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Hep C Discussion Forum -> Hep C News -> A "new?" NS5A - "PP1-668" (Ravidasvir)
Post Info TOPIC: A "new?" NS5A - "PP1-668" (Ravidasvir)
Canuck


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RE: A "new?" NS5A - "PP1-668" (Ravidasvir)
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So, I guess our new-"er" lower-cost powerhouse NS5A ravidasvir (RAV) is finally taking off (after a very slow start). In China anyway, as opposed to other countries such as Malaysia where RAV has been paired with NS5B (SOF) to be a double ... in this article, in China they have been and they are pairing RAV with a NS3/4A danoprevir - apparently China has not been using a NS5B like (SOF) with the NS5A (RAV) but will be using the NS5A RAV paired with a NS3/4A danoprevir instead (and also boosting the danoprevir with ritonavir, and, adding riba - yuck to the riba)! Oh well. Why exactly China is opting to utilize this NS3/4A-based 4 drug cocktail, including riba, versus doing what other countries have done (which was coupling the RAV with SOF - I am quandrying what the likely reasons are that they are wishing to use the 4 drug formula - I will have to do better/further reading on the actual past China trials on the 4 drug formula versus using RAV as a double.

  

Helio - HCV/Next

Ravidasvir for HCV added to Chinese FDA priority review list

 
 
October 22, 2018

The Chinese Food and Drug Administration added Ascletis? hepatitis C NS5A inhibitor ravidasvir to the list of proposed priority review to accelerate its new drug application process, according to a press release.

?We launched our first breakthrough HCV regimen 3 months ago,? Jinzi J. Wu, PhD,chairman and CEO of Ascletis, said in the release. ?The priority review for ravidasvir NDA will accelerate the launch of Ascletis? all-oral regimen. This will enable Ascletis to soon provide two breakthrough HCV treatment regimens for Chinese patients and further strengthen our leadership position as an integrated solution provider in HCV treatment in China.?

The Chinese Food and Drug Administration added Ascletis? hepatitis C NS5A inhibitor ravidasvir to the list of proposed priority review to accelerate its new drug application process, according to a press release.

?We launched our first breakthrough HCV regimen 3 months ago,? Jinzi J. Wu, PhD,chairman and CEO of Ascletis, said in the release. ?The priority review for ravidasvir NDA will accelerate the launch of Ascletis? all-oral regimen. This will enable Ascletis to soon provide two breakthrough HCV treatment regimens for Chinese patients and further strengthen our leadership position as an integrated solution provider in HCV treatment in China.?

Results from a study published early in 2018 showed that ravidasvir in combination with Ganovo (ritonavir-boosted danoprevir, Asceltis) provided 100% sustained virologic response among patients with HCV and baseline NS5A resistance mutations after 12 weeks of treatment.

The WHO also recently added ravidasvir to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C.

Reference: www.ascletis.com



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Canuck


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Brother!, at a snails pace this "ravidasvir" has taken off! Since Egypt, this NS5A's efficacy (as a double with sof) cannot be doubted. Slooooo-mo, lo-cost cures. 

 

From Helio - HCV Next

WHO adds ravidasvir to HCV recommendation guidelines - August 9, 2018

The World Health Organization has added ravidasvir as a future pangenotypic direct-acting antiviral to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C, according to a press release.

We are so excited that ravidasvir is recommended as a pangenotypic DAA by the WHO HCV guidelines, Jinzi J. Wu, PhD, founder, president and CEO of Ascletis Pharma, said in the release. Ravidasvir is not only recognized by international academic communities, but also recognized by an internationally renowned public health organization. 

  • Previously, ravidasvir has demonstrated high sustained virologic response rates in combination with other approved DAA regimens.

One study of combined ravidasvir with Sovaldi (sofosbuvir, Gilead Sciences) among Egyptian patients had an overall SVR rate of 98%. Another study in Egypt with the same combination resulted in a rate of 97%.

(See also: Combination sofosbuvir, ravidasvir effective in HCV genotype 4)

Additionally, ravidasvir plus ritonavir-boosted danoprevir with ribavirin for 12 weeks resulted in 100% sustained virologic response among a cohort of Asian patients with hepatitis C genotype 1 without cirrhosis.

According to the release, a recent phase 2/3 clinical trial of ravidasvir with Ascletis Ganovo demonstrated an overall cure rate of 99% over a 12-week course in Chinese patients with HCV genotype 1 and a rate of 100% in patients with NS5A resistance mutations.

