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Drug Trials Snapshots: DAKLINZA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the DAKLINZA Prescribing Informationfor complete information.

DAKLINZA (daclatasvir)
(dak lin za)
Bristol-Myers-Squibb
Approval date: July 24, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

DAKLINZA is a drug for the treatment of a specific type of Hepatitis C, called chronic Hepatitis C genotype 3 infection. It is to be used in combination with another drug called sofosbuvir.

Hepatitis C is a virus that causes inflammation of the liver that can lead to decreased liver function or liver failure. Approximately 10% of Hepatitis C infections in the United States result from genotype 3 infection.

How is this drug used?

DAKLINZA is a tablet that is taken once a day together with sofosbuvir.

What are the benefits of this drug?

DAKLINZA in combination with sofosbuvir may show that the hepatitis C virus is no longer detected in the blood at least 12 weeks after finishing treatment (called a sustained virologic response), suggesting HCV infection has been cured.

What are the benefits of this drug?

The table below summarizes the percentage of subjects who achieved the primary efficacy endpoint for treatment-naïve and treatment-experienced (previously-treated) patients. The primary endpoint was Sustained Virologic Response (SVR) at post-treatment week 12 and was defined as HCV RNA below the lower limit of quantification of 25 IU per mL.

Table 2. Summary of Efficacy Results

Treatment Outcomes Treatment-
Naive
N=101
Treatment-
Experienced
N=51
Total
N=152

SVR*

All
No cirrhosis a
With cirrhosis

 

90% (91/101)
98% (80/82)
58% (11/19)

 

86% (44/51)
92% (35/38)
69% (9/13)

 

89% (135/152)
96% (115/120)
63% (20/32)

Outcomes for subjects without SVR

On-treatment virologic failureb
Relapse c

 

1% (1/101)
9% (9/100)

 

0
14% (7/51)

 

0.7% (1/152)
11% (16/151)

*SVR =Sustained Virologic Response
a Includes 11 subjects with missing or inconclusive cirrhosis status.
b One subject had quantifiable HCV RNA at end of treatment.
c Relapse rates are calculated with a denominator of subjects with HCV RNA not detected at the end of treatment.
Source: DAKLINZA Prescribing Information Section 14, Table 8

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: DAKLINZA worked similarly in men and women.
  • Race: Most of the patients in the trial were white. Differences in response to DAKLINZA among races could not be determined.
  • Age: Most of the patients in the trial were less than 65 years of age. DAKLINZA worked similarly in patients younger than 65 years and patients 65 years and older.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The table below summarizes the primary endpoint by subgroup.

Table 3. Subgroup Analysis of Primary Endpoint

Subgroup Total
(N=152)
n/N, (%)
Overall Response/All patients 135/152  ( 89)
Sex 
  Male 77/90      ( 86)
  Female 58/62      ( 94)
Age Group 
17 - 64 years 128/142  ( 90)
>=65 years 7/10        ( 70)
Race 
  White 120/137  ( 88)
  Black or African American 6/6         (100)
  Asian 7/7         (100)
  American Indian or Alaska Native 2/2         (100)

Source: Company Trial Data

What are the possible side effects?

The most common side effects are headache and tiredness.

What are the possible side effects?

The table below summarizes adverse reactions from the trial.

Table 4. Adverse Reactions Reported at ≥5% Frequency

Adverse reaction DAKLINZA
(N= 152 )
n (%)
Headache 21 (14%)
Fatigue 21 (14%)
Nausea 12 (8%)
Diarrhea 7 (5%)

Source: DAKLINZA Prescribing Information Section 6, Table 2

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: The risk of overall side effects appeared to be similar in men and women.
  • Race: Most of the patients in the trial were white. Differences in side effects among races could not be determined.
  • Age: Most of the patients in the trial were younger than 65 years. The risk of overall side effects appeared to be similar in patients younger than 65 years and patients 65 years and older.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The tables below summarize adverse events, including headache and fatigue, by subgroup.

