Matching articles for "Ritonavir"
Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury),...
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated outpatients.
COVID-19 Update: Bebtelovimab EUA Withdrawn (online only)
The Medical Letter on Drugs and Therapeutics • December 26, 2022; (Issue 1666)
The FDA has withdrawn its Emergency Use
Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
(LY-CoV1404 – Lilly) for treatment of COVID-19.
Bebtelovimab is not...
The FDA has withdrawn its Emergency Use
Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab
(LY-CoV1404 – Lilly) for treatment of COVID-19.
Bebtelovimab is not expected to retain activity
against the Omicron variants BQ.1 and BQ.1.1, which
currently cause the majority of COVID-19 cases in all
regions of the US.
COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
COVID-19 Update: NIH Recommends Against Ivermectin
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled...
On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled trials of ivermectin have produced negative results and because alternative drugs that have been shown to be effective for treatment of COVID-19 are available.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • April 18, 2022; (Issue 1648)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose ≥4 months after a first booster dose in
adults ≥50 years old and in persons aged ≥12 years
(Pfizer) or ≥18 years (Moderna) who have undergone
solid organ transplantation or have a condition that
compromises the immune system to a similar extent.
An EUA for Bebtelovimab for Treatment of COVID-19
The Medical Letter on Drugs and Therapeutics • March 21, 2022; (Issue 1646)
The investigational monoclonal antibody
bebtelovimab (LY-CoV1404 – Lilly) has been granted
an FDA Emergency Use Authorization (EUA) for IV
treatment of mild to moderate COVID-19 in patients
≥12 years...
The investigational monoclonal antibody
bebtelovimab (LY-CoV1404 – Lilly) has been granted
an FDA Emergency Use Authorization (EUA) for IV
treatment of mild to moderate COVID-19 in patients
≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death, and for whom alternative
treatment options are unavailable or inappropriate.
Bebtelovimab is active against the Omicron variant of
SARS-CoV-2; sotrovimab (VIR-7831) is the only other
monoclonal antibody currently available for treatment
of COVID-19 that is active against Omicron.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to moderate
COVID-19 in outpatients ≥12 years old who weigh
≥40 kg and are at high risk for progression to severe
disease, including hospitalization or death; they
also issued an Emergency Use Authorization (EUA)
allowing its use in any other high-risk outpatient who
weighs ≥3.5 kg.
Treatment of COVID-19 in High-Risk Outpatients (online only)
The Medical Letter on Drugs and Therapeutics • January 28, 2022; (Issue 1643)
...
View the Treatment of COVID-19 in High-Risk Outpatients Chart
Paxlovid for Treatment of COVID-19
The Medical Letter on Drugs and Therapeutics • January 24, 2022; (Issue 1642)
On December 22, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the investigational
antiviral drug nirmatrelvir copackaged with the HIV-1
protease inhibitor ritonavir (Paxlovid – Pfizer)...
On December 22, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the investigational
antiviral drug nirmatrelvir copackaged with the HIV-1
protease inhibitor ritonavir (Paxlovid – Pfizer) for
oral treatment of mild to moderate COVID-19 in
outpatients ≥12 years old who weigh at least 40 kg
and are at high risk of progressing to severe disease,
including hospitalization or death. Paxlovid was the
first oral antiviral drug to be authorized in the US for
treatment of COVID-19; Merck's oral antiviral drug
molnupiravir was granted an EUA for treatment of
COVID-19 on December 23, 2021. The
IV antiviral drug remdesivir (Veklury) was approved
by the FDA in 2020 for treatment of COVID-19 in
hospitalized patients.
Twirla - A New Contraceptive Patch
The Medical Letter on Drugs and Therapeutics • February 8, 2021; (Issue 1617)
The FDA has approved Twirla (Agile Therapeutics),
a transdermal contraceptive patch containing the
estrogen ethinyl estradiol and the progestin
levonorgestrel, for use in women with a BMI...
The FDA has approved Twirla (Agile Therapeutics),
a transdermal contraceptive patch containing the
estrogen ethinyl estradiol and the progestin
levonorgestrel, for use in women with a BMI <30 kg/m2.
It is the second contraceptive patch to become
available in the US; Xulane, a patch that delivers
ethinyl estradiol and the progestin norelgestromin,
has been available since 2014.
Some Drugs for COVID-19
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1595)
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in...
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in treating it. Definitive answers are lacking, but some recommendations can be made. For additional information on specific drugs, see our table Some Drugs Being Considered for Treatment of COVID-19.
Table: Treatments Considered for COVID-19 (Archived) (online only)
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1595)
...
View the Table: Treatments Considered for COVID-19
Some Drugs for COVID-19
The Medical Letter on Drugs and Therapeutics • April 6, 2020; (Issue 1919)
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in...
The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in treating it. Definitive answers are lacking, but some recommendations can be made. For additional information on specific drugs, see our table Some Drugs Being Considered for Treatment of COVID-19.
Annovera - A New Contraceptive Vaginal Ring
The Medical Letter on Drugs and Therapeutics • December 16, 2019; (Issue 1587)
Annovera (TherapeuticsMD), a contraceptive vaginal
ring that releases segesterone acetate, a synthetic
progestin, and ethinyl estradiol, was approved by the
FDA in 2018 and is now available. It is the first...