References: www.ascletis.com

Andrieux-Meyer I, et al. Abstract LBP-032. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.



-- Edited by Canuck on Tuesday 14th of August 2018 05:24:56 AM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Tig


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Well dang! I missed this one. The only reason it's not front page news is that Big Pharma won't get rich off it. What an absolutely incredible price and cure rate. I think (I know), the answer to the eradication of this disease is generic medication and the costs they clearly save everyone. When they want to get serious, they'll have to do what they already know...



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Tig

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Canuck


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Article (update) about ravidasvir (RAV) coming out of the current "Liver Meeting" going on in Paris.

Sounds much like the successful sof/dac what with the 12 and/or 24 weeks course durations. And the very good SVR success rates at par and competitive with a lot of the new DAA's - certainly can't beat the nice price and prize for countries such Malaysia/ Thailand! Quite a little powerhouse Egypt created in their NS5A (RAV)!

 

Helio - Meeting News

$300 HCV combination reaches 97% cure rates in Malaysia, Thailand

 
 
April 13, 2018

PARIS - Using a new medication and generic sofosbuvir, researchers reached 97% sustained virologic response in patients with hepatitis C both with and without cirrhosis; in this exclusive video from the International Liver Congress 2018, Drugs for Neglected Diseases Initiative (DNDi) addresses the impact of this research.

"These countries are interested by our commission to contribute to their national program," Isabelle Andrieux-Meyer, MD, head of clinical development for HCV at DNDi, told Healio Gastroenterology and Liver Disease. "This is really what we're trying to figure out: how do we do a very good clinical development, but also taking into account the affordability and accessibility of the treatment later on."

In the late-breaking poster presented at ILC 2018, DNDi showed data from 300 patients with a variety genotypes, cirrhosis status, HIV coinfection and prior exposure to HCV treatments. These patients received sofosbuvir and ravidasvir, both medicines produced by Egyptian drug manufacturer Pharco Pharmaceuticals, for 12 weeks if without cirrhosis and 24 weeks if with compensated cirrhosis.

Overall, SVR12 was reached in 97% (95% CI: 94.4-98.6). Cure was achieved in 96% of those with cirrhosis, 97% of those with HIV, 97% of those with genotype 3 and 96% of those exposed to prior treatment.

"From a treatment provider perspective, this is very exciting as we have been waiting for a simple, affordable, robust treatment tolerated by all patients groups, including those whose treatment outcomes are currently poorer, like patients under antiretroviral therapy," said Pierre Mendiharat, deputy operations director for Doctors Without Borders, which supported this study. "This will be crucial to expand treatment to the most vulnerable categories of patients in developing countries."

This study was co-sponsored by the Malaysian Ministry of Health.

For more information:

Andrieux-Meyer I, et al. LBP-032. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.

Disclosure: Andrieux-Meyer is an employee of DNDi, which is a non-profit organization.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Canuck


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Since prior posts (below) there has been some further scattered talk about the explorations of RAV and SOF (with and without riba) mostly in GT4's, and mostly in other mid and low income countries, but this is the most recent article I have seen pop up on the use of this double, just now. Obviously more and more data will keep surfacing for us to follow on this combo, as more GT's and populations receive it. I note in Egypt, where they have this huge population of GT4's, that they have finally managed, recently, to get about 800,000+ of their people sucessfully treated (whether that be with RAV or other drugs), still, no small feat! We still have yet to see how pan this "pan" turns out to be.

 

 

Helio - IN THE JOURNALS - Esmat G, et al. J Hepatol. 2017;doi:10.1016/j.jhep.2017.09.006. - December 20, 2017

Combination sofosbuvir, ravidasvir effective in HCV genotype 4

 

For patients with hepatitis C genotype 4, treatment with ravidasvir and sofosbuvir, with or without ribavirin, was safe and effective regardless of cirrhosis or previous interferon-based treatment experience.

"[Ravidasvir (RDV)] is a pan-genotypic anti-HCV NS5A inhibitor with a favorable pharmacokinetic profile, rapid plasma concentrations, and high [24-hour] trough concentrations, allowing for continuous HCV inhibitory drug concentrations with once daily oral dosing," Gamal Esmat, MD, from Cairo University, Egypt, and colleagues wrote. "RDV achieves steady-state with the first dose, and from day 2 onward, peak and trough levels remain constant without evidence for either subsequent drug accumulation or drug induced clearance."

