean. I started PEP within 24 hours. (Teneogovir, emtricitabine, lamivudine ) What are the odds of being infected ? is this low risk ?
Avatar m tn I started a course of PEP that included Tenvor-EM (Indian version Emtricitabine/Tenofovir DF) and Kaluvia (generic of lopinavir/retonavir) for 25 days and interrupted it for two reasons: 1-My partner tested Negative(Antigen/ Antibody) on 22 days post exposure 2-Thinking that i might be developing facial Lipodystrophy (slight facial fat loss under cheek bones). I cant tell if my face was like this before the treatment or it is just an illusion.
29837 tn?1414534648 Because of my persistence, I received three phone calls from the FDA today. I'm going to now present you with the clarity of what's about to happen with the "Rolling NDA" (New Drug Application) from Vertex and other pharmaceutical companies. A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference.
Avatar f tn Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.