Table 5. Subgroup Analysis of Any Adverse Event

Subgroup Total
(N=152)
n/N, (%)

Any On-treatment AEs

107/152  ( 70)
Sex

Male

62/90      ( 69)

Female

45/62      ( 73)
Age Group

17 - 64 years

100/142  ( 70)

>=65 years

7/10         ( 70)
Race

White

98/137  ( 72)

Black or African American

3/6         ( 50)

Asian

4/7         ( 57)

American Indian or Alaska Native

2/2         (100)

Source: Company Trial Data

Table 6. Subgroup Analysis of Adverse Event-Headache

Subgroup Total
(N=152)
n/N, (%)

Any On-treatment Headache

30/152  ( 20)
Sex

Male

17/90    ( 19)

Female

13/62    ( 21)
Age Group

17 - 64 years

29/142   ( 20)

>=65 years

1/10       ( 10)
Race

White

25/137  ( 18)

Black or African American

2/6         ( 33)

Asian

1/7         ( 14)

American Indian or Alaska Native

2/2        (100)

Source: Company Trial Data

Table 7. Subgroup Analysis of Adverse Event-Fatigue

Subgroup Total
(N=152)
n/N, (%)
Any On-treatment Fatigue 107/152  ( 70)
Sex 
Male 62/90      ( 69)
Female 45/62      ( 73)
Age Group 
17 - 64 years 100/142  ( 70)
>=65 years 7/10         ( 70)
Race 
White 98/137  ( 72)
Black or African American 3/6         ( 50)
Asian 4/7         ( 57)
American Indian or Alaska Native 2/2         (100)

Source: Company Trial Data

 

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved DAKLINZA primarily based on evidence from a clinical trial of 152 patients with hepatitis C genotype 3 infection. In this trial, some patients were previously treated for hepatitis C and some were never treated before. Some patients had cirrhosis and some did not. The trial was conducted in the United States and Puerto Rico.

This Snapshot focuses on the demographics of this trial. Additional data from other clinical trials were considered by FDA to approve DAKLINZA that are not included in this Snapshot.

The figure below summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Figure 1. Baseline Demographics by Sex

Source: Company Trial Data

The figure and table below summarize the percentage of patients by race enrolled in the clinical trial.

Figure 2. Baseline Demographics by Race

Figure 2. Baseline Demographics by Race enrolled in the DAKLINZA clinical trial

Source: Company Trial Data

Table 1. Demographics of Efficacy Trials by Race

Race Number of Patients  Percentage of Patients
  White 137 90%
  Black or African American 6        4%
  Asian 7        5%
  American Indian or Alaska Native 2        1%

Source: Company Trial Data

The figure below summarizes how many patients by age participated in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the DAKLINZA clinical trial.  In total, 142 were between 17 and 64 years (93%) and 10 were 65 years and older (7%).

Source: Company Trial Data
 

Who participated in the trial?

The table below summarizes baseline demographics.

Table 8. Baseline Demographics for the Trial

Demographic Parameters Total
(N=152)
n (%)
Sex 
Male 90     (59)
Female 62     (41)
Age 
Mean years (SD) 52.3  (9.94)
Median (years) 55
Min, Max (years) 24, 73
Age Group 
17 - 64 years 142  ( 93)
>=65 years 10 (7)
Race 
White 137 ( 90)
Black or African American 6 (4)
Asian 7 (5)
American Indian or Alaska Native 2 (1)
Ethnicity 
Hispanic or Latino 25 (16)
Not Hispanic or Latino 127 (84)
Region 
United States 146 ( 96)
Puerto Rico 6 (3)

 Source: Company Trial Data

How were the trials designed?

How were the trials designed?

The efficacy and safety of DAKLINZA in combination with sofosbuvir were evaluated in an open-label trial that included 152 subjects with chronic HCV genotype 3 infection and compensated liver disease. Both treatment-naïve and previously-treated patients were included.

Patients received DAKLINZA plus sofosbuvir once daily for 12 weeks and were monitored for 24 weeks post treatment.

The primary endpoint was Sustained Virologic Response (SVR) at post-treatment week 12 and was defined as HCV RNA below the lower limit of quantification of 25 IU per mL.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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