The study comprised 298 adult patients with HCV genotype 4 and no coinfection with hepatitis B, HIV or mixed genotypes. One group of patients (n = 149) were treatment naive, 59 of whom had cirrhosis. A second group (n = 149) had unsuccessfully undergone treatment with interferon-based therapy previously, 70 of whom had cirrhosis.

During the study, seven patients were lost to follow-up due to withdrawn consent, a serious adverse event unrelated to treatment, or death unrelated to treatment.

At the end of 24 weeks, 282 patients achieved sustained virologic response (94.6%; 95% CI, 91.5-96.7). Two patients did not return for their 12 week SVR assessment, but met SVR at 24 weeks; including these two patients increased the SVR rate to 95.3% (95% CI, 92.3-97.2).

The researchers observed no virologic failures in patients without cirrhosis. Seven patients with cirrhosis experienced virologic relapse, three of whom were treatment-experienced. The SVR rate, however, was similar between all treatment-naive and treatment-experienced patients.

While cirrhosis did decrease response in certain patients, the addition of ribavirin did not affect therapy outcome.

Throughout both groups, 69% of patients reported adverse events. Most adverse events were mild or moderate and the most common included headache, fatigue, abdominal pain and pruritus. The researchers judged that approximately half of the reported adverse events were unlikely related to therapy.

Eleven severe adverse events occurred in 11 different patients, two of which led to study discontinuation. The two severe adverse events that led to discontinuation included a case of hearing impairment and a transient episode of symptomatic bradycardia.

"While there are several very effective treatments for HCV [genotype 4], the combination of [sofosbuvir (SOF) and RDV] has the potential to be a very cheap option both in Egypt (with the availability of generic SOF, and with RDV developed by a local company that is promising a very cheap local market price) and to all low and middle income countries (LMICs) through its development with Drugs for Neglected Diseases Initiative, who are also promising to make medications for HCV affordable to all LMICs (including this combination if ongoing trials in other genotypes also prove effective)," the researchers concluded. - by Talitha Bennett

Disclosure: Esmat reports he received financial support from AbbVie, Gilead, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Pharco and Roche. Please see the full study for the other authors' relevant financial disclosures.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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alinaborodina


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Sofosbuvir plus the investigational HCV NS5A inhibitor ravidasvir, with or without ribavirin, cured 95 to 100% of people with hepatitis C virus (HCV) genotype 4, the most common type in Egypt, according to findings from the Pyramid 1 study presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016). As of record More than 1 million people are estimated to be chronically infected with HCV in Thailand and 400,000 in Malaysia (genotypes 1, 3, and 6). Both countries have been excluded from all global voluntary licensing agreements with drug companies that have developed effective treatments for HCV that include low and some middle income countries. In the short term, DNDi will focus on combining SOF already registered for hepatitis C and RDV a drug candidate developed by Presidio and licensed to Pharco to evaluate pan-genotypic activity in Thai and Malaysian populations.

As far as the medicine will be a great boost for middle income countries in fighting of Hepatitis, it also encourages to make new medicines with more effective and affordable way. when i used to think about affordable medicine one middle income country comes in my mind, India who is the major supplier of generic medicines to the world in a very affordable price. Lets see what the future will bring in.

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Canuck


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RE: A "new?" NS5A - "PP1-668" (Ravidasvir)
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Just another write up I found on Rav, not really a lot of "new" data on it, just a new write up about it, and which GT's they now wish to recruit:

EASL 2016: $300 Hepatitis C Combination with Ravidasvir to Enter Clinical Trials   Published on Friday, 15 April 2016 00:00     Written by Keith Alcorn

The Drugs for Neglected Diseases Initiative (DNDi) is launching clinical trials in Thailand and Malaysia to test a combination of sofosbuvir and ravidasvir, an NS5A inhibitor, in at least 800 people with all genotypes of hepatitis C virus (HCV). The combination, manufactured by Egyptian company Pharco, could be made available for $300 for a course of treatment if it proves safe and effective, DNDi executive director Bernard Pécoul announced ahead of the 2016 EASL International Liver Congress this week in Barcelona. The studies will aim to test an affordable pangenotypic combination and to provide data for regulatory submission.

Affordable pangenotypic treatment would allow many lower- and middle-income countries to treat a wide range of people with hepatitis C, without the need for genotype testing, reducing the cost of treating each patient.

