COMPASSIONATE USE - Compassionate use is a term used for a type of clinical research trial often conducted by a physician in private practice apart from licensing trials. The physician has to have an IND (individual new drug number) which has to be acquired from the FDA. There are no placebos. The person to whom the drug is given often doesn't meet the inclusion/exclusion criteria for a phase 3 licensing trial and will have no other therapeutic alternatives. Informed consent is still given and the compassionate use has to go through an institutional review board. ICN does not have compassionate use program that provides Ribavirin for free to people with proof of chronic hepatitis C who can not afford or do not qualify( unlike Schering-Plough for Interferon ).

MEXICO - In Mexico Ribavarin is called Ribavarina and is callel by the product names Virazide or Vilona. Amantadine is called Amantadina. Both are readily available at many farmacias and you do not need a prescription to purchase them there. Latest reports of pricing: Ribavirin 96 capsules (400 mg) $300-350 Amantadine 100 tablets (100 mg) $30 - $50. If you do not speak Spanish: Bring a pen and piece of paper and write things down for the farmacia employees. Instead of having to constantly translate things, just write down: "96 capsulas Ribavirina" then, write down, "$350 US," etc. This will save time, and prevent misunderstanding. - TIJUANA( across from San Diego, California ) - This Farmicia is only a few blocks across the border( within a walking distance ): Vania Farmacia Juan Valencia Centro Commercial - Viva Tijuana - Local 2202 - Ed. #22( or Via Del Amistad 8800 #2 ),  Tel( from US ): 011-52-66-824877. Price( 8/25/98 ): 18 capsulas( 400 mg ) of Vilona is 560 pesos( $62 ), but also ask for 10% off.  Visa and MC accepted. If you are driving, take the first right after the border, and then right again, farmacia is on a square with circular car traffic and next to a bus station/depo.- MATAMOROS( across from Brownsville, Texas ) - If you are going there yourself, the Farmicia is in the "old market" area, a popular place that is known to all Mexican taxi drivers. These folks will allow you to order by phone. If you are taking this route, get an international operator to make the call for you. Only one person speaks English at the Farmacia, so get someone who is bi-lingual to help you make the call. The contact will tell you the total amount to remit and will give you all the instructions. With your order, they require that you send a letter (in English is OK) that states the details of your request (medication name, quantity, capsule dosage...ex. 400 mg. capsules, and total amount enclosed) and your name and mailing address. Payment will be required in advance and a charge (around $20 for U.S. shipments) will be added for packaging and mailing costs: The contact person is Christina de Delgado. Farmacia Regis Centro Tel: 91(88) 13-85-79 or 91(88) 12-04-17 or 91(88) 13-68-54 Fax: 91(88) 16-64-59 10a Abasolo Y Matamoros H. Matamoros, Tam., Mexico Visa & MC are not accepted

LONDON - Interlab BCM Box 5890 London, WC1N 3XX, England Latest reports of pricing: Ribavirin 100 capsules (100 mg) $68 US 400 capsules (100 mg) $250 US

HONG KONG - Another safe port for Ribavirin and other medications is Hong Kong. One nonprofit company endorsed by Life Extension Foundation: Libertarian Solutions GPO Box 12496 Hong Kong Latest report of pricing: 100 capsules (400 mg) $360 US. 


SUBFULMINANT SYNCYTIAL GIANT CELL HEPATITIS: recurrence after liver transplantation treated with ribavirin

François Durand, Claude Degott, Alain Sauvanet, Georges Molas, Christian Sicot, Patrick Marcellin, JacquesBelghiti, Serge Erlinger, Jean-Pierre Benhamou and Jacques Bernuau; Journal of Hepatology, Volume 26 - issue 3( March 1997 ) - page 722 - 726

We report the case of an adult patient affected by acute syncytial giant cell hepatitis which had a subfulminant course leading to liver transplantation. Syncytial giant cell hepatitis recurred after transplantation and was efficiently treated with ribavirin. In this patient, the recurrence of the disease, the presence of filamentous strands on electron microscopy during both bouts of hepatitis and the efficacy of ribavirin on post-transplantation hepatitis suggest that the disease was caused by an original virus. This observation also suggests that early administration of ribavirin in patients affected by acute syncytial giant cell hepatitis of unknown origin could avoid liver transplantation. 


