Pifeltro

Antiretroviral Therapy, Human Immunodeficiency Virus Type 1 (HIV-1), HIV + 5 more
Treatment
2 FDA approvals
20 Active Studies for Pifeltro

What is Pifeltro

DoravirineThe Generic name of this drug
Treatment SummaryDoravirine is a medication used to treat HIV-1 infections in adults who have not taken any antiretroviral medication before. It is available as a single drug or as a combination of doravirine, lamivudine, and tenofovir disoproxil fumarate. Doravirine is intended to be used with other antiretroviral medicines to provide more treatment options for HIV-1 infection.
Delstrigois the brand name
Pifeltro Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Delstrigo
Doravirine
2018
4

Approved as Treatment by the FDA

Doravirine, also called Delstrigo, is approved by the FDA for 2 uses including HIV and Pharmacotherapy .
HIV
Used to treat Human Immunodeficiency Virus Type 1 (HIV-1) Infection in combination with null
Pharmacotherapy
Used to treat responsive to previous drug therapy in combination with null

Effectiveness

How Pifeltro Affects PatientsA clinical trial testing different doses of doravirine (combined with emtricitabine/tenofovir) in HIV-1 infected people without prior antiretroviral treatment did not find a link between the dose taken and its effectiveness. Additionally, taking a dose of 1200 mg (which is 4 times more than the recommended dose) did not cause any significant changes to the QT interval.
How Pifeltro works in the bodyDoravirine works to stop HIV from replicating. It does this by targeting the HIV enzyme reverse transcriptase. Doravirine blocks the enzyme, preventing HIV from turning its RNA into DNA. This stops HIV from reproducing and spreading. Doravirine does not interfere with the body's normal DNA polymerases.

When to interrupt dosage

The dosage of Pifeltro is contingent upon the specified condition, including Antiretroviral Therapy, Human Immunodeficiency Virus Type 1 (HIV-1) and HIV (Human Immunodeficiency Virus). The measure varies, as per the administration approach (e.g. Tablet, film coated or Oral) provided in the table beneath.
Condition
Dosage
Administration
treatment failure
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
virologically-suppressed
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Pharmacotherapy
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Antiretroviral Therapy
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Human Immunodeficiency Virus Type 1 (HIV-1)
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
HIV
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Antiretroviral Treatment-Naïve
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
no doravirine resistance-associated mutations
100.0 mg,
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Warnings

Pifeltro has two contraindications, and so its use should be avoided in cases of the conditions outlined in the following table.Pifeltro Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Doravirine may interact with Pulse Frequency
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Pifeltro.
Common Pifeltro Drug Interactions
Drug Name
Risk Level
Description
Astemizole
Major
The metabolism of Astemizole can be decreased when combined with Doravirine.
Axitinib
Major
The metabolism of Axitinib can be decreased when combined with Doravirine.
Cabazitaxel
Major
The metabolism of Cabazitaxel can be decreased when combined with Doravirine.
Carbamazepine
Major
The metabolism of Carbamazepine can be decreased when combined with Doravirine.
Clonidine
Major
The metabolism of Clonidine can be decreased when combined with Doravirine.
Pifeltro Toxicity & Overdose RiskDoravirine affects people differently based on age, sex, race/ethnicity, kidney function, and liver function. It is not known if doravirine is safe for pregnant women or if it is present in breastmilk, so mothers should not breastfeed when taking doravirine. Doravirine has not been tested for safety in children under 18 years old or in elderly people. People with mild or moderate kidney or liver damage do not need to adjust their dosage, but people with severe kidney or liver damage have not been studied. In animal studies, Doravirine did not cause cancer,
image of a doctor in a lab doing drug, clinical research

Pifeltro Novel Uses: Which Conditions Have a Clinical Trial Featuring Pifeltro?

51 active studies are examining the viability of Pifeltro in providing Pharmacotherapy, HIV (Human Immunodeficiency Virus) and treatment failure remedies.
Condition
Clinical Trials
Trial Phases
HIV
39 Actively Recruiting
Phase 2, Phase 3, Phase 1, Early Phase 1, Not Applicable, Phase 4
Antiretroviral Therapy
0 Actively Recruiting
Human Immunodeficiency Virus Type 1 (HIV-1)
5 Actively Recruiting
Phase 3, Phase 1, Early Phase 1
virologically-suppressed
0 Actively Recruiting
Pharmacotherapy
0 Actively Recruiting
treatment failure
0 Actively Recruiting
Antiretroviral Treatment-Naïve
0 Actively Recruiting
no doravirine resistance-associated mutations
0 Actively Recruiting

Pifeltro Reviews: What are patients saying about Pifeltro?