Ravidasvir has already been studied in patients with genotype 4 HCV infection in Egypt, where a recently presented study showed that a combination of ravidasvir and sofosbuvir (Sovaldi) cured between 86% and 100% of treated people, according to duration of treatment and whether ribavirin was included in the regimen.

The studies in Malaysia and Thailand will test the combination in comparison with sofosbuvir and daclatasvir (Daklinza), the only currently recommended pangenotypic combination. The studies will test the combination using a public health approach, where the only criterion determining treatment eligibility will be cirrhosis status. Study participants who do not have cirrhosis will receive a 12-week course of treatment, while people with cirrhosis will receive a 24-week course.

The study will recruit people with all genotypes of HCV; genotypes 3 and 6 are particularly prevalent in both countries, "and we wanted to test in countries with a large genotype range -- and particularly 3 and 6 which are the most complex to treat," Pécoul said.

The studies will examine efficacy, safety, and pharmacokinetics of the study drugs with a view to providing clinical as well as manufacturing data for regulatory submission -- including World Health Organization (WHO) pre-qualification -- of the ravidasvir/sofosbuvir combination manufactured by Pharco.

The studies will also provide data on drug-drug interactions, in particular with antiretroviral drugs for HIV treatment. The prevalence of coinfection with HIV and HCV is high in Thailand, and these data will also be especially relevant in Brazil, Eastern Europe, and southern Europe, where coinfection is common.

Recruitment will begin in July 2016, and the 300-person Malaysian study aims to complete recruitment within 3 months, indicating that study results may become available during 2017. DNDi also hopes to study the combination in populations in South Africa and Mozambique, where HCV genotype 5 predominates.

The study forms part of a 5-year strategy for development of affordable treatments for hepatitis C launched by DNDi. The cost of hepatitis C treatment is a major barrier to curing people and eliminating hepatitis C as a public health problem. The original sofosbuvir product, Sovaldi, manufactured by Gilead Sciences, costs around $84,000 in the U.S., $53,000 in the U.K., and $27,900 in Spain (although prices paid might be considerably lower due to negotiations regarding volume).

Voluntary licensing agreements between Gilead and Indian manufacturers have resulted in very large cost reductions. A recent analysis suggests that the cost of manufacturing a combination of sofosbuvir and daclatsavir in India might fall to under $200 if order volumes continue to grow. But purchase of the Indian generic versions of the drugs is restricted to named lower-income countries, and many middle-income countries are excluded from purchasing generic versions of each drug by the terms of voluntary licensing agreements.

Malaysia and Thailand are among the many middle-income countries that are excluded from the voluntary licensing agreements that Gilead and Bristol-Myers Squibb, the intellectual property holders of sofosbuvir and daclatasvir, respectively, have concluded with generic companies. Of the up to 150 million people with chronic hepatitis C globally, approximately 75% live in middle-income countries.

Achieving widespread access to a combination regimen at less than $300 per course of treatment will require some governments to take decisions regarding which tools they can use to reduce the price of sofosbuvir. For some countries, this will be taking advantage of voluntary licenses; for others it will be use of the TRIPS-Plus provisions of international trade agreements, which allow governments to oppose patent applications or to override patents and use compulsory licenses on public health grounds.

The licensing status of ravidasvir means that it will be widely available at an affordable price. Ravidasvir was licensed to Pharco by Presidio, a San Francisco-based biotechnology company, for manufacturing in Egypt. Presidio has licensed ravidasvir separately to DNDi in a range of middle-income countries with a higher burden of hepatitis C including India, Brazil, South Africa, Thailand, Indonesia, and South Korea. DNDi also has an option to take up a license to sell the drug in higher-income countries (Europe, North America, Australasia, and Japan) starting in March 2018. No patents cover lower-income countries in Africa and Asia. Ravidasvir is licensed to other companies in North Africa, the Middle East, Russia and China.

Pharco chief executive officer Sherine Helmy told a press conference that he hopes that the price of the combination will fall by $50 a course until it reaches $150 a course in 2020. He also hinted that Pharco may have other affordable drugs in development that could be paired with ravidasvir to replace sofosbuvir.

4/15/16

Source

Drugs for Neglected Diseases Initiative. Drugs for Neglected Diseases Initiativeand Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments. Press release. April 13, 2016.

