Ombitasvir/paritaprevir/ritonavir

Ombitasvir/paritaprevir/ritonavir, sold under the brand name Technivie among others, is a medication used to treat hepatitis C. It is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir. Specifically it is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4.[5] Cure rates are around 95%.[5] It is taken by mouth.

It is generally well tolerated.[6] Common side effects include nausea, itchiness, rash, and trouble sleeping. Other side effects include allergic reactions and reactivation of hepatitis B among those previously infected. Use is not recommended in those with significant liver problems. While there is no evidence of harm with use during pregnancy, this use has not been well studied. Each of the medications works by a different mechanism.[5]

Society and culture

It is manufactured by Abbvie. In the United States ombitasvir/paritaprevir/ritonavir together with dasabuvir is sold as Viekira Pak.[16] Technivie consists of only ombitasvir/paritaprevir/ritonavir tablets.[17] Technivie was discontinued in the US market in 2020.[18]

Approval

United States

Ombitasvir/paritaprevir/ritonavir together with dasabuvir was approved in its first review cycle by the FDA in December 2014.[19] The Center for Drug Evaluation and Research (CDER) designated the product for Fast Track because it had potential to treat unmet medical need. This track allows the CDER to view certain information ahead of a completed NDA to cut down the time to approval. Additionally, it was designated Breakthrough Therapy for its substantial improvement in the primary endpoint SVR12 and given Priority Review under the Prescription Drug User Fee Act allowing the review to be completed in six months rather than the standard ten months.[20]

European Union

In the European Union, ombitasvir/paritaprevir/ritonavir is approved under the brand name Viekirax for combination therapy together with dasabuvir, with or without ribavirin.[21][22]

United States

European Union

In the European Union, ombitasvir/paritaprevir/ritonavir is approved under the brand name Viekirax for combination therapy together with dasabuvir, with or without ribavirin.[21][22]

Research

Sapphire I

Sapphire I was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1a and GT1b - who were new to HCV treatment - and were given Viekira Pak and ribavirin (RBV). Sapphire I reported a 96% cure rate.[23]

Sapphire II

Sapphire II was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1a and GT1b - who had previously received treatment - and were given Viekira Pak and (RBV). SAPPHIRE II reported a 96% cure rate.[23]

Pearl II

Pearl II was a 12-week open-label, randomized trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who had previously received treatment - and were given either Viekira Pak and (RBV) or Viekira Pak alone. Pearl II reported a 100% cure rate.[23]

Pearl III

Pearl III was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who were new to HCV treatment - and were given Viekira Pak and (RBV) or Viekira Pak and a RBV placebo. Pearl III reported a 100% cure rate[23]

Pearl IV

Pearl IV was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who were new to HCV treatment - and were given Viekira Pak and (RBV) or Viekira Pak and a RBV placebo. The primary difference between Pearl III and PEARL IV was that PEARL IV had a 1:2 allocation ratio meaning twice as many participants were given Viekira Pak and RBV placebo compared to Viekira Pack and RBV. Pearl IV had a 97% cure rate.[23]

Turquoise II

Turquoise II was an open-label, randomized trial which had a primary endpoint of cure (SVR12) rate in patients with compensated cirrhosis and either HCV GT1a or GT1b and both treatment arms were given Viekira Pak and (RBV). The two treatment arms differed by length of treatment: subjects were randomly assigned to receive treatment for either 12 or 24 weeks. The results were stratified based on whether or not subjects had previously received pegIFN/RBV treatment. This is the only phase III trial which has been completed with Viekira Pak and cirrhotic patients with HCV. TURQUOISE II reported a 95% cure rate for the 24-week arm and 99% cure rate for the 12-week arm. Subjects with genotype 1a had higher cure rates in the 24-week arm than the 12-week arm.[23]

verifiedrevid	439439973
type	combo
component1	Ombitasvir
class1	Antiviral (NS5A inhibitor)
component2	Paritaprevir
class2	Antiviral (NS3 inhibitor)
component3	Ritonavir
class3	PK enhancer (CYP3A4, CYP2D6 inhibitor)
tradename	Technivie, Viekirax, others
medlineplus	a615036
dailymedid	Technivie
routes of administration	By mouth
atc prefix	J05
atc suffix	AP53
legal au	S4
legal au comment	‡R1R‡
legal us	Rx-only
legal us comment	‡R2R‡
legal eu	Rx-only
cas number	1799419-19-4
chemspiderid	none
kegg	D10745
chebi	90919

Ombitasvir/paritaprevir/ritonavir

Medical uses

Contraindications

Side effects

Society and culture

Approval

United States

European Union

United States

European Union

Research

Sapphire I

Sapphire II

Pearl II

Pearl III

Pearl IV

Turquoise II

External links

References