Annovera (TherapeuticsMD), a contraceptive vaginal
ring that releases segesterone acetate, a synthetic
progestin, and ethinyl estradiol, was approved by the
FDA in 2018 and is now available. It is the first product
to contain segesterone and the second vaginal ring
to become available in the US; NuvaRing, which
delivers etonogestrel and ethinyl estradiol, was the
first. Unlike NuvaRing, which requires use of a new
ring each month, the Annovera ring can be used for
an entire year, but it must be removed for one week
each month.
Symfi, Symfi Lo, and Cimduo for HIV (online only)
The Medical Letter on Drugs and Therapeutics • January 14, 2019; (Issue 1563)
The FDA has approved three new once-daily fixed-dose
antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the
non-nucleoside reverse transcriptase inhibitor...
The FDA has approved three new once-daily fixed-dose
antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the
non-nucleoside reverse transcriptase inhibitor (NNRTI)
efavirenz and the nucleoside reverse transcriptase
inhibitors (NRTIs) lamivudine and tenofovir disoproxil
fumarate (TDF) and were approved as complete
antiretroviral regimens. Symfi Lo contains a lower
dose of efavirenz than both Symfi and Atripla, a fixed-dose
combination of efavirenz, TDF, and the NRTI
emtricitabine that was approved in 2006. Cimduo
(Mylan), which contains lamivudine and TDF, was
approved for use in combination with other antiretroviral
drugs. All three new products are marketed as less
expensive alternatives to other available fixed-dose
antiretroviral combinations (see Table 1).
In Brief: Hepatitis B Reactivation with Direct-Acting Antiviral Drugs for Hepatitis C
The Medical Letter on Drugs and Therapeutics • October 24, 2016; (Issue 1506)
The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B...
The FDA recently announced that it will require the labeling of all direct-acting antiviral drugs used for treatment of hepatitis C virus (HCV) infection to include a boxed warning about a risk of hepatitis B virus (HBV) reactivation associated with their use.1
Twenty-four cases of HBV reactivation occurring during treatment with direct-acting antiviral drugs for HCV were identified from the FDA Adverse Event Reporting System and the medical literature.2-5 Before starting direct-acting antiviral treatment for HCV, some of these patients were hepatitis B surface antigen (HbsAG) positive and others showed evidence of resolved HBV infection. HBV reactivation generally occurred within 4-8 weeks of starting treatment. Reactivation of HBV can cause increases in bilirubin and aminotransferase levels, fulminant hepatitis, hepatic failure, and death. Of the 24 patients, two died and one required a liver transplant.
HBV reactivation was not identified before FDA approval of these drugs because the clinical trials used to support their approval excluded patients with HBV co-infection. The mechanism by which HBV reactivation occurs during treatment with direct-acting antiviral drugs for HCV is unknown. Patients should be screened for current or past HBV infection before starting treatment with a direct-acting antiviral and monitored for HBV reactivation during and following treatment with these drugs.
Download complete U.S. English article
Twenty-four cases of HBV reactivation occurring during treatment with direct-acting antiviral drugs for HCV were identified from the FDA Adverse Event Reporting System and the medical literature.2-5 Before starting direct-acting antiviral treatment for HCV, some of these patients were hepatitis B surface antigen (HbsAG) positive and others showed evidence of resolved HBV infection. HBV reactivation generally occurred within 4-8 weeks of starting treatment. Reactivation of HBV can cause increases in bilirubin and aminotransferase levels, fulminant hepatitis, hepatic failure, and death. Of the 24 patients, two died and one required a liver transplant.
HBV reactivation was not identified before FDA approval of these drugs because the clinical trials used to support their approval excluded patients with HBV co-infection. The mechanism by which HBV reactivation occurs during treatment with direct-acting antiviral drugs for HCV is unknown. Patients should be screened for current or past HBV infection before starting treatment with a direct-acting antiviral and monitored for HBV reactivation during and following treatment with these drugs.
- FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. Available at: www.fda.gov. Accessed October 13, 2016.
- JM Collins et al. Hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir. Clin Infect Dis 2015; 61:1304.
- A De Monte et al. Direct-acting antiviral treatment in adults infected with hepatitis C virus: reactivation of hepatitis B virus coinfection as a further challenge. J Clin Virol 2016; 78:27.
- AR Ende et al. Fulminant hepatitis B reactivation leading to liver transplantation in a patient with chronic hepatitis C treated with simeprevir and sofosbuvir: a case report. J Med Case Rep 2015; 9:164.
- C Wang et al. Hepatitis due to reactivation of hepatitis B virus in endemic areas among patients with hepatitis C treated with direct-acting antiviral agents. Clin Gastroenterol Hepatol 2016 July 5 (epub).
Download complete U.S. English article
Sofosbuvir/Velpatasvir (Epclusa) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • August 15, 2016; (Issue 1501)
The FDA has approved Epclusa (Gilead), a fixed-dose
combination of sofosbuvir (Sovaldi) and velpatasvir,
a new direct-acting antiviral agent, for oral treatment
of chronic hepatitis C virus (HCV) infection....
The FDA has approved Epclusa (Gilead), a fixed-dose
combination of sofosbuvir (Sovaldi) and velpatasvir,
a new direct-acting antiviral agent, for oral treatment
of chronic hepatitis C virus (HCV) infection. Epclusa
is the first oral combination to be approved for
treatment of all six major HCV genotypes.
