Sofosbuvir: what is it for and what are the side effects

The Hepatitis C is a disease that generates major impacts, both in public health issues and in the lives of (a) patient. It is among the causes of liver disease, especially if the infected person has HIV on antiretroviral therapy.

Estimates from the Ministries of Health of 2019 indicate that about 1 million people have contracted the Hepatitis C virus. Of these, approximately 675,000 have the virus circulating in their blood.

And many of these people have not been diagnosed. This is because there are not always symptoms or they are very mild and develop slowly.

Treatments for infection are intended to eradicate the virus and, according to the Clinical Protocol and Therapeutic Guidelines for Hepatitis C and Co-infections, drug options may include the use of pills or injections. Among them, Sofosbuvir.


What is Sofosbuvir?

Sofosbuvir is an active ingredient that inhibits the action of the hepatitis C virus. The substance has high antiviral activity against all genotypes of the virus.

Launched in 2013, the drug entered the list offered by SUS in 2015 (in the combination sofosbuvir / daclatasvir), this due to its effectiveness, lower rate of side effects and shorter treatment duration.

It is considered a second-generation Direct Action (DAA) drug – that is, more modern.

More recently, in 2018, preliminary studies indicated that sofosbuvir may be effective against damage from the Zika virus, an infection transmitted by the aedes aegypti mosquito.

As in the fight against Hepatitis C, the drug inhibits viral replication, protecting cells from death caused by infection, as soon as there is a similarity between the disease viruses. However, the drug is not yet used as a treatment.

What is it for?

Sofosbuvir is indicated for the treatment of HCV type 1, 2 or 3 viral infections, including cases of patients with hepatitis C and HIV-1 co-infection. That is, it is important to know that although hepatitis C is a single disease, there are small variations in the virus.

Thus, the active substance is administered in conjunction with other drugs, usually in a single tablet (Sofosbuvir / Velpatasvir, Sofosbuvir / Ledipasvir or Sofosbuvir / Daclatasvir) or associated with riboflavin.

What is hepatitis C?

Hepatitis C

Hepatitis C is an inflammation of the liver, caused by the HCV virus. Transmission occurs mainly through blood transfusion, shared use of piercing materials (needles, cuticle pliers, tattoo machines).

More rarely, it occurs through vertical transmission (from mother to baby, during pregnancy) and through unprotected sex.

Symptoms are not always common and usually mild. The progression of the disease is slow, causing it to take time until some manifestations are noticed. Among them, pain, change in the color of urine, nausea, nausea, fatigue and yellowing of the skin and eyes.

What is the mechanism of action of sofosbuvir?

After ingested, sofosbuvir is absorbed and has a peak plasma concentration between 30 minutes and 2 hours. The substance is metabolized in the liver, inhibiting viral replication.

For this, the substance, after metabolism, forms a pharmacologically active analogue of uridine triphosphate (GS-461203).

This inhibits viral multiplication, until HCV is eliminated from the body.

Did ANVISA approve the generic?

Yea! Sofosbuvir was approved in 2013 in the United States, arriving in Brazil in 2015 under the patent of the pharmaceutical industry Gilead.

But in May 2018, ANVISA published the registration of the generic drug Sofosbuvir, which significantly reduces treatment costs and facilitates population access.

The update of the 2018 Clinical Protocol and Therapeutic Guidelines for Hepatitis C and Co-infections, included the therapeutic guidance of the velpatasvir / sofosbuvir combination, recently approved by ANVISA.

Is Sofosbuvir provided by SUS?

Yes. In October 2018, the Ministry of Health published a note indicating that the combination of sofosbuvir and velpatasvir was incorporated into SUS. The distribution is according to the patient’s clinical status.

What is the price and where to buy?

Currently, there are options with sofosbuvir alone or combined with other substances necessary for treatment. However, according to the package leaflet, the single treatment, that is, not combined with other remedies, is not oriented towards the treatment of any condition.

Therefore, the choice of drug combinations or coterapies should be made based on the clinical status and genotype of the virus.

The drugs can be found in pharmacies and in the Unified Health System (SUS), in addition to the judicial request. To find out how it works, patients can count on the personalized service of advising on high-cost medication quotes. Just access the link to receive a quote from Sofosbuvir.

Sofosbuvir isolated

Among the options of the active substance alone are Sovaldi (average price of R $ 63,500 *) and the generic Sofosbuvir Blanver (average price of R $ 46,200).

Sofosbuvir / Velpatasvir

The combination of velpatasvir and sofosbuvir demonstrates good efficacy in combating hepatitis C. In a single tablet, the person undergoes treatment that, in some cases, can be associated with the use of riboflavin.

The combination of velpatasvir and sofosbuvir is considered to be pangenotypical, that is, suitable for all genotypes, with or without associated cirrhosis .

Among the options is Epclusa , with an average value of R $ 35,106 *.

Sofosbuvir / Ledipasvir

Indicated for the treatment of Chronic Hepatitis C (HCC) genotype 1 in adults, the combination Sofosbuvir and Ledipasvir is marketed under the name Harvoni , with an average price of R $ 67,000 *.

* Prices consulted in October 2019. Prices may change.

What are the side effects?

Sofosbuvir can cause adverse reactions, such as fatigue, headache, nausea, insomnia , skin rashes, changes in appetite, diarrhea , irritability, chills and dermatological reactions (such as itchy skin).

Laboratory changes may also occur, such as:

  • Low concentration of red blood cells (anemia);
  • Low concentration of white blood cells (neutropenia);
  • Low concentration of platelets;
  • Increased rates of bilirubin (related to liver function), creatine kinase (related to muscle damage, including cardiac muscles), lipase (pancreatic enzyme).


All cases of hepatitis C must be evaluated by the medical team, aiming at the best treatment. Pregnant and breastfeeding women are contraindicated to treatment with Sofosbuvir. Children under 18, children and people using other medications must receive specific medical advice.

The treatment of hepatitis C has evolved considerably, showing good results and improvements in the lives of patients.

Sofosbuvir is a drug that has been on the market for a short time, but shows a very significant improvement potential.

Want to know more about treatments and remedies? Keep an eye on the Healthy Minute!

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