INTERFERON-RIBAVIRIN COMBINATION THERAPY

Following preliminary reports of small studies that suggested a clinically important enhanced benefit from combination therapy with interferon-a (IFN) and ribavirin over IFN monotherapy in chronic hepatitis C, a meta-analysis of data from these studies was performed to estimate the efficacy and tolerability of combination therapy in chronic hepatitis C.

Records were obtained from 59 patients who had received combination therapy with IFN 3 MU three times weekly and ribavirin 1000-1200 mg daily for six months and were followed for six months after stopping combination therapy. Outcome measures included the percentage of patients showing ALT normalization and HCV-RNA negativity six months after therapy (sustained response) and the percentage of patients stopping therapy because of side effects. Sustained response was observed in 21% of IFN nonresponders and in 60% of patients who had relapsed after IFN. For naive patients, the estimated sustained response rate was 52%; the observed response rate was 46%. No serious adverse effects were noted; less than 10% of patients discontinued study medication.

This meta-analysis of IFN-ribavirin combination therapy for chronic hepatitis C suggests that combination therapy results in a two- to threefold greater efficacy than IFN monotherapy, whereas side effects are similar to IFN monotherapy, with the exception of ribavirin-induced anemia. Interferon-ribavirin combination therapy might become the next step in antiviral therapy for chronic hepatitis C.

Author: SCHALM SW, ERASMUS UNIV ROTTERDAM, HOSP DIJKZIGT, DEPT INTERNAL MED 2, HEPATOL SECT, NL-3015 GD ROTTERDAM, NETHERLANDS Source: DIGESTIVE DISEASES AND SCIENCES 1996 DEC;41(12):S 131-S 134


RIBAVIRIN INTERFERON COMBINATION WITH PHLEBOTOMY

Background : Alpha interferon is currently the only licensed drug for Chronic Hepatitis C (=CHC). As monotherapy it is unsatisfactory. Recent data from several countries suggest that Ribavirin interferon combination (=Ribinf) is an important improvement. There are also indications that phlebotomy is beneficial in CHC.

Aim to evaluate Ribinf in CHC patients who were either relapsers or non responders to previous interferon therapy. Methods We undertook a 1 year open trial of Ribinf (interferon alpha 2b 9MU/WK plus Ribavirin 1000 mg/dy for wt<75Kg, 1200 mg/dy for wt>75Kg) in 21 selected CHC patients. Patients also underwent phlebotomy, mostly prior to Ribinf, aiming at serum ferritin of 10 ng/ml.

Patient's characteristics: Mean age: 48 ± 13 (range 16 to 68), 13 women, genotypes: 1b-18, 3a-2 ND-1. Relapsers/non responders: 8/13 Histology:CIR-3, CPH-2, CAH-5, CAH+Fib-9, ND2

Results Alt levels declined into normal range in 20/21 patients. As shown in the figure, Mean levels for the group (expressed as multiples of the upper limit of normal values.) and 9 out of 16 patients tested, became serum HCV RNA negative.

The combination had few side effects and was well tolerated. Hemoglobin dropped approximately 2 g/dl. The lowest hemoglobin value recorded in the group was 9 g/dl. One patient developed thyrotoxicosis and continues treatment. There were two dropouts - a patient who developed depression, and one for unrelated causes.

Conclusions: Ribinf (with prior phlebotomy) yielded a 95% biochemical response rate in less than 120 days. Our patients were predominantly non responders to previous INF therapy with the unfavorable genotype 1b. These results are markedly better than the widely quoted approximately 50% biochemical response rate at the end of INF treatment. Ribinf and phlebotomy either alone or with other modalities, are an important addition to our therapeutic armamentarium.

Y. Lurie,?(1) M. Beer-Gabel,(1) S.D.H. Malnick,(2) I. Lambort,(1) T. Soumatzki,(1) A. Kaftory,(3) A. Fink,(3) D. Ketter,(1) M. Cooper,(4)M. Illuz,(1) Y. Bass Elhanany, (5) D.D. Bass,(1) 1. Institute of gastroenterology 2. Dept. of medicine "C" 3. Division of laboratories 4. Pediatric Day-care 5. Pharmacy, Kaplan Hospital Rehovot, Israel. From: American Gastroenterology Association Digestive Disease Week meeting in Washington in May 1997. 


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