 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Canuck


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Canuck wrote:

Where more info may be forthcoming about Ravidasvir:  http://www.croiconference.org/sessions/high-response-rate-hcv-genotype-4-patients-treated-ravidasvir-and-sofosbuvir

While scouring for info, out of Egypt, on this NS5A - I happened to note Egypt's national strategy for combating HCV - their goal is to treat 250,000 to 300,000 people per year! A good start, compared to the paltry numbers I have heard the UK plans to tackle!! 

Forgot to add this (hope this link to the video works):

Data from earlier Egyptian trials of Ravidasvir:   http://www.croiwebcasts.org/console/player/29746?mediaType=slideVideo&



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Canuck


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Where more info may be forthcoming about Ravidasvir:  http://www.croiconference.org/sessions/high-response-rate-hcv-genotype-4-patients-treated-ravidasvir-and-sofosbuvir

While scouring for info, out of Egypt, on this NS5A - I happened to note Egypt's national strategy for combating HCV - their goal is to treat 250,000 to 300,000 people per year! A good start, compared to the paltry numbers I have heard the UK plans to tackle!! 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Canuck


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The Egyptian "Ravidasvir" trial (not recruiting, completed):

A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4

I have not yet found any of the new upcoming trials for Malaysia, etc.



-- Edited by Canuck on Saturday 22nd of October 2016 06:40:42 PM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Tig


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I like the sound of that! These articles really help to educate. When you realize 75% of people infected with HCV are in middle income economies and unable to afford the latest and greatest care or anything at all, you know there's work to be done.

I hope these trials pay off, sounds real promising. You know, somebody at Gilead and Squibb is staying up late working on a sweetheart deal. Piece of the generic pie? Of course! I encourage these "middle income" professionals to continue working on effective and affordable treatments for all forms of liver disease. If brand name manufacturers won't deliver it, then someone is going to fill the vacuum. Access and affordability need attention, big time!



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Canuck


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A relatively "new?" NS5A - (formerly called PP1-668), now named Ravidasvir.

Well, it's news to me anyway. Out of Egypt (where there are many GT4's to trial it on), but reading other articles about it tonight, it IS being touted as pan, coupled with sof, with some impressive results, and more interesting (to many I am sure, or to the consternation of others!) is it's purported LOW COST/affordability!!

From earlier Egyption trial results (with and without riba), I now see announcements about Ravidasvir from earlier in the spring!

If this stuff ends up being a go, I will enjoy referring to it as RAV/SOF for RAV'S hee hee. smile C.

Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments

[The International Liver Congress 2016, Barcelona, Spain, 13 April 2016]

Potentially pan-genotypic combination of ravidasvir and sofosbuvir to be tested in Malaysia and Thailand with target price of under $300

The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under $300.
[Español] [Français] [Português]

'If our clinical trials are successful, this regimen could become part of a public health approach to treating hepatitis C that will be an alternative to today's high drug prices and treatment rationing,' said Dr Bernard Pécoul, Executive Director of DNDi. "An affordable cure for this deadly disease that treats all strains, or genotypes, of the disease, is essential to tackling the worldwide hepatitis C epidemic."

DNDi will be launching clinical trials to test a combination treatment of the drug candidate ravidasvir and the registered hepatitis C drug sofosbuvir in pan-genotypic patient populations in Malaysia and Thailand, as soon as the necessary approvals are received. Ravidasvir is an NS5A inhibitor, one of a new generation of direct-acting antivirals (DAAs) that are revolutionizing the treatment of hepatitis C. In a Phase III clinical trial in Egypt, conducted by Pharco, ravidasvir showed cure rates of up to 100% in patients with genotype 4 when used in combination with sofosbuvir, which also is a DAA.

DNDi has licensed rights for ravidasvir in low- and middle-income countries from Presidio Pharmaceuticals.

Pharco has agreed to supply DNDi with the combination sofosbuvir plus ravidasvir for its clinical studies for $300 per course of treatment. For the scale-up of this regimen, once approved, Pharco has agreed to set the commercial price at $294 or less per treatment course.

"Because of the high prices of new hepatitis C medicines, it has been almost impossible for governments to provide access to treatment at the necessary scale," said YB Datuk Seri Dr. S. Subramaniam, the Minister of Health in Malaysia. "We are pleased to support this project and hope data from these studies will support our efforts to introduce this combination as soon as possible and scale up to reach all patients in need."