Elbasvir/Grazoprevir (Zepatier) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • February 29, 2016; (Issue 1489)
The FDA has approved Zepatier (Merck), a fixed-dose
combination of two direct-acting antiviral
agents — elbasvir, an NS5A inhibitor, and grazoprevir,
an NS3/4A protease inhibitor — for oral treatment
of...
The FDA has approved Zepatier (Merck), a fixed-dose
combination of two direct-acting antiviral
agents — elbasvir, an NS5A inhibitor, and grazoprevir,
an NS3/4A protease inhibitor — for oral treatment
of chronic hepatitis C virus (HCV) genotype 1 or 4
infection.
Elvitegravir (Vitekta) for HIV
The Medical Letter on Drugs and Therapeutics • January 18, 2016; (Issue 1486)
The FDA has approved elvitegravir (Vitekta – Gilead),
an integrase strand transfer inhibitor (INSTI), for use
with a protease inhibitor (PI) plus ritonavir and other
antiretroviral drugs for treatment of...
The FDA has approved elvitegravir (Vitekta – Gilead),
an integrase strand transfer inhibitor (INSTI), for use
with a protease inhibitor (PI) plus ritonavir and other
antiretroviral drugs for treatment of HIV-1 infection
in treatment-experienced adults. Elvitegravir is also
available in a fixed-dose combination (Stribild) with
the pharmacokinetic enhancer cobicistat and the
nucleoside/nucleotide reverse transcriptase inhibitors
(NRTIs) emtricitabine and tenofovir disoproxil
fumarate (DF). A similar combination (Genvoya) that
includes tenofovir alafenamide instead of tenofovir DF
was recently approved by the FDA and will be reviewed
in a future issue.
Cobicistat (Tybost) and Combinations for HIV
The Medical Letter on Drugs and Therapeutics • November 23, 2015; (Issue 1482)
Cobicistat, a pharmacokinetic enhancer that boosts
levels of some HIV drugs but has no antiretroviral
activity of its own, is now available alone as Tybost
(Gilead) and in fixed-dose combinations with...
Cobicistat, a pharmacokinetic enhancer that boosts
levels of some HIV drugs but has no antiretroviral
activity of its own, is now available alone as Tybost
(Gilead) and in fixed-dose combinations with the
protease inhibitors atazanavir (Evotaz — BMS) and
darunavir (Prezcobix — Janssen) for treatment of
HIV-1 infection. Both atazanavir and darunavir have
traditionally been used in combination with the
CYP3A inhibitor ritonavir (Norvir) to boost their serum
concentrations, but neither is available in a fixed-dose
combination with ritonavir.
In Brief: Technivie for HCV Genotype 4 Infection (online only)
The Medical Letter on Drugs and Therapeutics • November 23, 2015; (Issue 1482)
The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic...
The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1
HCV genotype 4 is uncommon in the US and Canada. It is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.2 Technivie plus ribavirin was the first all-oral treatment approved for treatment of HCV genotype 4. Ledipasvir/sofosbuvir (Harvoni)3 was also recently approved for this indication; it does not require coadministration with ribavirin and can be used in patients with or without cirrhosis. Its use for this and other new indications will be reviewed in a future issue.
FDA approval of Technivie was based on an open-label trial (PEARL-I) in 86 treatment-naive and 49 treatment-experienced non-cirrhotic patients with HCV genotype 4 infection. Treatment-naive patients were randomized to receive Technivie with or without ribavirin for 12 weeks; all treatment-experienced patients received the combination plus ribavirin for 12 weeks. The rate of sustained virologic response 12 weeks after stopping treatment (SVR12), the primary endpoint, was 91% (40/44) in treatment-naive patients not receiving ribavirin and was 100% in both treatment-naive (42/42) and treatment-experienced (49/49) patients receiving the combination plus ribavirin.4
Adverse effects observed with Technivie in the clinical trial included asthenia, fatigue, nausea, insomnia, pruritus, and skin reactions. Like Viekira Pak, Technivie has been associated with serious, sometimes fatal cases of hepatic decompensation and is contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment.5 It is also contraindicated in patients taking ethinyl estradiol (because of a risk of ALT elevation), CYP3A4 inducers such as rifampin, or certain sensitive CYP3A4 substrates such as midazolam or simvastatin.6
Each Technivie tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir, and 50 mg of ritonavir. The recommended dosage is two tablets taken once daily in the morning with a meal for 12 weeks. Ribavirin should be coadministered with Technivie at a daily dose of 1000 mg in patients weighing <75 kg or 1200 mg in those weighing ≥75 kg. Use of Technivie alone may be considered in treatment-naive patients who cannot take or tolerate ribavirin. A 12-week supply of Technivie costs $76,653.7
Download complete U.S. English article
HCV genotype 4 is uncommon in the US and Canada. It is the most prevalent strain of HCV in Central sub-Saharan Africa, North Africa, and the Middle East.2 Technivie plus ribavirin was the first all-oral treatment approved for treatment of HCV genotype 4. Ledipasvir/sofosbuvir (Harvoni)3 was also recently approved for this indication; it does not require coadministration with ribavirin and can be used in patients with or without cirrhosis. Its use for this and other new indications will be reviewed in a future issue.