3.7Patient Review
9/8/2021
Pifeltro for HIV
Since taking Pifeltro, I've developed a yeast rash and my skin has become extremely dry--neither of which were issues before. Additionally, I'm losing hair at an alarming rate. Doctors have noticed this as well. I can't take a break from the medication, so I'm wondering if anyone else has had similar problems?
2.7Patient Review
10/4/2021
Pifeltro for HIV
I was experiencing extensive hair loss, skin problems, and general malaise while taking Pifeltro. Once I stopped the medication, everything returned to normal. Thank goodness!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about pifeltro

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of PIFELTRO?

"The most frequently reported side effects of PIFELTRO are: nausea, dizziness, headache, tiredness, diarrhea, stomach (abdominal) pain, and abnormal dreams."

Answered by AI

How much does PIFELTRO cost?

"A single dose of Pifeltro is around $56

The cost of Pifeltro oral tablet 100 mg is $1,691 for a supply of 30 tablets. Prices may vary depending on the pharmacy you visit. A single dose of Pifeltro is $56. Note that prices listed here are for cash paying customers only and may not be valid with some insurance plans."

Answered by AI

What class is Doravirine?

"Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that reduces the amount of HIV in the blood."

Answered by AI

What is PIFELTRO used for?

"This drug is used with other HIV medications to control the HIV infection by lowering the amount of HIV in the body. This, in turn, allows the immune system to work better, decreasing the likelihood of HIV complications, and improving the quality of life."

Answered by AI

Clinical Trials for Pifeltro

Image of UCSF Zuckerberg San Francisco General Hospital in San Francisco, United States.

MucoCept-CVN for HIV Prevention

18 - 45
Female
San Francisco, CA
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.
Phase 1
Waitlist Available
UCSF Zuckerberg San Francisco General HospitalCraig Cohen, MD, MPHOsel, Inc.
Have you considered Pifeltro clinical trials? We made a collection of clinical trials featuring Pifeltro, we think they might fit your search criteria.Go to Trials
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SGLT2 Inhibitors for Metabolic Diseases

45 - 75
Female
Boston, MA
Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.
Phase 2
Recruiting
Massachusetts General HospitalMarkella V Zanni, MD
Have you considered Pifeltro clinical trials? We made a collection of clinical trials featuring Pifeltro, we think they might fit your search criteria.Go to Trials
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Acceptance and Commitment Therapy for Alcohol Consumption in People with HIV

18+
All Sexes
Syracuse, NY
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and/or other behaviors to escape or avoid unwanted thoughts, feelings, and/or urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH/NIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.
Recruiting
Has No Placebo
Syracuse University
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GS-1720 + GS-4182 for HIV

18+
All Sexes
West Hollywood, CA
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
Phase 2 & 3
Waitlist Available
Mills Clinical Research (+25 Sites)Gilead Study DirectorGilead Sciences
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DOVATO for HIV

18+
All Sexes
Regina, Canada
The goal of this clinical trial is to determine the efficacy of Dolutegravir/Lamivudine (DTG/3TC), or "Dovato", in virally-suppressed (HIV-1 RNA \< 200 copies/mL) individuals receiving opioid agonist therapy such as methadone, buprenorphine, slow-release morphine, after switching from their current suppressive antiretroviral therapy (ART). The main questions this trial seeks to answer are: 1. whether people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) remain virally suppressed after switching to DTG/3TC from their current suppressive ART 48 weeks post-switch; 2. the number and type of adverse events (AEs) and serious adverse events (SAEs) attributable to DTG/3TC as documented per standard process at each study visit, and any discontinuations of DTG/3TC due to AEs and SAEs as determined by the study investigator; 3. the number of dosing changes in OAT attributable to DTG/3TC as determined by the study investigator and documented as per standard progress at each study visit; 4. the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed (HIV-1 RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC; 5. any change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC of serum creatinine and non-fasting lipid parameters; 6. any change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIV Treatment Satisfaction Questionnaire (Status) (HIVTSQs) scores; 7. the number of persons who remain virally suppressed (HIV RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC in conjunction with differing levels of adherence to DTG/3TC, and; 8. the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events) During the course of the study, participants will complete: * A set of questionnaires * Blood draws * A review of adverse events and concomitant medications * ECG scans at screening and 48 weeks * Urine drug screening * Physical exams * Review of alcohol consumption
Phase 4
Waitlist Available
Saskatchewan Health AuthorityViiV Healthcare
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