Hepatitis C oral drug to hit local market soon!

[Ali.Pakistani]

​

An estimated 10 million hepatitis C patients in the country may hear the good news soon.

A life-saving drug to be administered orally to such patients is expected to be cleared for distribution next week, long after it got the approval of the Drug Regulatory Authority of Pakistan.

The matter has been pending with the Federal Ministry of Health Services Regulations and Coordination for the last three months, which somehow could not take out the time to give a formal nod to the medicine called Sovaldi. Whereas doctors have prescribed the tablet to a few thousand suffering Pakistanis in anticipation of its availability on the local market, one distribution company has been selected for its supply.

The company is going to buy it from the United States. It was initially in competition with many other aspiring distributors, but managed to convince DRAP that it had the right combination of price and quality.

As opposed to the painful process of getting injections over a prolonged period, the patients will be required to take one tablet of Sovaldi daily.
At around Rs 2,000 a tablet it is a very costly medication, but as compared to the interferon injection the oral drug is said to have fewer side effects and greater efficiency. Experts say the tablet has a 95pc success rate and it is already being tried as a remedy for hepatitis C in many countries.

With a slightly more efficient ministry in place the drug could have been made available to patients in Pakistan much earlier than its expected introduction now. If that gives one a cause to sigh and protest at official lethargy, it is something that cannot be undone. Millions in the country will now be hoping that the medicine lives up to its billing as a life-saver. One hopes that this will encourage other drug companies to find and market affordable alternatives — without compromising on quality and efficacy — so that the maximum number of hepatitis C patients can benefit.

Source

 

[kwan225]

Drug Regulatory Authority of Pakistan... what the hell..... [hilar][hilar][hilar].... that was hilarious... [hilar][hilar][hilar]

 

[values]

but there is risk to take this drug and all should consult their doctor before using it.It has harm fetal affects.
take when benefits outweigh risk

 

[values]

IN USA,price for 28 tablets is $30,000.
mean Rs 1 Lac for one tablet

 

[iltaf]

Drug Regulatory Authority of Pakistan... what the hell..... [hilar][hilar][hilar].... that was hilarious... [hilar][hilar][hilar]

Yes bro it is an organization which I visited with a friend recently for NOC regarding Sovaldi drug which is imported by Feroz Sons :)

 

[GujjarPakistani]

USA mein pooray course ki qeemat 84000$ se 168000$ tak hai jab ke UK mein 35000 hai __news reports ke mutabiq Gilead ne is medicine ki generic manufacturers ko certificate dena shuru kar diya hai jin mein India bhi shamil hai _India mein course ki price 300 Dollars hai

 

[Sheikh bilal]

Yes bro it is an organization which I visited with a friend recently for NOC regarding Sovaldi drug which is imported by Feroz Sons :)

How much it cost you, coz I also want to prefer someone

 

[iltaf]

How much it cost you, coz I also want to prefer someone

I will confirm details by tomorrow and will update you here.

 

[Tyrion Lannister]

How much it cost you, coz I also want to prefer someone

55000 per bottle, bottle has 30 tablets, its course is either 3 months or 6 months depending on viral load, its side effects are very minor as compare to injections and its results are 95%, Gov is giving subsidy so its cheap in PAK, patient have to fill a form with all reports and send it to authorities, they import it in 2 months to stop black in market.

 

[chanji]

55000 per bottle, bottle has 30 tablets, its course is either 3 months or 6 months depending on viral load, its side effects are very minor as compare to injections and its results are 95%, Gov is giving subsidy so its cheap in PAK, patient have to fill a form with all reports and send it to authorities, they import it in 2 months to stop black in market.

I am wandering how much subsidy is Govt going to give on this ~$80K drug...... You must be kidding...

Gilead would not sell at significant discount as they already refused in India, I suppose. The only possible way is locally manufacture the generic version but that would be against the patent laws..

 

[Tyrion Lannister]

I am wandering how much subsidy is Govt going to give on this ~$80K drug...... You must be kidding...

Gilead would not sell at significant discount as they already refused in India, I suppose. The only possible way is locally manufacture the generic version but that would be against the patent laws..

Ferozsons got the license for local manufacturing from USA, US is helping developing countries as patients of Hep C are in millions in such countries

 

[iltaf]

How much it cost you, coz I also want to prefer someone

I just confirmed from my friend, usually Feroz Sons deliver a pills bottle (of Rs. 56,000) for ONE month use, then after depositing the same amount they then deliver bottles as per demand. Doctors suggest approx. 6 months course but this drugs shows good results after 2 months and may be discontinued after 2 months.

DRAP (Drug Regulatory Authority of Pakistan) is on 4th floor, TF Complex, G-9, Islamabad.

 

[toothpick]

very informative post; thanks indeed; but it seems quite costly if a patient have to take it for six months; there should be subsidy from government since there are too many poor people who are suffering from HC

 

[toothpick]

Important information

Source: http://www.sovaldi.com/


[h=3]Important Safety Information[/h]What is the most important information I should know about SOVALDI?
SOVALDI combination therapy with ribavirin or peginterferon alfa and ribavirin can cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.