FDA approval of Technivie was based on an open-label trial (PEARL-I) in 86 treatment-naive and 49 treatment-experienced non-cirrhotic patients with HCV genotype 4 infection. Treatment-naive patients were randomized to receive Technivie with or without ribavirin for 12 weeks; all treatment-experienced patients received the combination plus ribavirin for 12 weeks. The rate of sustained virologic response 12 weeks after stopping treatment (SVR12), the primary endpoint, was 91% (40/44) in treatment-naive patients not receiving ribavirin and was 100% in both treatment-naive (42/42) and treatment-experienced (49/49) patients receiving the combination plus ribavirin.4
Adverse effects observed with Technivie in the clinical trial included asthenia, fatigue, nausea, insomnia, pruritus, and skin reactions. Like Viekira Pak, Technivie has been associated with serious, sometimes fatal cases of hepatic decompensation and is contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment.5 It is also contraindicated in patients taking ethinyl estradiol (because of a risk of ALT elevation), CYP3A4 inducers such as rifampin, or certain sensitive CYP3A4 substrates such as midazolam or simvastatin.6
Each Technivie tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir, and 50 mg of ritonavir. The recommended dosage is two tablets taken once daily in the morning with a meal for 12 weeks. Ribavirin should be coadministered with Technivie at a daily dose of 1000 mg in patients weighing <75 kg or 1200 mg in those weighing ≥75 kg. Use of Technivie alone may be considered in treatment-naive patients who cannot take or tolerate ribavirin. A 12-week supply of Technivie costs $76,653.7
- A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015; 57:15.
- JP Messina et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61:77.
- A combination of ledipasvir plus sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther 2014; 56:11.
- C Hézode et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015; 385:2502.
- In brief: hepatic injury with hepatitis C drugs. Med Lett Drugs Ther 2015; 57:156.
- Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2013; 55:e44.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. November 5, 2015. Reprinted with permission by First Databank, Inc. All rights reserved. ©2015 www.fdbhealth.com/policies/drug-pricing-policy.
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In Brief: Hepatic Injury with Hepatitis C Drugs
The Medical Letter on Drugs and Therapeutics • November 9, 2015; (Issue 1481)
The FDA recently announced labeling changes for the combination antiviral products Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir)1 and Technivie (ombitasvir/paritaprevir/ritonavir)2 warning of a...
The FDA recently announced labeling changes for the combination antiviral products Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir)1 and Technivie (ombitasvir/paritaprevir/ritonavir)2 warning of a risk of serious, potentially fatal liver injury.3 Viekira Pak, approved in December 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection, including patients with compensated cirrhosis, and Technivie, approved in July 2015 for treatment of HCV genotype 4 infection without cirrhosis, have been identified as "possible" or "probable" causes in 26 postmarketing cases of hepatic decompensation, including 10 cases (mostly in patients with preexisting advanced cirrhosis) that resulted in death or liver transplant. Hepatic injury generally occurred within 1-4 weeks of treatment initiation.
All therapies for chronic HCV infection have been associated with cases of hepatic decompensation in patients with advanced fibrosis or cirrhosis, but cause and effect are difficult to determine. Viekira Pak and Technivie are now contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment. Ledipasvir/sofosbuvir (Harvoni), another recently approved treatment for HCV genotype 1 infection,4 is still indicated for treatment of patients with any degree of compensated hepatic impairment (Child-Pugh A/B/C). The efficacy and safety of all three combinations in patients with decompensated cirrhosis have not been established.
Download complete U.S. English article
All therapies for chronic HCV infection have been associated with cases of hepatic decompensation in patients with advanced fibrosis or cirrhosis, but cause and effect are difficult to determine. Viekira Pak and Technivie are now contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment. Ledipasvir/sofosbuvir (Harvoni), another recently approved treatment for HCV genotype 1 infection,4 is still indicated for treatment of patients with any degree of compensated hepatic impairment (Child-Pugh A/B/C). The efficacy and safety of all three combinations in patients with decompensated cirrhosis have not been established.
- A 4-drug combination (Viekira Pak) for hepatitis C. Med Lett Drugs Ther 2015; 57:15.
- In brief: Technivie for HCV genotype 4 infection. Med Lett Drugs Ther 2015; in press.
- FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie. Available at: www.fda.gov. Accessed October 29, 2015.
- A combination of ledipasvir and sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther 2014; 56:111.
Download complete U.S. English article
A 4-Drug Combination (Viekira Pak) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • February 2, 2015; (Issue 1461)
The FDA has approved Viekira Pak (Abbvie), a fixed-dose
combination of two new direct-acting antiviral
agents (ombitasvir, paritaprevir) with the pharmacologic
enhancer ritonavir in one tablet, co-packaged...
The FDA has approved Viekira Pak (Abbvie), a fixed-dose
combination of two new direct-acting antiviral
agents (ombitasvir, paritaprevir) with the pharmacologic
enhancer ritonavir in one tablet, co-packaged with
a third new direct-acting antiviral agent (dasabuvir) in
a second tablet, for oral treatment of chronic hepatitis
C virus (HCV) genotype 1 infection. Genotype 1 is
responsible for 70-80% of HCV infections in the US.
