The FDA Approves Gilead’s HCV Drugs Harvoni and Sovaldi for Adolescents

The FDA Approves Harvoni® and Sovaldi® in Pediatric

Patients 12 Years and Older with Chronic Hepatitis C Infection

First HCV Direct-Acting Antivirals Approved for Adolescents

Gilead Sciences (GILD) announced that the FDA has approved its supplemental application for its HCV drugs HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and its HCV drug SOVALDI® (sofosbuvir 400 mg) tablets for pediatric patients with genotype 2 or 3 chronic HCV infection in combination with ribavirin. The approval this time is for use in adolescents 12 years old and older without cirrhosis or with compensated cirrhosis, or those weighing at least 35kg.

There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth.

Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead said, “For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”

Harvoni for Pediatric Patients

The supplemental new drug application (sNDA) approval was supported by data from an open-label clinical trial (Study 1116), which evaluated 12 weeks of treatment with Harvoni once-daily in genotype 1 treatment-naïve and treatment-experienced HCV-infected adolescents 12 years of age and older without cirrhosis or with compensated cirrhosis.

– The SVR12 rate: 98 percent overall (98/100).

No subject experienced on-treatment virologic failure or relapse.

– Two subjects were lost to follow-up.

Adverse events were consistent with those observed in clinical studies of Harvoni in adults. The most common adverse reactions (≥10 percent, all grades) observed with treatment with Harvoni in HCV-infected pediatric patients were fatigue, headache and asthenia.

Sovaldi for Pediatric Patients

The sNDA approval is supported by data from an open-label clinical trial (Study 1112), which evaluated 12 or 24 weeks of treatment with Sovaldi and weight-based ribavirin in adolescents 12 years of age and older with HCV genotype 2 or 3.

– The SVR12 rate: 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients.

No subject experienced on-treatment virologic failure or relapse.

– One patient was lost to follow up.

To read details about the FDA approval; the Adverse events; the U.S. Patient Support Program; the information about how to enroll; important Safety Information for Harvoni; Contraindications; Warnings; Precautions; Serious interactions especially when Co-administered with Amiodarone: Harvoni and Sovaldi’s interactions and general interactions; Click the following link U.S. FDA Approves New Indications for Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection 

Prohost Observations

The approval will enable adolescents to finally benefit from interferon-free treatment for HCV infection, which is a blessing. Indeed, the approval of Gilead direct-acting antivirals will spare the the adolescents’ the suffering of long-term use progressive excruciating interferon side ef­fects and, more important, Gilead HCV drugs will bring them cures that does not happen with interferon.

Interferon Side Effects 

Interferon treatment for hepatitis C typically lasts 24–48 weeks (6–12 months). Interferons have many long-term side effects partly because of this long treatment time. It gives side effects a chance to develop and get worse. Another reason for the long-term side effects is that interferons are often used with ribavirin to treat hepatitis C. Ribavirin further raises the risk of side effects. The side effects include swelling or other reactions at the injection site; flu-like symptoms such as headache, tiredness, and weakness; chills; Fever; trouble sleeping; nausea; vomiting; diarrhea; irritability; muscle pain; decrease of the white blood cells; loss of appetite; itchy skin;

More serious side effects comprise: Autoimmune disease; hallucinations; suicidal tendencies; conges-tion; worsening symptoms of old infections such as herpes or fungal infections; pain; stroke; blurred vision; weakness; confusion; decreased blood cell count; anemia; bleeding problems and more


GILD was cremated and has become in 2016. It became obviously undervalued since mid- 2016 and continued to decline under pressure exerted by the advocate of selling the stock of a great firm. The stock was under continued pressure as if the negative analysts, traders and investors have transplanted a checkpoint protein on the stock surface. GILD’s 52-week Range is $65.38 – $103.10 and its current price $66.58, which means means that the stock is still trading at the lowest end of the 52-week Range.

We believe that the stock was evidently undervalued at less than $85 when it was evaluated using rational criteria, rather than the misleading repeated claims that a merger, or acquisition are the only savior of the stock from bottoming.

Analysts Are Reiterating a BUY Rating on GILD

Some responsible analysts have suddenly become aware that the time has come (it had come half a year ago by the way) for a fair evaluation of the stock price. As a matter of fact, we read that GILD has been the subject of a number of recent positive research reports.

Jefferies analyst Brian Abrahams reiterated a BUY rating on GILD, with a price target of $82, representing an upside of 23% from where the stock is currently trading.

Before Jefferies analysts, Credit Suisse analyst Alethia Young has maintained a Buy rating on GILD and with a target price of $79.

Currently, of the analysts known to cover GILD, 66% are rating the stock a BUY, while 33% recommend to Hold the stock. The 12-month average price target assigned to the stock is $82.57, which represents a potential upside of 24% from where the stock is currently trading.

Prohost Target for GILD price remains unchanged. (See Prohost Portfolio in the Prohost Letters). Our Target might look much higher than other analysts’ targets, but we base our assessment on what we know about Gilead’s capabilities from our past experiences and apply what we observed on the firm’s potential future accomplishments and decisions. We estimate this year’s revenues to be a little less than $27 Billion, which will increase to over $30 Billion in 2018. Our estimation will increase regarding the revenues, income and EPS.

We also believe that Gilead has become determined to acquire a biotech company that has approved products, which can rapidly boost the firm’s revenues. Gilead has an enormous amount of cash that needs to be invested in the best rewarding way and the best rewarding way is to invest it on itself. This possibility can be accomplished through acquiring a firm with solid fundamentals, including approved products and a pipeline with promising oncology products.

Could this firm be Incyte?

Incyte is a good possibility as it has drugs that Gilead would love to own, to market and to grow their sales. Gilead will also love to have cancer immunotherapy drugs that demonstrated superior efficacy. These products exist in Incyte’s pipeline. We personally believe that Incyte is a perfect match for Gilead, however, nobody knows whose firms Gilead has in mind. It seems that the firm has discussed the merger with several companies.

We do not want to get involved in a speculation game, especially when it is about acquisitions. All we know now is that the HCV approval for adolescents is great news for Gilead and for the HCV infected children.

Tomorrow, we will post the second article about non-stop improvement and non-stop discoveries in cancer immunotherapy. This article will tackle CAR-T Cell Treatments. We will also post and comment on the news that came from a small firm, which we believe it might have solved important complications caused by the CAR-T approach.   

Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.

Leave a Reply