• You and your sexual partner must use 2 effective forms of birth control and should not become pregnant while being treated with SOVALDI combination therapy and for 6 months after your treatment is over. Talk to your doctor about forms of birth control.
• If you or your partner can become pregnant you must have a pregnancy test before starting treatment with SOVALDI combination therapy, every month while being treated, and for 6 months after your treatment ends.
• Tell your healthcare provider right away if a pregnancy occurs while taking or within 6 months after you stop taking SOVALDI combination therapy. You or your healthcare provider should contact the Ribavirin Pregnancy Registry. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available. For contact information, please see full Prescribing Information.

You should not take SOVALDI alone. SOVALDI should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.

What should I tell my healthcare provider before taking SOVALDI?

• If you have: liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; or if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take SOVALDI or breastfeed. You should not do both.
• If you take rifampin (Rifadin, Rifamate, Rifater), St. John’s wort or a product that contains St. John’s wort. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

What are the most common side effects of SOVALDI?
For SOVALDI used in combination with ribavirin they include tiredness and headache and for SOVALDI used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.

 

[airbender]

we will be used as guinea pigs and multinationals can data mine the results and further do the research , the same medicine in usa costs more...... What about the privacy of our PCR results (uploaded to the cloud of multinationals) to see effect of drugs.....

 

[toothpick]

we will be used as guinea pigs and multinationals can data mine the results and further do the research , the same medicine in usa costs more...... What about the privacy of our PCR results (uploaded to the cloud of multinationals) to see effect of drugs.....

The same medicine is already in use in USA; its not that they are testing it in Pakistan;

[h=2]SOVALDI combination therapy cure rates in clinical studies[/h]SOVALDI is a groundbreaking hepatitis C (Hep C) treatment. Clinical studies have shown that SOVALDI combination therapy can be effective for people withgenotypes 1, 2, 3, and 4.

The table below includes the percentages of patients, in SOVALDI clinical studies, who were cured of the Hep C virus. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.
Learn about another treatment for genotype 1.
[TABLE="class: mar-top, width: 610"]
[TR="class: td-F49030"]
[TH="class: one, bgcolor: #F49030, align: center"]GENOTYPE[/TH]
[TH="class: two, bgcolor: #F49030, align: center"]DURATION[/TH]
[TH="class: three, bgcolor: #F49030, align: center"]TREATMENT[/TH]
[TH="class: four, bgcolor: #F49030, align: center"]CURE RATE[/TH]
[/TR]
[TR]
[TD="class: td-empty, colspan: 4, align: center"][/TD]
[/TR]
[TR="class: td-F49030"]
[TD="align: center"]1 OR 4[/TD]
[TD="class: duration, align: center"]12 WEEKS[/TD]
[TD="align: center"]SOVALDI + ribavirin+ peginterferon alfa[/TD]
[TD="class: lastChild, bgcolor: #F49030, align: center"]89% / 96%[/TD]
[/TR]
[TR]
[TD="class: td-empty, colspan: 4, align: center"][/TD]
[/TR]
[TR="class: td-587988"]
[TD="align: center"]2[/TD]
[TD="class: duration, align: center"]12 WEEKS[/TD]
[TD="align: center"]SOVALDI + ribavirin[/TD]
[TD="class: lastChild, bgcolor: #587988, align: center"]93%[/TD]
[/TR]
[TR]
[TD="class: td-empty, colspan: 4, align: center"][/TD]
[/TR]
[TR="class: td-8dc635"]
[TD="align: center"]3[/TD]
[TD="class: duration, align: center"]24 WEEKS[/TD]
[TD="align: center"]SOVALDI + ribavirin[/TD]
[TD="class: lastChild, bgcolor: #8DC635, align: center"]84%[/TD]
[/TR]
[/TABLE]
[h=3]Clinical study details[/h]CURE RATES
Genotype 1 (GT1) and genotype 4 (GT4):
In a clinical study of 327 patients with Hep C genotypes 1, 4, 5, and 6 without prior Hep C treatment taking SOVALDI + ribavirin + peginterferon alfa for a treatment duration of 12 weeks, the cure rate was 90% (295 out of 327 patients studied). The cure rate was 89% (261 out of 292 patients studied) for GT1 and 96% (27 out of 28 patients studied) for GT4.

CURE RATES
Genotype 2 (GT2) and genotype 3 (GT3):
In a clinical study of patients with Hep C genotypes 2 and 3 with and without prior Hep C treatment taking SOVALDI + ribavirin, the cure rate for patients with GT2 was 93% (68 out of 73 patients studied) and the cure rate for patients with GT3 was 84% (210 out of 250 patients studied).
Other Hep C clinical studies in GT2 and GT3 patients with and without prior Hep C treatment:
• For patients with GT2, cure rates ranged from 82% to 95% for a treatment duration of 12 or 16 weeks of SOVALDI + ribavirin. For GT2, the approved treatment duration is 12 weeks of SOVALDI + ribavirin
• For patients with GT3, cure rates ranged from 30% to 62% for a treatment duration of 12 or 16 weeks of SOVALDI + ribavirin. For GT3, the approved treatment duration is 24 weeks of SOVALDI + ribavirin