Triumeq: A 3-Drug Combination for HIV
The Medical Letter on Drugs and Therapeutics • January 5, 2015; (Issue 1459)
The FDA has approved Triumeq (Viiv Healthcare),
a fixed-dose combination of the integrase strand
transfer inhibitor (INSTI) dolutegravir and the
nucleoside reverse transcriptase inhibitors (NRTIs)
abacavir...
The FDA has approved Triumeq (Viiv Healthcare),
a fixed-dose combination of the integrase strand
transfer inhibitor (INSTI) dolutegravir and the
nucleoside reverse transcriptase inhibitors (NRTIs)
abacavir and lamivudine, for once-daily treatment of
HIV-1 infection. Dolutegravir (Tivicay) was approved
as a single agent in 2013.
Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • February 1, 2014; (Issue 138)
Antiretroviral therapy is recommended for all HIV-infected
patients, both to reduce the risk of disease
progression and to prevent transmission of the virus to
others. Various guidelines for treatment of HIV...
Antiretroviral therapy is recommended for all HIV-infected
patients, both to reduce the risk of disease
progression and to prevent transmission of the virus to
others. Various guidelines for treatment of HIV infection
are available.
Dolutegravir (Tivicay) for HIV
The Medical Letter on Drugs and Therapeutics • September 30, 2013; (Issue 1426)
The FDA has approved dolutegravir (doll-you-TEG-rah-veer;
Tivicay – Viiv Healthcare), an integrase strand
transfer inhibitor (INSTI), for treatment of HIV-1 infection
in adults and in children ≥12 years...
The FDA has approved dolutegravir (doll-you-TEG-rah-veer;
Tivicay – Viiv Healthcare), an integrase strand
transfer inhibitor (INSTI), for treatment of HIV-1 infection
in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir
and elvitegravir were approved earlier.
Drugs for Tuberculosis
The Medical Letter on Drugs and Therapeutics • April 1, 2012; (Issue 116)
Tuberculosis (TB) is still a common cause of death
worldwide, and the prevalence of drug-resistant TB
poses challenges to its treatment and control.
Guidelines with detailed management recommendations
are...
Tuberculosis (TB) is still a common cause of death
worldwide, and the prevalence of drug-resistant TB
poses challenges to its treatment and control.
Guidelines with detailed management recommendations
are available from the American Thoracic
Society, Centers for Disease Control and Prevention
(CDC) and Infectious Diseases Society of America
(IDSA).
Tesamorelin (Egrifta) for HIV-Associated Lipodystrophy
The Medical Letter on Drugs and Therapeutics • May 2, 2011; (Issue 1363)
The FDA has approved tesamorelin (Egrifta – EMD
Serono), an injectable synthetic analog of growth-hormone-
releasing factor (GRF), for reduction of excess
abdominal fat in patients with lipodystrophy...
The FDA has approved tesamorelin (Egrifta – EMD
Serono), an injectable synthetic analog of growth-hormone-
releasing factor (GRF), for reduction of excess
abdominal fat in patients with lipodystrophy associated
with HIV infection. Growth hormone (somatropin –
Serostim; EMD Serono) has been available for years for
treatment of HIV wasting.
Drugs for Tuberculosis
The Medical Letter on Drugs and Therapeutics • October 1, 2009; (Issue 86)
Even though the incidence continues to decline in the United States, tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses severe challenges to its...
Even though the incidence continues to decline in the United States, tuberculosis (TB) is still a common cause of death worldwide, and the prevalence of drug-resistant TB poses severe challenges to its treatment and control. Guidelines with detailed management recommendations are available from the Centers for Disease Control and Prevention (CDC), American Thoracic Society and Infectious Diseases Society of America (IDSA).
Drugs for Thyroid Disorders
The Medical Letter on Drugs and Therapeutics • August 1, 2009; (Issue 84)
Primary hypothyroidism is usually the result of Hashimoto's thyroiditis, thyroidectomy for hyperthyroidism, goiter or cancer, or radioactive iodine therapy for...
Primary hypothyroidism is usually the result of Hashimoto's thyroiditis, thyroidectomy for hyperthyroidism, goiter or cancer, or radioactive iodine therapy for hyperthyroidism.
Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • February 1, 2009; (Issue 78)
New guidelines for use of antiretroviral agents have been published, with a shift towards earlier and more continuous treatment. HIV infection is treated with combinations of antiretroviral drugs depending on...
New guidelines for use of antiretroviral agents have been published, with a shift towards earlier and more continuous treatment. HIV infection is treated with combinations of antiretroviral drugs depending on the patientÆs HIV RNA levels ("viral load") and CD4 cell count. Increases in viral load while on therapy may indicate development of drug resistance, requiring further testing and a change in treatment regimen. Resistance testing is now recommended when a patient is first seen, regardless of when therapy will be started.
Drug Interactions with Simvastatin
The Medical Letter on Drugs and Therapeutics • October 20, 2008; (Issue 1297)
A recent letter to the editor of the Annals of Internal Medicine documented a single case of myopathy apparently due to an interaction between simvastatin (Zocor, and others) and green tea. Since it became...
A recent letter to the editor of the Annals of Internal Medicine documented a single case of myopathy apparently due to an interaction between simvastatin (Zocor, and others) and green tea. Since it became available generically, simvastatin has surpassed atorvastatin (Lipitor) as the best selling statin. As such, it is probably the most common cause of statin-induced myopathy, which is often a result of drug interactions.