DNDi's Phase II/III studies in Malaysia and Thailand will be conducted with the full cooperation of both governments and will compare sofosbuvir plus ravidasvir with a current standard of care, sofosbuvir plus daclatasvir. These studies will enroll approximately 1,000 participants and will evaluate the efficacy, safety, and pharmacokinetics of the sofosbuvir plus ravidasvir combination in patients with various levels of liver fibrosis, various genotypes, and with/without HIV co-infection.

"We are encouraged by the signing of these agreements as they will help millions of people who are affected by chronic hepatitis C infection around the world," said Dr. Amnuay Gajeena, Director General of the Department of Disease Control in Thailand."Accessibility to affordable DAAs is key and participation in this research will facilitate the process of scaling up effective treatment of hepatitis C infection, and foster the prevention and control of the disease."

Malaysia and Thailand are among the many middle-income countries that are excluded from the voluntary licensing agreements that Gilead and Bristol-Myers Squibb, the intellectual property holders of the hepatitis C drugs sofosbuvir and daclatasvir, respectively, have concluded with generic companies. Of the up to 150 million people infected with chronic hepatitis C globally, approximately 75% live in middle-income countries.

"Once these trials have been successfully completed and the safety and efficacy data of this combination assessed, we will encourage governments to design their national health strategies to use all options at their disposal to gain access to life-saving DAAs, including price negotiation, voluntary licensing, or the use of TRIPS flexibilities such as patent oppositions and compulsory licensing," added Dr. Pécoul.

Before DAAs became available, hepatitis C treatment consisted of multiple injections over a period of up to one year and frequently caused severe side effects. Treatment was only successful 40-80% of the time. DAAs have transformed treatment options for patients and clinicians, but multiple barriers to access for patients exist, in particular, price. As with the introduction and scale-up of antiretroviral therapy for HIV/AIDS over the past 15 years, new and innovative public health approaches to HCV treatment will require affordable access to DAAs.

"Egypt has the world's highest hepatitis C prevalence, yet thanks to an Egyptian Presidential program that aims to treat one million patients a year, economies of scale have helped make DAAs affordable and are helping to reach our goal of a world free from hepatitis C," said Dr. Sherine Helmy, CEO of Pharco Pharmaceuticals. "We hope that our collaboration with DNDi to develop a combination treatment that costs $3.50 per day or less - as opposed to $1000 per day for only one pill - will lead to widespread access to safe, effective, and affordable treatment for hepatitis C patients around the world."

 

Note to editors:

  • Today, DNDi released a paper outlining its R&D strategy for hepatitis C, 'An alternative Research and Development Strategy to Deliver Affordable Treatments for Hepatitis C Patients'. DNDi's paper describes how the race to approve blockbuster DAAs in the US and the European Union has led to exorbitant drug prices and also has neglected certain patient populations. Under the current R&D model, research has prioritized genotypes which are predominant in high-income markets, and has promoted competition rather than collaboration for the development of optimal combinations for public health use.
  • Further details of the terms of the non-exclusive license agreement between DNDi and Presidio, including the lists of countries covered, are provided in DNDi's R&D strategy paper (see above).
  • The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) sets forth minimum standards for intellectual property protection. "TRIPS flexibilities" refers to fully legal steps governments can take to overcome intellectual property barriers to access to medicines, including compulsory licensing, parallel importation, etc. and were reaffirmed in the November 2001 Declaration on the TRIPS Agreement and Public Health.

 

Press contacts:

Ilan Moss (on site at the International Liver Congress), DNDi North America: +1 646 266 5216, imoss@dndi.org

Manisha Sharma, DNDi India: +91 9711 009 088, msharma@dndi.org

Violaine Dällenbach, DNDi Europe: +41 22 906 92 47, +41 79 424 14 74, vdallenbach@dndi.org

 

About DNDi:
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary.www.dndi.org

About Pharco:
Pharco Pharmaceuticals, Inc. is the largest manufacturer of pharmaceuticals in Egypt, focused on research, formulation, manufacturing and commercialization of pharmaceutical products in the MENA region. Today, Pharco employs over 8,000 employees, and has over 500M product sales units - ranking as the leader in the Egyptian pharmaceutical market. Pharco also exports to 47 countries around the world. Pharco works towards one goal... provide highly effective and safe pharmaceutical products to patients at an affordable price. Pharco licensed ravidasvir hydrochloride, formerly known as (PPI-668), from Presidio Pharmaceuticals, a San Francisco-based clinical stage, specialty pharmaceutical company. pharco.org



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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