Etravirine (Intelence) for HIV Infection
The Medical Letter on Drugs and Therapeutics • June 16, 2008; (Issue 1288)
Etravirine (Intelence - Tibotec), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), has received fast-track FDA approval for use in combination therapy in treatment-experienced adults who have HIV-1...
Etravirine (Intelence - Tibotec), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), has received fast-track FDA approval for use in combination therapy in treatment-experienced adults who have HIV-1 infection resistant to an NNRTI and other antiretroviral agents.
Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • January 1, 2008; (Issue 65)
The drugs of choice for treatment of some fungal infections are listed in the tables. Some of the indications and dosages recommended here have not been approved by the FDA. Other guidelines are available from...
The drugs of choice for treatment of some fungal infections are listed in the tables. Some of the indications and dosages recommended here have not been approved by the FDA. Other guidelines are available from the Infectious Diseases Society of America (www.idsociety.org).
Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • October 1, 2006; (Issue 50)
The approval of new drugs and continuing concerns about drug toxicity and resistance have prompted new antiretroviral treatment guidelines. Resistance testing is not recommended before starting antiretroviral...
The approval of new drugs and continuing concerns about drug toxicity and resistance have prompted new antiretroviral treatment guidelines. Resistance testing is not recommended before starting antiretroviral therapy. HIV infection is treated with combinations of antiretroviral drugs while monitoring the patient's HIV RNA levels ("viral load") and CD4 cell count. Increases in viral load while on therapy may indicate development of drug resistance requiring further testing and a change in treatment regimen.
Darunavir (Prezista) for HIV Infection
The Medical Letter on Drugs and Therapeutics • September 11, 2006; (Issue 1243)
Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated...
Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated adults. It is coadministered with low-dose ritonavir (Norvir), which increases its bioavailability.
Tipranavir (Aptivus) for HIV
The Medical Letter on Drugs and Therapeutics • October 10, 2005; (Issue 1219)
Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other...
Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.
CYP3A and Drug Interactions
The Medical Letter on Drugs and Therapeutics • July 4, 2005; (Issue 1212)
Serious adverse interactions between drugs continue to be reported. Many of these are due to inhibition or induction of cytochrome P450 (CYP) enzymes, particularly CYP3A4. CYP3A is thought to be involved in the...
Serious adverse interactions between drugs continue to be reported. Many of these are due to inhibition or induction of cytochrome P450 (CYP) enzymes, particularly CYP3A4. CYP3A is thought to be involved in the metabolism of more than 50 percent of currently prescribed drugs.2 CYP3A4, which is more abundantly expressed than CYP3A5, accounts for most CYP3A activity in vivo.
Erlotinib (Tarceva) for Advanced Non-Small Cell Lung Cancer
The Medical Letter on Drugs and Therapeutics • March 28, 2005; (Issue 1205)
Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a...
Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a response rate of only 8.9%, but increased median survival from 4.7 to 6.7 months. Patients who had never smoked and those with EGFR-positive tumors survived longer. Erlotinib is generally well tolerated; diarrhea and rash are the most common adverse effects.
Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • February 1, 2005; (Issue 30)
The drugs of choice for treatment of some fungal infections are listed in the table that begins on page 8. Some of the indications and dosages recommended here have not been approved by the...
The drugs of choice for treatment of some fungal infections are listed in the table that begins on page 8. Some of the indications and dosages recommended here have not been approved by the FDA.
Alprazolam (Xanax, and others) Revisited
The Medical Letter on Drugs and Therapeutics • January 17, 2005; (Issue 1200)
Alprazolam, a short-acting benzodiazepine, is one of the most widely prescribed drugs in the US. It is approved by the FDA for treatment of anxiety and panic disorder. An extended-release formulation, Xanax XR,...
Alprazolam, a short-acting benzodiazepine, is one of the most widely prescribed drugs in the US. It is approved by the FDA for treatment of anxiety and panic disorder. An extended-release formulation, Xanax XR, which can be taken once a day, recently became available for panic disorder.
Drugs for Tuberculosis
The Medical Letter on Drugs and Therapeutics • December 1, 2004; (Issue 28)
Tuberculosis (TB) is still a problem in the United States, even though the incidence continues to decline in most of the country (MMWR Morbid Mortal Wkly Rep 2004; 53:209). Treatment of TB can be divided into...
Tuberculosis (TB) is still a problem in the United States, even though the incidence continues to decline in most of the country (MMWR Morbid Mortal Wkly Rep 2004; 53:209). Treatment of TB can be divided into treatment of latent infection diagnosed by a positive PPD and treatment of active clinical TB. Guidelines with detailed management recommendations are available from the US Centers for Disease Control and Prevention (CDC) (MMWR Morbid Mortal Wkly Rep 2003; 52RR-11:1).
Drugs for Migraine
The Medical Letter on Drugs and Therapeutics • September 1, 2004; (Issue 25)
Drugs for treatment of migraine attacks are listed in the table on page 64. All of the oral drugs are most effective if taken early in an attack when the pain is mild (H Christoph-Diener et al, Neurology 2004;...
Drugs for treatment of migraine attacks are listed in the table on page 64. All of the oral drugs are most effective if taken early in an attack when the pain is mild (H Christoph-Diener et al, Neurology 2004; 63:520). Drugs for prevention of migraine are listed in the table on page 65. Treatment of migraine in the emergency room, which may involve use of intravenous drugs, is not included here.
Telithromycin (Ketek) for Respiratory Infections
The Medical Letter on Drugs and Therapeutics • August 16, 2004; (Issue 1189)
Telithromycin (Ketek - Aventis) has been approved by the FDA for oral treatment of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis in...
Telithromycin (Ketek - Aventis) has been approved by the FDA for oral treatment of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis in patients age 18 and older. The drug is the first in a new class of antibiotics, the ketolides, derived from the macrolide erythromycin. Telithromycin has been marketed in Europe since 2001.
Methamphetamine Abuse
The Medical Letter on Drugs and Therapeutics • August 2, 2004; (Issue 1188)
Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an...
Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).
Alfuzosin (Uroxatral) -- Another Alpha1-blocker for Benign Prostatic Hyperplasia
The Medical Letter on Drugs and Therapeutics • January 5, 2004; (Issue 1173)
Alfuzosin hydrochloride (Uroxatral - Sanofi-Synthelabo) is now available in the US in a new formulation for once-daily treatment of benign prostatic hyperplasia (BPH). The drug has been used in Europe since...
Alfuzosin hydrochloride (Uroxatral - Sanofi-Synthelabo) is now available in the US in a new formulation for once-daily treatment of benign prostatic hyperplasia (BPH). The drug has been used in Europe since 1987. Alpha1-blockers cause relaxation of smooth muscle tone in the bladder neck, prostatic capsule and prostatic urethra, relieving symptoms of urinary obstruction.
Drugs for HIV
The Medical Letter on Drugs and Therapeutics • January 1, 2004; (Issue 17)
New drug approvals as well as continuing concerns about drug toxicity and the development of resistance have prompted new antiretroviral treatment guidelines (Panel on Clinical Practices for Treatment of HIV...
New drug approvals as well as continuing concerns about drug toxicity and the development of resistance have prompted new antiretroviral treatment guidelines (Panel on Clinical Practices for Treatment of HIV Infection, November 10, 2003, www.aidsinfo.nih.gov).
Tadalafil (Cialis) for Erectile Dysfunction
The Medical Letter on Drugs and Therapeutics • December 22, 2003; (Issue 1172)
Tadalafil (Cialis - Lilly Icos) is the third oral drug to be approved by the FDA for treatment of erectile dysfunction. It has a longer duration of action than sildenafil (Viagra) or vardenafil (Levitra -...
Tadalafil (Cialis - Lilly Icos) is the third oral drug to be approved by the FDA for treatment of erectile dysfunction. It has a longer duration of action than sildenafil (Viagra) or vardenafil (Levitra - Medical Letter 2003; 45:77).
Atazanavir (Reyataz) and Emtricitabine (Emtriva) for HIV Infection
The Medical Letter on Drugs and Therapeutics • November 10, 2003; (Issue 1169)
Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine,...
Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.
Vardenafil (Levitra) for Erectile Dysfunction
The Medical Letter on Drugs and Therapeutics • September 29, 2003; (Issue 1166)
Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5...
Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.
Drug Interactions
The Medical Letter on Drugs and Therapeutics • June 8, 2003; (Issue 1158)
Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug...
Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug interactions, such as vasodilation caused by both sildenafil (Viagra) and nitrates, can also have adverse effects.
Eplerenone (Inspra)
The Medical Letter on Drugs and Therapeutics • May 12, 2003; (Issue 1156)
Eplerenone (e pler' en one; Inspra - Pharmacia), an aldosterone receptor antagonist similar to spironolactone (Aldactone, and others), has been approved by the FDA, but not yet marketed, for treatment of...
Eplerenone (e pler' en one; Inspra - Pharmacia), an aldosterone receptor antagonist similar to spironolactone (Aldactone, and others), has been approved by the FDA, but not yet marketed, for treatment of hypertension. It has also been tried for treatment of heart failure.
Eletriptan (Relpax) for Migraine
The Medical Letter on Drugs and Therapeutics • April 28, 2003; (Issue 1155)
Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA...
Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA for this indication. This review describes the pharmacokinetics, adverse effects, drug interactions and recommended dosage of eletriptan. Clinical trials comparing the new drug to placebo and to sumatriptan are presented. A dosage and cost table for all the triptans available in the US is also included. The review concludes with an overall assessment of eletriptan's efficacy and safety.
Drugs for HIV
The Medical Letter on Drugs and Therapeutics • November 26, 2001; (Issue 1119)
Since the last Medical Letter article on this subject, continuing concerns about drug toxicity and development of resistance have prompted new antiretroviral treatment guidelines. The dosage and cost of drugs...
Since the last Medical Letter article on this subject, continuing concerns about drug toxicity and development of resistance have prompted new antiretroviral treatment guidelines. The dosage and cost of drugs for HIV infection are listed in the table in this article.
Lopinavir/Ritonavir: A Protease-inhibitor Combination
The Medical Letter on Drugs and Therapeutics • January 8, 2001; (Issue 1095)
Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more...
Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more than six months old. Lopinavir is a new drug available only in this combination. Ritonavir is often used with other protease inhibitors to raise their plasma concentrations.
Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • January 10, 2000; (Issue 1069)
Highly active anti-retroviral therapy (HAART) combining three or four drugs has become the standard of care for treatment of human immunodeficiency virus (HIV)...
Highly active anti-retroviral therapy (HAART) combining three or four drugs has become the standard of care for treatment of human immunodeficiency virus (HIV) infection
Amprenavir: A New HIV Protease Inhibitor
The Medical Letter on Drugs and Therapeutics • July 16, 1999; (Issue 1057)
Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least...
Amprenavir is the fifth protease inhibitor to become available for treatment of HIV infection. It was approved by the FDA for use with other drugs in the treatment of HIV-infected adults and children at least four years old.
Drug Interactions
The Medical Letter on Drugs and Therapeutics • July 2, 1999; (Issue 1056)
Reports of adverse interactions between drugs continue to accumulate. Recently, the FDA has expanded the recommendations on drug interactions found in the package inserts of new...
Reports of adverse interactions between drugs continue to accumulate. Recently, the FDA has expanded the recommendations on drug interactions found in the package inserts of new drugs.
Three New Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • December 4, 1998; (Issue 1041)
Combination antiretroviral therapy including protease inhibitors has dramatically changed the treatment of HIV infection and the prognosis of those affected (Medical Letter Handbook of Antimicrobial Therapy,...
Combination antiretroviral therapy including protease inhibitors has dramatically changed the treatment of HIV infection and the prognosis of those affected (Medical Letter Handbook of Antimicrobial Therapy, 1998, page 122). Due to limitations and failures with these drugs in many patients, however, three new drugs, none of them protease inhibitors, have rapidly come into wide use in clinical trials or 'expanded access' programs. They are abacavir (Ziagen - Glaxo Wellcome), adefovir (Preveon - Gilead) and efavirenz (Sustiva - DuPont). Efavirenz was recently approved for treatment of adults and children by the FDA. Abacavir has been recommended for approval by an FDA advisory committee.
Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • December 5, 1997; (Issue 1015)
Recent studies have led to changes in the approach to treating human immunodeficiency virus (HIV) infection (CCJ Carpenter et al, JAMA, 277:1962, 1997). None of the drugs currently available to treat...
Recent studies have led to changes in the approach to treating human immunodeficiency virus (HIV) infection (CCJ Carpenter et al, JAMA, 277:1962, 1997). None of the drugs currently available to treat HIV-infected patients has been shown to eradicate the infection, but used in combination they can decrease viral replication, improve immunologic status, delay infectious complications and prolong life. The drug regimens recommended by Medical Letter consultants are listed in the table on page 114. Adult regimens and dosages may not be applicable to children (Guidelines for use of Antiretroviral Agents in Pediatric HIV Infection, HIV/AIDS Treatment Information Services, www.hivatis.org/glarvped.html). Some drugs interactions of anti-HIV drugs are listed on the table that begins on page 115.
Systemic Antifungal Drugs
The Medical Letter on Drugs and Therapeutics • September 12, 1997; (Issue 1009)
The drugs of choice for treatment of deep fungal infections are listed in the table below. Some of the indications and dosages recommended here have not been approved by the...
The drugs of choice for treatment of deep fungal infections are listed in the table below. Some of the indications and dosages recommended here have not been approved by the FDA.
Bupropion (Zyban) for Smoking Cessation
The Medical Letter on Drugs and Therapeutics • August 15, 1997; (Issue 1007)
Bupropion hydrochloride, currently available as an antidepressant (Wellbutrin - Medical Letter, 31:97, 1989; Wellbutrin SR), is now being marketed in a sustainedrelease formulation as Zyban (Glaxo Wellcome)...
Bupropion hydrochloride, currently available as an antidepressant (Wellbutrin - Medical Letter, 31:97, 1989; Wellbutrin SR), is now being marketed in a sustainedrelease formulation as Zyban (Glaxo Wellcome) for use as an aid in smoking cessation.
More New Drugs for HIV and Associated Infections
The Medical Letter on Drugs and Therapeutics • February 14, 1997; (Issue 994)
Four new drugs have become available in the USA for HIV infection or its complications. Nevirapine (Viramune - Roxane), intravenous cidofovir (Vistide - Gilead), and amphotericin B oral suspension (Fungizone...
Four new drugs have become available in the USA for HIV infection or its complications. Nevirapine (Viramune - Roxane), intravenous cidofovir (Vistide - Gilead), and amphotericin B oral suspension (Fungizone Oral Suspension - Bristol-Myers Squibb) have been approved by the US Food and Drug Administration; nelfinavir (Viracept - Agouron) is currently available only through an "Expanded Access Program."
New Drugs for HIV Infection
The Medical Letter on Drugs and Therapeutics • April 12, 1996; (Issue 972)
The US Food and Drug Administration (FDA) has approved the marketing of five new drugs for treatment of HIV Infection. Stavudine (D4T; Zerit - Bristol-Myers Squibb) and lamivudine (3TC; Epivir - Glaxo...
The US Food and Drug Administration (FDA) has approved the marketing of five new drugs for treatment of HIV Infection. Stavudine (D4T; Zerit - Bristol-Myers Squibb) and lamivudine (3TC; Epivir - Glaxo Wellcome) are nucleoside analogs similar to zidovudine (AZT), didanosine (ddl) and zalcitabine (ddC). Saquinavir (Invirase - Roche), ritonavir (Norvir - Abbott) and indinavir (Crixivan - Merck) are protease inhibitors, a new class of anti-HIV drugs.